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Study Will Compare Mammography Screening Methods
Which method is better for breast cancer screening: 3-D mammography or 2-D mammography? Researchers from the ECOG-ACRIN Cancer Research Group and the National Cancer Institute are hoping to find out, with the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).
It has been decades since the last large-scale randomized trial of mammography, points out Worta McCaskill-Stevens, MD, director of the NCI Community Oncology Research Program. In the meantime, mammography technology has evolved, from “conventional” 2-D mammography to tomosynthesis, also known as 3-D mammography.
However, although 3-D mammography is more likely to detect more findings that require follow-up, it is also likely to lead to more procedures and treatments. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” said Etta Pisano, MD, ECOG-ACRIN study chair.
Researchers plan to enroll 165,000 participants aged between 45 and 74 years who already are scheduled for routine mammograms. They will follow all participants for breast cancer status, treatment, and outcomes until at least 2025. About 100 mammography clinics are expected to take part.
Which method is better for breast cancer screening: 3-D mammography or 2-D mammography? Researchers from the ECOG-ACRIN Cancer Research Group and the National Cancer Institute are hoping to find out, with the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).
It has been decades since the last large-scale randomized trial of mammography, points out Worta McCaskill-Stevens, MD, director of the NCI Community Oncology Research Program. In the meantime, mammography technology has evolved, from “conventional” 2-D mammography to tomosynthesis, also known as 3-D mammography.
However, although 3-D mammography is more likely to detect more findings that require follow-up, it is also likely to lead to more procedures and treatments. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” said Etta Pisano, MD, ECOG-ACRIN study chair.
Researchers plan to enroll 165,000 participants aged between 45 and 74 years who already are scheduled for routine mammograms. They will follow all participants for breast cancer status, treatment, and outcomes until at least 2025. About 100 mammography clinics are expected to take part.
Which method is better for breast cancer screening: 3-D mammography or 2-D mammography? Researchers from the ECOG-ACRIN Cancer Research Group and the National Cancer Institute are hoping to find out, with the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).
It has been decades since the last large-scale randomized trial of mammography, points out Worta McCaskill-Stevens, MD, director of the NCI Community Oncology Research Program. In the meantime, mammography technology has evolved, from “conventional” 2-D mammography to tomosynthesis, also known as 3-D mammography.
However, although 3-D mammography is more likely to detect more findings that require follow-up, it is also likely to lead to more procedures and treatments. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” said Etta Pisano, MD, ECOG-ACRIN study chair.
Researchers plan to enroll 165,000 participants aged between 45 and 74 years who already are scheduled for routine mammograms. They will follow all participants for breast cancer status, treatment, and outcomes until at least 2025. About 100 mammography clinics are expected to take part.
The better mammogram: Experts explore sensitivity of new modalities
PHILADELPHIA – Is it time to think about “the better mammogram” as the new standard of care? Can nuclear medicine provide a cost-effective workaround for imaging of women with dense breasts? According to two leading breast imaging researchers,
“Digital breast tomosynthesis is the new kid on the block for screening,” said Emily F. Conant, MD, professor of radiology and chief of breast imaging at the University of Pennsylvania, Philadelphia. “It’s becoming the new standard of care in mammography,” she said, speaking during a plenary session at the annual meeting of the North American Menopause Society.
Digital breast tomosynthesis (DBT) can involve simultaneous acquisition of a conventional 2D mammogram along with a series of images to create a 3D image. Another protocol, which delivers a lower radiation dose, produces a “synthetic” 2D reconstruction of 3D mammography.*
In addition to making visible tumors that otherwise might be obscured by the overlay of dense breast tissue, DBT can help reduce the recall rate, with the 3D images providing immediate clarification at the initial appointment. Studies show that the recall rate can go down by up to 31%, Dr. Conant said.
DBT has been shown to increase detection of invasive cancers, but it does not pick up more ductal carcinoma in situ, Dr. Conant said. This fact helps address the problem of overdiagnosis of small tumors that might regress. Overall, cancer detection is reported to increase by up to 53% with DBT, Dr. Conant said.
When primarily retrospective American studies are taken together with smaller prospective European studies, “the improvement in outcomes achieved with DBT directly addresses the major concerns regarding screening for breast cancer with mammography,” she said.
However, so far the studies have not offered DBT routinely to all comers. Since 2011, DBT has been offered to every woman screened at the University of Pennsylvania, at no additional cost. This created “a sort of natural experiment – there was no bias as to who got it.” Three consecutive years’ worth of outcomes have now been analyzed, Dr. Conant said.
Patient-level data from the University of Pennsylvania experience show statistically significant reductions in recall rate from diagnostic mammography alone. Also, researchers saw a steady increase in the rate of cancers detected per 1,000 patients, from 4.6 with digital mammography alone, to 6.1 by year three of DBT (JAMA Oncol. 2016 Jun 1;2[6]:737-43). This reflected the institutional learning curve with DBT, Dr. Conant said.
She said that the data also showed “a promising trend down in false negatives,” with an early reduction in cancers that were missed by DBT. Time is needed for mature cancer registry data to bear out these early trends, she added.
Other recent data show that DBT has promise to improve detection rates in a population of great interest – younger women, where there are often too many false positives and not enough cancers found, Dr. Conant said. If the risk-benefit ratio for DBT continues to play out as the data pile up, “I would strongly suggest that we should be doing screening in the 40s,” she said.
An important caveat, noted Dr. Conant, is that whether tomosynthesis is used or not, mammography captures anatomy, not physiology, and very dense breast tissue may still obscure a tumor, even when the tomographic slices are peeled back.
Though “DBT is ‘the better mammogram,’ additional outcome data are needed,” she said, including studies that compare modalities, include subgroup analyses, and better delineate the effect of cancer biology.
Molecular breast imaging
Another imaging modality uses nuclear medicine to capture the physiologic changes that accompany cancer. Molecular breast imaging (MBI), or scintimammography, can help “unveil the reservoir of hidden cancers in dense breasts,” said Deborah J. Rhodes, MD, professor of medicine at the Mayo Clinic, Rochester, Minn.
Dr. Rhodes – along with Michael O’Connor, PhD, Connie Hruska, PhD, Katie Hunt, MD, and Amy Conners, MD, her collaborators at the Mayo Clinic – uses a specialized array of gamma cameras to detect uptake of an injected radionuclide that’s preferentially avid for tumor tissue. This technique can unmask smaller tumors not seen on mammogram because it’s not impeded by having to “see” through dense breast tissue.
The radiation dose for an MBI study is a bit more than for DBT, but less than a coronary calcium score scan. The cost is about one-tenth that of breast magnetic resonance imaging (MRI), and interpretation is relatively straightforward, said Dr. Rhodes, who also presented data at the North American Menopause Society plenary.
“The traditional measure of mammography’s performance inflates its effectiveness,” especially in dense breast tissue, said Dr. Rhodes. “What is the sensitivity of mammography in the dense breast? It depends on what you measure it against.”
When cancers detected by MRI or MBI are added, the sensitivity of mammography drops from the 86.9% reported by the Breast Cancer Surveillance Consortium to 21%-31%, according to several published studies.
In one study, Dr. Rhodes and her Mayo colleagues found that the diagnostic yield per 1,000 patients with dense breasts by mammogram alone was 1.9 cancers. When MBI was added, that figure jumped to 8.8 cancers per 1,000 patients, an incremental gain of 363%.
“Tumor size matters profoundly,” she added. “If a tumor is detected above 2 cm, long-term survival drops below 50%.”
That contrasts with the better-than-80% long-term survival rate seen for those with sub-centimeter tumors, even in node-positive disease. “Only a third of tumors are detected when they are less than 1 cm” with regular screening mammography, Dr. Rhodes said.
However, in 2016 the U.S. Preventive Services Task Force concluded that the current evidence was insufficient to assess whether adjunctive screening for breast cancer using breast ultrasonography, MRI, DBT, or other methods should be used in women with dense breasts. The USPSTF noted that there weren’t studies that addressed the effect of supplemental screening on breast cancer morbidity or mortality.
The problem is that it can take 20 years or more to demonstrate mortality reduction, meaning that “no other imaging modality can compete” with mammography when this yardstick is used, Dr. Rhodes said. “This insistence on a mortality endpoint before we change practice” is impeding progress in screening, she said.
The American College of Obstetricians and Gynecologists “does not recommend adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.” However, the organization “strongly supports additional research to identify more effective screening methods” that will improve outcomes and minimize false positives in women with dense breasts.
Though DBT is becoming more widely available, MBI is still primarily used in research centers. Both Dr. Conant and Dr. Rhodes acknowledged that since these techniques are not required to be covered by insurance, payment – and patient access – may vary. Both physicians said their home institutions have worked hard to keep costs down for their studies.
Dr. Conant is consultant or advisory board member for Hologic. Dr. Rhodes reported having no conflicts of interest.
*Correction, 11/15/2017: An earlier version of this story misstated the synthetic mammography protocol.
[email protected]
On Twitter @karioakes
PHILADELPHIA – Is it time to think about “the better mammogram” as the new standard of care? Can nuclear medicine provide a cost-effective workaround for imaging of women with dense breasts? According to two leading breast imaging researchers,
“Digital breast tomosynthesis is the new kid on the block for screening,” said Emily F. Conant, MD, professor of radiology and chief of breast imaging at the University of Pennsylvania, Philadelphia. “It’s becoming the new standard of care in mammography,” she said, speaking during a plenary session at the annual meeting of the North American Menopause Society.
