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Two-drug combo should be first-line standard of care in advanced endometrial cancer
The combination proved to be noninferior to paclitaxel-doxorubicin-cisplatin (TAP) in terms of response, progression-free survival, and overall survival, and with lower toxicity.
Overall survival was a median of 37 months for TC and 41 months for TAP, and there were more adverse events of grade 3 or higher with TAP.
The data were initially presented at the 2012 annual meeting of the Society of Gynecologic Oncology. In the original presentation, lead author David Scott Miller, MD, said this combination should be the standard of care in this setting. Dr. Miller is professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas.
“This subsequent long-term follow-up publication confirmed that,” he said in an interview. “TAP is now rarely used.”
The results have now been published in the Journal of Clinical Oncology.
The Gynecologic Oncology Group 177 trial established TAP about a decade earlier as the standard for systemic treatment of stage III-IV and recurrent endometrial cancer. However, the regimen was associated with substantially more toxicity than doxorubicin-cisplatin.
Phase 2 trials of TC suggested that the combination was active in endometrial cancer, the authors noted. They hypothesized that doxorubicin could be omitted from the regimen and that carboplatin could be substituted for cisplatin.
Equivalent survival, lower toxicity
In the current trial, Dr. Miller and colleagues sought to determine whether TC was therapeutically equivalent or noninferior to TAP with regard to survival outcomes. Secondary endpoints involved the toxicity profile of TC, compared with TAP. The two regimens were also compared with respect to patient-reported neurotoxicity and health-related quality of life (HRQoL).
From 2003 to 2009, 1,381 women with stage III, stage IV, and recurrent endometrial cancers were enrolled in the phase 3 GOG0209 trial. Patients were treated with doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m2 (day 2) with granulocyte colony–stimulating factor or paclitaxel 175 mg/m2 and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles.
After treatment was completed, patients were followed quarterly for 2 years, semiannually for 3 years, and then annually until death. Most of the patients (61%) had measurable or recurrent disease at baseline.
In this updated analysis, with a median follow-up of 124 months, about two-thirds (>65%) of the patients had died; 28% remain alive without evidence of cancer. The adjusted ratio of death hazard of TC versus TAP was 1.002; for progression, the HR of TC to TAP was 1.032.
Median progression-free survival for TAP versus TC was 14 months versus 13 months, and for overall survival, 41 months versus 37 months.
As for adverse events, neutropenic fever was reported in 7% of patients who received TAP and in 6% of those who received TC. The rate of sensory neuropathy was greater among patients who received TAP (26% vs. 20%; P = .40), as was the rate of thrombocytopenia of grade ≥3 (23% vs. 12%), vomiting (7% vs. 4%), diarrhea (6% vs. 2%), and metabolic toxicities (14% vs. 8%). The rate of neutropenia was greater with TC (52% vs. 80%).
Data on HRQoL were collected from the first 538 patients enrolled before March 26, 2007. HRQoL was assessed at baseline and then at 6 weeks, 15 weeks, and 26 weeks. At 6 weeks, the TC group had higher scores on physical well-being and functional well-being (2.1-point difference; 0.3 to approximately 3.9 points; P = .009; effect size, 0.19). There were no statistically significant differences between groups at 15 and 26 weeks.
On the Functional Assessment of Cancer Therapy/GOG-Neurotoxicity four-item measure of sensory neuropathy (FACT/GOG-Ntx) subscale, scores were higher (indicating fewer neurotoxic symptoms) for patients in the TC group by 1.4 points (0.4 to approximately 2.5 points; P = .003; effect size, 0.64) at 26 weeks. There were no statistically significant differences between the groups at 6 and 15 weeks.
Dr. Miller noted that TC became the “backbone or control arm for most subsequent trials,” such as those evaluating immunotherapy and other agents in this setting.
The study was supported by National Cancer Institute grants to the GOG Administrative Office, the GOG Statistical Office, NRG Oncology (1 U10 CA180822), NRG Operations, and the National Cancer Institute Community Oncology Research Program. Dr. Miller has had a consulting or advisory role with Genentech, Tesaro, Eisai, AstraZeneca, Guardant Health, Janssen Oncology, Alexion Pharmaceuticals, Karyopharm Therapeutics, Incyte, Guardant Health, Janssen, Alexion Pharmaceuticals, Clovis Oncology, and Merck Sharp & Dohme; has been on the speakers’ bureaus for Clovis Oncology and Genentech; and has received institutional research funding from US Biotest, Advenchen Laboratories, Millennium, Tesaro, Xenetic Biosciences, Advaxis, Janssen, Aeterna Zentaris, TRACON Pharma, Pfizer, Immunogen, Mateon Therapeutics, and Merck Sharp & Dohme.
A version of this article originally appeared on Medscape.com.
The combination proved to be noninferior to paclitaxel-doxorubicin-cisplatin (TAP) in terms of response, progression-free survival, and overall survival, and with lower toxicity.
Overall survival was a median of 37 months for TC and 41 months for TAP, and there were more adverse events of grade 3 or higher with TAP.
The data were initially presented at the 2012 annual meeting of the Society of Gynecologic Oncology. In the original presentation, lead author David Scott Miller, MD, said this combination should be the standard of care in this setting. Dr. Miller is professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas.
“This subsequent long-term follow-up publication confirmed that,” he said in an interview. “TAP is now rarely used.”
The results have now been published in the Journal of Clinical Oncology.
The Gynecologic Oncology Group 177 trial established TAP about a decade earlier as the standard for systemic treatment of stage III-IV and recurrent endometrial cancer. However, the regimen was associated with substantially more toxicity than doxorubicin-cisplatin.
Phase 2 trials of TC suggested that the combination was active in endometrial cancer, the authors noted. They hypothesized that doxorubicin could be omitted from the regimen and that carboplatin could be substituted for cisplatin.
Equivalent survival, lower toxicity
In the current trial, Dr. Miller and colleagues sought to determine whether TC was therapeutically equivalent or noninferior to TAP with regard to survival outcomes. Secondary endpoints involved the toxicity profile of TC, compared with TAP. The two regimens were also compared with respect to patient-reported neurotoxicity and health-related quality of life (HRQoL).
From 2003 to 2009, 1,381 women with stage III, stage IV, and recurrent endometrial cancers were enrolled in the phase 3 GOG0209 trial. Patients were treated with doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m2 (day 2) with granulocyte colony–stimulating factor or paclitaxel 175 mg/m2 and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles.
After treatment was completed, patients were followed quarterly for 2 years, semiannually for 3 years, and then annually until death. Most of the patients (61%) had measurable or recurrent disease at baseline.
In this updated analysis, with a median follow-up of 124 months, about two-thirds (>65%) of the patients had died; 28% remain alive without evidence of cancer. The adjusted ratio of death hazard of TC versus TAP was 1.002; for progression, the HR of TC to TAP was 1.032.
Median progression-free survival for TAP versus TC was 14 months versus 13 months, and for overall survival, 41 months versus 37 months.
As for adverse events, neutropenic fever was reported in 7% of patients who received TAP and in 6% of those who received TC. The rate of sensory neuropathy was greater among patients who received TAP (26% vs. 20%; P = .40), as was the rate of thrombocytopenia of grade ≥3 (23% vs. 12%), vomiting (7% vs. 4%), diarrhea (6% vs. 2%), and metabolic toxicities (14% vs. 8%). The rate of neutropenia was greater with TC (52% vs. 80%).
Data on HRQoL were collected from the first 538 patients enrolled before March 26, 2007. HRQoL was assessed at baseline and then at 6 weeks, 15 weeks, and 26 weeks. At 6 weeks, the TC group had higher scores on physical well-being and functional well-being (2.1-point difference; 0.3 to approximately 3.9 points; P = .009; effect size, 0.19). There were no statistically significant differences between groups at 15 and 26 weeks.
On the Functional Assessment of Cancer Therapy/GOG-Neurotoxicity four-item measure of sensory neuropathy (FACT/GOG-Ntx) subscale, scores were higher (indicating fewer neurotoxic symptoms) for patients in the TC group by 1.4 points (0.4 to approximately 2.5 points; P = .003; effect size, 0.64) at 26 weeks. There were no statistically significant differences between the groups at 6 and 15 weeks.
Dr. Miller noted that TC became the “backbone or control arm for most subsequent trials,” such as those evaluating immunotherapy and other agents in this setting.
The study was supported by National Cancer Institute grants to the GOG Administrative Office, the GOG Statistical Office, NRG Oncology (1 U10 CA180822), NRG Operations, and the National Cancer Institute Community Oncology Research Program. Dr. Miller has had a consulting or advisory role with Genentech, Tesaro, Eisai, AstraZeneca, Guardant Health, Janssen Oncology, Alexion Pharmaceuticals, Karyopharm Therapeutics, Incyte, Guardant Health, Janssen, Alexion Pharmaceuticals, Clovis Oncology, and Merck Sharp & Dohme; has been on the speakers’ bureaus for Clovis Oncology and Genentech; and has received institutional research funding from US Biotest, Advenchen Laboratories, Millennium, Tesaro, Xenetic Biosciences, Advaxis, Janssen, Aeterna Zentaris, TRACON Pharma, Pfizer, Immunogen, Mateon Therapeutics, and Merck Sharp & Dohme.
A version of this article originally appeared on Medscape.com.
The combination proved to be noninferior to paclitaxel-doxorubicin-cisplatin (TAP) in terms of response, progression-free survival, and overall survival, and with lower toxicity.
Overall survival was a median of 37 months for TC and 41 months for TAP, and there were more adverse events of grade 3 or higher with TAP.
The data were initially presented at the 2012 annual meeting of the Society of Gynecologic Oncology. In the original presentation, lead author David Scott Miller, MD, said this combination should be the standard of care in this setting. Dr. Miller is professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center, Dallas.
“This subsequent long-term follow-up publication confirmed that,” he said in an interview. “TAP is now rarely used.”
The results have now been published in the Journal of Clinical Oncology.
The Gynecologic Oncology Group 177 trial established TAP about a decade earlier as the standard for systemic treatment of stage III-IV and recurrent endometrial cancer. However, the regimen was associated with substantially more toxicity than doxorubicin-cisplatin.
Phase 2 trials of TC suggested that the combination was active in endometrial cancer, the authors noted. They hypothesized that doxorubicin could be omitted from the regimen and that carboplatin could be substituted for cisplatin.
