CT simulation not needed in palliative radiotherapy planning

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Thu, 10/05/2023 - 15:17

When planning for palliative radiotherapy, clinicians can forgo an additional CT scan on the same day as treatment and instead use a recent diagnostic CT scan, according to a results from a randomized trial presented at the annual meeting of the American Society for Radiation Oncology.

The aim of this same-day CT scan, called a CT simulation scan, is to optimize radiation targeting by mimicking the conditions under which radiation is delivered using the latest information on the size and location of lesions.

But investigators reported that skipping the CT simulation scan saves patients hours in the clinic, allows patients to experience pain relief faster, and saves radiation oncologists time without compromising dosimetric coverage of cancerous lesions.

“This is huge in a symptomatic patient population,” said Melissa O’Neil, an advanced practice radiation therapist at the London, Ont., Health Sciences Centre and the lead investigator on the trial, dubbed DART (Diagnostic CT-Enabled Radiation Therapy).

“Diagnostic CT-based radiation planning substantially reduces time in the [treatment] center without a detriment in plan deliverability or quality,” Ms. O’Neil said.

In addition, patients are exposed to less radiation, and staff doesn’t have to spend as much time tending to symptomatic patients before treatment. Omitting this scan “should be considered for patients with a recent diagnostic CT scan who are undergoing simple palliative radiation,” Ms. O’Neil said.

CT simulation scans are standard of care in cases involving palliative radiation, but they create bottlenecks in the workflow. When a CT simulation is performed on the day of treatment, patients must wait hours as the results are translated into a treatment plan.

In the DART analysis, 33 patients with 42 treatment sites were randomly assigned to CT simulation planning or diagnostic CT planning.

Patients received up to 30 Gy in up to 10 fractions for bone or soft tissue metastases or primary tumor targets in the thorax, abdomen, pelvis, or proximal limbs. Single-fraction treatments were most common.

Three-quarters of the patients were men (median age, 72 years). Lung cancer was the most common type of primary tumor, followed by prostate and breast cancer.

The eight participants for whom the CT simulation approach was used waited 3-4 hours for treatment planning and overall spent a median of 4.8 hours in the cancer center on their day of treatment.

The 25 patients for whom diagnostic CT planning was used spent a median of 0.4 hours, or about 24 minutes, in the center on their day of treatment because radiation plans were completed before they arrived. The median time between their diagnostic CTs and radiation treatment was 13 days (range, 8-22 days).

Ms. O’Neil and her team found that if the original diagnostic CT was performed within 28 days, lesion anatomy would not have changed enough to warrant a new scan.

On the day of treatment, the study team used surface-guided radiation therapy techniques to ensure patients in the diagnostic CT planning group were positioned within 3 mm of where they were during their diagnostic scans, an essential step to ensure that radiation is delivered to the correct location. Ms. O’Neil noted that other investigators have used anatomic landmarks, a simpler approach, to achieve these results.

Overall, radiation oncologists rated radiation dose distribution as “acceptable” in about 80% of cases in both arms of DART and “acceptable with minor deviation” in the remaining 20% of cases.

Every radiation oncologist and medical physicists in the trial gave the workflow with diagnostic CT planning a 5 out of 5 rating for acceptability, and 90% of patients in this group rated the amount of time they spent for treatment as “acceptable.”

In contrast, only half of patients in the simulation arm said the amount of time spent was acceptable.

These findings align with several previous studies that support the diagnostic approach.

Jacob Scott, MD, a radiation oncologist at the Cleveland Clinic, said, “The comparable results using a recent diagnostic CT in place of a CT simulation for palliative radiation is an exciting step forward in radiation oncology. We may soon be in a world where we no longer need simulations.”

Dr. Scott also noted that combining diagnostic scans with cone beam or surface-guided positioning in lieu of CT simulations could further save “the health system and patients time and money.”

No external funding for the study was reported. The investigators, Ms. O’Neil, and Dr. Scott have disclosed no relevant financial relationships. One investigator reported receiving honoraria from Knight Therapeutics, AbbVie, Tersera, and Eisai and owns stock in Myovant.

A version of this article first appeared on Medscape.com.

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When planning for palliative radiotherapy, clinicians can forgo an additional CT scan on the same day as treatment and instead use a recent diagnostic CT scan, according to a results from a randomized trial presented at the annual meeting of the American Society for Radiation Oncology.

The aim of this same-day CT scan, called a CT simulation scan, is to optimize radiation targeting by mimicking the conditions under which radiation is delivered using the latest information on the size and location of lesions.

But investigators reported that skipping the CT simulation scan saves patients hours in the clinic, allows patients to experience pain relief faster, and saves radiation oncologists time without compromising dosimetric coverage of cancerous lesions.

“This is huge in a symptomatic patient population,” said Melissa O’Neil, an advanced practice radiation therapist at the London, Ont., Health Sciences Centre and the lead investigator on the trial, dubbed DART (Diagnostic CT-Enabled Radiation Therapy).

“Diagnostic CT-based radiation planning substantially reduces time in the [treatment] center without a detriment in plan deliverability or quality,” Ms. O’Neil said.

In addition, patients are exposed to less radiation, and staff doesn’t have to spend as much time tending to symptomatic patients before treatment. Omitting this scan “should be considered for patients with a recent diagnostic CT scan who are undergoing simple palliative radiation,” Ms. O’Neil said.

CT simulation scans are standard of care in cases involving palliative radiation, but they create bottlenecks in the workflow. When a CT simulation is performed on the day of treatment, patients must wait hours as the results are translated into a treatment plan.

In the DART analysis, 33 patients with 42 treatment sites were randomly assigned to CT simulation planning or diagnostic CT planning.

Patients received up to 30 Gy in up to 10 fractions for bone or soft tissue metastases or primary tumor targets in the thorax, abdomen, pelvis, or proximal limbs. Single-fraction treatments were most common.

Three-quarters of the patients were men (median age, 72 years). Lung cancer was the most common type of primary tumor, followed by prostate and breast cancer.

The eight participants for whom the CT simulation approach was used waited 3-4 hours for treatment planning and overall spent a median of 4.8 hours in the cancer center on their day of treatment.

The 25 patients for whom diagnostic CT planning was used spent a median of 0.4 hours, or about 24 minutes, in the center on their day of treatment because radiation plans were completed before they arrived. The median time between their diagnostic CTs and radiation treatment was 13 days (range, 8-22 days).

Ms. O’Neil and her team found that if the original diagnostic CT was performed within 28 days, lesion anatomy would not have changed enough to warrant a new scan.

On the day of treatment, the study team used surface-guided radiation therapy techniques to ensure patients in the diagnostic CT planning group were positioned within 3 mm of where they were during their diagnostic scans, an essential step to ensure that radiation is delivered to the correct location. Ms. O’Neil noted that other investigators have used anatomic landmarks, a simpler approach, to achieve these results.

Overall, radiation oncologists rated radiation dose distribution as “acceptable” in about 80% of cases in both arms of DART and “acceptable with minor deviation” in the remaining 20% of cases.

Every radiation oncologist and medical physicists in the trial gave the workflow with diagnostic CT planning a 5 out of 5 rating for acceptability, and 90% of patients in this group rated the amount of time they spent for treatment as “acceptable.”

In contrast, only half of patients in the simulation arm said the amount of time spent was acceptable.

These findings align with several previous studies that support the diagnostic approach.

Jacob Scott, MD, a radiation oncologist at the Cleveland Clinic, said, “The comparable results using a recent diagnostic CT in place of a CT simulation for palliative radiation is an exciting step forward in radiation oncology. We may soon be in a world where we no longer need simulations.”

Dr. Scott also noted that combining diagnostic scans with cone beam or surface-guided positioning in lieu of CT simulations could further save “the health system and patients time and money.”

No external funding for the study was reported. The investigators, Ms. O’Neil, and Dr. Scott have disclosed no relevant financial relationships. One investigator reported receiving honoraria from Knight Therapeutics, AbbVie, Tersera, and Eisai and owns stock in Myovant.

A version of this article first appeared on Medscape.com.