Digital breast tomosynthesis (DBT) can involve simultaneous acquisition of a conventional 2D mammogram along with a series of images to create a 3D image. Another protocol, which delivers a lower radiation dose, produces a “synthetic” 2D reconstruction of 3D mammography.*
In addition to making visible tumors that otherwise might be obscured by the overlay of dense breast tissue, DBT can help reduce the recall rate, with the 3D images providing immediate clarification at the initial appointment. Studies show that the recall rate can go down by up to 31%, Dr. Conant said.
DBT has been shown to increase detection of invasive cancers, but it does not pick up more ductal carcinoma in situ, Dr. Conant said. This fact helps address the problem of overdiagnosis of small tumors that might regress. Overall, cancer detection is reported to increase by up to 53% with DBT, Dr. Conant said.
When primarily retrospective American studies are taken together with smaller prospective European studies, “the improvement in outcomes achieved with DBT directly addresses the major concerns regarding screening for breast cancer with mammography,” she said.
However, so far the studies have not offered DBT routinely to all comers. Since 2011, DBT has been offered to every woman screened at the University of Pennsylvania, at no additional cost. This created “a sort of natural experiment – there was no bias as to who got it.” Three consecutive years’ worth of outcomes have now been analyzed, Dr. Conant said.
Patient-level data from the University of Pennsylvania experience show statistically significant reductions in recall rate from diagnostic mammography alone. Also, researchers saw a steady increase in the rate of cancers detected per 1,000 patients, from 4.6 with digital mammography alone, to 6.1 by year three of DBT (JAMA Oncol. 2016 Jun 1;2[6]:737-43). This reflected the institutional learning curve with DBT, Dr. Conant said.
She said that the data also showed “a promising trend down in false negatives,” with an early reduction in cancers that were missed by DBT. Time is needed for mature cancer registry data to bear out these early trends, she added.
Other recent data show that DBT has promise to improve detection rates in a population of great interest – younger women, where there are often too many false positives and not enough cancers found, Dr. Conant said. If the risk-benefit ratio for DBT continues to play out as the data pile up, “I would strongly suggest that we should be doing screening in the 40s,” she said.
An important caveat, noted Dr. Conant, is that whether tomosynthesis is used or not, mammography captures anatomy, not physiology, and very dense breast tissue may still obscure a tumor, even when the tomographic slices are peeled back.
Though “DBT is ‘the better mammogram,’ additional outcome data are needed,” she said, including studies that compare modalities, include subgroup analyses, and better delineate the effect of cancer biology.
Molecular breast imaging
Another imaging modality uses nuclear medicine to capture the physiologic changes that accompany cancer. Molecular breast imaging (MBI), or scintimammography, can help “unveil the reservoir of hidden cancers in dense breasts,” said Deborah J. Rhodes, MD, professor of medicine at the Mayo Clinic, Rochester, Minn.
Dr. Rhodes – along with Michael O’Connor, PhD, Connie Hruska, PhD, Katie Hunt, MD, and Amy Conners, MD, her collaborators at the Mayo Clinic – uses a specialized array of gamma cameras to detect uptake of an injected radionuclide that’s preferentially avid for tumor tissue. This technique can unmask smaller tumors not seen on mammogram because it’s not impeded by having to “see” through dense breast tissue.
The radiation dose for an MBI study is a bit more than for DBT, but less than a coronary calcium score scan. The cost is about one-tenth that of breast magnetic resonance imaging (MRI), and interpretation is relatively straightforward, said Dr. Rhodes, who also presented data at the North American Menopause Society plenary.
“The traditional measure of mammography’s performance inflates its effectiveness,” especially in dense breast tissue, said Dr. Rhodes. “What is the sensitivity of mammography in the dense breast? It depends on what you measure it against.”
When cancers detected by MRI or MBI are added, the sensitivity of mammography drops from the 86.9% reported by the Breast Cancer Surveillance Consortium to 21%-31%, according to several published studies.
In one study, Dr. Rhodes and her Mayo colleagues found that the diagnostic yield per 1,000 patients with dense breasts by mammogram alone was 1.9 cancers. When MBI was added, that figure jumped to 8.8 cancers per 1,000 patients, an incremental gain of 363%.
“Tumor size matters profoundly,” she added. “If a tumor is detected above 2 cm, long-term survival drops below 50%.”
That contrasts with the better-than-80% long-term survival rate seen for those with sub-centimeter tumors, even in node-positive disease. “Only a third of tumors are detected when they are less than 1 cm” with regular screening mammography, Dr. Rhodes said.
However, in 2016 the U.S. Preventive Services Task Force concluded that the current evidence was insufficient to assess whether adjunctive screening for breast cancer using breast ultrasonography, MRI, DBT, or other methods should be used in women with dense breasts. The USPSTF noted that there weren’t studies that addressed the effect of supplemental screening on breast cancer morbidity or mortality.
The problem is that it can take 20 years or more to demonstrate mortality reduction, meaning that “no other imaging modality can compete” with mammography when this yardstick is used, Dr. Rhodes said. “This insistence on a mortality endpoint before we change practice” is impeding progress in screening, she said.
The American College of Obstetricians and Gynecologists “does not recommend adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.” However, the organization “strongly supports additional research to identify more effective screening methods” that will improve outcomes and minimize false positives in women with dense breasts.
Though DBT is becoming more widely available, MBI is still primarily used in research centers. Both Dr. Conant and Dr. Rhodes acknowledged that since these techniques are not required to be covered by insurance, payment – and patient access – may vary. Both physicians said their home institutions have worked hard to keep costs down for their studies.
Dr. Conant is consultant or advisory board member for Hologic. Dr. Rhodes reported having no conflicts of interest.
*Correction, 11/15/2017: An earlier version of this story misstated the synthetic mammography protocol.
[email protected]
On Twitter @karioakes
PHILADELPHIA – Is it time to think about “the better mammogram” as the new standard of care? Can nuclear medicine provide a cost-effective workaround for imaging of women with dense breasts? According to two leading breast imaging researchers,
“Digital breast tomosynthesis is the new kid on the block for screening,” said Emily F. Conant, MD, professor of radiology and chief of breast imaging at the University of Pennsylvania, Philadelphia. “It’s becoming the new standard of care in mammography,” she said, speaking during a plenary session at the annual meeting of the North American Menopause Society.
Digital breast tomosynthesis (DBT) can involve simultaneous acquisition of a conventional 2D mammogram along with a series of images to create a 3D image. Another protocol, which delivers a lower radiation dose, produces a “synthetic” 2D reconstruction of 3D mammography.*
In addition to making visible tumors that otherwise might be obscured by the overlay of dense breast tissue, DBT can help reduce the recall rate, with the 3D images providing immediate clarification at the initial appointment. Studies show that the recall rate can go down by up to 31%, Dr. Conant said.
DBT has been shown to increase detection of invasive cancers, but it does not pick up more ductal carcinoma in situ, Dr. Conant said. This fact helps address the problem of overdiagnosis of small tumors that might regress. Overall, cancer detection is reported to increase by up to 53% with DBT, Dr. Conant said.
When primarily retrospective American studies are taken together with smaller prospective European studies, “the improvement in outcomes achieved with DBT directly addresses the major concerns regarding screening for breast cancer with mammography,” she said.
However, so far the studies have not offered DBT routinely to all comers. Since 2011, DBT has been offered to every woman screened at the University of Pennsylvania, at no additional cost. This created “a sort of natural experiment – there was no bias as to who got it.” Three consecutive years’ worth of outcomes have now been analyzed, Dr. Conant said.
Patient-level data from the University of Pennsylvania experience show statistically significant reductions in recall rate from diagnostic mammography alone. Also, researchers saw a steady increase in the rate of cancers detected per 1,000 patients, from 4.6 with digital mammography alone, to 6.1 by year three of DBT (JAMA Oncol. 2016 Jun 1;2[6]:737-43). This reflected the institutional learning curve with DBT, Dr. Conant said.
She said that the data also showed “a promising trend down in false negatives,” with an early reduction in cancers that were missed by DBT. Time is needed for mature cancer registry data to bear out these early trends, she added.
Other recent data show that DBT has promise to improve detection rates in a population of great interest – younger women, where there are often too many false positives and not enough cancers found, Dr. Conant said. If the risk-benefit ratio for DBT continues to play out as the data pile up, “I would strongly suggest that we should be doing screening in the 40s,” she said.
An important caveat, noted Dr. Conant, is that whether tomosynthesis is used or not, mammography captures anatomy, not physiology, and very dense breast tissue may still obscure a tumor, even when the tomographic slices are peeled back.
Though “DBT is ‘the better mammogram,’ additional outcome data are needed,” she said, including studies that compare modalities, include subgroup analyses, and better delineate the effect of cancer biology.
Molecular breast imaging
Another imaging modality uses nuclear medicine to capture the physiologic changes that accompany cancer. Molecular breast imaging (MBI), or scintimammography, can help “unveil the reservoir of hidden cancers in dense breasts,” said Deborah J. Rhodes, MD, professor of medicine at the Mayo Clinic, Rochester, Minn.
Dr. Rhodes – along with Michael O’Connor, PhD, Connie Hruska, PhD, Katie Hunt, MD, and Amy Conners, MD, her collaborators at the Mayo Clinic – uses a specialized array of gamma cameras to detect uptake of an injected radionuclide that’s preferentially avid for tumor tissue. This technique can unmask smaller tumors not seen on mammogram because it’s not impeded by having to “see” through dense breast tissue.