Equivalent survival, lower toxicity
In the current trial, Dr. Miller and colleagues sought to determine whether TC was therapeutically equivalent or noninferior to TAP with regard to survival outcomes. Secondary endpoints involved the toxicity profile of TC, compared with TAP. The two regimens were also compared with respect to patient-reported neurotoxicity and health-related quality of life (HRQoL).
From 2003 to 2009, 1,381 women with stage III, stage IV, and recurrent endometrial cancers were enrolled in the phase 3 GOG0209 trial. Patients were treated with doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m2 (day 2) with granulocyte colony–stimulating factor or paclitaxel 175 mg/m2 and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles.
After treatment was completed, patients were followed quarterly for 2 years, semiannually for 3 years, and then annually until death. Most of the patients (61%) had measurable or recurrent disease at baseline.
In this updated analysis, with a median follow-up of 124 months, about two-thirds (>65%) of the patients had died; 28% remain alive without evidence of cancer. The adjusted ratio of death hazard of TC versus TAP was 1.002; for progression, the HR of TC to TAP was 1.032.
Median progression-free survival for TAP versus TC was 14 months versus 13 months, and for overall survival, 41 months versus 37 months.
As for adverse events, neutropenic fever was reported in 7% of patients who received TAP and in 6% of those who received TC. The rate of sensory neuropathy was greater among patients who received TAP (26% vs. 20%; P = .40), as was the rate of thrombocytopenia of grade ≥3 (23% vs. 12%), vomiting (7% vs. 4%), diarrhea (6% vs. 2%), and metabolic toxicities (14% vs. 8%). The rate of neutropenia was greater with TC (52% vs. 80%).
Data on HRQoL were collected from the first 538 patients enrolled before March 26, 2007. HRQoL was assessed at baseline and then at 6 weeks, 15 weeks, and 26 weeks. At 6 weeks, the TC group had higher scores on physical well-being and functional well-being (2.1-point difference; 0.3 to approximately 3.9 points; P = .009; effect size, 0.19). There were no statistically significant differences between groups at 15 and 26 weeks.
On the Functional Assessment of Cancer Therapy/GOG-Neurotoxicity four-item measure of sensory neuropathy (FACT/GOG-Ntx) subscale, scores were higher (indicating fewer neurotoxic symptoms) for patients in the TC group by 1.4 points (0.4 to approximately 2.5 points; P = .003; effect size, 0.64) at 26 weeks. There were no statistically significant differences between the groups at 6 and 15 weeks.
Dr. Miller noted that TC became the “backbone or control arm for most subsequent trials,” such as those evaluating immunotherapy and other agents in this setting.
The study was supported by National Cancer Institute grants to the GOG Administrative Office, the GOG Statistical Office, NRG Oncology (1 U10 CA180822), NRG Operations, and the National Cancer Institute Community Oncology Research Program. Dr. Miller has had a consulting or advisory role with Genentech, Tesaro, Eisai, AstraZeneca, Guardant Health, Janssen Oncology, Alexion Pharmaceuticals, Karyopharm Therapeutics, Incyte, Guardant Health, Janssen, Alexion Pharmaceuticals, Clovis Oncology, and Merck Sharp & Dohme; has been on the speakers’ bureaus for Clovis Oncology and Genentech; and has received institutional research funding from US Biotest, Advenchen Laboratories, Millennium, Tesaro, Xenetic Biosciences, Advaxis, Janssen, Aeterna Zentaris, TRACON Pharma, Pfizer, Immunogen, Mateon Therapeutics, and Merck Sharp & Dohme.
A version of this article originally appeared on Medscape.com.
Rare event: Iatrogenic injury during cervical cancer screening
Cervical cancer screening is a routine procedure, but in rare instances, there can be medical complications. A new study finds that, compared with women who have normal results, women who are diagnosed with an invasive malignancy have an increased risk for iatrogenic injuries.
Researchers in Sweden analyzed data on more than 3 million women who had undergone cervical cancer screening. The team found that 42 iatrogenic injuries that required at least 2 days of hospitalization occurred during the diagnostic work-up of women who had an abnormal screening test.
“Although cervical cancer screening is one of the most successful cancer prevention programs ... our research indicates that women with invasive cervical cancer experienced medical complications and psychological stress during their diagnostic work-up, although at a very low level,” commented corresponding author Qing Shen, PhD, from the department of medical epidemiology and biostatistics at the Karolinska Institute in Stockholm, Sweden.
The study was published in Cancer Epidemiology, Biomarkers & Prevention.
“Injuries can occur with diagnostic evaluation for cervical cancer,” commented Kecia Gaither, MD, MPH, FACOG, director of perinatal services at Lincoln Medical and Mental Health Center, New York City Health and Hospitals System, who was not involved in the study.
“Given the fact that neovascularization occurs with cancers, a large biopsy in such a circumstance could lead to a hematoma or excessive blood loss. It rarely occurs but most certainly is possible,” said Dr. Gaither.
Also weighing in with comments, Cathy Popadiuk, MD, FRCS, an associate professor of medicine in the department of obstetrics and gynecology at Memorial University of Newfoundland, St. John’s, said the findings are reflective of the real-world and North American experience.
“There are indeed rare bad things that can happen during diagnostic work-up of abnormal pap smears, and usually this is with associated other disease, such as actual cancer or fibroids that can also bleed and may be in the cervix, etc.,” she told this news organization. “And definitely, when there is undetected cancer, this can bleed, requiring transfusion and hospital admission.”
Dr. Popadiuk pointed out that Sweden may be more liberal in admitting patients to hospital, whereas in North America, “we are trying to move away from inpatient care.” She added, “When you are getting these relatively minor procedures, you don’t expect something bad to happen in the clinic.”
Women may become anxious, and admission is the easiest way to arrange for care such as transfusions or observation for more bleeding, she noted. In addition, vaginal packing may be needed to control hemorrhage, and “with vaginal packing, women are unable to void and need a Foley catheter, and that, again, cannot be managed at home easily,” she explained. “After bleeding settles, the vaginal pack is removed, often the next day.” This may be why some women are admitted to hospital.
Increased risk of injury
In a previous study, Dr. Shen and colleagues found there was an increased risk for injuries during the period before and after a diagnosis of any cancer (BMJ. 2016;354:i4218). Those findings suggested the interval between first suspicion of cancer and diagnosis or initiation of treatment might be a high-risk time for injuries in cancer care.
In this latest study, they assessed whether there was a similar increase in injury risk among patients screened for cervical cancer. Using the Swedish Total Population Register, they identified 3,016,307 women who had undergone cervical screening during the period 2001-2012.
The final analysis included 1,853,510 women whose pap smear results were normal; 22,435 women who were diagnosed with cervical intraepithelial neoplasia (CIN); 20,692 women with CIN2; 36,542 women with CIN3 or adenocarcinoma in situ (AIS); and 5,189 women with invasive cervical cancer.
The team found that, among women who had an abnormal screening test, 42 iatrogenic injuries occurred that required at least 2 days of hospital admission. The highest risk was among women diagnosed with invasive cancer. The risk was also increased among women diagnosed with CIN3/AIS, but not among women with lower grades of CIN.
The most common types of iatrogenic injuries were hemorrhage or hematoma and infections. Among all groups of women, the incidence rate of injuries that were caused by medical procedures and care was greater than that of injuries caused by drugs or biological substances.
A total of 91 noniatrogenic injuries that required at least 1 day of hospitalization were identified. The risk was increased among women with invasive cervical cancer but not for women with other cervical abnormalities. The most common type of noniatrogenic injury was unintentional injuries.
The study was sponsored by the Swedish Cancer Society and the Swedish Research Council for Health, Working Life and Welfare. One author received a Karolinska Institute Senior Researcher Award and a Strategic Research Area in Epidemiology Award, and one author received a grant from the China Scholarship Council. Dr. Shen has disclosed no relevant financial relationships. Dr. Popadiuk has received personal fees and nonfinancial support as a member of the OncoSim Initiative from the Canadian Partnership Against Cancer.
A version of this article originally appeared on Medscape.com.
Cervical cancer screening is a routine procedure, but in rare instances, there can be medical complications. A new study finds that, compared with women who have normal results, women who are diagnosed with an invasive malignancy have an increased risk for iatrogenic injuries.
Researchers in Sweden analyzed data on more than 3 million women who had undergone cervical cancer screening. The team found that 42 iatrogenic injuries that required at least 2 days of hospitalization occurred during the diagnostic work-up of women who had an abnormal screening test.
“Although cervical cancer screening is one of the most successful cancer prevention programs ... our research indicates that women with invasive cervical cancer experienced medical complications and psychological stress during their diagnostic work-up, although at a very low level,” commented corresponding author Qing Shen, PhD, from the department of medical epidemiology and biostatistics at the Karolinska Institute in Stockholm, Sweden.
The study was published in Cancer Epidemiology, Biomarkers & Prevention.
“Injuries can occur with diagnostic evaluation for cervical cancer,” commented Kecia Gaither, MD, MPH, FACOG, director of perinatal services at Lincoln Medical and Mental Health Center, New York City Health and Hospitals System, who was not involved in the study.
“Given the fact that neovascularization occurs with cancers, a large biopsy in such a circumstance could lead to a hematoma or excessive blood loss. It rarely occurs but most certainly is possible,” said Dr. Gaither.
Also weighing in with comments, Cathy Popadiuk, MD, FRCS, an associate professor of medicine in the department of obstetrics and gynecology at Memorial University of Newfoundland, St. John’s, said the findings are reflective of the real-world and North American experience.
“There are indeed rare bad things that can happen during diagnostic work-up of abnormal pap smears, and usually this is with associated other disease, such as actual cancer or fibroids that can also bleed and may be in the cervix, etc.,” she told this news organization. “And definitely, when there is undetected cancer, this can bleed, requiring transfusion and hospital admission.”
Dr. Popadiuk pointed out that Sweden may be more liberal in admitting patients to hospital, whereas in North America, “we are trying to move away from inpatient care.” She added, “When you are getting these relatively minor procedures, you don’t expect something bad to happen in the clinic.”
Women may become anxious, and admission is the easiest way to arrange for care such as transfusions or observation for more bleeding, she noted. In addition, vaginal packing may be needed to control hemorrhage, and “with vaginal packing, women are unable to void and need a Foley catheter, and that, again, cannot be managed at home easily,” she explained. “After bleeding settles, the vaginal pack is removed, often the next day.” This may be why some women are admitted to hospital.
Increased risk of injury
In a previous study, Dr. Shen and colleagues found there was an increased risk for injuries during the period before and after a diagnosis of any cancer (BMJ. 2016;354:i4218). Those findings suggested the interval between first suspicion of cancer and diagnosis or initiation of treatment might be a high-risk time for injuries in cancer care.