When planning for palliative radiotherapy, clinicians can forgo an additional CT scan on the same day as treatment and instead use a recent diagnostic CT scan, according to a results from a randomized trial presented at the annual meeting of the American Society for Radiation Oncology.

The aim of this same-day CT scan, called a CT simulation scan, is to optimize radiation targeting by mimicking the conditions under which radiation is delivered using the latest information on the size and location of lesions.

But investigators reported that skipping the CT simulation scan saves patients hours in the clinic, allows patients to experience pain relief faster, and saves radiation oncologists time without compromising dosimetric coverage of cancerous lesions.

“This is huge in a symptomatic patient population,” said Melissa O’Neil, an advanced practice radiation therapist at the London, Ont., Health Sciences Centre and the lead investigator on the trial, dubbed DART (Diagnostic CT-Enabled Radiation Therapy).

“Diagnostic CT-based radiation planning substantially reduces time in the [treatment] center without a detriment in plan deliverability or quality,” Ms. O’Neil said.

In addition, patients are exposed to less radiation, and staff doesn’t have to spend as much time tending to symptomatic patients before treatment. Omitting this scan “should be considered for patients with a recent diagnostic CT scan who are undergoing simple palliative radiation,” Ms. O’Neil said.

CT simulation scans are standard of care in cases involving palliative radiation, but they create bottlenecks in the workflow. When a CT simulation is performed on the day of treatment, patients must wait hours as the results are translated into a treatment plan.

In the DART analysis, 33 patients with 42 treatment sites were randomly assigned to CT simulation planning or diagnostic CT planning.

Patients received up to 30 Gy in up to 10 fractions for bone or soft tissue metastases or primary tumor targets in the thorax, abdomen, pelvis, or proximal limbs. Single-fraction treatments were most common.

Three-quarters of the patients were men (median age, 72 years). Lung cancer was the most common type of primary tumor, followed by prostate and breast cancer.

The eight participants for whom the CT simulation approach was used waited 3-4 hours for treatment planning and overall spent a median of 4.8 hours in the cancer center on their day of treatment.

The 25 patients for whom diagnostic CT planning was used spent a median of 0.4 hours, or about 24 minutes, in the center on their day of treatment because radiation plans were completed before they arrived. The median time between their diagnostic CTs and radiation treatment was 13 days (range, 8-22 days).

Ms. O’Neil and her team found that if the original diagnostic CT was performed within 28 days, lesion anatomy would not have changed enough to warrant a new scan.

On the day of treatment, the study team used surface-guided radiation therapy techniques to ensure patients in the diagnostic CT planning group were positioned within 3 mm of where they were during their diagnostic scans, an essential step to ensure that radiation is delivered to the correct location. Ms. O’Neil noted that other investigators have used anatomic landmarks, a simpler approach, to achieve these results.

Overall, radiation oncologists rated radiation dose distribution as “acceptable” in about 80% of cases in both arms of DART and “acceptable with minor deviation” in the remaining 20% of cases.

Every radiation oncologist and medical physicists in the trial gave the workflow with diagnostic CT planning a 5 out of 5 rating for acceptability, and 90% of patients in this group rated the amount of time they spent for treatment as “acceptable.”

In contrast, only half of patients in the simulation arm said the amount of time spent was acceptable.

These findings align with several previous studies that support the diagnostic approach.

Jacob Scott, MD, a radiation oncologist at the Cleveland Clinic, said, “The comparable results using a recent diagnostic CT in place of a CT simulation for palliative radiation is an exciting step forward in radiation oncology. We may soon be in a world where we no longer need simulations.”

Dr. Scott also noted that combining diagnostic scans with cone beam or surface-guided positioning in lieu of CT simulations could further save “the health system and patients time and money.”

No external funding for the study was reported. The investigators, Ms. O’Neil, and Dr. Scott have disclosed no relevant financial relationships. One investigator reported receiving honoraria from Knight Therapeutics, AbbVie, Tersera, and Eisai and owns stock in Myovant.

A version of this article first appeared on Medscape.com.

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Cost concerns lead to cancer treatment delays, nonadherence

Article Type
Changed
Thu, 10/05/2023 - 19:29

 

TOPLINE:

When patients deal directly with their insurance companies for answers about copayments and other issues, they are more likely to experience delays in cancer care and to be nonadherent.

METHODOLOGY:

  • Navigating the complexities of insurance coverage is difficult for cancer patients, and the clinical impact of managing these intricacies remains unclear.
  • To understand the issue, investigators surveyed 510 insured cancer patients in the United States about how often they estimate out-of-pocket costs for medications, doctors’ visits, and lab tests and scans, as well as how often they ask their insurance company to help them understand their coverage and how often they appeal coverage decisions.
  • The team then correlated the answers with how often patients reported postponing or skipping doctors’ appointments and lab tests and how often they delayed filling prescriptions or skipped doses.
  • Breast, colorectal, lung, and prostate cancer were the most common diagnoses among respondents.

TAKEAWAY:

  • Overall, 55% of participants said they “never” or “rarely” engaged in any insurance-related cost tasks. The most frequently performed administrative tasks included finding out the cost before filling a prescription (28%) or before undergoing lab tests or scans (20%), as well as estimating the cost before agreeing to a treatment (20%), asking an insurance company for help understanding coverage (18%), or appealing a denial (17%).
  • After adjusting for age, race/ethnicity, education, and monthly out-of-pocket costs, participants who engaged in any cost task were 18% more likely to experience treatment delays or forgo care.
  • Every additional cost task or increase in frequency of a cost task was associated with 32% higher frequency of treatment delay or nonadherence.
  • Age, race, and monthly out-of-pocket costs were more strongly associated with treatment delays/nonadherence than cost-task burden. Younger patients and Black patients were more likely than others to experience cost-related delays/nonadherence.

IN PRACTICE:

  • “Reductions to administrative burden on patients, whether through patient-level education interventions, the adaptation of hospital-based navigation programs, or policy-focused changes to insurance systems, will be crucial” for helping patients with cancer to overcome administrative burdens and improve access to care, the authors said.

SOURCE:

  • The study, led by Meredith Doherty, PhD, of the University of Pennsylvania, Philadelphia, was published in Cancer Epidemiology, Biomarkers and Prevention.

LIMITATIONS:

The survey was voluntary, which raises the possibility of self-selection bias. Recall bias may also have occurred, particularly among patients farther out from diagnosis and treatment. The investigators did not include uninsured patients and did not stratify patients by insurance type, and they did not measure or account for health care literacy.

DISCLOSURES:

The study was funded by the American Cancer Society. The investigators have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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TOPLINE:

When patients deal directly with their insurance companies for answers about copayments and other issues, they are more likely to experience delays in cancer care and to be nonadherent.

METHODOLOGY:

  • Navigating the complexities of insurance coverage is difficult for cancer patients, and the clinical impact of managing these intricacies remains unclear.
  • To understand the issue, investigators surveyed 510 insured cancer patients in the United States about how often they estimate out-of-pocket costs for medications, doctors’ visits, and lab tests and scans, as well as how often they ask their insurance company to help them understand their coverage and how often they appeal coverage decisions.
  • The team then correlated the answers with how often patients reported postponing or skipping doctors’ appointments and lab tests and how often they delayed filling prescriptions or skipped doses.
  • Breast, colorectal, lung, and prostate cancer were the most common diagnoses among respondents.

TAKEAWAY:

  • Overall, 55% of participants said they “never” or “rarely” engaged in any insurance-related cost tasks. The most frequently performed administrative tasks included finding out the cost before filling a prescription (28%) or before undergoing lab tests or scans (20%), as well as estimating the cost before agreeing to a treatment (20%), asking an insurance company for help understanding coverage (18%), or appealing a denial (17%).
  • After adjusting for age, race/ethnicity, education, and monthly out-of-pocket costs, participants who engaged in any cost task were 18% more likely to experience treatment delays or forgo care.
  • Every additional cost task or increase in frequency of a cost task was associated with 32% higher frequency of treatment delay or nonadherence.
  • Age, race, and monthly out-of-pocket costs were more strongly associated with treatment delays/nonadherence than cost-task burden. Younger patients and Black patients were more likely than others to experience cost-related delays/nonadherence.