The radiation dose for an MBI study is a bit more than for DBT, but less than a coronary calcium score scan. The cost is about one-tenth that of breast magnetic resonance imaging (MRI), and interpretation is relatively straightforward, said Dr. Rhodes, who also presented data at the North American Menopause Society plenary.
“The traditional measure of mammography’s performance inflates its effectiveness,” especially in dense breast tissue, said Dr. Rhodes. “What is the sensitivity of mammography in the dense breast? It depends on what you measure it against.”
When cancers detected by MRI or MBI are added, the sensitivity of mammography drops from the 86.9% reported by the Breast Cancer Surveillance Consortium to 21%-31%, according to several published studies.
In one study, Dr. Rhodes and her Mayo colleagues found that the diagnostic yield per 1,000 patients with dense breasts by mammogram alone was 1.9 cancers. When MBI was added, that figure jumped to 8.8 cancers per 1,000 patients, an incremental gain of 363%.
“Tumor size matters profoundly,” she added. “If a tumor is detected above 2 cm, long-term survival drops below 50%.”
That contrasts with the better-than-80% long-term survival rate seen for those with sub-centimeter tumors, even in node-positive disease. “Only a third of tumors are detected when they are less than 1 cm” with regular screening mammography, Dr. Rhodes said.
However, in 2016 the U.S. Preventive Services Task Force concluded that the current evidence was insufficient to assess whether adjunctive screening for breast cancer using breast ultrasonography, MRI, DBT, or other methods should be used in women with dense breasts. The USPSTF noted that there weren’t studies that addressed the effect of supplemental screening on breast cancer morbidity or mortality.
The problem is that it can take 20 years or more to demonstrate mortality reduction, meaning that “no other imaging modality can compete” with mammography when this yardstick is used, Dr. Rhodes said. “This insistence on a mortality endpoint before we change practice” is impeding progress in screening, she said.
The American College of Obstetricians and Gynecologists “does not recommend adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.” However, the organization “strongly supports additional research to identify more effective screening methods” that will improve outcomes and minimize false positives in women with dense breasts.
Though DBT is becoming more widely available, MBI is still primarily used in research centers. Both Dr. Conant and Dr. Rhodes acknowledged that since these techniques are not required to be covered by insurance, payment – and patient access – may vary. Both physicians said their home institutions have worked hard to keep costs down for their studies.
Dr. Conant is consultant or advisory board member for Hologic. Dr. Rhodes reported having no conflicts of interest.
*Correction, 11/15/2017: An earlier version of this story misstated the synthetic mammography protocol.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM NAMS 2017
Frailty, not age, predicted complications after ambulatory surgery
Frailty was associated with a significant increase in 30-day complications after ambulatory hernia repair or ambulatory surgery of the breast, thyroid, or parathyroid, according to the results of a large retrospective cohort study.
The findings reinforce prior work indicating that frailty, not chronologic age, should be a primary factor when deciding about and preparing for surgery, Carolyn D. Seib, MD, and her associates at the University of California, San Francisco, wrote in JAMA Surgery. “Informed consent should be adjusted based on frailty to ensure that patients have an accurate assessment of their risk when making decisions about whether to undergo surgery,” the researchers said.
To test the hypothesis that frailty predicts morbidity and mortality after ambulatory general surgery, the researchers studied 140,828 patients older than 40 years from the 2007-2010 American College of Surgeons National Surgical Quality Improvement Program (JAMA Surg. 2017 Oct 11. doi: 10.1001/jamasurg.2017.4007). Nearly 2,500 (1.7%) patients experienced perioperative complications, and 0.7% had serious complications, the researchers said. After controlling for age sex, race or ethnicity, smoking, type of anesthesia, and corticosteroid use, patients with an intermediate (0.18-0.35) frailty score had a 70% higher odds of any complication (odds ratio, 1.7; 95% confidence interval, 1.5-1.9) and a 100% higher odds of serious complications (OR, 2.0; 95% CI, 1.7-2.3), compared with patients with a low frailty score.
An intermediate score reflected the presence of two to three frailty traits, such as impaired functional status, history of diabetes, pneumonia, chronic cardiovascular or lung disease, or impaired sensorium, the investigators noted. Notably, having a high modified frailty index (four or more frailty traits) was associated with 3.3-fold higher odds of any complication and with nearly 4-fold higher odds of serious complications, even after controlling for potential confounders.
Among modifiable risk factors, only the use of local and monitored anesthesia was associated with a significant decrease in the likelihood of serious 30-day complications (adjusted OR, 0.66; 95% CI, 0.53-0.81). Single-center studies of elderly patients undergoing inguinal hernia repair have reported similar findings, the researchers said. “For frail patients who choose to undergo hernia repair, local and monitored anesthesia care should be used whenever possible,” they wrote. “The use of local with monitored anesthesia care may be challenging in complex surgical procedures for breast cancer, such as modified radical mastectomy or axillary dissection, but it should be considered for patients with increased anesthesia risk who are undergoing ambulatory breast surgery.”
The National Institute on Aging provided partial funding. The investigators reported having no conflicts of interest.
Frailty was associated with a significant increase in 30-day complications after ambulatory hernia repair or ambulatory surgery of the breast, thyroid, or parathyroid, according to the results of a large retrospective cohort study.
The findings reinforce prior work indicating that frailty, not chronologic age, should be a primary factor when deciding about and preparing for surgery, Carolyn D. Seib, MD, and her associates at the University of California, San Francisco, wrote in JAMA Surgery. “Informed consent should be adjusted based on frailty to ensure that patients have an accurate assessment of their risk when making decisions about whether to undergo surgery,” the researchers said.
To test the hypothesis that frailty predicts morbidity and mortality after ambulatory general surgery, the researchers studied 140,828 patients older than 40 years from the 2007-2010 American College of Surgeons National Surgical Quality Improvement Program (JAMA Surg. 2017 Oct 11. doi: 10.1001/jamasurg.2017.4007). Nearly 2,500 (1.7%) patients experienced perioperative complications, and 0.7% had serious complications, the researchers said. After controlling for age sex, race or ethnicity, smoking, type of anesthesia, and corticosteroid use, patients with an intermediate (0.18-0.35) frailty score had a 70% higher odds of any complication (odds ratio, 1.7; 95% confidence interval, 1.5-1.9) and a 100% higher odds of serious complications (OR, 2.0; 95% CI, 1.7-2.3), compared with patients with a low frailty score.
An intermediate score reflected the presence of two to three frailty traits, such as impaired functional status, history of diabetes, pneumonia, chronic cardiovascular or lung disease, or impaired sensorium, the investigators noted. Notably, having a high modified frailty index (four or more frailty traits) was associated with 3.3-fold higher odds of any complication and with nearly 4-fold higher odds of serious complications, even after controlling for potential confounders.
Among modifiable risk factors, only the use of local and monitored anesthesia was associated with a significant decrease in the likelihood of serious 30-day complications (adjusted OR, 0.66; 95% CI, 0.53-0.81). Single-center studies of elderly patients undergoing inguinal hernia repair have reported similar findings, the researchers said. “For frail patients who choose to undergo hernia repair, local and monitored anesthesia care should be used whenever possible,” they wrote. “The use of local with monitored anesthesia care may be challenging in complex surgical procedures for breast cancer, such as modified radical mastectomy or axillary dissection, but it should be considered for patients with increased anesthesia risk who are undergoing ambulatory breast surgery.”
The National Institute on Aging provided partial funding. The investigators reported having no conflicts of interest.
Frailty was associated with a significant increase in 30-day complications after ambulatory hernia repair or ambulatory surgery of the breast, thyroid, or parathyroid, according to the results of a large retrospective cohort study.
The findings reinforce prior work indicating that frailty, not chronologic age, should be a primary factor when deciding about and preparing for surgery, Carolyn D. Seib, MD, and her associates at the University of California, San Francisco, wrote in JAMA Surgery. “Informed consent should be adjusted based on frailty to ensure that patients have an accurate assessment of their risk when making decisions about whether to undergo surgery,” the researchers said.
To test the hypothesis that frailty predicts morbidity and mortality after ambulatory general surgery, the researchers studied 140,828 patients older than 40 years from the 2007-2010 American College of Surgeons National Surgical Quality Improvement Program (JAMA Surg. 2017 Oct 11. doi: 10.1001/jamasurg.2017.4007). Nearly 2,500 (1.7%) patients experienced perioperative complications, and 0.7% had serious complications, the researchers said. After controlling for age sex, race or ethnicity, smoking, type of anesthesia, and corticosteroid use, patients with an intermediate (0.18-0.35) frailty score had a 70% higher odds of any complication (odds ratio, 1.7; 95% confidence interval, 1.5-1.9) and a 100% higher odds of serious complications (OR, 2.0; 95% CI, 1.7-2.3), compared with patients with a low frailty score.
An intermediate score reflected the presence of two to three frailty traits, such as impaired functional status, history of diabetes, pneumonia, chronic cardiovascular or lung disease, or impaired sensorium, the investigators noted. Notably, having a high modified frailty index (four or more frailty traits) was associated with 3.3-fold higher odds of any complication and with nearly 4-fold higher odds of serious complications, even after controlling for potential confounders.