In this latest study, they assessed whether there was a similar increase in injury risk among patients screened for cervical cancer. Using the Swedish Total Population Register, they identified 3,016,307 women who had undergone cervical screening during the period 2001-2012.
The final analysis included 1,853,510 women whose pap smear results were normal; 22,435 women who were diagnosed with cervical intraepithelial neoplasia (CIN); 20,692 women with CIN2; 36,542 women with CIN3 or adenocarcinoma in situ (AIS); and 5,189 women with invasive cervical cancer.
The team found that, among women who had an abnormal screening test, 42 iatrogenic injuries occurred that required at least 2 days of hospital admission. The highest risk was among women diagnosed with invasive cancer. The risk was also increased among women diagnosed with CIN3/AIS, but not among women with lower grades of CIN.
The most common types of iatrogenic injuries were hemorrhage or hematoma and infections. Among all groups of women, the incidence rate of injuries that were caused by medical procedures and care was greater than that of injuries caused by drugs or biological substances.
A total of 91 noniatrogenic injuries that required at least 1 day of hospitalization were identified. The risk was increased among women with invasive cervical cancer but not for women with other cervical abnormalities. The most common type of noniatrogenic injury was unintentional injuries.
The study was sponsored by the Swedish Cancer Society and the Swedish Research Council for Health, Working Life and Welfare. One author received a Karolinska Institute Senior Researcher Award and a Strategic Research Area in Epidemiology Award, and one author received a grant from the China Scholarship Council. Dr. Shen has disclosed no relevant financial relationships. Dr. Popadiuk has received personal fees and nonfinancial support as a member of the OncoSim Initiative from the Canadian Partnership Against Cancer.
A version of this article originally appeared on Medscape.com.
Cervical cancer screening is a routine procedure, but in rare instances, there can be medical complications. A new study finds that, compared with women who have normal results, women who are diagnosed with an invasive malignancy have an increased risk for iatrogenic injuries.
Researchers in Sweden analyzed data on more than 3 million women who had undergone cervical cancer screening. The team found that 42 iatrogenic injuries that required at least 2 days of hospitalization occurred during the diagnostic work-up of women who had an abnormal screening test.
“Although cervical cancer screening is one of the most successful cancer prevention programs ... our research indicates that women with invasive cervical cancer experienced medical complications and psychological stress during their diagnostic work-up, although at a very low level,” commented corresponding author Qing Shen, PhD, from the department of medical epidemiology and biostatistics at the Karolinska Institute in Stockholm, Sweden.
The study was published in Cancer Epidemiology, Biomarkers & Prevention.
“Injuries can occur with diagnostic evaluation for cervical cancer,” commented Kecia Gaither, MD, MPH, FACOG, director of perinatal services at Lincoln Medical and Mental Health Center, New York City Health and Hospitals System, who was not involved in the study.
“Given the fact that neovascularization occurs with cancers, a large biopsy in such a circumstance could lead to a hematoma or excessive blood loss. It rarely occurs but most certainly is possible,” said Dr. Gaither.
Also weighing in with comments, Cathy Popadiuk, MD, FRCS, an associate professor of medicine in the department of obstetrics and gynecology at Memorial University of Newfoundland, St. John’s, said the findings are reflective of the real-world and North American experience.
“There are indeed rare bad things that can happen during diagnostic work-up of abnormal pap smears, and usually this is with associated other disease, such as actual cancer or fibroids that can also bleed and may be in the cervix, etc.,” she told this news organization. “And definitely, when there is undetected cancer, this can bleed, requiring transfusion and hospital admission.”
Dr. Popadiuk pointed out that Sweden may be more liberal in admitting patients to hospital, whereas in North America, “we are trying to move away from inpatient care.” She added, “When you are getting these relatively minor procedures, you don’t expect something bad to happen in the clinic.”
Women may become anxious, and admission is the easiest way to arrange for care such as transfusions or observation for more bleeding, she noted. In addition, vaginal packing may be needed to control hemorrhage, and “with vaginal packing, women are unable to void and need a Foley catheter, and that, again, cannot be managed at home easily,” she explained. “After bleeding settles, the vaginal pack is removed, often the next day.” This may be why some women are admitted to hospital.
Increased risk of injury
In a previous study, Dr. Shen and colleagues found there was an increased risk for injuries during the period before and after a diagnosis of any cancer (BMJ. 2016;354:i4218). Those findings suggested the interval between first suspicion of cancer and diagnosis or initiation of treatment might be a high-risk time for injuries in cancer care.
In this latest study, they assessed whether there was a similar increase in injury risk among patients screened for cervical cancer. Using the Swedish Total Population Register, they identified 3,016,307 women who had undergone cervical screening during the period 2001-2012.
The final analysis included 1,853,510 women whose pap smear results were normal; 22,435 women who were diagnosed with cervical intraepithelial neoplasia (CIN); 20,692 women with CIN2; 36,542 women with CIN3 or adenocarcinoma in situ (AIS); and 5,189 women with invasive cervical cancer.
The team found that, among women who had an abnormal screening test, 42 iatrogenic injuries occurred that required at least 2 days of hospital admission. The highest risk was among women diagnosed with invasive cancer. The risk was also increased among women diagnosed with CIN3/AIS, but not among women with lower grades of CIN.
The most common types of iatrogenic injuries were hemorrhage or hematoma and infections. Among all groups of women, the incidence rate of injuries that were caused by medical procedures and care was greater than that of injuries caused by drugs or biological substances.
A total of 91 noniatrogenic injuries that required at least 1 day of hospitalization were identified. The risk was increased among women with invasive cervical cancer but not for women with other cervical abnormalities. The most common type of noniatrogenic injury was unintentional injuries.
The study was sponsored by the Swedish Cancer Society and the Swedish Research Council for Health, Working Life and Welfare. One author received a Karolinska Institute Senior Researcher Award and a Strategic Research Area in Epidemiology Award, and one author received a grant from the China Scholarship Council. Dr. Shen has disclosed no relevant financial relationships. Dr. Popadiuk has received personal fees and nonfinancial support as a member of the OncoSim Initiative from the Canadian Partnership Against Cancer.
A version of this article originally appeared on Medscape.com.
IMRT new standard of care for high-risk cervical cancer
“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.
She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.
At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).
Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.
Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.
“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.
The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”
Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”
In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
Now at 49 months’ follow-up
The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.
The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.
Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).
Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).
As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).
Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.
She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.
At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).
Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.
Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.
“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.
The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”
Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”
In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
Now at 49 months’ follow-up
The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.
The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.
Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).
Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).
As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).
Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
“IG-IMRT should represent the new standard of care for postoperative pelvic radiation therapy in women with gynecological cancers,” said study lead author Supriya Chopra, MD, of the Tata Memorial Center in Mumbai, India.
She noted that the study, known as PARCER, is the first in gynecologic cancer to show the impact of advanced technology in reducing long-term morbidity and thus improving the experience of survivors.
At 4 years, rates of late GI toxicity of grade 2 or higher in the IG-IMRT and 3D-CRT arms were 19.2% and 36.2%, respectively (P = .005). Rates of toxicity of grade 3 or higher were 2.0% and 8.7%, respectively (P < .01).
Chopra presented the results at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online.
Postoperative radiotherapy is indicated for women with cervical and endometrial cancers who have high-risk features, but long-term follow-up has shown an increase in GI symptom burden and toxicity in long-term survivors after adjuvant radiotherapy.
“The uptake of IMRT has been relatively slow in gynecological cancers,” said Chopra. She explained that previous data suggested a benefit with the use of IMRT, but long-term postoperative effects were unclear.
The new data amount to a “practice-change use” of IMRT for this indication, said Sue Yom, MD, PhD, of the University of California, San Francisco, who was not involved with the study. “I see this as having potentially important future impacts on clinical practice.”
Yom explained that, although there have been studies in the United States on the use of postoperative IMRT for pelvic cancer, “this is the first phase 3 study that has shown definite long-term advantages with the use of IMRT, and I would consider it confirmatory.”
In 2015, the preliminary results of PARCER were presented at the plenary session at ASTRO. The results showed that patients treated with IG-IMRT had fewer late GI toxicities at a median follow-up of 20 months. However, the difference between groups was not statistically significant in this earlier analysis.
Now at 49 months’ follow-up
The study was conducted in three clinical sites of Tata Memorial Center and included a total of 300 patients with cervical cancer. The patients had undergone type III hysterectomy and had intermediate- or high-risk features, or they had undergone type I/II hysterectomy necessitating adjuvant chemoradiotherapy. They were randomly assigned to IG-IMRT (n = 151) or 3D-CRT (n = 149). Most patients (117 in the IG-IMRT arm and 114 in the 3D-CRT arm) received concurrent chemotherapy.
The primary endpoint was late GI toxicity of grade 2 or higher. Follow-up included clinical and quality-of-life evaluations, which were conducted every 3 months for 2 years and then every 6 months for years 2 to 5.
Chopra and colleagues evaluated 11 different GI-related side effects. Differences emerged over time between the two groups. Among the group that received IG-IMRT, significantly fewer patients reported moderate to severe acute diarrhea (17% in the IG-IMRT arm vs 27% in the 3D-CRT arm), late abdominal bloating (14% vs 28%), bowel obstruction (1% vs 7%), and anorexia/appetite loss (1% vs 7%).
Overall, for patients treated with IG-IMRT, grade 2 toxicity–free survival rates were significantly higher (78% with IG-IMRT vs 57% with 3D-CRT; P = .0009), as were grade 3 toxicity–free survival rates (97.6% vs 81.6%; P = .001).
As noted above, rates of disease-free survival were similar for both groups (73% with image-guided IMRT vs 68% with 3D-CRT; P = .30).
Funding for the study was provided by the Department of Science and Technology and the Department of Atomic Energy, Clinical Trials Center, in India, and by Varian International and the Terry Fox Foundation. Chopra and Yom have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
SRS instead of WBRT for patients with multiple brain metastases
Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases
“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.
She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.
“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.
SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.
However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.
This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.
Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
Reduces cognitive decline
The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.
Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.
All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.
The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.
In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).
Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).
A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).
In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted
Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.
Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).
The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”
Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.
This article first appeared on Medscape.com.
Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases
“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.
She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.
“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.
SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.
However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.
This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.
Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
Reduces cognitive decline
The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.
Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.
All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.
The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.
In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).
Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).
A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).
In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted
Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.
Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).
The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”
Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.
This article first appeared on Medscape.com.
Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases
“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.
She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.
“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.
SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.
However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.
This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.
Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
Reduces cognitive decline
The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.
Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.
All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.
The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.
In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).
Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).
A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).
In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted
Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.
Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).
The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”
Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.
This article first appeared on Medscape.com.
Cancer therapy affects sexual health in most patients
Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.
However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.
“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.
“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.
Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.
“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”
Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
Not discussed, not warned
Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.
A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).
“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”
Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.
Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.
“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.
Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.
Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”
The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
Importance of being holistic
The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.
“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.
“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”
The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.
However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.
“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.
“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.
Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.
“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”
Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
Not discussed, not warned
Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.
A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).
“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”
Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.
Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.
“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.
Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.
Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”
The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
Importance of being holistic
The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.
“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.
“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”
The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.
However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.
“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.
“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.
Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.
“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”
Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
Not discussed, not warned
Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.
A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).
“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”
Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.
Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.
“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.
Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.
Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”
The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
Importance of being holistic
The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.
“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.
“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”
The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Now USPSTF also suggests start CRC screening at age 45
that is open for public comment.
“This is the only change that was made,” said task force member Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston.
The recommendation is that all adults aged 45-75 years be screened for CRC.
This is an “A” recommendation for adults aged 50-75 and a “B” recommendation for adults aged 45-49. Dr. Barry explained that the reason for this difference is that the benefit is smaller for the 45- to 49-years age group. “But there’s not much difference between A and B from a practical standpoint,” he explained.
For adults aged 76-85, the benefits and harms of screening need to be weighed against the individual’s overall health and personal circumstances. This is a “C” recommendation.
Barry emphasized that the USPSTF document is not final. The draft recommendation and supporting evidence is posted on the task force website and will be available for public comments until Nov. 23.
Mounting pressure
The move comes after mounting evidence of an increase in CRC among younger adults and mounting pressure to lower the starting age.
Two years ago, the American Cancer Society (ACS) revised its own screening guidelines and lowered the starting age to 45 years. Soon afterward, a coalition of 22 public health and patient advocacy groups joined the ACS in submitting a letter to the USPSTF asking that the task force reconsider its 2016 guidance (which recommends starting at age 50 years).
The starting age for screening is an important issue, commented Judy Yee, MD, chair of radiology at the Albert Einstein College of Medicine and the Montefiore Health System in New York and chair of the Colon Cancer Committee of the American College of Radiology.
“Right now it is very confusing to physicians and to the public,” Dr. Yee said in an interview at that time. “The USPSTF and the ACS differ as far as the age to begin screening, and insurers may not cover the cost of colorectal cancer screening before age 50.”
Dr. Barry said that the Task Force took notice of recent data showing an increase in the incidence of CRC among younger adults. “The risk now for age 45 to 49 is pretty similar to the risk for people in their early 50s. So in some ways, today’s late 40-year-olds are like yesterday’s 50-year-olds,” he commented.
The task force used simulation models that confirmed what the epidemiologic data suggested and “that we could prevent some additional colorectal cancer deaths by starting screening at age 45,” he said.
The rest of the new draft recommendation is similar to the 2016 guidelines, in which the task force says there is convincing evidence that CRC screening substantially reduces disease-related mortality. However, it does not recommend any one screening approach over another. It recommends both direct visualization, such as colonoscopy, as well as noninvasive stool-based tests. It does not recommend serum tests, urine tests, or capsule endoscopy because there is not yet enough evidence about the benefits and harms of these tests.
“The right test is the one a patient will do,” Dr. Barry commented.
Defining populations
CRC in young adults made the news in August 2020 when Chadwick Boseman, known for his role as King T’Challa in Marvel’s “Black Panther,” died of colon cancer. Diagnosed in 2016, he was only 43 years old.
“The recent passing of Chadwick Boseman is tragic, and our thoughts are with his loved ones during this difficult time,” said Dr. Barry. “As a Black man, the data show that Chadwick was at higher risk for developing colorectal cancer.”
Unfortunately, there is currently not enough evidence that screening Black men younger than 45 could help prevent tragic deaths such as Chadwick’s, he commented. “The task force is calling for more research on colorectal cancer screening in Black adults,” he added.
Limit screening to those at higher risk
In contrast to the USPSTF and ACS guidelines, which recommend screening for CRC for everyone over a certain age, a set of recommendations developed by an international panel of experts suggests screening only for individuals who are at higher risk for CRC.
As previously reported, these guidelines suggest restricting screening to adults whose cumulative cancer risk is 3% or more in the next 15 years, the point at which the balance between benefits and harms favors screening.
The authors, led by Lise Helsingen, MD, Clinical Effectiveness Research Group, University of Oslo, said “the optimal choice for each person requires shared decision-making.”
Such a risk-based approach is “increasingly regarded as the most appropriate way to discuss cancer screening.” That approach is already used in prostate and lung cancer screening, they noted.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have actively debated the pros and cons of lowering the screening age to 45 years since 2018, when the American Cancer Society released its colorectal cancer (CRC) screening guidelines. The most compelling argument in support of lowering the screening age is that recent data from Surveillance Epidemiology and End Results (SEER) show that the CRC incidence rates in 45- to 50-year-olds are similar to rates seen in 50- to 54-year-olds about 20 years ago, when the first guidelines to initiate screening at age 50 were widely established. Termed early-onset CRC (EOCRC), the underlying reasons for this increase are not completely understood, and while the absolute numbers of EOCRC cases are smaller than in older age groups, modeling studies show that screening this age group is both efficient and effective.
Over the last 20 years we have made major strides in reducing the incidence and mortality from CRC in ages 50 years and older, and now we must rise to the challenge of delivering CRC screening to this younger group in order to see similar dividends over time and curb the rising incidence curve of EOCRC. And we must do so without direct evidence to guide us as to the magnitude of the benefit of screening this younger group, the best modality to use, or tools to risk stratify who is likely to benefit from screening in this group. We must also be careful not to worsen racial and geographic disparities in CRC screening, which already exist for African Americans, Native Americans, and other minorities and rural residents. Finally, even though the goal posts are changing, our target remains to get to 80% screening rates for all age groups, and not neglect the currently underscreened 50- to 75-year-olds, who are at a much higher risk of CRC than their younger counterparts.
Aasma Shaukat, MD, MPH, is an investigator, Center for Care Delivery and Outcomes Research, section chief and staff physician, GI section, Minneapolis VA Health Care System; staff physician, Fairview University of Minnesota Medical Center, Minneapolis; and professor, University of Minnesota department of medicine, division of gastroenterology, Minneapolis. She has no conflicts of interest.
Clinicians and researchers have actively debated the pros and cons of lowering the screening age to 45 years since 2018, when the American Cancer Society released its colorectal cancer (CRC) screening guidelines. The most compelling argument in support of lowering the screening age is that recent data from Surveillance Epidemiology and End Results (SEER) show that the CRC incidence rates in 45- to 50-year-olds are similar to rates seen in 50- to 54-year-olds about 20 years ago, when the first guidelines to initiate screening at age 50 were widely established. Termed early-onset CRC (EOCRC), the underlying reasons for this increase are not completely understood, and while the absolute numbers of EOCRC cases are smaller than in older age groups, modeling studies show that screening this age group is both efficient and effective.
Over the last 20 years we have made major strides in reducing the incidence and mortality from CRC in ages 50 years and older, and now we must rise to the challenge of delivering CRC screening to this younger group in order to see similar dividends over time and curb the rising incidence curve of EOCRC. And we must do so without direct evidence to guide us as to the magnitude of the benefit of screening this younger group, the best modality to use, or tools to risk stratify who is likely to benefit from screening in this group. We must also be careful not to worsen racial and geographic disparities in CRC screening, which already exist for African Americans, Native Americans, and other minorities and rural residents. Finally, even though the goal posts are changing, our target remains to get to 80% screening rates for all age groups, and not neglect the currently underscreened 50- to 75-year-olds, who are at a much higher risk of CRC than their younger counterparts.
Aasma Shaukat, MD, MPH, is an investigator, Center for Care Delivery and Outcomes Research, section chief and staff physician, GI section, Minneapolis VA Health Care System; staff physician, Fairview University of Minnesota Medical Center, Minneapolis; and professor, University of Minnesota department of medicine, division of gastroenterology, Minneapolis. She has no conflicts of interest.
Clinicians and researchers have actively debated the pros and cons of lowering the screening age to 45 years since 2018, when the American Cancer Society released its colorectal cancer (CRC) screening guidelines. The most compelling argument in support of lowering the screening age is that recent data from Surveillance Epidemiology and End Results (SEER) show that the CRC incidence rates in 45- to 50-year-olds are similar to rates seen in 50- to 54-year-olds about 20 years ago, when the first guidelines to initiate screening at age 50 were widely established. Termed early-onset CRC (EOCRC), the underlying reasons for this increase are not completely understood, and while the absolute numbers of EOCRC cases are smaller than in older age groups, modeling studies show that screening this age group is both efficient and effective.
Over the last 20 years we have made major strides in reducing the incidence and mortality from CRC in ages 50 years and older, and now we must rise to the challenge of delivering CRC screening to this younger group in order to see similar dividends over time and curb the rising incidence curve of EOCRC. And we must do so without direct evidence to guide us as to the magnitude of the benefit of screening this younger group, the best modality to use, or tools to risk stratify who is likely to benefit from screening in this group. We must also be careful not to worsen racial and geographic disparities in CRC screening, which already exist for African Americans, Native Americans, and other minorities and rural residents. Finally, even though the goal posts are changing, our target remains to get to 80% screening rates for all age groups, and not neglect the currently underscreened 50- to 75-year-olds, who are at a much higher risk of CRC than their younger counterparts.
Aasma Shaukat, MD, MPH, is an investigator, Center for Care Delivery and Outcomes Research, section chief and staff physician, GI section, Minneapolis VA Health Care System; staff physician, Fairview University of Minnesota Medical Center, Minneapolis; and professor, University of Minnesota department of medicine, division of gastroenterology, Minneapolis. She has no conflicts of interest.
that is open for public comment.
“This is the only change that was made,” said task force member Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston.
The recommendation is that all adults aged 45-75 years be screened for CRC.
This is an “A” recommendation for adults aged 50-75 and a “B” recommendation for adults aged 45-49. Dr. Barry explained that the reason for this difference is that the benefit is smaller for the 45- to 49-years age group. “But there’s not much difference between A and B from a practical standpoint,” he explained.
For adults aged 76-85, the benefits and harms of screening need to be weighed against the individual’s overall health and personal circumstances. This is a “C” recommendation.