IN PRACTICE:

  • “Reductions to administrative burden on patients, whether through patient-level education interventions, the adaptation of hospital-based navigation programs, or policy-focused changes to insurance systems, will be crucial” for helping patients with cancer to overcome administrative burdens and improve access to care, the authors said.

SOURCE:

  • The study, led by Meredith Doherty, PhD, of the University of Pennsylvania, Philadelphia, was published in Cancer Epidemiology, Biomarkers and Prevention.

LIMITATIONS:

The survey was voluntary, which raises the possibility of self-selection bias. Recall bias may also have occurred, particularly among patients farther out from diagnosis and treatment. The investigators did not include uninsured patients and did not stratify patients by insurance type, and they did not measure or account for health care literacy.

DISCLOSURES:

The study was funded by the American Cancer Society. The investigators have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

TOPLINE:

When patients deal directly with their insurance companies for answers about copayments and other issues, they are more likely to experience delays in cancer care and to be nonadherent.

METHODOLOGY:

  • Navigating the complexities of insurance coverage is difficult for cancer patients, and the clinical impact of managing these intricacies remains unclear.
  • To understand the issue, investigators surveyed 510 insured cancer patients in the United States about how often they estimate out-of-pocket costs for medications, doctors’ visits, and lab tests and scans, as well as how often they ask their insurance company to help them understand their coverage and how often they appeal coverage decisions.
  • The team then correlated the answers with how often patients reported postponing or skipping doctors’ appointments and lab tests and how often they delayed filling prescriptions or skipped doses.
  • Breast, colorectal, lung, and prostate cancer were the most common diagnoses among respondents.

TAKEAWAY:

  • Overall, 55% of participants said they “never” or “rarely” engaged in any insurance-related cost tasks. The most frequently performed administrative tasks included finding out the cost before filling a prescription (28%) or before undergoing lab tests or scans (20%), as well as estimating the cost before agreeing to a treatment (20%), asking an insurance company for help understanding coverage (18%), or appealing a denial (17%).
  • After adjusting for age, race/ethnicity, education, and monthly out-of-pocket costs, participants who engaged in any cost task were 18% more likely to experience treatment delays or forgo care.
  • Every additional cost task or increase in frequency of a cost task was associated with 32% higher frequency of treatment delay or nonadherence.
  • Age, race, and monthly out-of-pocket costs were more strongly associated with treatment delays/nonadherence than cost-task burden. Younger patients and Black patients were more likely than others to experience cost-related delays/nonadherence.

IN PRACTICE:

  • “Reductions to administrative burden on patients, whether through patient-level education interventions, the adaptation of hospital-based navigation programs, or policy-focused changes to insurance systems, will be crucial” for helping patients with cancer to overcome administrative burdens and improve access to care, the authors said.

SOURCE:

  • The study, led by Meredith Doherty, PhD, of the University of Pennsylvania, Philadelphia, was published in Cancer Epidemiology, Biomarkers and Prevention.

LIMITATIONS:

The survey was voluntary, which raises the possibility of self-selection bias. Recall bias may also have occurred, particularly among patients farther out from diagnosis and treatment. The investigators did not include uninsured patients and did not stratify patients by insurance type, and they did not measure or account for health care literacy.

DISCLOSURES:

The study was funded by the American Cancer Society. The investigators have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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FDA approves bosutinib for children with CML

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Fri, 09/29/2023 - 11:24

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m2, the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m2, the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

A version of this article first appeared on Medscape.com.

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The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m2, the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m2, the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m2, the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m2, the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

A version of this article first appeared on Medscape.com.

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Older women who get mammograms risk overdiagnosis

Article Type
Changed
Wed, 09/27/2023 - 09:31

 

TOPLINE:

Women who continue breast cancer screening after age 70 face a considerable risk for overdiagnosis.

METHODOLOGY:

  • Overdiagnosis – the risk of detecting and treating cancers that would never have caused issues in a person’s lifetime – is increasingly recognized as a harm of breast cancer screening; however, the scope of the problem among older women remains uncertain. 
  • To get an idea, investigators linked Medicare claims data with Surveillance, Epidemiology, and End Results (SEER) data for 54,635 women 70 years or older to compare the incidence of breast cancer and breast cancer–specific death among women who continued screening mammography with those who did not.
  • The women all had undergone recent screening mammograms and had no history of breast cancer at study entry. Those who had a subsequent mammogram within 3 years were classified as undergoing continued screening while those who did not were classified as not undergoing continued screening.
  • Overdiagnosis was defined as the difference in cumulative incidence of breast cancer between screened and unscreened women divided by the cumulative incidence among screened women. 
  • Results were adjusted for potential confounders, including age, race, and ethnicity.

TAKEAWAY:

  • Over 80% of women 70-84 years old and more than 60% of women 85 years or older continued screening.
  • Among women 70-74 years old, the adjusted cumulative incidence of breast cancer was 6.1 cases per 100 screened women vs. 4.2 cases per 100 unscreened women; for women aged 75-84 years old, the cumulative incidence was 4.9 per 100 screened women vs. 2.6 per 100 unscreened women, and for women 85 years and older, the cumulative incidence was 2.8 vs. 1.3 per 100, respectively.
  • Estimates of overdiagnosis ranged from 31% of breast cancer cases among screened women in the 70-74 age group to 54% of cases in the 85 and older group.
  • The researchers found no statistically significant reduction in breast cancer–specific death associated with screening in any age or life-expectancy group. Overdiagnosis appeared to be driven by in situ and localized invasive breast cancer, not advanced breast cancer.

IN PRACTICE:

The proportion of older women who continue to receive screening mammograms and may experience breast cancer overdiagnosis is “considerable” and “increases with advancing age and with decreasing life expectancy,” the authors conclude. Given potential benefits and harms of screening in this population, “patient preferences, including risk tolerance, comfort with uncertainty, and willingness to undergo treatment, are important for informing screening decisions.”

SOURCE:

The study was led by Ilana Richman, MD, MHS, of the Yale School of Medicine, New Haven, Connecticut, and published in the Annals of Internal Medicine.

LIMITATIONS:

The definition of screening mammography in the study may have misclassified some diagnostic mammograms as screening. Using a more conservative definition of screening mammogram, which largely accounted for this misclassification, estimates for overdiagnosis were smaller, ranging from 15% of cases in the 70-74 age group to 44% of cases in the 85 and older group. Results could not be adjusted for breast density, family history, and other breast cancer risk factors not captured by the data.

DISCLOSURES:

The work was funded by the National Cancer Institute. One author reported funding from Genentech and Johnson & Johnson.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Women who continue breast cancer screening after age 70 face a considerable risk for overdiagnosis.

METHODOLOGY:

  • Overdiagnosis – the risk of detecting and treating cancers that would never have caused issues in a person’s lifetime – is increasingly recognized as a harm of breast cancer screening; however, the scope of the problem among older women remains uncertain. 
  • To get an idea, investigators linked Medicare claims data with Surveillance, Epidemiology, and End Results (SEER) data for 54,635 women 70 years or older to compare the incidence of breast cancer and breast cancer–specific death among women who continued screening mammography with those who did not.
  • The women all had undergone recent screening mammograms and had no history of breast cancer at study entry. Those who had a subsequent mammogram within 3 years were classified as undergoing continued screening while those who did not were classified as not undergoing continued screening.
  • Overdiagnosis was defined as the difference in cumulative incidence of breast cancer between screened and unscreened women divided by the cumulative incidence among screened women. 
  • Results were adjusted for potential confounders, including age, race, and ethnicity.

TAKEAWAY:

  • Over 80% of women 70-84 years old and more than 60% of women 85 years or older continued screening.
  • Among women 70-74 years old, the adjusted cumulative incidence of breast cancer was 6.1 cases per 100 screened women vs. 4.2 cases per 100 unscreened women; for women aged 75-84 years old, the cumulative incidence was 4.9 per 100 screened women vs. 2.6 per 100 unscreened women, and for women 85 years and older, the cumulative incidence was 2.8 vs. 1.3 per 100, respectively.
  • Estimates of overdiagnosis ranged from 31% of breast cancer cases among screened women in the 70-74 age group to 54% of cases in the 85 and older group.
  • The researchers found no statistically significant reduction in breast cancer–specific death associated with screening in any age or life-expectancy group. Overdiagnosis appeared to be driven by in situ and localized invasive breast cancer, not advanced breast cancer.