Among modifiable risk factors, only the use of local and monitored anesthesia was associated with a significant decrease in the likelihood of serious 30-day complications (adjusted OR, 0.66; 95% CI, 0.53-0.81). Single-center studies of elderly patients undergoing inguinal hernia repair have reported similar findings, the researchers said. “For frail patients who choose to undergo hernia repair, local and monitored anesthesia care should be used whenever possible,” they wrote. “The use of local with monitored anesthesia care may be challenging in complex surgical procedures for breast cancer, such as modified radical mastectomy or axillary dissection, but it should be considered for patients with increased anesthesia risk who are undergoing ambulatory breast surgery.”
The National Institute on Aging provided partial funding. The investigators reported having no conflicts of interest.
FROM JAMA SURGERY
Key clinical point: Frailty was an independent risk factor for 30-day complications of ambulatory surgery, independent of age and other correlates.
Major finding: Having an intermediate (0.18-0.35) frailty score increased the odds of any complication by 70% (OR, 1.7).
Data source: A single-center retrospective cohort study of 140,828 patients older than 40 years from the 2007-2010 American College of Surgeons National Surgical Quality Improvement Program.
Disclosures: The investigators had no disclosures.
Breast cancer margin guidelines reduced re-excisions, cost
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
AT WSA 2017
Key clinical point: Breast cancer margin guidelines may help reduce re-excisions and lower costs.
Major finding: Operative costs per patient fell by $1,218 after the adoption of the “no ink on tumor” guidelines.
Data source: Retrospective analysis of 237 patients undergoing breast conservation surgery.
Disclosures: The study received no external funding. Dr. Ajkay reported having no financial disclosures.
Breast cancer recurrence risk substantial after endocrine treatment
Women who stop adjuvant endocrine therapy after 5 years are still at substantial risk of distant recurrence over the next 15 years, even if their tumors were small, according to results of a recent meta-analysis of 88 clinical trials.
For women with T1N0 disease, the annual rate of distant recurrence was approximately 1% each year during 5-20 years, resulting in a cumulative risk of distant recurrence of 13%, authors of the meta-analysis reported (N Engl J Med. 2017 Nov. 8. doi: 10.1056/NEJMoa1701830).
Tumor diameter and nodal status was associated with the risk of distant recurrence during the later years and was approximately additive, with the risk increasing from 13% for T1N0 to 41% for T2N4–9 disease, wrote investigator Hongchao Pan, PhD, of the Nuffield Department of Population Health, University of Oxford, England, and his coauthors.
“Recognition of the magnitude of the long-term risks of ER-positive disease can help women and their health care professionals decide whether to extend therapy beyond 5 years and whether to persist if adverse events occur,” the authors wrote in the report.
The meta-analysis by Dr. Pan and his colleagues included 62,923 women with ER-positive breast cancer who were free of disease after 5 years of scheduled endocrine therapy.
They had hoped to identify a subgroup of women with a recurrence risks so small that the risk of additional side effects caused by extending endocrine therapy would outweigh any potential benefits of that additional treatment. However, the finding of measurable risk even in the women with T1N0 disease led them to recommend that extending endocrine therapy at least be considered for all patients.
“An absolute reduction of a few percentage points in the risk of distant metastases over the next 15 years might well be possible even for such low-risk women, with correspondingly greater absolute benefits for women with larger tumors or node-positive disease,” they wrote.
Whether reducing risk translates into improved survival remains to be seen.
As of now, “reliable trial evidence is not yet available” to confirm the clinical benefit of extending endocrine therapy beyond 5 years, the authors noted.
Cancer Research UK and others funded the study. Senior author Daniel F. Hayes, MD, reported grant support from Eli Lilly, Janssen Research & Development, Veridex, Puma, Pfizer, and AstraZeneca, among other disclosures. Full disclosures for all authors were provided on the NEJM website.
“This study reaffirms the potential for recurrences very late after the original diagnosis, an observation made with other datasets as well. This pattern of recurrence is most consistent with hormone-sensitive breast cancer,” William J. Gradishar, MD, said in an interview.
Dr. William J. Gradishar is the Betsy Bramsen Professor of Breast Oncology & professor of medicine at Northwestern University, Chicago.
“This study reaffirms the potential for recurrences very late after the original diagnosis, an observation made with other datasets as well. This pattern of recurrence is most consistent with hormone-sensitive breast cancer,” William J. Gradishar, MD, said in an interview.
Dr. William J. Gradishar is the Betsy Bramsen Professor of Breast Oncology & professor of medicine at Northwestern University, Chicago.
“This study reaffirms the potential for recurrences very late after the original diagnosis, an observation made with other datasets as well. This pattern of recurrence is most consistent with hormone-sensitive breast cancer,” William J. Gradishar, MD, said in an interview.
Dr. William J. Gradishar is the Betsy Bramsen Professor of Breast Oncology & professor of medicine at Northwestern University, Chicago.
Women who stop adjuvant endocrine therapy after 5 years are still at substantial risk of distant recurrence over the next 15 years, even if their tumors were small, according to results of a recent meta-analysis of 88 clinical trials.
For women with T1N0 disease, the annual rate of distant recurrence was approximately 1% each year during 5-20 years, resulting in a cumulative risk of distant recurrence of 13%, authors of the meta-analysis reported (N Engl J Med. 2017 Nov. 8. doi: 10.1056/NEJMoa1701830).
Tumor diameter and nodal status was associated with the risk of distant recurrence during the later years and was approximately additive, with the risk increasing from 13% for T1N0 to 41% for T2N4–9 disease, wrote investigator Hongchao Pan, PhD, of the Nuffield Department of Population Health, University of Oxford, England, and his coauthors.
“Recognition of the magnitude of the long-term risks of ER-positive disease can help women and their health care professionals decide whether to extend therapy beyond 5 years and whether to persist if adverse events occur,” the authors wrote in the report.
The meta-analysis by Dr. Pan and his colleagues included 62,923 women with ER-positive breast cancer who were free of disease after 5 years of scheduled endocrine therapy.
They had hoped to identify a subgroup of women with a recurrence risks so small that the risk of additional side effects caused by extending endocrine therapy would outweigh any potential benefits of that additional treatment. However, the finding of measurable risk even in the women with T1N0 disease led them to recommend that extending endocrine therapy at least be considered for all patients.
“An absolute reduction of a few percentage points in the risk of distant metastases over the next 15 years might well be possible even for such low-risk women, with correspondingly greater absolute benefits for women with larger tumors or node-positive disease,” they wrote.
Whether reducing risk translates into improved survival remains to be seen.
As of now, “reliable trial evidence is not yet available” to confirm the clinical benefit of extending endocrine therapy beyond 5 years, the authors noted.
Cancer Research UK and others funded the study. Senior author Daniel F. Hayes, MD, reported grant support from Eli Lilly, Janssen Research & Development, Veridex, Puma, Pfizer, and AstraZeneca, among other disclosures. Full disclosures for all authors were provided on the NEJM website.
Women who stop adjuvant endocrine therapy after 5 years are still at substantial risk of distant recurrence over the next 15 years, even if their tumors were small, according to results of a recent meta-analysis of 88 clinical trials.
For women with T1N0 disease, the annual rate of distant recurrence was approximately 1% each year during 5-20 years, resulting in a cumulative risk of distant recurrence of 13%, authors of the meta-analysis reported (N Engl J Med. 2017 Nov. 8. doi: 10.1056/NEJMoa1701830).
Tumor diameter and nodal status was associated with the risk of distant recurrence during the later years and was approximately additive, with the risk increasing from 13% for T1N0 to 41% for T2N4–9 disease, wrote investigator Hongchao Pan, PhD, of the Nuffield Department of Population Health, University of Oxford, England, and his coauthors.
“Recognition of the magnitude of the long-term risks of ER-positive disease can help women and their health care professionals decide whether to extend therapy beyond 5 years and whether to persist if adverse events occur,” the authors wrote in the report.
The meta-analysis by Dr. Pan and his colleagues included 62,923 women with ER-positive breast cancer who were free of disease after 5 years of scheduled endocrine therapy.
They had hoped to identify a subgroup of women with a recurrence risks so small that the risk of additional side effects caused by extending endocrine therapy would outweigh any potential benefits of that additional treatment. However, the finding of measurable risk even in the women with T1N0 disease led them to recommend that extending endocrine therapy at least be considered for all patients.
“An absolute reduction of a few percentage points in the risk of distant metastases over the next 15 years might well be possible even for such low-risk women, with correspondingly greater absolute benefits for women with larger tumors or node-positive disease,” they wrote.
Whether reducing risk translates into improved survival remains to be seen.
As of now, “reliable trial evidence is not yet available” to confirm the clinical benefit of extending endocrine therapy beyond 5 years, the authors noted.
Cancer Research UK and others funded the study. Senior author Daniel F. Hayes, MD, reported grant support from Eli Lilly, Janssen Research & Development, Veridex, Puma, Pfizer, and AstraZeneca, among other disclosures. Full disclosures for all authors were provided on the NEJM website.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Among women with early-stage, estrogen-receptor (ER)–positive breast cancer who stop adjuvant endocrine therapy after 5 years, distant recurrences happened at a steady rate over the ensuing 15 years.
Major finding: Distant recurrence risk ranged from 10% to 41%, depending on tumor diameter and nodal status (TN) and tumor grade.
Data source: A meta-analysis of 88 trials including 62,923 women with ER-positive breast cancer who were disease free after 5 years of scheduled endocrine therapy.
Disclosures: The study was funded by Cancer Research UK and others. Senior author Daniel F. Hayes, MD, reported grant support from Eli Lilly, Janssen Research & Development, Veridex, Puma, Pfizer, and AstraZeneca, among other disclosures. Full disclosures for all authors were provided on the NEJM website.