Barry emphasized that the USPSTF document is not final. The draft recommendation and supporting evidence is posted on the task force website and will be available for public comments until Nov. 23.
Mounting pressure
The move comes after mounting evidence of an increase in CRC among younger adults and mounting pressure to lower the starting age.
Two years ago, the American Cancer Society (ACS) revised its own screening guidelines and lowered the starting age to 45 years. Soon afterward, a coalition of 22 public health and patient advocacy groups joined the ACS in submitting a letter to the USPSTF asking that the task force reconsider its 2016 guidance (which recommends starting at age 50 years).
The starting age for screening is an important issue, commented Judy Yee, MD, chair of radiology at the Albert Einstein College of Medicine and the Montefiore Health System in New York and chair of the Colon Cancer Committee of the American College of Radiology.
“Right now it is very confusing to physicians and to the public,” Dr. Yee said in an interview at that time. “The USPSTF and the ACS differ as far as the age to begin screening, and insurers may not cover the cost of colorectal cancer screening before age 50.”
Dr. Barry said that the Task Force took notice of recent data showing an increase in the incidence of CRC among younger adults. “The risk now for age 45 to 49 is pretty similar to the risk for people in their early 50s. So in some ways, today’s late 40-year-olds are like yesterday’s 50-year-olds,” he commented.
The task force used simulation models that confirmed what the epidemiologic data suggested and “that we could prevent some additional colorectal cancer deaths by starting screening at age 45,” he said.
The rest of the new draft recommendation is similar to the 2016 guidelines, in which the task force says there is convincing evidence that CRC screening substantially reduces disease-related mortality. However, it does not recommend any one screening approach over another. It recommends both direct visualization, such as colonoscopy, as well as noninvasive stool-based tests. It does not recommend serum tests, urine tests, or capsule endoscopy because there is not yet enough evidence about the benefits and harms of these tests.
“The right test is the one a patient will do,” Dr. Barry commented.
Defining populations
CRC in young adults made the news in August 2020 when Chadwick Boseman, known for his role as King T’Challa in Marvel’s “Black Panther,” died of colon cancer. Diagnosed in 2016, he was only 43 years old.
“The recent passing of Chadwick Boseman is tragic, and our thoughts are with his loved ones during this difficult time,” said Dr. Barry. “As a Black man, the data show that Chadwick was at higher risk for developing colorectal cancer.”
Unfortunately, there is currently not enough evidence that screening Black men younger than 45 could help prevent tragic deaths such as Chadwick’s, he commented. “The task force is calling for more research on colorectal cancer screening in Black adults,” he added.
Limit screening to those at higher risk
In contrast to the USPSTF and ACS guidelines, which recommend screening for CRC for everyone over a certain age, a set of recommendations developed by an international panel of experts suggests screening only for individuals who are at higher risk for CRC.
As previously reported, these guidelines suggest restricting screening to adults whose cumulative cancer risk is 3% or more in the next 15 years, the point at which the balance between benefits and harms favors screening.
The authors, led by Lise Helsingen, MD, Clinical Effectiveness Research Group, University of Oslo, said “the optimal choice for each person requires shared decision-making.”
Such a risk-based approach is “increasingly regarded as the most appropriate way to discuss cancer screening.” That approach is already used in prostate and lung cancer screening, they noted.
A version of this article originally appeared on Medscape.com.
that is open for public comment.
“This is the only change that was made,” said task force member Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston.
The recommendation is that all adults aged 45-75 years be screened for CRC.
This is an “A” recommendation for adults aged 50-75 and a “B” recommendation for adults aged 45-49. Dr. Barry explained that the reason for this difference is that the benefit is smaller for the 45- to 49-years age group. “But there’s not much difference between A and B from a practical standpoint,” he explained.
For adults aged 76-85, the benefits and harms of screening need to be weighed against the individual’s overall health and personal circumstances. This is a “C” recommendation.
Barry emphasized that the USPSTF document is not final. The draft recommendation and supporting evidence is posted on the task force website and will be available for public comments until Nov. 23.
Mounting pressure
The move comes after mounting evidence of an increase in CRC among younger adults and mounting pressure to lower the starting age.
Two years ago, the American Cancer Society (ACS) revised its own screening guidelines and lowered the starting age to 45 years. Soon afterward, a coalition of 22 public health and patient advocacy groups joined the ACS in submitting a letter to the USPSTF asking that the task force reconsider its 2016 guidance (which recommends starting at age 50 years).
The starting age for screening is an important issue, commented Judy Yee, MD, chair of radiology at the Albert Einstein College of Medicine and the Montefiore Health System in New York and chair of the Colon Cancer Committee of the American College of Radiology.
“Right now it is very confusing to physicians and to the public,” Dr. Yee said in an interview at that time. “The USPSTF and the ACS differ as far as the age to begin screening, and insurers may not cover the cost of colorectal cancer screening before age 50.”
Dr. Barry said that the Task Force took notice of recent data showing an increase in the incidence of CRC among younger adults. “The risk now for age 45 to 49 is pretty similar to the risk for people in their early 50s. So in some ways, today’s late 40-year-olds are like yesterday’s 50-year-olds,” he commented.
The task force used simulation models that confirmed what the epidemiologic data suggested and “that we could prevent some additional colorectal cancer deaths by starting screening at age 45,” he said.
The rest of the new draft recommendation is similar to the 2016 guidelines, in which the task force says there is convincing evidence that CRC screening substantially reduces disease-related mortality. However, it does not recommend any one screening approach over another. It recommends both direct visualization, such as colonoscopy, as well as noninvasive stool-based tests. It does not recommend serum tests, urine tests, or capsule endoscopy because there is not yet enough evidence about the benefits and harms of these tests.
“The right test is the one a patient will do,” Dr. Barry commented.
Defining populations
CRC in young adults made the news in August 2020 when Chadwick Boseman, known for his role as King T’Challa in Marvel’s “Black Panther,” died of colon cancer. Diagnosed in 2016, he was only 43 years old.
“The recent passing of Chadwick Boseman is tragic, and our thoughts are with his loved ones during this difficult time,” said Dr. Barry. “As a Black man, the data show that Chadwick was at higher risk for developing colorectal cancer.”
Unfortunately, there is currently not enough evidence that screening Black men younger than 45 could help prevent tragic deaths such as Chadwick’s, he commented. “The task force is calling for more research on colorectal cancer screening in Black adults,” he added.
Limit screening to those at higher risk
In contrast to the USPSTF and ACS guidelines, which recommend screening for CRC for everyone over a certain age, a set of recommendations developed by an international panel of experts suggests screening only for individuals who are at higher risk for CRC.
As previously reported, these guidelines suggest restricting screening to adults whose cumulative cancer risk is 3% or more in the next 15 years, the point at which the balance between benefits and harms favors screening.
The authors, led by Lise Helsingen, MD, Clinical Effectiveness Research Group, University of Oslo, said “the optimal choice for each person requires shared decision-making.”
Such a risk-based approach is “increasingly regarded as the most appropriate way to discuss cancer screening.” That approach is already used in prostate and lung cancer screening, they noted.
A version of this article originally appeared on Medscape.com.
Colonoscopy patients may get hit with a ‘surprise bill’
A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.
The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.
Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.
The median surprise bill was $418 (range $152-$981).
The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”
Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.
“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”
“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”
But is it really that simple for physicians to make sure that all members of the team are in-network?
It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.
“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”
In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.
Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”
“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
Details of the surprise bills
Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.
To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.
The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.
A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).
If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.
The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.
“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.
The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.
This article first appeared on Medscape.com.
Screening colonoscopy is the most cost effective test for prevention of colorectal cancer. The American Gastroenterological Association (AGA) believes that patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country and this benefit should be preserved in any health care reform legislation. Learn more about how AGA advocates for patients at http://ow.ly/ULCZ30rf6J8.
Help your patients understand what to expect when paying for their colonoscopy by sharing AGA patient education at http://ow.ly/OteU30rf6HF.
A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.
The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.
Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.
The median surprise bill was $418 (range $152-$981).
The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”
Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.
“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”
“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”
But is it really that simple for physicians to make sure that all members of the team are in-network?
It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.
“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”
In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.
Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”
“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
Details of the surprise bills
Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.
To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.
The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.
A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).
If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.
The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.
“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.
The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.
This article first appeared on Medscape.com.
Screening colonoscopy is the most cost effective test for prevention of colorectal cancer. The American Gastroenterological Association (AGA) believes that patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country and this benefit should be preserved in any health care reform legislation. Learn more about how AGA advocates for patients at http://ow.ly/ULCZ30rf6J8.
Help your patients understand what to expect when paying for their colonoscopy by sharing AGA patient education at http://ow.ly/OteU30rf6HF.
A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.
The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.
Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.
The median surprise bill was $418 (range $152-$981).
The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”
Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.
“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”
“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”
But is it really that simple for physicians to make sure that all members of the team are in-network?
It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.
“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”
In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.
Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”
“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
Details of the surprise bills
Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.
To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.
The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.
A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).
If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.
The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.
“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.
The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.
This article first appeared on Medscape.com.
Screening colonoscopy is the most cost effective test for prevention of colorectal cancer. The American Gastroenterological Association (AGA) believes that patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country and this benefit should be preserved in any health care reform legislation. Learn more about how AGA advocates for patients at http://ow.ly/ULCZ30rf6J8.
Help your patients understand what to expect when paying for their colonoscopy by sharing AGA patient education at http://ow.ly/OteU30rf6HF.
Colonoscopy patients may get hit with a ‘surprise bill’
A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.
The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.
Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.
The median surprise bill was $418 (range $152-$981).
The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”
Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.
“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”
“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”
But is it really that simple for physicians to make sure that all members of the team are in-network?
It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.
“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”
In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.
Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”
“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
Details of the surprise bills
Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.
To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.
The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.
A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).
If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.
The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.
“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.
The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.
This article first appeared on Medscape.com.
A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.
The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.
Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.
The median surprise bill was $418 (range $152-$981).
The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”
Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.
“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”
“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”
But is it really that simple for physicians to make sure that all members of the team are in-network?
It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.
“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”
In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.
Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”
“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
Details of the surprise bills
Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.
To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.
The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.
A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).
If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.
The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.
“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.
The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.
This article first appeared on Medscape.com.
A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.
The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.
Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.
The median surprise bill was $418 (range $152-$981).
The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”
Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.
“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”
“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”
But is it really that simple for physicians to make sure that all members of the team are in-network?
It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.
“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”
In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.
Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”
“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
Details of the surprise bills
Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.
To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.
The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.
A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).