IN PRACTICE:

The proportion of older women who continue to receive screening mammograms and may experience breast cancer overdiagnosis is “considerable” and “increases with advancing age and with decreasing life expectancy,” the authors conclude. Given potential benefits and harms of screening in this population, “patient preferences, including risk tolerance, comfort with uncertainty, and willingness to undergo treatment, are important for informing screening decisions.”

SOURCE:

The study was led by Ilana Richman, MD, MHS, of the Yale School of Medicine, New Haven, Connecticut, and published in the Annals of Internal Medicine.

LIMITATIONS:

The definition of screening mammography in the study may have misclassified some diagnostic mammograms as screening. Using a more conservative definition of screening mammogram, which largely accounted for this misclassification, estimates for overdiagnosis were smaller, ranging from 15% of cases in the 70-74 age group to 44% of cases in the 85 and older group. Results could not be adjusted for breast density, family history, and other breast cancer risk factors not captured by the data.

DISCLOSURES:

The work was funded by the National Cancer Institute. One author reported funding from Genentech and Johnson & Johnson.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Women who continue breast cancer screening after age 70 face a considerable risk for overdiagnosis.

METHODOLOGY:

  • Overdiagnosis – the risk of detecting and treating cancers that would never have caused issues in a person’s lifetime – is increasingly recognized as a harm of breast cancer screening; however, the scope of the problem among older women remains uncertain. 
  • To get an idea, investigators linked Medicare claims data with Surveillance, Epidemiology, and End Results (SEER) data for 54,635 women 70 years or older to compare the incidence of breast cancer and breast cancer–specific death among women who continued screening mammography with those who did not.
  • The women all had undergone recent screening mammograms and had no history of breast cancer at study entry. Those who had a subsequent mammogram within 3 years were classified as undergoing continued screening while those who did not were classified as not undergoing continued screening.
  • Overdiagnosis was defined as the difference in cumulative incidence of breast cancer between screened and unscreened women divided by the cumulative incidence among screened women. 
  • Results were adjusted for potential confounders, including age, race, and ethnicity.

TAKEAWAY:

  • Over 80% of women 70-84 years old and more than 60% of women 85 years or older continued screening.
  • Among women 70-74 years old, the adjusted cumulative incidence of breast cancer was 6.1 cases per 100 screened women vs. 4.2 cases per 100 unscreened women; for women aged 75-84 years old, the cumulative incidence was 4.9 per 100 screened women vs. 2.6 per 100 unscreened women, and for women 85 years and older, the cumulative incidence was 2.8 vs. 1.3 per 100, respectively.
  • Estimates of overdiagnosis ranged from 31% of breast cancer cases among screened women in the 70-74 age group to 54% of cases in the 85 and older group.
  • The researchers found no statistically significant reduction in breast cancer–specific death associated with screening in any age or life-expectancy group. Overdiagnosis appeared to be driven by in situ and localized invasive breast cancer, not advanced breast cancer.

IN PRACTICE:

The proportion of older women who continue to receive screening mammograms and may experience breast cancer overdiagnosis is “considerable” and “increases with advancing age and with decreasing life expectancy,” the authors conclude. Given potential benefits and harms of screening in this population, “patient preferences, including risk tolerance, comfort with uncertainty, and willingness to undergo treatment, are important for informing screening decisions.”

SOURCE:

The study was led by Ilana Richman, MD, MHS, of the Yale School of Medicine, New Haven, Connecticut, and published in the Annals of Internal Medicine.

LIMITATIONS:

The definition of screening mammography in the study may have misclassified some diagnostic mammograms as screening. Using a more conservative definition of screening mammogram, which largely accounted for this misclassification, estimates for overdiagnosis were smaller, ranging from 15% of cases in the 70-74 age group to 44% of cases in the 85 and older group. Results could not be adjusted for breast density, family history, and other breast cancer risk factors not captured by the data.

DISCLOSURES:

The work was funded by the National Cancer Institute. One author reported funding from Genentech and Johnson & Johnson.

A version of this article first appeared on Medscape.com.

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FDA approves JAK inhibitor momelotinib for myelofibrosis with anemia

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Mon, 09/18/2023 - 14:33

The Food and Drug Administration on Sept. 15 approved the Janus kinase (JAK) inhibitor momelotinib (Ojjaara) for myelofibrosis patients with anemia, according to a press release from maker GSK.

Momelotinib is the fourth JAK inhibitor to be approved by the agency for myelofibrosis but the only one indicated for patients with hemoglobin levels below 10 g/dL.

It’s an important development because, while JAK inhibitors are standard treatment for myelofibrosis, those previously approved for the uncommon blood cancer can cause cytopenia, particularly anemia, which, ironically, is also a hallmark of myelofibrosis itself.

This issue makes using JAK inhibitors for myelofibrosis challenging, according to Anthony Hunter, MD, a myeloid malignancies specialist at Emory University, Atlanta, who spoke on the topic recently at the annual meeting of the Society of Hematologic Oncology in Houston. “Momelotinib is an important emerging agent for these more anemic patients.” Momelotinib has a spleen response comparable with ruxolitinib – the first JAK inhibitor approved for myelofibrosis in the United States – and significantly higher rates of transfusion independence, although lower rates of symptom control, he said.

In GSK’s press release, hematologist/oncologist Ruben Mesa, MD, executive director of Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, N.C., said that, “with momelotinib, we have the potential to establish a new standard of care for myelofibrosis patients with anemia.”

Momelotinib’s specific indication is for “the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post–polycythemia vera and post–essential thrombocythemia), in adults with anemia.”

The once-daily oral medication was approved based on two trials. One trial, MOMENTUM, showed statistically significant response with respect to constitutional symptoms, splenic response, and transfusion independence in anemic patients treated with momelotinib versus danazol.

An anemic subset of the SIMPLIFY-1 trial showed comparable spleen volume reduction versus ruxolitinib but a numerically lower symptom response rate.

The most common momelotinib adverse reactions in trials were thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.

A version of this article appeared on Medscape.com.

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The Food and Drug Administration on Sept. 15 approved the Janus kinase (JAK) inhibitor momelotinib (Ojjaara) for myelofibrosis patients with anemia, according to a press release from maker GSK.

Momelotinib is the fourth JAK inhibitor to be approved by the agency for myelofibrosis but the only one indicated for patients with hemoglobin levels below 10 g/dL.

It’s an important development because, while JAK inhibitors are standard treatment for myelofibrosis, those previously approved for the uncommon blood cancer can cause cytopenia, particularly anemia, which, ironically, is also a hallmark of myelofibrosis itself.

This issue makes using JAK inhibitors for myelofibrosis challenging, according to Anthony Hunter, MD, a myeloid malignancies specialist at Emory University, Atlanta, who spoke on the topic recently at the annual meeting of the Society of Hematologic Oncology in Houston. “Momelotinib is an important emerging agent for these more anemic patients.” Momelotinib has a spleen response comparable with ruxolitinib – the first JAK inhibitor approved for myelofibrosis in the United States – and significantly higher rates of transfusion independence, although lower rates of symptom control, he said.

In GSK’s press release, hematologist/oncologist Ruben Mesa, MD, executive director of Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, N.C., said that, “with momelotinib, we have the potential to establish a new standard of care for myelofibrosis patients with anemia.”

Momelotinib’s specific indication is for “the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post–polycythemia vera and post–essential thrombocythemia), in adults with anemia.”

The once-daily oral medication was approved based on two trials. One trial, MOMENTUM, showed statistically significant response with respect to constitutional symptoms, splenic response, and transfusion independence in anemic patients treated with momelotinib versus danazol.

An anemic subset of the SIMPLIFY-1 trial showed comparable spleen volume reduction versus ruxolitinib but a numerically lower symptom response rate.

The most common momelotinib adverse reactions in trials were thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.

A version of this article appeared on Medscape.com.