Seven days of opioids adequate for most hernia and other general surgery procedures
A 7-day limit on the initial opioid prescription may be sufficient for many common general surgery procedures, including hernia surgery and gynecologic procedures, findings of a large retrospective study suggest.
Rebecca E. Scully, MD, of the Center for Surgery and Public Health at Brigham and Women’s Hospital in Boston, and her associates examined opioid pain medication prescriptions and refills from records of the Military Health System Data Repository and the TRICARE insurance program of 215,140 opioid-naive patients. These patients were aged 18-64 years who underwent either cholecystectomy, appendectomy, inguinal hernia repair, anterior cruciate ligament reconstruction, rotator cuff tear repair, discectomy, mastectomy, or hysterectomy (JAMA Surg. 2017. doi: 10.1001/jamasurg.2017.3132). Only 20% of the covered individuals are active members of the U.S. military. The mean age was 40 years; 50% were male, and 60% were white.
For appendectomy, cholecystectomy, and hysterectomy, the prescription was a median 4 days. For inguinal hernia repair, anterior cruciate ligament repair, rotator cuff repair, and mastectomy, the initial prescription was for 5 days. For discectomy, the median was 7 days.
Refill rates were the least at 11.3% for cholecystectomy and the most at 39.3% after anterior cruciate ligament repair. The time after the initial prescription until a refill was a median 6 days for appendectomy, cholecystectomy, and inguinal hernia repair, compared with a median 10 days for discectomy. The median duration of a refill prescription was 4 days for appendectomy, cholecystectomy, hernia repair, and hysterectomy versus 8 days for discectomy.
“Although 7 days appears to be more than adequate for many patients undergoing common general surgery and gynecologic procedures, prescription lengths likely should be extended to 10 days, particularly after common neurosurgical and musculoskeletal procedures, recognizing that as many as 40% of patients may still require one refill at a 7-day limit,” Dr. Scully and her associates said.
Although this study did not include rates of unused prescriptions or use of nonopioid pain relievers such as acetaminophen or NSAIDs, it did include a large population considered to be nationally representative “in many respects,” and it included a variety of procedures for which patients are commonly discharged to home, the researchers said.
The study was funded in part by the Department of Defense/Henry M. Jackson Foundation. The investigators had no conflict of interests. Adil H. Haider, MD, MPH, is deputy editor of JAMA Surgery, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance.
A 7-day limit on the initial opioid prescription may be sufficient for many common general surgery procedures, including hernia surgery and gynecologic procedures, findings of a large retrospective study suggest.
Rebecca E. Scully, MD, of the Center for Surgery and Public Health at Brigham and Women’s Hospital in Boston, and her associates examined opioid pain medication prescriptions and refills from records of the Military Health System Data Repository and the TRICARE insurance program of 215,140 opioid-naive patients. These patients were aged 18-64 years who underwent either cholecystectomy, appendectomy, inguinal hernia repair, anterior cruciate ligament reconstruction, rotator cuff tear repair, discectomy, mastectomy, or hysterectomy (JAMA Surg. 2017. doi: 10.1001/jamasurg.2017.3132). Only 20% of the covered individuals are active members of the U.S. military. The mean age was 40 years; 50% were male, and 60% were white.
For appendectomy, cholecystectomy, and hysterectomy, the prescription was a median 4 days. For inguinal hernia repair, anterior cruciate ligament repair, rotator cuff repair, and mastectomy, the initial prescription was for 5 days. For discectomy, the median was 7 days.
Refill rates were the least at 11.3% for cholecystectomy and the most at 39.3% after anterior cruciate ligament repair. The time after the initial prescription until a refill was a median 6 days for appendectomy, cholecystectomy, and inguinal hernia repair, compared with a median 10 days for discectomy. The median duration of a refill prescription was 4 days for appendectomy, cholecystectomy, hernia repair, and hysterectomy versus 8 days for discectomy.
“Although 7 days appears to be more than adequate for many patients undergoing common general surgery and gynecologic procedures, prescription lengths likely should be extended to 10 days, particularly after common neurosurgical and musculoskeletal procedures, recognizing that as many as 40% of patients may still require one refill at a 7-day limit,” Dr. Scully and her associates said.
Although this study did not include rates of unused prescriptions or use of nonopioid pain relievers such as acetaminophen or NSAIDs, it did include a large population considered to be nationally representative “in many respects,” and it included a variety of procedures for which patients are commonly discharged to home, the researchers said.
The study was funded in part by the Department of Defense/Henry M. Jackson Foundation. The investigators had no conflict of interests. Adil H. Haider, MD, MPH, is deputy editor of JAMA Surgery, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance.
A 7-day limit on the initial opioid prescription may be sufficient for many common general surgery procedures, including hernia surgery and gynecologic procedures, findings of a large retrospective study suggest.
Rebecca E. Scully, MD, of the Center for Surgery and Public Health at Brigham and Women’s Hospital in Boston, and her associates examined opioid pain medication prescriptions and refills from records of the Military Health System Data Repository and the TRICARE insurance program of 215,140 opioid-naive patients. These patients were aged 18-64 years who underwent either cholecystectomy, appendectomy, inguinal hernia repair, anterior cruciate ligament reconstruction, rotator cuff tear repair, discectomy, mastectomy, or hysterectomy (JAMA Surg. 2017. doi: 10.1001/jamasurg.2017.3132). Only 20% of the covered individuals are active members of the U.S. military. The mean age was 40 years; 50% were male, and 60% were white.
For appendectomy, cholecystectomy, and hysterectomy, the prescription was a median 4 days. For inguinal hernia repair, anterior cruciate ligament repair, rotator cuff repair, and mastectomy, the initial prescription was for 5 days. For discectomy, the median was 7 days.
Refill rates were the least at 11.3% for cholecystectomy and the most at 39.3% after anterior cruciate ligament repair. The time after the initial prescription until a refill was a median 6 days for appendectomy, cholecystectomy, and inguinal hernia repair, compared with a median 10 days for discectomy. The median duration of a refill prescription was 4 days for appendectomy, cholecystectomy, hernia repair, and hysterectomy versus 8 days for discectomy.
“Although 7 days appears to be more than adequate for many patients undergoing common general surgery and gynecologic procedures, prescription lengths likely should be extended to 10 days, particularly after common neurosurgical and musculoskeletal procedures, recognizing that as many as 40% of patients may still require one refill at a 7-day limit,” Dr. Scully and her associates said.
Although this study did not include rates of unused prescriptions or use of nonopioid pain relievers such as acetaminophen or NSAIDs, it did include a large population considered to be nationally representative “in many respects,” and it included a variety of procedures for which patients are commonly discharged to home, the researchers said.
The study was funded in part by the Department of Defense/Henry M. Jackson Foundation. The investigators had no conflict of interests. Adil H. Haider, MD, MPH, is deputy editor of JAMA Surgery, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance.
FROM JAMA SURGERY
Key clinical point:
Major finding: The initial opioid prescription was a median 4 days for appendectomy and cholecystectomy, a median 5 days for inguinal hernia repair and anterior cruciate ligament and rotator cuff repair, and a median 7 days for discectomy.
Data source: A study of opioid prescriptions in 215,140 surgery patients aged 18-64 years.
Disclosures: The study was funded in part by the Department of Defense/Henry M. Jackson Foundation. The investigators had no conflict of interests. Adil H. Haider, MD, MPH, is deputy editor of JAMA Surgery, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance.
New persistent opioid use common after cancer surgery
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Prescribing guidelines and patient counseling need to change to combat new persistent opioid use, which authors confirmed is a common problem in patients undergoing surgery for early-stage cancer.
Major finding: The risk of new persistent opioid use was 10.4% (95% CI, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery.
Data source: Retrospective cohort study based on examination of deidentified insurance claims from employer health plans from 2010 to 2014.
Disclosures: First author Jay Soong-Jin Lee, MD, had no relationships to disclose. Coauthors reported relationships with Neuros Medical and Merck and Anesthesia Associates of Ann Arbor.
Breast cancer screening: Is the controversy of benefits versus harms resolved?
Breast cancer is the most common cancer and the second leading cause of cancer death in women in the United States, with an estimated 252,710 new cases and 40,610 deaths in 2017.1 Breast cancer mortality is prevented by the use of regular screening mammography, as demonstrated by randomized controlled trials (20% reduction), incidence-based mortality studies (38% to 40% reduction), and service screening studies (48% to 49% reduction).2
Controversy continues, however, on when to start mammography screening, when to stop screening, and the frequency with which screening should be performed for women at average risk for breast cancer. Indeed, 3 national recommendations—written by the American College of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), and the US Preventive Services Task Force (USPSTF)—offer different guidelines for mammography screening (TABLE 1).2–4
There are 2 principal reasons for the controversy over screening:
- mammography has both benefits and harms, and individuals place differential weight on the importance of these relative to each other
- randomized controlled trials on screening mammography did not include all of the starting age, stopping age, and screening intervals that are included in screening recommendations.
New comparison of recommendations
An ongoing project funded by the National Cancer Institute, known as the Cancer Intervention and Surveillance Modeling Network (CISNET), models different starting and stopping ages and screening intervals for mammography to assess their impact on both benefits (mortality improvement, life-years gained) and harms (callbacks, benign breast biopsies). Recently, Arleo and colleagues used CISNET model data to compare the breast cancer screening recommendations from ACOG, the ACS, and the USPSTF, focusing on the differential effect on benefits and harms.5
Benefits vs harms of screening in perspective
Without question, the principal goal of cancer screening strategies is to effectively and efficiently reduce cancer mortality. Because mammography screening has both benefits and harms, a clear understanding of the relative frequency of these events among the different screening recommendations should be an important element in patient counseling.