If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.
The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.
“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.
The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.
This article first appeared on Medscape.com.
CRC risk: Raised by meat/alcohol, lowered by aspirin/NSAIDs
A new meta-analysis has largely confirmed what is already known about the lifestyle factors that increase and those that decrease the risk of developing colorectal cancer.
The use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a decreased risk for colorectal cancer, the new article concludes. But it also adds a number of other factors that are associated with a decreased risk for the disease, including taking magnesium and folate supplements and eating dairy products, fiber, soy, and fruits and vegetables.
On the other hand, consumption of meat and alcohol was associated with an increased risk for colorectal cancer in almost all of the analyses included in this article.
The study was published online September 28 in Gut.
However, the authors pointed out that it is important to keep in mind that in most cases, the level of evidence is low or very low, primarily because of the heterogeneity of the various published studies, as well as the type of study.
“Furthermore, in most cases, we were unable to identify an optimal dose and duration of exposure/intake for any of the products, even in the case of low-dose aspirin and other compounds that have been extensively assessed,” they wrote.
The findings of this new meta-analysis echo previous findings on this issue.
A number of studies, for example, have found varying associations between the consumption of red meat and cancer. The American Institute for Cancer Research and the World Cancer Research Fund have published several reports during the past 10 years on the effect of diet, nutrition, and/or physical activity on risk for several cancer types. Their most recent study, published in 2017, concluded that eating red meat and processed meat may increase the risk for colorectal cancer, as may drinking two or more alcoholic beverages per day.
Another large meta-analysis published earlier this year found that regular use of aspirin reduced the risk for cancers of the digestive tract by 22%-38%, compared with nonuse.
Umbrella review
In the latest article in Gut, researchers led by Marc Bardou, MD, PhD, Centre Hospitalier Universitaire de Dijon (France), conducted an umbrella review of systematic reviews and meta-analyses of interventions that assessed chemopreventive products for colorectal cancer in an average-risk population.
A total of 80 meta-analyses of interventional and observational studies were included. The studies investigated a wide range of chemopreventive agents in an average-risk population and the risk for colorectal cancer. Agents included medications (aspirin, NSAIDs, statins), vitamins or supplements (magnesium; calcium; folic acid; vitamin A, B, C, E, and D; beta-carotene; and selenium), and dietary items (coffee, tea, fish, dairy products, fiber, fruits, vegetables, meat, and alcohol).
The studies included randomized controlled trials and observational studies. Most of the meta-analyses found a protective effect for aspirin, which lowered the risk by between 14% and 29% even at doses as low as 75 mg/day, with a dose-response effect of up to 325 mg/day. The certainty of evidence was moderate.
NSAID use was also associated with a protective effect, with a significant 26%-43% decrease in the incidence in colorectal cancer. The optimal duration for the observed protective effect remains unclear. Two meta-analyses suggested that NSAIDs may need to be taken for at least 5 years, although one article suggested a protective effect after the first year. The certainty of evidence was low.
Use of magnesium was found to be protective, with a relative risk (RR) of 0.78-0.87. High intake of folic acid was associated with a significant decrease in risk (RR, 0.85-0.88). The certainty of evidence was low and very low, respectively.
Consumption of dairy products was associated with 13%-19% lower risk for the disease. However, the authors note that, because of the small number of available meta-analyses, the multiplicity of outcomes, and the variety of dairy products, it was not possible to reach any firm conclusions about the amount needed or the duration necessary for a protective effect.
Another dietary item, fiber, was associated with a 22%-43% lower risk. Consumption of fruits and vegetables was associated with up to a 52% lower risk, with an added benefit for every additional 100 g/day increase in intake. Soy intake was also associated with a small but significant decrease in risk (8%-15%).
For many of the other items reviewed, evidence was either weak or no beneficial effect was seen.
Increased risk
Consumption of both meat and alcohol was found to increase the risk for colorectal cancer.
Most of the meta-analyses of observational studies have reported a significant increase in risk (RR, 1.12-1.21) with meat consumption (particularly red and processed) and the incidence of colorectal cancer. Studies of the dose effect reported a 10%-30% increased risk for each increment of 100 g/day of total or red meat.
Alcohol consumption was also associated with a significantly increased risk. The higher the intake, the greater the risk. The risk was evident even at the lowest consumption doses that were investigated (1-2 drinks per day).
Balanced for the individual patient
Commenting on the article, Thomas J. George Jr, MD, professor of medicine and director, GI Oncology Program, the University of Florida Health Cancer Center, Gainesville, feels that the take-home message for clinicians and patients alike is that these data help to reinforce behaviors that have already been recommended.
“We know that excessive alcohol and red meat consumption is not healthy, so seeing that there may be a negative effect on colorectal cancer is just more evidence that we should be avoiding that and recommend avoiding that,” said Dr. George. “So yes, I recommend minimizing those, and likewise, a diet that is inclusive of fruits, vegetables, fiber, soy – perhaps as an alternative to meat consumption – is healthier than a diet devoid of these, so again, more reassuring data to support doing what we should already be doing.”
However, he pointed out that there are risks associated with medications such as NSAIDs and aspirin, including bleeding, gastric ulcer formation, and kidney damage. “The risks are low but very real,” Dr. George said. “So I think those recommendations need to be considered on a very individual level, balancing any other risk factors that the patient may have for both colorectal cancer, as well as risks from the medications.”
The study had no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Share AGA GI Patient Center education on colorectal cancer to help your patients better understand their risks and treatment options at http://ow.ly/mZ9q30rcz1U.
A new meta-analysis has largely confirmed what is already known about the lifestyle factors that increase and those that decrease the risk of developing colorectal cancer.
The use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a decreased risk for colorectal cancer, the new article concludes. But it also adds a number of other factors that are associated with a decreased risk for the disease, including taking magnesium and folate supplements and eating dairy products, fiber, soy, and fruits and vegetables.
On the other hand, consumption of meat and alcohol was associated with an increased risk for colorectal cancer in almost all of the analyses included in this article.
The study was published online September 28 in Gut.
However, the authors pointed out that it is important to keep in mind that in most cases, the level of evidence is low or very low, primarily because of the heterogeneity of the various published studies, as well as the type of study.
“Furthermore, in most cases, we were unable to identify an optimal dose and duration of exposure/intake for any of the products, even in the case of low-dose aspirin and other compounds that have been extensively assessed,” they wrote.
The findings of this new meta-analysis echo previous findings on this issue.
A number of studies, for example, have found varying associations between the consumption of red meat and cancer. The American Institute for Cancer Research and the World Cancer Research Fund have published several reports during the past 10 years on the effect of diet, nutrition, and/or physical activity on risk for several cancer types. Their most recent study, published in 2017, concluded that eating red meat and processed meat may increase the risk for colorectal cancer, as may drinking two or more alcoholic beverages per day.
Another large meta-analysis published earlier this year found that regular use of aspirin reduced the risk for cancers of the digestive tract by 22%-38%, compared with nonuse.
Umbrella review
In the latest article in Gut, researchers led by Marc Bardou, MD, PhD, Centre Hospitalier Universitaire de Dijon (France), conducted an umbrella review of systematic reviews and meta-analyses of interventions that assessed chemopreventive products for colorectal cancer in an average-risk population.
A total of 80 meta-analyses of interventional and observational studies were included. The studies investigated a wide range of chemopreventive agents in an average-risk population and the risk for colorectal cancer. Agents included medications (aspirin, NSAIDs, statins), vitamins or supplements (magnesium; calcium; folic acid; vitamin A, B, C, E, and D; beta-carotene; and selenium), and dietary items (coffee, tea, fish, dairy products, fiber, fruits, vegetables, meat, and alcohol).
The studies included randomized controlled trials and observational studies. Most of the meta-analyses found a protective effect for aspirin, which lowered the risk by between 14% and 29% even at doses as low as 75 mg/day, with a dose-response effect of up to 325 mg/day. The certainty of evidence was moderate.
NSAID use was also associated with a protective effect, with a significant 26%-43% decrease in the incidence in colorectal cancer. The optimal duration for the observed protective effect remains unclear. Two meta-analyses suggested that NSAIDs may need to be taken for at least 5 years, although one article suggested a protective effect after the first year. The certainty of evidence was low.
Use of magnesium was found to be protective, with a relative risk (RR) of 0.78-0.87. High intake of folic acid was associated with a significant decrease in risk (RR, 0.85-0.88). The certainty of evidence was low and very low, respectively.
Consumption of dairy products was associated with 13%-19% lower risk for the disease. However, the authors note that, because of the small number of available meta-analyses, the multiplicity of outcomes, and the variety of dairy products, it was not possible to reach any firm conclusions about the amount needed or the duration necessary for a protective effect.
Another dietary item, fiber, was associated with a 22%-43% lower risk. Consumption of fruits and vegetables was associated with up to a 52% lower risk, with an added benefit for every additional 100 g/day increase in intake. Soy intake was also associated with a small but significant decrease in risk (8%-15%).
For many of the other items reviewed, evidence was either weak or no beneficial effect was seen.
Increased risk
Consumption of both meat and alcohol was found to increase the risk for colorectal cancer.
Most of the meta-analyses of observational studies have reported a significant increase in risk (RR, 1.12-1.21) with meat consumption (particularly red and processed) and the incidence of colorectal cancer. Studies of the dose effect reported a 10%-30% increased risk for each increment of 100 g/day of total or red meat.
Alcohol consumption was also associated with a significantly increased risk. The higher the intake, the greater the risk. The risk was evident even at the lowest consumption doses that were investigated (1-2 drinks per day).
Balanced for the individual patient
Commenting on the article, Thomas J. George Jr, MD, professor of medicine and director, GI Oncology Program, the University of Florida Health Cancer Center, Gainesville, feels that the take-home message for clinicians and patients alike is that these data help to reinforce behaviors that have already been recommended.
“We know that excessive alcohol and red meat consumption is not healthy, so seeing that there may be a negative effect on colorectal cancer is just more evidence that we should be avoiding that and recommend avoiding that,” said Dr. George. “So yes, I recommend minimizing those, and likewise, a diet that is inclusive of fruits, vegetables, fiber, soy – perhaps as an alternative to meat consumption – is healthier than a diet devoid of these, so again, more reassuring data to support doing what we should already be doing.”
However, he pointed out that there are risks associated with medications such as NSAIDs and aspirin, including bleeding, gastric ulcer formation, and kidney damage. “The risks are low but very real,” Dr. George said. “So I think those recommendations need to be considered on a very individual level, balancing any other risk factors that the patient may have for both colorectal cancer, as well as risks from the medications.”