The Food and Drug Administration on Sept. 15 approved the Janus kinase (JAK) inhibitor momelotinib (Ojjaara) for myelofibrosis patients with anemia, according to a press release from maker GSK.

Momelotinib is the fourth JAK inhibitor to be approved by the agency for myelofibrosis but the only one indicated for patients with hemoglobin levels below 10 g/dL.

It’s an important development because, while JAK inhibitors are standard treatment for myelofibrosis, those previously approved for the uncommon blood cancer can cause cytopenia, particularly anemia, which, ironically, is also a hallmark of myelofibrosis itself.

This issue makes using JAK inhibitors for myelofibrosis challenging, according to Anthony Hunter, MD, a myeloid malignancies specialist at Emory University, Atlanta, who spoke on the topic recently at the annual meeting of the Society of Hematologic Oncology in Houston. “Momelotinib is an important emerging agent for these more anemic patients.” Momelotinib has a spleen response comparable with ruxolitinib – the first JAK inhibitor approved for myelofibrosis in the United States – and significantly higher rates of transfusion independence, although lower rates of symptom control, he said.

In GSK’s press release, hematologist/oncologist Ruben Mesa, MD, executive director of Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, N.C., said that, “with momelotinib, we have the potential to establish a new standard of care for myelofibrosis patients with anemia.”

Momelotinib’s specific indication is for “the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post–polycythemia vera and post–essential thrombocythemia), in adults with anemia.”

The once-daily oral medication was approved based on two trials. One trial, MOMENTUM, showed statistically significant response with respect to constitutional symptoms, splenic response, and transfusion independence in anemic patients treated with momelotinib versus danazol.

An anemic subset of the SIMPLIFY-1 trial showed comparable spleen volume reduction versus ruxolitinib but a numerically lower symptom response rate.

The most common momelotinib adverse reactions in trials were thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.

A version of this article appeared on Medscape.com.

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FDA approves motixafortide for stem cell mobilization in myeloma

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Mon, 09/11/2023 - 17:51

 

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

A version of this article first appeared on Medscape.com.

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The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

A version of this article first appeared on Medscape.com.

 

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

A version of this article first appeared on Medscape.com.

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Delaying palliative chemo may improve QoL without affecting survival for asymptomatic patients

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Fri, 09/01/2023 - 17:25

 

TOPLINE:

Holding off on palliative chemotherapy until symptoms start appears to improve quality of life (QoL) without affecting survival for asymptomatic patients with advanced cancer.

METHODOLOGY:

  • Traditionally, chemotherapy is started immediately when advanced cancer is diagnosed, but delaying chemotherapy until symptoms start could improve QoL.
  • To find out, investigators performed a meta-analysis of five studies that explored the timing of palliative chemotherapy. The analysis included three randomized trials in advanced colorectal cancer (CRC), one in advanced ovarian cancer, and a review of patients with stage IV gastric cancer.
  • Of the 919 patients, treatment was delayed for 467 patients (50.8%) until symptoms started in the colorectal trials. It was delayed until tumor recurrence in the ovarian cancer trial, and it was delayed until a month or more had passed in the gastric cancer study, regardless of symptoms.
  • QoL was assessed largely by the EORTC-QLQ-C30 questionnaire. Median follow-up ranged from 11 to 60 months.

TAKEAWAY:

  • The researchers found no significant differences in overall survival between patients for whom chemotherapy was delayed and those for whom chemotherapy began immediately (pooled hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.90-1.22; P = .52).
  • Median overall survival was 11.9 to 25.7 months with immediate treatment, vs. 9 to 27.1 months with delayed treatment.
  • In the three studies that evaluated QoL, the findings suggested that QoL was largely better among patients whose treatment was delayed. In the CRC studies that assessed QoL, for instance, global health status in the delayed treatment group was higher than that in the immediate treatment group at almost all time points, but not significantly so.
  • Rates of grade 3/4 toxicities, evaluated in two studies, did not differ significantly between the groups.

IN PRACTICE:

There is limited evidence on the optimal timing for starting chemotherapy for asymptomatic patients with advanced cancer. In these studies, delaying chemotherapy until symptoms occurred did not result in worse overall survival compared with immediate treatment and may have resulted in better QoL, the researchers concluded. They noted that for asymptomatic patients, delaying the start of systemic therapy should be discussed with the patient.

SOURCE:

The study, led by Simone Augustinus of the University of Amsterdam, was published online Aug. 17 in The Oncologist.

LIMITATIONS:

  • Only three types of cancer were included in the analysis, and the findings may not be generalizable to other types of cancer.
  • Some of the studies were older and employed out-of-date treatment regimens.
  • QoL was only evaluated in three of five studies and could not be evaluated overall in the meta-analysis because of the different time points measured in each trial.

DISCLOSURES:

The study received no external funding. Two investigators have advisory, speaker, and/or research ties to Celgene, Novartis, AstraZeneca, and other companies.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Holding off on palliative chemotherapy until symptoms start appears to improve quality of life (QoL) without affecting survival for asymptomatic patients with advanced cancer.

METHODOLOGY:

  • Traditionally, chemotherapy is started immediately when advanced cancer is diagnosed, but delaying chemotherapy until symptoms start could improve QoL.
  • To find out, investigators performed a meta-analysis of five studies that explored the timing of palliative chemotherapy. The analysis included three randomized trials in advanced colorectal cancer (CRC), one in advanced ovarian cancer, and a review of patients with stage IV gastric cancer.
  • Of the 919 patients, treatment was delayed for 467 patients (50.8%) until symptoms started in the colorectal trials. It was delayed until tumor recurrence in the ovarian cancer trial, and it was delayed until a month or more had passed in the gastric cancer study, regardless of symptoms.
  • QoL was assessed largely by the EORTC-QLQ-C30 questionnaire. Median follow-up ranged from 11 to 60 months.

TAKEAWAY:

  • The researchers found no significant differences in overall survival between patients for whom chemotherapy was delayed and those for whom chemotherapy began immediately (pooled hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.90-1.22; P = .52).
  • Median overall survival was 11.9 to 25.7 months with immediate treatment, vs. 9 to 27.1 months with delayed treatment.
  • In the three studies that evaluated QoL, the findings suggested that QoL was largely better among patients whose treatment was delayed. In the CRC studies that assessed QoL, for instance, global health status in the delayed treatment group was higher than that in the immediate treatment group at almost all time points, but not significantly so.
  • Rates of grade 3/4 toxicities, evaluated in two studies, did not differ significantly between the groups.

IN PRACTICE:

There is limited evidence on the optimal timing for starting chemotherapy for asymptomatic patients with advanced cancer. In these studies, delaying chemotherapy until symptoms occurred did not result in worse overall survival compared with immediate treatment and may have resulted in better QoL, the researchers concluded. They noted that for asymptomatic patients, delaying the start of systemic therapy should be discussed with the patient.

SOURCE:

The study, led by Simone Augustinus of the University of Amsterdam, was published online Aug. 17 in The Oncologist.

LIMITATIONS:

  • Only three types of cancer were included in the analysis, and the findings may not be generalizable to other types of cancer.
  • Some of the studies were older and employed out-of-date treatment regimens.
  • QoL was only evaluated in three of five studies and could not be evaluated overall in the meta-analysis because of the different time points measured in each trial.

DISCLOSURES:

The study received no external funding. Two investigators have advisory, speaker, and/or research ties to Celgene, Novartis, AstraZeneca, and other companies.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Holding off on palliative chemotherapy until symptoms start appears to improve quality of life (QoL) without affecting survival for asymptomatic patients with advanced cancer.

METHODOLOGY:

  • Traditionally, chemotherapy is started immediately when advanced cancer is diagnosed, but delaying chemotherapy until symptoms start could improve QoL.
  • To find out, investigators performed a meta-analysis of five studies that explored the timing of palliative chemotherapy. The analysis included three randomized trials in advanced colorectal cancer (CRC), one in advanced ovarian cancer, and a review of patients with stage IV gastric cancer.
  • Of the 919 patients, treatment was delayed for 467 patients (50.8%) until symptoms started in the colorectal trials. It was delayed until tumor recurrence in the ovarian cancer trial, and it was delayed until a month or more had passed in the gastric cancer study, regardless of symptoms.
  • QoL was assessed largely by the EORTC-QLQ-C30 questionnaire. Median follow-up ranged from 11 to 60 months.