Based on CISNET-modeled estimates, TABLE 2, illustrates the differences in both benefits and harms of the 3 screening strategies. With all strategies, there is a clear benefit in both fewer breast cancer–related deaths and life-years gained per 1,000 women screened.
The greatest benefit is seen in the A40–84 group, that is, women who undergo the most intensive screening strategy with annual screening starting at age 40 and ending at age 84 (ACOG) compared with the USPSTF’s least intensive screening strategy, B50–74, which includes biennial screening starting at age 50 and stopping at age 74; benefits of the ACS’s H45–79 strategy (annual screening at ages 45 to 54 years then biennial screening at ages 55 to 79) were in-between. Not surprisingly, the A40–84 screening strategy was also associated with the most harms, with more recalls and benign breast biopsies; the least harms occurred with the USPSTF strategy, with the ACS strategy again in-between in terms of harms.
Related articles:
Breast density and optimal screening for breast cancer
To further demonstrate differences between the 3 strategies, CISNET also modeled results by looking at all women born in a single birth year cohort (1960) who were still alive at age 40 (2.468 million women). The modeling estimates the number of women who would die from breast cancer without screening mammography and compares that with the number of women who would die from breast cancer using any of the 3 screening strategies. Using this 1960 birth year cohort analysis, there would be approximately 12,000 fewer breast cancer deaths using the ACOG-recommended screening strategy compared with the USPSTF-recommended approach.4
These data show that while there are more harms associated with the most intense screening recommendation, the less frequent screening recommendations will result in higher mortality and more life-years lost. It is reasonable to assume that most patients would value mortality reduction and life-years gained over a likelihood of more benign biopsies or callbacks. As a result, each of the guidelines recommends that by age 40, women at average risk for breast cancer should be counseled and offered mammography screening based on their personal values.
Read about how Dr. Pearlman counsels his patients on screening.
My counseling approach on screening
Notably, the Women’s Preventive Services Initiative recommends that average risk women initiate mammography screening no earlier than age 40 and no later than age 50.6 This creates more flexibility around starting time for screening. In the population of women that I personally counsel, we discuss that fewer women (1 in 68) will experience breast cancer in their 40s compared with in their 50s (1 in 43); therefore as a population, more women will benefit from screening mammography in their 50s. However, there is clear evidence of mortality benefit for a woman in either decade should she develop breast cancer.
We also discuss that the frequency of harms is fairly comparable in either decade, but women who choose to start screening at age 50 will obviously not experience any callbacks or screening-associated benign breast biopsies in their 40s. With this understanding of benefits and harms, most (but not all) average risk women in my practice choose to start screening at age 40.
Related articles:
Breast cancer screening: My practices and response to the USPSTF guidelines
Be mindful of study limitations
The study by Arleo and colleagues has several weaknesses.5
Simulation studies/computer models have limitations. They are only as accurate as the assumptions that are used in the model. However, CISNET modeling has the benefit of having 6 different models with different assumptions on mortality, efficacy of mammography, and efficacy of treatment, and Arleo and colleagues’ analysis takes the mean of these 6 different models.5 It is reassuring to know that the modeling results are consistent with virtually all studies that show that annual screening mammography has a mortality benefit for women in their 40s.
Cost differences are not included. The actual cost of differences between the strategies is difficult to calculate and was not analyzed in this study. While it is easy to calculate the “front end” costs in a study like this (for example, how many more mammograms or biopsies in the different strategies), it is very difficult to calculate the “back end” costs (such as avoided chemotherapy or end-of-life care).
Overtreatment and overdiagnosis have been discussed extensively with regard to the different screening strategies. For example, approximately 80% of women with ductal carcinoma in situ (DCIS) have these tumors detected on screening mammography, and DCIS is not an obligate precursor to invasive breast cancer. Because the natural history of DCIS cannot be predicted, treatment is recommended for all women with DCIS, even though many of these tumors will remain indolent and never cause harm. As a result, concerns have been raised that more intensive screening strategies may result in more overdiagnosis and overtreatment compared with less intensive strategies.
Increasingly, this argument has been questioned, since the prevailing thought is that DCIS does not regress or disappear on mammography. In other words, if DCIS is present at age 40, it will be detected whenever screening starts (age 40, 45, or 50), and age of starting screening or the screening interval will not impact overdiagnosis or overtreatment.7
Related articles:
More than one-third of tumors found on breast cancer screening represent overdiagnosis
Counsel patients, offer screening at age 40
While 3 different breast cancer mammography screening strategies are recommended in the United States, the study by Arleo and colleagues suggests that based on CISNET data, the A40–84 strategy appears to be the most effective at reducing breast cancer mortality and resulting in the most life-years gained. This strategy also requires the most lifetime mammograms and results in the most callbacks and benign biopsies. Women should be offered annual screening mammography starting at age 40 and should start no later than age 50 after receiving counseling about benefits and harms.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Cancer Facts & Figures 2017. American Cancer Society website. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed October 4, 2017.
- Oeffinger KC, Frontham ET, Etzioni R, et al; American Cancer Society. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599–1614.
- American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Gynecology. ACOG Practice Bulletin No. 179: Breast cancer risk assessment and screening in average risk women. Obstet Gynecol. 2017;130(1):e1–e16.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(4):279–296.
- Arleo EK, Hendrick RE, Helvie MA, Sickles EA. Comparison of recommendations for screening mammography using CISNET models. Cancer. 2017;123(19):3673–3680.
- Women’s Preventive Services Initiative. Breast cancer screening for average-risk women. https://www.womenspreventivehealth.org/recommendations/breast-cancer-screening-for-average-risk-women/. Published 2016. Accessed October 4, 2017.
- Arleo EK, Monticciolo DL, Monsees B, McGinty G, Sickles EA. Persistent untreated screening-detected breast cancer: an argument against delaying screening or increasing the interval between screenings. J Am Coll Radiol. 2017;14(7):863–867.
Dr. Pearlman is S. Jan Behrman Professor and Interim Chair, Director, Fellowship in Breast Health and Cancer Genetics, Department of Obstetrics and Gynecology, Michigan Medicine (University of Michigan), Ann Arbor, Michigan.
The author reports no financial relationships relevant to this article.
Dr. Pearlman is S. Jan Behrman Professor and Interim Chair, Director, Fellowship in Breast Health and Cancer Genetics, Department of Obstetrics and Gynecology, Michigan Medicine (University of Michigan), Ann Arbor, Michigan.
The author reports no financial relationships relevant to this article.
Dr. Pearlman is S. Jan Behrman Professor and Interim Chair, Director, Fellowship in Breast Health and Cancer Genetics, Department of Obstetrics and Gynecology, Michigan Medicine (University of Michigan), Ann Arbor, Michigan.
The author reports no financial relationships relevant to this article.
Breast cancer is the most common cancer and the second leading cause of cancer death in women in the United States, with an estimated 252,710 new cases and 40,610 deaths in 2017.1 Breast cancer mortality is prevented by the use of regular screening mammography, as demonstrated by randomized controlled trials (20% reduction), incidence-based mortality studies (38% to 40% reduction), and service screening studies (48% to 49% reduction).2
Controversy continues, however, on when to start mammography screening, when to stop screening, and the frequency with which screening should be performed for women at average risk for breast cancer. Indeed, 3 national recommendations—written by the American College of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), and the US Preventive Services Task Force (USPSTF)—offer different guidelines for mammography screening (TABLE 1).2–4
There are 2 principal reasons for the controversy over screening:
- mammography has both benefits and harms, and individuals place differential weight on the importance of these relative to each other
- randomized controlled trials on screening mammography did not include all of the starting age, stopping age, and screening intervals that are included in screening recommendations.
New comparison of recommendations
An ongoing project funded by the National Cancer Institute, known as the Cancer Intervention and Surveillance Modeling Network (CISNET), models different starting and stopping ages and screening intervals for mammography to assess their impact on both benefits (mortality improvement, life-years gained) and harms (callbacks, benign breast biopsies). Recently, Arleo and colleagues used CISNET model data to compare the breast cancer screening recommendations from ACOG, the ACS, and the USPSTF, focusing on the differential effect on benefits and harms.5
Benefits vs harms of screening in perspective
Without question, the principal goal of cancer screening strategies is to effectively and efficiently reduce cancer mortality. Because mammography screening has both benefits and harms, a clear understanding of the relative frequency of these events among the different screening recommendations should be an important element in patient counseling.
Based on CISNET-modeled estimates, TABLE 2, illustrates the differences in both benefits and harms of the 3 screening strategies. With all strategies, there is a clear benefit in both fewer breast cancer–related deaths and life-years gained per 1,000 women screened.
The greatest benefit is seen in the A40–84 group, that is, women who undergo the most intensive screening strategy with annual screening starting at age 40 and ending at age 84 (ACOG) compared with the USPSTF’s least intensive screening strategy, B50–74, which includes biennial screening starting at age 50 and stopping at age 74; benefits of the ACS’s H45–79 strategy (annual screening at ages 45 to 54 years then biennial screening at ages 55 to 79) were in-between. Not surprisingly, the A40–84 screening strategy was also associated with the most harms, with more recalls and benign breast biopsies; the least harms occurred with the USPSTF strategy, with the ACS strategy again in-between in terms of harms.