The study had no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Share AGA GI Patient Center education on colorectal cancer to help your patients better understand their risks and treatment options at http://ow.ly/mZ9q30rcz1U.
A new meta-analysis has largely confirmed what is already known about the lifestyle factors that increase and those that decrease the risk of developing colorectal cancer.
The use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a decreased risk for colorectal cancer, the new article concludes. But it also adds a number of other factors that are associated with a decreased risk for the disease, including taking magnesium and folate supplements and eating dairy products, fiber, soy, and fruits and vegetables.
On the other hand, consumption of meat and alcohol was associated with an increased risk for colorectal cancer in almost all of the analyses included in this article.
The study was published online September 28 in Gut.
However, the authors pointed out that it is important to keep in mind that in most cases, the level of evidence is low or very low, primarily because of the heterogeneity of the various published studies, as well as the type of study.
“Furthermore, in most cases, we were unable to identify an optimal dose and duration of exposure/intake for any of the products, even in the case of low-dose aspirin and other compounds that have been extensively assessed,” they wrote.
The findings of this new meta-analysis echo previous findings on this issue.
A number of studies, for example, have found varying associations between the consumption of red meat and cancer. The American Institute for Cancer Research and the World Cancer Research Fund have published several reports during the past 10 years on the effect of diet, nutrition, and/or physical activity on risk for several cancer types. Their most recent study, published in 2017, concluded that eating red meat and processed meat may increase the risk for colorectal cancer, as may drinking two or more alcoholic beverages per day.
Another large meta-analysis published earlier this year found that regular use of aspirin reduced the risk for cancers of the digestive tract by 22%-38%, compared with nonuse.
Umbrella review
In the latest article in Gut, researchers led by Marc Bardou, MD, PhD, Centre Hospitalier Universitaire de Dijon (France), conducted an umbrella review of systematic reviews and meta-analyses of interventions that assessed chemopreventive products for colorectal cancer in an average-risk population.
A total of 80 meta-analyses of interventional and observational studies were included. The studies investigated a wide range of chemopreventive agents in an average-risk population and the risk for colorectal cancer. Agents included medications (aspirin, NSAIDs, statins), vitamins or supplements (magnesium; calcium; folic acid; vitamin A, B, C, E, and D; beta-carotene; and selenium), and dietary items (coffee, tea, fish, dairy products, fiber, fruits, vegetables, meat, and alcohol).
The studies included randomized controlled trials and observational studies. Most of the meta-analyses found a protective effect for aspirin, which lowered the risk by between 14% and 29% even at doses as low as 75 mg/day, with a dose-response effect of up to 325 mg/day. The certainty of evidence was moderate.
NSAID use was also associated with a protective effect, with a significant 26%-43% decrease in the incidence in colorectal cancer. The optimal duration for the observed protective effect remains unclear. Two meta-analyses suggested that NSAIDs may need to be taken for at least 5 years, although one article suggested a protective effect after the first year. The certainty of evidence was low.
Use of magnesium was found to be protective, with a relative risk (RR) of 0.78-0.87. High intake of folic acid was associated with a significant decrease in risk (RR, 0.85-0.88). The certainty of evidence was low and very low, respectively.
Consumption of dairy products was associated with 13%-19% lower risk for the disease. However, the authors note that, because of the small number of available meta-analyses, the multiplicity of outcomes, and the variety of dairy products, it was not possible to reach any firm conclusions about the amount needed or the duration necessary for a protective effect.
Another dietary item, fiber, was associated with a 22%-43% lower risk. Consumption of fruits and vegetables was associated with up to a 52% lower risk, with an added benefit for every additional 100 g/day increase in intake. Soy intake was also associated with a small but significant decrease in risk (8%-15%).
For many of the other items reviewed, evidence was either weak or no beneficial effect was seen.
Increased risk
Consumption of both meat and alcohol was found to increase the risk for colorectal cancer.
Most of the meta-analyses of observational studies have reported a significant increase in risk (RR, 1.12-1.21) with meat consumption (particularly red and processed) and the incidence of colorectal cancer. Studies of the dose effect reported a 10%-30% increased risk for each increment of 100 g/day of total or red meat.
Alcohol consumption was also associated with a significantly increased risk. The higher the intake, the greater the risk. The risk was evident even at the lowest consumption doses that were investigated (1-2 drinks per day).
Balanced for the individual patient
Commenting on the article, Thomas J. George Jr, MD, professor of medicine and director, GI Oncology Program, the University of Florida Health Cancer Center, Gainesville, feels that the take-home message for clinicians and patients alike is that these data help to reinforce behaviors that have already been recommended.
“We know that excessive alcohol and red meat consumption is not healthy, so seeing that there may be a negative effect on colorectal cancer is just more evidence that we should be avoiding that and recommend avoiding that,” said Dr. George. “So yes, I recommend minimizing those, and likewise, a diet that is inclusive of fruits, vegetables, fiber, soy – perhaps as an alternative to meat consumption – is healthier than a diet devoid of these, so again, more reassuring data to support doing what we should already be doing.”
However, he pointed out that there are risks associated with medications such as NSAIDs and aspirin, including bleeding, gastric ulcer formation, and kidney damage. “The risks are low but very real,” Dr. George said. “So I think those recommendations need to be considered on a very individual level, balancing any other risk factors that the patient may have for both colorectal cancer, as well as risks from the medications.”
The study had no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Share AGA GI Patient Center education on colorectal cancer to help your patients better understand their risks and treatment options at http://ow.ly/mZ9q30rcz1U.
CRC risk: Raised by meat/alcohol, lowered by aspirin/NSAIDs
A new meta-analysis has largely confirmed what is already known about the lifestyle factors that increase and those that decrease the risk of developing colorectal cancer.
The use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a decreased risk for colorectal cancer, the new article concludes. But it also adds a number of other factors that are associated with a decreased risk for the disease, including taking magnesium and folate supplements and eating dairy products, fiber, soy, and fruits and vegetables.
On the other hand, consumption of meat and alcohol was associated with an increased risk for colorectal cancer in almost all of the analyses included in this article.
The study was published online September 28 in Gut.
However, the authors pointed out that it is important to keep in mind that in most cases, the level of evidence is low or very low, primarily because of the heterogeneity of the various published studies, as well as the type of study.
“Furthermore, in most cases, we were unable to identify an optimal dose and duration of exposure/intake for any of the products, even in the case of low-dose aspirin and other compounds that have been extensively assessed,” they wrote.
The findings of this new meta-analysis echo previous findings on this issue.
A number of studies, for example, have found varying associations between the consumption of red meat and cancer. The American Institute for Cancer Research and the World Cancer Research Fund have published several reports during the past 10 years on the effect of diet, nutrition, and/or physical activity on risk for several cancer types. Their most recent study, published in 2017, concluded that eating red meat and processed meat may increase the risk for colorectal cancer, as may drinking two or more alcoholic beverages per day.
Another large meta-analysis published earlier this year found that regular use of aspirin reduced the risk for cancers of the digestive tract by 22%-38%, compared with nonuse.
Umbrella review
In the latest article in Gut, researchers led by Marc Bardou, MD, PhD, Centre Hospitalier Universitaire de Dijon (France), conducted an umbrella review of systematic reviews and meta-analyses of interventions that assessed chemopreventive products for colorectal cancer in an average-risk population.
A total of 80 meta-analyses of interventional and observational studies were included. The studies investigated a wide range of chemopreventive agents in an average-risk population and the risk for colorectal cancer. Agents included medications (aspirin, NSAIDs, statins), vitamins or supplements (magnesium; calcium; folic acid; vitamin A, B, C, E, and D; beta-carotene; and selenium), and dietary items (coffee, tea, fish, dairy products, fiber, fruits, vegetables, meat, and alcohol).
The studies included randomized controlled trials and observational studies. Most of the meta-analyses found a protective effect for aspirin, which lowered the risk by between 14% and 29% even at doses as low as 75 mg/day, with a dose-response effect of up to 325 mg/day. The certainty of evidence was moderate.
NSAID use was also associated with a protective effect, with a significant 26%-43% decrease in the incidence in colorectal cancer. The optimal duration for the observed protective effect remains unclear. Two meta-analyses suggested that NSAIDs may need to be taken for at least 5 years, although one article suggested a protective effect after the first year. The certainty of evidence was low.
Use of magnesium was found to be protective, with a relative risk (RR) of 0.78-0.87. High intake of folic acid was associated with a significant decrease in risk (RR, 0.85-0.88). The certainty of evidence was low and very low, respectively.
Consumption of dairy products was associated with 13%-19% lower risk for the disease. However, the authors note that, because of the small number of available meta-analyses, the multiplicity of outcomes, and the variety of dairy products, it was not possible to reach any firm conclusions about the amount needed or the duration necessary for a protective effect.
Another dietary item, fiber, was associated with a 22%-43% lower risk. Consumption of fruits and vegetables was associated with up to a 52% lower risk, with an added benefit for every additional 100 g/day increase in intake. Soy intake was also associated with a small but significant decrease in risk (8%-15%).
For many of the other items reviewed, evidence was either weak or no beneficial effect was seen.
Increased risk
Consumption of both meat and alcohol was found to increase the risk for colorectal cancer.
Most of the meta-analyses of observational studies have reported a significant increase in risk (RR, 1.12-1.21) with meat consumption (particularly red and processed) and the incidence of colorectal cancer. Studies of the dose effect reported a 10%-30% increased risk for each increment of 100 g/day of total or red meat.
Alcohol consumption was also associated with a significantly increased risk. The higher the intake, the greater the risk. The risk was evident even at the lowest consumption doses that were investigated (1-2 drinks per day).
Balanced for the individual patient
Commenting on the article, Thomas J. George Jr, MD, professor of medicine and director, GI Oncology Program, the University of Florida Health Cancer Center, Gainesville, feels that the take-home message for clinicians and patients alike is that these data help to reinforce behaviors that have already been recommended.
“We know that excessive alcohol and red meat consumption is not healthy, so seeing that there may be a negative effect on colorectal cancer is just more evidence that we should be avoiding that and recommend avoiding that,” said Dr. George. “So yes, I recommend minimizing those, and likewise, a diet that is inclusive of fruits, vegetables, fiber, soy – perhaps as an alternative to meat consumption – is healthier than a diet devoid of these, so again, more reassuring data to support doing what we should already be doing.”