TAKEAWAY:

  • The researchers found no significant differences in overall survival between patients for whom chemotherapy was delayed and those for whom chemotherapy began immediately (pooled hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.90-1.22; P = .52).
  • Median overall survival was 11.9 to 25.7 months with immediate treatment, vs. 9 to 27.1 months with delayed treatment.
  • In the three studies that evaluated QoL, the findings suggested that QoL was largely better among patients whose treatment was delayed. In the CRC studies that assessed QoL, for instance, global health status in the delayed treatment group was higher than that in the immediate treatment group at almost all time points, but not significantly so.
  • Rates of grade 3/4 toxicities, evaluated in two studies, did not differ significantly between the groups.

IN PRACTICE:

There is limited evidence on the optimal timing for starting chemotherapy for asymptomatic patients with advanced cancer. In these studies, delaying chemotherapy until symptoms occurred did not result in worse overall survival compared with immediate treatment and may have resulted in better QoL, the researchers concluded. They noted that for asymptomatic patients, delaying the start of systemic therapy should be discussed with the patient.

SOURCE:

The study, led by Simone Augustinus of the University of Amsterdam, was published online Aug. 17 in The Oncologist.

LIMITATIONS:

  • Only three types of cancer were included in the analysis, and the findings may not be generalizable to other types of cancer.
  • Some of the studies were older and employed out-of-date treatment regimens.
  • QoL was only evaluated in three of five studies and could not be evaluated overall in the meta-analysis because of the different time points measured in each trial.

DISCLOSURES:

The study received no external funding. Two investigators have advisory, speaker, and/or research ties to Celgene, Novartis, AstraZeneca, and other companies.

A version of this article first appeared on Medscape.com.

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Liver transplant in CRC: Who might benefit?

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Thu, 10/05/2023 - 19:31

For carefully selected patients with colorectal cancer (CRC), a liver transplant may offer long-term survival and potentially even cure unresectable liver metastases.

Findings from a Norwegian review of 61 patients who had liver transplants for unresectable colorectal liver metastases found half of patients were still alive at 5 years, and about one in five appeared to be cured at 10 years.

“It seems likely that there is a small group of patients with unresectable colorectal liver metastases who should be considered for transplant, and long-term survival and possibly cure are achievable in these patients with appropriate selection,” Ryan Ellis, MD, and Michael D’Angelica, MD, wrote in a commentary published alongside the study in JAMA Surgery.

The core question, however, is how to identify patients who will benefit the most from a liver transplant, said Dr. Ellis and Dr. D’Angelica, both surgical oncologists in the Hepatopancreatobiliary Service at Memorial Sloan Kettering Cancer Center, New York. Looking closely at who did well in this analysis can offer clues to appropriate patient selection, the editorialists said.

Three decades ago, the oncology community had largely abandoned liver transplant in this population after studies showed overall 5-year survival of less than 20%. Some patients, however, did better, which prompted the Norwegian investigators to attempt to refine patient selection.

In the current prospective nonrandomized study, 61 patients had liver transplants for unresectable metastases at Oslo University Hospital from 2006 to 2020.

The researchers reported a median overall survival of 60.3 months, with about half of patients (50.4%) alive at 5 years.

Most patients (78.3%) experienced a relapse after liver transplant, with a median time to relapse of 9 months and with most occurring within 2 years of transplant. Median overall survival from time of relapse was 37.1 months, with 5-year survival at nearly 35% in this group and with one patient still alive 156 months after relapse.

The remaining 21.7% of patients (n = 13) did not experience a relapse post-transplant at their last follow-up.

Given the variety of responses to liver transplant, how can experts differentiate patients who will benefit most from those who won’t?

The researchers looked at several factors, including Oslo score and Fong Clinical Risk Score. The Oslo score assesses overall survival among liver transplant patients, while the Fong score predicts recurrence risk for patients with CRC liver metastasis following resection. These scores assign one point for each adverse prognostic factor.

Among the 10 patients who had an Oslo Score of 0, median overall survival was 151.6 months, and the 5-year and 10-year survival rates reached nearly 89%. Among the 27 patients with an Oslo Score of 1, median overall survival was 60.3 months, and 5-year overall survival was 54.7%. No patients with an Oslo score of 4 lived for 5 years.

As for FCRS, median overall survival was 164.9 months among those with a score of 1, 90.5 months among those with a score of 2, 59.9 months for those with a score of 3, 32.8 months for those with a score of 4, and 25.3 months for those with the highest score of 5 (P < .001). Overall, these patients had 5-year overall survival of 100%, 63.9%, 49.4%, 33.3%, and 0%, respectively.

In addition to Oslo and Fong scores, metabolic tumor volume on PET scan (PET-MTV) was also a good prognostic factor for survival. Among the 40 patients with MTV values less than 70 cm3, median 5-year overall survival was nearly 67%, while those with values above 70 cm3 had a median 5-year overall survival of 23.3%.

Additional harbingers of low 5-year survival, in addition to higher Oslo and Fong scores and PET-MTV above 70 cm3, included a tumor size greater than 5.5 cm, progressive disease while receiving chemotherapy, primary tumors in the ascending colon, tumor burden scores of 9 or higher, and nine or more liver lesions.

Overall, the current analysis can help oncologists identify patients who may benefit from a liver transplant.

The findings indicate that “patients with liver-only metastases and favorable pretransplant prognostic scoring [have] long-term survival comparable with conventional indications for liver transplant, thus providing a potential curative treatment option in patients otherwise offered only palliative care,” said investigators led by Svein Dueland, MD, PhD, a member of the Transplant Oncology Research Group at Oslo University Hospital.

Perhaps “the most compelling argument in favor of liver transplant lies in the likely curative potential evidenced by the 13 disease-free patients,” Dr. Ellis and Dr. D’Angelica wrote.

But even some patients who had early recurrences did well following transplant. The investigators noted that early recurrences in this population aren’t as dire as in other settings because they generally manifest as slow growing lung metastases that can be caught early and resected with curative intent.

A major hurdle to broader use of liver transplants in this population is the scarcity of donor grafts. To manage demand, the investigators suggested “extended-criteria donor grafts” – grafts that don’t meet ideal criteria – and the use of the RAPID technique for liver transplant, which opens the door to using one graft for two patients and using living donors with low risk to the donor.

Another challenge will be identifying patients with unresectable colorectal liver metastases who may experience long-term survival following transplant and possibly a cure. “We all will need to keep a sharp eye out for these patients – they might be hard to find!” Dr. Ellis and Dr. D’Angelica wrote.

The study was supported by Oslo University Hospital, the Norwegian Cancer Society, and South-Eastern Norway Regional Health Authority. The investigators and editorialists report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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For carefully selected patients with colorectal cancer (CRC), a liver transplant may offer long-term survival and potentially even cure unresectable liver metastases.

Findings from a Norwegian review of 61 patients who had liver transplants for unresectable colorectal liver metastases found half of patients were still alive at 5 years, and about one in five appeared to be cured at 10 years.

“It seems likely that there is a small group of patients with unresectable colorectal liver metastases who should be considered for transplant, and long-term survival and possibly cure are achievable in these patients with appropriate selection,” Ryan Ellis, MD, and Michael D’Angelica, MD, wrote in a commentary published alongside the study in JAMA Surgery.

The core question, however, is how to identify patients who will benefit the most from a liver transplant, said Dr. Ellis and Dr. D’Angelica, both surgical oncologists in the Hepatopancreatobiliary Service at Memorial Sloan Kettering Cancer Center, New York. Looking closely at who did well in this analysis can offer clues to appropriate patient selection, the editorialists said.

Three decades ago, the oncology community had largely abandoned liver transplant in this population after studies showed overall 5-year survival of less than 20%. Some patients, however, did better, which prompted the Norwegian investigators to attempt to refine patient selection.

In the current prospective nonrandomized study, 61 patients had liver transplants for unresectable metastases at Oslo University Hospital from 2006 to 2020.