Related articles:
Breast density and optimal screening for breast cancer
To further demonstrate differences between the 3 strategies, CISNET also modeled results by looking at all women born in a single birth year cohort (1960) who were still alive at age 40 (2.468 million women). The modeling estimates the number of women who would die from breast cancer without screening mammography and compares that with the number of women who would die from breast cancer using any of the 3 screening strategies. Using this 1960 birth year cohort analysis, there would be approximately 12,000 fewer breast cancer deaths using the ACOG-recommended screening strategy compared with the USPSTF-recommended approach.4
These data show that while there are more harms associated with the most intense screening recommendation, the less frequent screening recommendations will result in higher mortality and more life-years lost. It is reasonable to assume that most patients would value mortality reduction and life-years gained over a likelihood of more benign biopsies or callbacks. As a result, each of the guidelines recommends that by age 40, women at average risk for breast cancer should be counseled and offered mammography screening based on their personal values.
Read about how Dr. Pearlman counsels his patients on screening.
My counseling approach on screening
Notably, the Women’s Preventive Services Initiative recommends that average risk women initiate mammography screening no earlier than age 40 and no later than age 50.6 This creates more flexibility around starting time for screening. In the population of women that I personally counsel, we discuss that fewer women (1 in 68) will experience breast cancer in their 40s compared with in their 50s (1 in 43); therefore as a population, more women will benefit from screening mammography in their 50s. However, there is clear evidence of mortality benefit for a woman in either decade should she develop breast cancer.
We also discuss that the frequency of harms is fairly comparable in either decade, but women who choose to start screening at age 50 will obviously not experience any callbacks or screening-associated benign breast biopsies in their 40s. With this understanding of benefits and harms, most (but not all) average risk women in my practice choose to start screening at age 40.
Related articles:
Breast cancer screening: My practices and response to the USPSTF guidelines
Be mindful of study limitations
The study by Arleo and colleagues has several weaknesses.5
Simulation studies/computer models have limitations. They are only as accurate as the assumptions that are used in the model. However, CISNET modeling has the benefit of having 6 different models with different assumptions on mortality, efficacy of mammography, and efficacy of treatment, and Arleo and colleagues’ analysis takes the mean of these 6 different models.5 It is reassuring to know that the modeling results are consistent with virtually all studies that show that annual screening mammography has a mortality benefit for women in their 40s.
Cost differences are not included. The actual cost of differences between the strategies is difficult to calculate and was not analyzed in this study. While it is easy to calculate the “front end” costs in a study like this (for example, how many more mammograms or biopsies in the different strategies), it is very difficult to calculate the “back end” costs (such as avoided chemotherapy or end-of-life care).
Overtreatment and overdiagnosis have been discussed extensively with regard to the different screening strategies. For example, approximately 80% of women with ductal carcinoma in situ (DCIS) have these tumors detected on screening mammography, and DCIS is not an obligate precursor to invasive breast cancer. Because the natural history of DCIS cannot be predicted, treatment is recommended for all women with DCIS, even though many of these tumors will remain indolent and never cause harm. As a result, concerns have been raised that more intensive screening strategies may result in more overdiagnosis and overtreatment compared with less intensive strategies.
Increasingly, this argument has been questioned, since the prevailing thought is that DCIS does not regress or disappear on mammography. In other words, if DCIS is present at age 40, it will be detected whenever screening starts (age 40, 45, or 50), and age of starting screening or the screening interval will not impact overdiagnosis or overtreatment.7
Related articles:
More than one-third of tumors found on breast cancer screening represent overdiagnosis
Counsel patients, offer screening at age 40
While 3 different breast cancer mammography screening strategies are recommended in the United States, the study by Arleo and colleagues suggests that based on CISNET data, the A40–84 strategy appears to be the most effective at reducing breast cancer mortality and resulting in the most life-years gained. This strategy also requires the most lifetime mammograms and results in the most callbacks and benign biopsies. Women should be offered annual screening mammography starting at age 40 and should start no later than age 50 after receiving counseling about benefits and harms.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Breast cancer is the most common cancer and the second leading cause of cancer death in women in the United States, with an estimated 252,710 new cases and 40,610 deaths in 2017.1 Breast cancer mortality is prevented by the use of regular screening mammography, as demonstrated by randomized controlled trials (20% reduction), incidence-based mortality studies (38% to 40% reduction), and service screening studies (48% to 49% reduction).2
Controversy continues, however, on when to start mammography screening, when to stop screening, and the frequency with which screening should be performed for women at average risk for breast cancer. Indeed, 3 national recommendations—written by the American College of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), and the US Preventive Services Task Force (USPSTF)—offer different guidelines for mammography screening (TABLE 1).2–4
There are 2 principal reasons for the controversy over screening:
- mammography has both benefits and harms, and individuals place differential weight on the importance of these relative to each other
- randomized controlled trials on screening mammography did not include all of the starting age, stopping age, and screening intervals that are included in screening recommendations.
New comparison of recommendations
An ongoing project funded by the National Cancer Institute, known as the Cancer Intervention and Surveillance Modeling Network (CISNET), models different starting and stopping ages and screening intervals for mammography to assess their impact on both benefits (mortality improvement, life-years gained) and harms (callbacks, benign breast biopsies). Recently, Arleo and colleagues used CISNET model data to compare the breast cancer screening recommendations from ACOG, the ACS, and the USPSTF, focusing on the differential effect on benefits and harms.5
Benefits vs harms of screening in perspective
Without question, the principal goal of cancer screening strategies is to effectively and efficiently reduce cancer mortality. Because mammography screening has both benefits and harms, a clear understanding of the relative frequency of these events among the different screening recommendations should be an important element in patient counseling.
Based on CISNET-modeled estimates, TABLE 2, illustrates the differences in both benefits and harms of the 3 screening strategies. With all strategies, there is a clear benefit in both fewer breast cancer–related deaths and life-years gained per 1,000 women screened.
The greatest benefit is seen in the A40–84 group, that is, women who undergo the most intensive screening strategy with annual screening starting at age 40 and ending at age 84 (ACOG) compared with the USPSTF’s least intensive screening strategy, B50–74, which includes biennial screening starting at age 50 and stopping at age 74; benefits of the ACS’s H45–79 strategy (annual screening at ages 45 to 54 years then biennial screening at ages 55 to 79) were in-between. Not surprisingly, the A40–84 screening strategy was also associated with the most harms, with more recalls and benign breast biopsies; the least harms occurred with the USPSTF strategy, with the ACS strategy again in-between in terms of harms.
Related articles:
Breast density and optimal screening for breast cancer
To further demonstrate differences between the 3 strategies, CISNET also modeled results by looking at all women born in a single birth year cohort (1960) who were still alive at age 40 (2.468 million women). The modeling estimates the number of women who would die from breast cancer without screening mammography and compares that with the number of women who would die from breast cancer using any of the 3 screening strategies. Using this 1960 birth year cohort analysis, there would be approximately 12,000 fewer breast cancer deaths using the ACOG-recommended screening strategy compared with the USPSTF-recommended approach.4
These data show that while there are more harms associated with the most intense screening recommendation, the less frequent screening recommendations will result in higher mortality and more life-years lost. It is reasonable to assume that most patients would value mortality reduction and life-years gained over a likelihood of more benign biopsies or callbacks. As a result, each of the guidelines recommends that by age 40, women at average risk for breast cancer should be counseled and offered mammography screening based on their personal values.
Read about how Dr. Pearlman counsels his patients on screening.
My counseling approach on screening
Notably, the Women’s Preventive Services Initiative recommends that average risk women initiate mammography screening no earlier than age 40 and no later than age 50.6 This creates more flexibility around starting time for screening. In the population of women that I personally counsel, we discuss that fewer women (1 in 68) will experience breast cancer in their 40s compared with in their 50s (1 in 43); therefore as a population, more women will benefit from screening mammography in their 50s. However, there is clear evidence of mortality benefit for a woman in either decade should she develop breast cancer.
We also discuss that the frequency of harms is fairly comparable in either decade, but women who choose to start screening at age 50 will obviously not experience any callbacks or screening-associated benign breast biopsies in their 40s. With this understanding of benefits and harms, most (but not all) average risk women in my practice choose to start screening at age 40.
Related articles:
Breast cancer screening: My practices and response to the USPSTF guidelines
Be mindful of study limitations
The study by Arleo and colleagues has several weaknesses.5
Simulation studies/computer models have limitations. They are only as accurate as the assumptions that are used in the model. However, CISNET modeling has the benefit of having 6 different models with different assumptions on mortality, efficacy of mammography, and efficacy of treatment, and Arleo and colleagues’ analysis takes the mean of these 6 different models.5 It is reassuring to know that the modeling results are consistent with virtually all studies that show that annual screening mammography has a mortality benefit for women in their 40s.
Cost differences are not included. The actual cost of differences between the strategies is difficult to calculate and was not analyzed in this study. While it is easy to calculate the “front end” costs in a study like this (for example, how many more mammograms or biopsies in the different strategies), it is very difficult to calculate the “back end” costs (such as avoided chemotherapy or end-of-life care).