However, he pointed out that there are risks associated with medications such as NSAIDs and aspirin, including bleeding, gastric ulcer formation, and kidney damage. “The risks are low but very real,” Dr. George said. “So I think those recommendations need to be considered on a very individual level, balancing any other risk factors that the patient may have for both colorectal cancer, as well as risks from the medications.”
The study had no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new meta-analysis has largely confirmed what is already known about the lifestyle factors that increase and those that decrease the risk of developing colorectal cancer.
The use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a decreased risk for colorectal cancer, the new article concludes. But it also adds a number of other factors that are associated with a decreased risk for the disease, including taking magnesium and folate supplements and eating dairy products, fiber, soy, and fruits and vegetables.
On the other hand, consumption of meat and alcohol was associated with an increased risk for colorectal cancer in almost all of the analyses included in this article.
The study was published online September 28 in Gut.
However, the authors pointed out that it is important to keep in mind that in most cases, the level of evidence is low or very low, primarily because of the heterogeneity of the various published studies, as well as the type of study.
“Furthermore, in most cases, we were unable to identify an optimal dose and duration of exposure/intake for any of the products, even in the case of low-dose aspirin and other compounds that have been extensively assessed,” they wrote.
The findings of this new meta-analysis echo previous findings on this issue.
A number of studies, for example, have found varying associations between the consumption of red meat and cancer. The American Institute for Cancer Research and the World Cancer Research Fund have published several reports during the past 10 years on the effect of diet, nutrition, and/or physical activity on risk for several cancer types. Their most recent study, published in 2017, concluded that eating red meat and processed meat may increase the risk for colorectal cancer, as may drinking two or more alcoholic beverages per day.
Another large meta-analysis published earlier this year found that regular use of aspirin reduced the risk for cancers of the digestive tract by 22%-38%, compared with nonuse.
Umbrella review
In the latest article in Gut, researchers led by Marc Bardou, MD, PhD, Centre Hospitalier Universitaire de Dijon (France), conducted an umbrella review of systematic reviews and meta-analyses of interventions that assessed chemopreventive products for colorectal cancer in an average-risk population.
A total of 80 meta-analyses of interventional and observational studies were included. The studies investigated a wide range of chemopreventive agents in an average-risk population and the risk for colorectal cancer. Agents included medications (aspirin, NSAIDs, statins), vitamins or supplements (magnesium; calcium; folic acid; vitamin A, B, C, E, and D; beta-carotene; and selenium), and dietary items (coffee, tea, fish, dairy products, fiber, fruits, vegetables, meat, and alcohol).
The studies included randomized controlled trials and observational studies. Most of the meta-analyses found a protective effect for aspirin, which lowered the risk by between 14% and 29% even at doses as low as 75 mg/day, with a dose-response effect of up to 325 mg/day. The certainty of evidence was moderate.
NSAID use was also associated with a protective effect, with a significant 26%-43% decrease in the incidence in colorectal cancer. The optimal duration for the observed protective effect remains unclear. Two meta-analyses suggested that NSAIDs may need to be taken for at least 5 years, although one article suggested a protective effect after the first year. The certainty of evidence was low.
Use of magnesium was found to be protective, with a relative risk (RR) of 0.78-0.87. High intake of folic acid was associated with a significant decrease in risk (RR, 0.85-0.88). The certainty of evidence was low and very low, respectively.
Consumption of dairy products was associated with 13%-19% lower risk for the disease. However, the authors note that, because of the small number of available meta-analyses, the multiplicity of outcomes, and the variety of dairy products, it was not possible to reach any firm conclusions about the amount needed or the duration necessary for a protective effect.
Another dietary item, fiber, was associated with a 22%-43% lower risk. Consumption of fruits and vegetables was associated with up to a 52% lower risk, with an added benefit for every additional 100 g/day increase in intake. Soy intake was also associated with a small but significant decrease in risk (8%-15%).
For many of the other items reviewed, evidence was either weak or no beneficial effect was seen.
Increased risk
Consumption of both meat and alcohol was found to increase the risk for colorectal cancer.
Most of the meta-analyses of observational studies have reported a significant increase in risk (RR, 1.12-1.21) with meat consumption (particularly red and processed) and the incidence of colorectal cancer. Studies of the dose effect reported a 10%-30% increased risk for each increment of 100 g/day of total or red meat.
Alcohol consumption was also associated with a significantly increased risk. The higher the intake, the greater the risk. The risk was evident even at the lowest consumption doses that were investigated (1-2 drinks per day).
Balanced for the individual patient
Commenting on the article, Thomas J. George Jr, MD, professor of medicine and director, GI Oncology Program, the University of Florida Health Cancer Center, Gainesville, feels that the take-home message for clinicians and patients alike is that these data help to reinforce behaviors that have already been recommended.
“We know that excessive alcohol and red meat consumption is not healthy, so seeing that there may be a negative effect on colorectal cancer is just more evidence that we should be avoiding that and recommend avoiding that,” said Dr. George. “So yes, I recommend minimizing those, and likewise, a diet that is inclusive of fruits, vegetables, fiber, soy – perhaps as an alternative to meat consumption – is healthier than a diet devoid of these, so again, more reassuring data to support doing what we should already be doing.”
However, he pointed out that there are risks associated with medications such as NSAIDs and aspirin, including bleeding, gastric ulcer formation, and kidney damage. “The risks are low but very real,” Dr. George said. “So I think those recommendations need to be considered on a very individual level, balancing any other risk factors that the patient may have for both colorectal cancer, as well as risks from the medications.”
The study had no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new meta-analysis has largely confirmed what is already known about the lifestyle factors that increase and those that decrease the risk of developing colorectal cancer.
The use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a decreased risk for colorectal cancer, the new article concludes. But it also adds a number of other factors that are associated with a decreased risk for the disease, including taking magnesium and folate supplements and eating dairy products, fiber, soy, and fruits and vegetables.
On the other hand, consumption of meat and alcohol was associated with an increased risk for colorectal cancer in almost all of the analyses included in this article.
The study was published online September 28 in Gut.
However, the authors pointed out that it is important to keep in mind that in most cases, the level of evidence is low or very low, primarily because of the heterogeneity of the various published studies, as well as the type of study.
“Furthermore, in most cases, we were unable to identify an optimal dose and duration of exposure/intake for any of the products, even in the case of low-dose aspirin and other compounds that have been extensively assessed,” they wrote.
The findings of this new meta-analysis echo previous findings on this issue.
A number of studies, for example, have found varying associations between the consumption of red meat and cancer. The American Institute for Cancer Research and the World Cancer Research Fund have published several reports during the past 10 years on the effect of diet, nutrition, and/or physical activity on risk for several cancer types. Their most recent study, published in 2017, concluded that eating red meat and processed meat may increase the risk for colorectal cancer, as may drinking two or more alcoholic beverages per day.
Another large meta-analysis published earlier this year found that regular use of aspirin reduced the risk for cancers of the digestive tract by 22%-38%, compared with nonuse.
Umbrella review
In the latest article in Gut, researchers led by Marc Bardou, MD, PhD, Centre Hospitalier Universitaire de Dijon (France), conducted an umbrella review of systematic reviews and meta-analyses of interventions that assessed chemopreventive products for colorectal cancer in an average-risk population.
A total of 80 meta-analyses of interventional and observational studies were included. The studies investigated a wide range of chemopreventive agents in an average-risk population and the risk for colorectal cancer. Agents included medications (aspirin, NSAIDs, statins), vitamins or supplements (magnesium; calcium; folic acid; vitamin A, B, C, E, and D; beta-carotene; and selenium), and dietary items (coffee, tea, fish, dairy products, fiber, fruits, vegetables, meat, and alcohol).
The studies included randomized controlled trials and observational studies. Most of the meta-analyses found a protective effect for aspirin, which lowered the risk by between 14% and 29% even at doses as low as 75 mg/day, with a dose-response effect of up to 325 mg/day. The certainty of evidence was moderate.
NSAID use was also associated with a protective effect, with a significant 26%-43% decrease in the incidence in colorectal cancer. The optimal duration for the observed protective effect remains unclear. Two meta-analyses suggested that NSAIDs may need to be taken for at least 5 years, although one article suggested a protective effect after the first year. The certainty of evidence was low.
Use of magnesium was found to be protective, with a relative risk (RR) of 0.78-0.87. High intake of folic acid was associated with a significant decrease in risk (RR, 0.85-0.88). The certainty of evidence was low and very low, respectively.
Consumption of dairy products was associated with 13%-19% lower risk for the disease. However, the authors note that, because of the small number of available meta-analyses, the multiplicity of outcomes, and the variety of dairy products, it was not possible to reach any firm conclusions about the amount needed or the duration necessary for a protective effect.
Another dietary item, fiber, was associated with a 22%-43% lower risk. Consumption of fruits and vegetables was associated with up to a 52% lower risk, with an added benefit for every additional 100 g/day increase in intake. Soy intake was also associated with a small but significant decrease in risk (8%-15%).
For many of the other items reviewed, evidence was either weak or no beneficial effect was seen.
Increased risk
Consumption of both meat and alcohol was found to increase the risk for colorectal cancer.
Most of the meta-analyses of observational studies have reported a significant increase in risk (RR, 1.12-1.21) with meat consumption (particularly red and processed) and the incidence of colorectal cancer. Studies of the dose effect reported a 10%-30% increased risk for each increment of 100 g/day of total or red meat.
Alcohol consumption was also associated with a significantly increased risk. The higher the intake, the greater the risk. The risk was evident even at the lowest consumption doses that were investigated (1-2 drinks per day).
Balanced for the individual patient
Commenting on the article, Thomas J. George Jr, MD, professor of medicine and director, GI Oncology Program, the University of Florida Health Cancer Center, Gainesville, feels that the take-home message for clinicians and patients alike is that these data help to reinforce behaviors that have already been recommended.
“We know that excessive alcohol and red meat consumption is not healthy, so seeing that there may be a negative effect on colorectal cancer is just more evidence that we should be avoiding that and recommend avoiding that,” said Dr. George. “So yes, I recommend minimizing those, and likewise, a diet that is inclusive of fruits, vegetables, fiber, soy – perhaps as an alternative to meat consumption – is healthier than a diet devoid of these, so again, more reassuring data to support doing what we should already be doing.”
However, he pointed out that there are risks associated with medications such as NSAIDs and aspirin, including bleeding, gastric ulcer formation, and kidney damage. “The risks are low but very real,” Dr. George said. “So I think those recommendations need to be considered on a very individual level, balancing any other risk factors that the patient may have for both colorectal cancer, as well as risks from the medications.”
The study had no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.