The researchers reported a median overall survival of 60.3 months, with about half of patients (50.4%) alive at 5 years.

Most patients (78.3%) experienced a relapse after liver transplant, with a median time to relapse of 9 months and with most occurring within 2 years of transplant. Median overall survival from time of relapse was 37.1 months, with 5-year survival at nearly 35% in this group and with one patient still alive 156 months after relapse.

The remaining 21.7% of patients (n = 13) did not experience a relapse post-transplant at their last follow-up.

Given the variety of responses to liver transplant, how can experts differentiate patients who will benefit most from those who won’t?

The researchers looked at several factors, including Oslo score and Fong Clinical Risk Score. The Oslo score assesses overall survival among liver transplant patients, while the Fong score predicts recurrence risk for patients with CRC liver metastasis following resection. These scores assign one point for each adverse prognostic factor.

Among the 10 patients who had an Oslo Score of 0, median overall survival was 151.6 months, and the 5-year and 10-year survival rates reached nearly 89%. Among the 27 patients with an Oslo Score of 1, median overall survival was 60.3 months, and 5-year overall survival was 54.7%. No patients with an Oslo score of 4 lived for 5 years.

As for FCRS, median overall survival was 164.9 months among those with a score of 1, 90.5 months among those with a score of 2, 59.9 months for those with a score of 3, 32.8 months for those with a score of 4, and 25.3 months for those with the highest score of 5 (P < .001). Overall, these patients had 5-year overall survival of 100%, 63.9%, 49.4%, 33.3%, and 0%, respectively.

In addition to Oslo and Fong scores, metabolic tumor volume on PET scan (PET-MTV) was also a good prognostic factor for survival. Among the 40 patients with MTV values less than 70 cm3, median 5-year overall survival was nearly 67%, while those with values above 70 cm3 had a median 5-year overall survival of 23.3%.

Additional harbingers of low 5-year survival, in addition to higher Oslo and Fong scores and PET-MTV above 70 cm3, included a tumor size greater than 5.5 cm, progressive disease while receiving chemotherapy, primary tumors in the ascending colon, tumor burden scores of 9 or higher, and nine or more liver lesions.

Overall, the current analysis can help oncologists identify patients who may benefit from a liver transplant.

The findings indicate that “patients with liver-only metastases and favorable pretransplant prognostic scoring [have] long-term survival comparable with conventional indications for liver transplant, thus providing a potential curative treatment option in patients otherwise offered only palliative care,” said investigators led by Svein Dueland, MD, PhD, a member of the Transplant Oncology Research Group at Oslo University Hospital.

Perhaps “the most compelling argument in favor of liver transplant lies in the likely curative potential evidenced by the 13 disease-free patients,” Dr. Ellis and Dr. D’Angelica wrote.

But even some patients who had early recurrences did well following transplant. The investigators noted that early recurrences in this population aren’t as dire as in other settings because they generally manifest as slow growing lung metastases that can be caught early and resected with curative intent.

A major hurdle to broader use of liver transplants in this population is the scarcity of donor grafts. To manage demand, the investigators suggested “extended-criteria donor grafts” – grafts that don’t meet ideal criteria – and the use of the RAPID technique for liver transplant, which opens the door to using one graft for two patients and using living donors with low risk to the donor.

Another challenge will be identifying patients with unresectable colorectal liver metastases who may experience long-term survival following transplant and possibly a cure. “We all will need to keep a sharp eye out for these patients – they might be hard to find!” Dr. Ellis and Dr. D’Angelica wrote.

The study was supported by Oslo University Hospital, the Norwegian Cancer Society, and South-Eastern Norway Regional Health Authority. The investigators and editorialists report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For carefully selected patients with colorectal cancer (CRC), a liver transplant may offer long-term survival and potentially even cure unresectable liver metastases.

Findings from a Norwegian review of 61 patients who had liver transplants for unresectable colorectal liver metastases found half of patients were still alive at 5 years, and about one in five appeared to be cured at 10 years.

“It seems likely that there is a small group of patients with unresectable colorectal liver metastases who should be considered for transplant, and long-term survival and possibly cure are achievable in these patients with appropriate selection,” Ryan Ellis, MD, and Michael D’Angelica, MD, wrote in a commentary published alongside the study in JAMA Surgery.

The core question, however, is how to identify patients who will benefit the most from a liver transplant, said Dr. Ellis and Dr. D’Angelica, both surgical oncologists in the Hepatopancreatobiliary Service at Memorial Sloan Kettering Cancer Center, New York. Looking closely at who did well in this analysis can offer clues to appropriate patient selection, the editorialists said.

Three decades ago, the oncology community had largely abandoned liver transplant in this population after studies showed overall 5-year survival of less than 20%. Some patients, however, did better, which prompted the Norwegian investigators to attempt to refine patient selection.

In the current prospective nonrandomized study, 61 patients had liver transplants for unresectable metastases at Oslo University Hospital from 2006 to 2020.

The researchers reported a median overall survival of 60.3 months, with about half of patients (50.4%) alive at 5 years.

Most patients (78.3%) experienced a relapse after liver transplant, with a median time to relapse of 9 months and with most occurring within 2 years of transplant. Median overall survival from time of relapse was 37.1 months, with 5-year survival at nearly 35% in this group and with one patient still alive 156 months after relapse.

The remaining 21.7% of patients (n = 13) did not experience a relapse post-transplant at their last follow-up.

Given the variety of responses to liver transplant, how can experts differentiate patients who will benefit most from those who won’t?

The researchers looked at several factors, including Oslo score and Fong Clinical Risk Score. The Oslo score assesses overall survival among liver transplant patients, while the Fong score predicts recurrence risk for patients with CRC liver metastasis following resection. These scores assign one point for each adverse prognostic factor.

Among the 10 patients who had an Oslo Score of 0, median overall survival was 151.6 months, and the 5-year and 10-year survival rates reached nearly 89%. Among the 27 patients with an Oslo Score of 1, median overall survival was 60.3 months, and 5-year overall survival was 54.7%. No patients with an Oslo score of 4 lived for 5 years.

As for FCRS, median overall survival was 164.9 months among those with a score of 1, 90.5 months among those with a score of 2, 59.9 months for those with a score of 3, 32.8 months for those with a score of 4, and 25.3 months for those with the highest score of 5 (P < .001). Overall, these patients had 5-year overall survival of 100%, 63.9%, 49.4%, 33.3%, and 0%, respectively.

In addition to Oslo and Fong scores, metabolic tumor volume on PET scan (PET-MTV) was also a good prognostic factor for survival. Among the 40 patients with MTV values less than 70 cm3, median 5-year overall survival was nearly 67%, while those with values above 70 cm3 had a median 5-year overall survival of 23.3%.

Additional harbingers of low 5-year survival, in addition to higher Oslo and Fong scores and PET-MTV above 70 cm3, included a tumor size greater than 5.5 cm, progressive disease while receiving chemotherapy, primary tumors in the ascending colon, tumor burden scores of 9 or higher, and nine or more liver lesions.

Overall, the current analysis can help oncologists identify patients who may benefit from a liver transplant.

The findings indicate that “patients with liver-only metastases and favorable pretransplant prognostic scoring [have] long-term survival comparable with conventional indications for liver transplant, thus providing a potential curative treatment option in patients otherwise offered only palliative care,” said investigators led by Svein Dueland, MD, PhD, a member of the Transplant Oncology Research Group at Oslo University Hospital.

Perhaps “the most compelling argument in favor of liver transplant lies in the likely curative potential evidenced by the 13 disease-free patients,” Dr. Ellis and Dr. D’Angelica wrote.

But even some patients who had early recurrences did well following transplant. The investigators noted that early recurrences in this population aren’t as dire as in other settings because they generally manifest as slow growing lung metastases that can be caught early and resected with curative intent.

A major hurdle to broader use of liver transplants in this population is the scarcity of donor grafts. To manage demand, the investigators suggested “extended-criteria donor grafts” – grafts that don’t meet ideal criteria – and the use of the RAPID technique for liver transplant, which opens the door to using one graft for two patients and using living donors with low risk to the donor.