Overtreatment and overdiagnosis have been discussed extensively with regard to the different screening strategies. For example, approximately 80% of women with ductal carcinoma in situ (DCIS) have these tumors detected on screening mammography, and DCIS is not an obligate precursor to invasive breast cancer. Because the natural history of DCIS cannot be predicted, treatment is recommended for all women with DCIS, even though many of these tumors will remain indolent and never cause harm. As a result, concerns have been raised that more intensive screening strategies may result in more overdiagnosis and overtreatment compared with less intensive strategies.
Increasingly, this argument has been questioned, since the prevailing thought is that DCIS does not regress or disappear on mammography. In other words, if DCIS is present at age 40, it will be detected whenever screening starts (age 40, 45, or 50), and age of starting screening or the screening interval will not impact overdiagnosis or overtreatment.7
Related articles:
More than one-third of tumors found on breast cancer screening represent overdiagnosis
Counsel patients, offer screening at age 40
While 3 different breast cancer mammography screening strategies are recommended in the United States, the study by Arleo and colleagues suggests that based on CISNET data, the A40–84 strategy appears to be the most effective at reducing breast cancer mortality and resulting in the most life-years gained. This strategy also requires the most lifetime mammograms and results in the most callbacks and benign biopsies. Women should be offered annual screening mammography starting at age 40 and should start no later than age 50 after receiving counseling about benefits and harms.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Cancer Facts & Figures 2017. American Cancer Society website. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed October 4, 2017.
- Oeffinger KC, Frontham ET, Etzioni R, et al; American Cancer Society. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599–1614.
- American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Gynecology. ACOG Practice Bulletin No. 179: Breast cancer risk assessment and screening in average risk women. Obstet Gynecol. 2017;130(1):e1–e16.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(4):279–296.
- Arleo EK, Hendrick RE, Helvie MA, Sickles EA. Comparison of recommendations for screening mammography using CISNET models. Cancer. 2017;123(19):3673–3680.
- Women’s Preventive Services Initiative. Breast cancer screening for average-risk women. https://www.womenspreventivehealth.org/recommendations/breast-cancer-screening-for-average-risk-women/. Published 2016. Accessed October 4, 2017.
- Arleo EK, Monticciolo DL, Monsees B, McGinty G, Sickles EA. Persistent untreated screening-detected breast cancer: an argument against delaying screening or increasing the interval between screenings. J Am Coll Radiol. 2017;14(7):863–867.
- Cancer Facts & Figures 2017. American Cancer Society website. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed October 4, 2017.
- Oeffinger KC, Frontham ET, Etzioni R, et al; American Cancer Society. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599–1614.
- American College of Obstetricians and Gynecologists Committee on Practice Bulletins–Gynecology. ACOG Practice Bulletin No. 179: Breast cancer risk assessment and screening in average risk women. Obstet Gynecol. 2017;130(1):e1–e16.
- Siu AL; US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(4):279–296.
- Arleo EK, Hendrick RE, Helvie MA, Sickles EA. Comparison of recommendations for screening mammography using CISNET models. Cancer. 2017;123(19):3673–3680.
- Women’s Preventive Services Initiative. Breast cancer screening for average-risk women. https://www.womenspreventivehealth.org/recommendations/breast-cancer-screening-for-average-risk-women/. Published 2016. Accessed October 4, 2017.
- Arleo EK, Monticciolo DL, Monsees B, McGinty G, Sickles EA. Persistent untreated screening-detected breast cancer: an argument against delaying screening or increasing the interval between screenings. J Am Coll Radiol. 2017;14(7):863–867.
FDA Approves Patient-Assisted Mammography
Women of all ages and sizes will be glad to know that they now have some say in the amount of pressure applied to the breast during a mammography. The FDA has cleared Senographe Pristina with Self-Compression, the first patient-assisted 2D digital mammography system.
Digital mammograms use a computer along with x-rays. During an exam with the new system, the technologist positions the patient and initiates compression, then guides the patient in using the handheld wireless remote control to adjust the compression to a comfortable level. The technologist makes the final decision on whether the compression is adequate.
A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively affect image quality. Nor did allowing the patient to help with adjustments make the exam take significantly longer.
Women of all ages and sizes will be glad to know that they now have some say in the amount of pressure applied to the breast during a mammography. The FDA has cleared Senographe Pristina with Self-Compression, the first patient-assisted 2D digital mammography system.
Digital mammograms use a computer along with x-rays. During an exam with the new system, the technologist positions the patient and initiates compression, then guides the patient in using the handheld wireless remote control to adjust the compression to a comfortable level. The technologist makes the final decision on whether the compression is adequate.
A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively affect image quality. Nor did allowing the patient to help with adjustments make the exam take significantly longer.
Women of all ages and sizes will be glad to know that they now have some say in the amount of pressure applied to the breast during a mammography. The FDA has cleared Senographe Pristina with Self-Compression, the first patient-assisted 2D digital mammography system.
Digital mammograms use a computer along with x-rays. During an exam with the new system, the technologist positions the patient and initiates compression, then guides the patient in using the handheld wireless remote control to adjust the compression to a comfortable level. The technologist makes the final decision on whether the compression is adequate.
A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively affect image quality. Nor did allowing the patient to help with adjustments make the exam take significantly longer.
Reconstruction becoming more common after mastectomy
The rate of breast reconstruction surgery for mastectomy increased 62% from 2009 to 2014, while the mastectomy rate itself “remained relatively stable,” according to the Agency for Healthcare Research and Quality.
The rate of breast reconstructions in hospitals and ambulatory surgery settings rose steadily over the 6-year period, going from 21.7 per 100,000 women in 2009 to 35.1 per 100,000 in 2014. Meanwhile, the mastectomy rate dipped from 90.1 in 2009 to 83.2 in 2010 but varied less than 10% over the 2009-2014 time period, reaching 88.4 per 100,000 women in 2014. To put those numbers in a different context, the ratio of reconstructions to mastectomies went from 24-to-100 in 2009 to 40-to-100 in 2014, the AHRQ reported in a Statistical Brief.
Those nonsimultaneous procedures were taking place much more often in ambulatory settings by 2014, as the rate of reconstructions at a separate visit increased 152% from 7.4 per 100,000 women in 2009 to 18.2. Simultaneous reconstructions in ambulatory settings were less common but increased at an even greater rate of 155%, going from 1.1 to 2.8 per 100,000 women. Inpatient reconstruction had little or no growth over the 6 years: Separate-visit procedures went from 6 to 6.8 and simultaneous reconstructions actually dropped from 7.4 per 100,000 women to 7.3, they reported.
The analysis was based on data from AHRQ State Inpatient Databases and State Ambulatory Surgery and Services Databases for 22 states that include 59% of the U.S. population: California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Wisconsin.
The rate of breast reconstruction surgery for mastectomy increased 62% from 2009 to 2014, while the mastectomy rate itself “remained relatively stable,” according to the Agency for Healthcare Research and Quality.
The rate of breast reconstructions in hospitals and ambulatory surgery settings rose steadily over the 6-year period, going from 21.7 per 100,000 women in 2009 to 35.1 per 100,000 in 2014. Meanwhile, the mastectomy rate dipped from 90.1 in 2009 to 83.2 in 2010 but varied less than 10% over the 2009-2014 time period, reaching 88.4 per 100,000 women in 2014. To put those numbers in a different context, the ratio of reconstructions to mastectomies went from 24-to-100 in 2009 to 40-to-100 in 2014, the AHRQ reported in a Statistical Brief.
Those nonsimultaneous procedures were taking place much more often in ambulatory settings by 2014, as the rate of reconstructions at a separate visit increased 152% from 7.4 per 100,000 women in 2009 to 18.2. Simultaneous reconstructions in ambulatory settings were less common but increased at an even greater rate of 155%, going from 1.1 to 2.8 per 100,000 women. Inpatient reconstruction had little or no growth over the 6 years: Separate-visit procedures went from 6 to 6.8 and simultaneous reconstructions actually dropped from 7.4 per 100,000 women to 7.3, they reported.
The analysis was based on data from AHRQ State Inpatient Databases and State Ambulatory Surgery and Services Databases for 22 states that include 59% of the U.S. population: California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Wisconsin.
The rate of breast reconstruction surgery for mastectomy increased 62% from 2009 to 2014, while the mastectomy rate itself “remained relatively stable,” according to the Agency for Healthcare Research and Quality.
The rate of breast reconstructions in hospitals and ambulatory surgery settings rose steadily over the 6-year period, going from 21.7 per 100,000 women in 2009 to 35.1 per 100,000 in 2014. Meanwhile, the mastectomy rate dipped from 90.1 in 2009 to 83.2 in 2010 but varied less than 10% over the 2009-2014 time period, reaching 88.4 per 100,000 women in 2014. To put those numbers in a different context, the ratio of reconstructions to mastectomies went from 24-to-100 in 2009 to 40-to-100 in 2014, the AHRQ reported in a Statistical Brief.
Those nonsimultaneous procedures were taking place much more often in ambulatory settings by 2014, as the rate of reconstructions at a separate visit increased 152% from 7.4 per 100,000 women in 2009 to 18.2. Simultaneous reconstructions in ambulatory settings were less common but increased at an even greater rate of 155%, going from 1.1 to 2.8 per 100,000 women. Inpatient reconstruction had little or no growth over the 6 years: Separate-visit procedures went from 6 to 6.8 and simultaneous reconstructions actually dropped from 7.4 per 100,000 women to 7.3, they reported.
The analysis was based on data from AHRQ State Inpatient Databases and State Ambulatory Surgery and Services Databases for 22 states that include 59% of the U.S. population: California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Wisconsin.