Another challenge will be identifying patients with unresectable colorectal liver metastases who may experience long-term survival following transplant and possibly a cure. “We all will need to keep a sharp eye out for these patients – they might be hard to find!” Dr. Ellis and Dr. D’Angelica wrote.

The study was supported by Oslo University Hospital, the Norwegian Cancer Society, and South-Eastern Norway Regional Health Authority. The investigators and editorialists report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Scalp cooling for chemo hair loss strikes out with patients

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Wed, 08/09/2023 - 15:40

 

TOPLINE:

Most women with breast cancer who received scalp cooling did not perceive benefits in preventing hair loss, overall quality of life, body image, and other outcomes, compared with those who opted to forgo scalp cooling.

METHODOLOGY:

  • Although studies have demonstrated the effectiveness of scalp cooling to reduce hair loss during breast cancer chemotherapy, most were in the setting of single-agent regimens instead of much more commonly used combined chemotherapy, and few studies assessed patients’ subjective experience.
  • To get a real-world sense of the treatment, investigators compared outcomes in 75 women who opted to use the Orbis Paxman cooling cap during taxane/anthracycline-based chemotherapy sessions with 38 women with breast cancer patients who declined to use the cooling cap.
  • The women were surveyed for hair loss perception, functional health, and body image at baseline, midchemotherapy, and at their last chemotherapy cycle, as well as at 3 months and 6-9 months following chemotherapy.
  • The women were treated at the Medical University of Innsbruck, Austria, for various stages of breast cancer; about half were premenopausal.

TAKEAWAY:

  • There was no significant difference between the scalp-cooling and control groups in patient-reported hair loss (P = .831), overall quality of life (P = .627), emotional functioning (P = .737), social functioning (P = .635), and body image (P = .463).
  • On average, women stayed on treatment with the cooling cap for about 40% of the duration of their chemotherapy.
  • Overall, 53 of 75 women (70.7%) stopped scalp cooling early, with most (73.9%) citing alopecia as the primary reason; only 30% completed treatment.

IN PRACTICE:

“The efficacy and tolerability of [scalp cooling] applied in a clinical routine setting ... appeared to be limited,” the authors concluded. “The further determination and up-front definition of criteria prognostic for effectiveness of [scalp cooling] may be helpful to identify patient subgroups that may experience a treatment benefit.”

SOURCE:

The work, led by Christine Brunner, Medical University of Innsbruck, Austria, was published in Breast Cancer: Targets and Therapy.

LIMITATIONS:

  • Shorter intervals between surveys might have given a more granular understanding of patients’ experiences with scalp cooling.
  • There were no biomarker assessments to help identify patients more likely to benefit.

DISCLOSURES:

The work was supported by the Medical University of Innsbruck. Dr. Brunner disclosed a grant from Paxman UK, maker of the cooling cap used in the study. Another investigator disclosed personal fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Novartis, and Sirius.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Most women with breast cancer who received scalp cooling did not perceive benefits in preventing hair loss, overall quality of life, body image, and other outcomes, compared with those who opted to forgo scalp cooling.

METHODOLOGY:

  • Although studies have demonstrated the effectiveness of scalp cooling to reduce hair loss during breast cancer chemotherapy, most were in the setting of single-agent regimens instead of much more commonly used combined chemotherapy, and few studies assessed patients’ subjective experience.
  • To get a real-world sense of the treatment, investigators compared outcomes in 75 women who opted to use the Orbis Paxman cooling cap during taxane/anthracycline-based chemotherapy sessions with 38 women with breast cancer patients who declined to use the cooling cap.
  • The women were surveyed for hair loss perception, functional health, and body image at baseline, midchemotherapy, and at their last chemotherapy cycle, as well as at 3 months and 6-9 months following chemotherapy.
  • The women were treated at the Medical University of Innsbruck, Austria, for various stages of breast cancer; about half were premenopausal.

TAKEAWAY:

  • There was no significant difference between the scalp-cooling and control groups in patient-reported hair loss (P = .831), overall quality of life (P = .627), emotional functioning (P = .737), social functioning (P = .635), and body image (P = .463).
  • On average, women stayed on treatment with the cooling cap for about 40% of the duration of their chemotherapy.
  • Overall, 53 of 75 women (70.7%) stopped scalp cooling early, with most (73.9%) citing alopecia as the primary reason; only 30% completed treatment.

IN PRACTICE:

“The efficacy and tolerability of [scalp cooling] applied in a clinical routine setting ... appeared to be limited,” the authors concluded. “The further determination and up-front definition of criteria prognostic for effectiveness of [scalp cooling] may be helpful to identify patient subgroups that may experience a treatment benefit.”

SOURCE:

The work, led by Christine Brunner, Medical University of Innsbruck, Austria, was published in Breast Cancer: Targets and Therapy.

LIMITATIONS:

  • Shorter intervals between surveys might have given a more granular understanding of patients’ experiences with scalp cooling.
  • There were no biomarker assessments to help identify patients more likely to benefit.

DISCLOSURES:

The work was supported by the Medical University of Innsbruck. Dr. Brunner disclosed a grant from Paxman UK, maker of the cooling cap used in the study. Another investigator disclosed personal fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Novartis, and Sirius.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Most women with breast cancer who received scalp cooling did not perceive benefits in preventing hair loss, overall quality of life, body image, and other outcomes, compared with those who opted to forgo scalp cooling.

METHODOLOGY:

  • Although studies have demonstrated the effectiveness of scalp cooling to reduce hair loss during breast cancer chemotherapy, most were in the setting of single-agent regimens instead of much more commonly used combined chemotherapy, and few studies assessed patients’ subjective experience.
  • To get a real-world sense of the treatment, investigators compared outcomes in 75 women who opted to use the Orbis Paxman cooling cap during taxane/anthracycline-based chemotherapy sessions with 38 women with breast cancer patients who declined to use the cooling cap.
  • The women were surveyed for hair loss perception, functional health, and body image at baseline, midchemotherapy, and at their last chemotherapy cycle, as well as at 3 months and 6-9 months following chemotherapy.
  • The women were treated at the Medical University of Innsbruck, Austria, for various stages of breast cancer; about half were premenopausal.

TAKEAWAY:

  • There was no significant difference between the scalp-cooling and control groups in patient-reported hair loss (P = .831), overall quality of life (P = .627), emotional functioning (P = .737), social functioning (P = .635), and body image (P = .463).
  • On average, women stayed on treatment with the cooling cap for about 40% of the duration of their chemotherapy.
  • Overall, 53 of 75 women (70.7%) stopped scalp cooling early, with most (73.9%) citing alopecia as the primary reason; only 30% completed treatment.

IN PRACTICE:

“The efficacy and tolerability of [scalp cooling] applied in a clinical routine setting ... appeared to be limited,” the authors concluded. “The further determination and up-front definition of criteria prognostic for effectiveness of [scalp cooling] may be helpful to identify patient subgroups that may experience a treatment benefit.”

SOURCE:

The work, led by Christine Brunner, Medical University of Innsbruck, Austria, was published in Breast Cancer: Targets and Therapy.

LIMITATIONS:

  • Shorter intervals between surveys might have given a more granular understanding of patients’ experiences with scalp cooling.
  • There were no biomarker assessments to help identify patients more likely to benefit.

DISCLOSURES:

The work was supported by the Medical University of Innsbruck. Dr. Brunner disclosed a grant from Paxman UK, maker of the cooling cap used in the study. Another investigator disclosed personal fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Novartis, and Sirius.

A version of this article first appeared on Medscape.com.

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Cancer diagnoses, care access rise after Medicaid expansion

Article Type
Changed
Tue, 08/08/2023 - 11:53

 

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

  • To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
  • State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

  • In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
  • In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
  • The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
  • The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

  • Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
  • The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

  • The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
  • One researcher reported a grant from Celgene.

A version of this article first appeared on Medscape.com.

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TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

  • To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
  • State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

  • In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
  • In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
  • The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
  • The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

  • Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
  • The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

  • The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
  • One researcher reported a grant from Celgene.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

  • To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
  • State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

  • In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
  • In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
  • The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
  • The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

  • Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
  • The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

  • The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
  • One researcher reported a grant from Celgene.

A version of this article first appeared on Medscape.com.

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