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SAN ANTONIO – The worldwide upsurge in bilateral mastectomy for unilateral breast cancer in the last decade came under withering fire from prominent breast surgeons at the San Antonio Breast Cancer Symposium.
“It seems crazy, doesn’t it, that we’re spending all this time trying to conserve the breast, yet we’re facing a tsunami of requests for bilateral mastectomy,” observed Dr. Fiona MacNeill, chairman of the education and training committee of the Royal College of Surgeons of England.
“A contralateral risk–reducing prophylactic mastectomy undoubtedly will reduce the risk of contralateral breast cancer, since you’re removing the breast, but this is overtreatment for the vast majority of women who request it. At 20 years we haven’t been able to demonstrate that it offers a significant survival advantage. I think a lot of what’s driving bilateral mastectomy is fear and ignorance, a failure to understand risk by patients and often by health professionals,” said Dr. MacNeill, a breast surgeon at Royal Marsden Hospital in London.
In an invited special lecture titled, “Less is more: minimizing breast cancer surgery,” Dr. MacNeill began by observing, “Only a surgeon could give this talk, because only a surgeon can tell you why we’re doing too much surgery.”
She stressed three main points: surgery is, as she put it, “a medieval treatment in a molecular era.” Overwhelming evidence shows that breast cancer outcomes are determined by disease biology, burden, and response to systemic therapy and not by the extent of surgery. And since there is no survival benefit for more aggressive surgery, the surgeon’s goal must be to optimize breast and axillary conservation.
In a separate presentation, Dr. Ismail Jatoi, professor and chief of surgical oncology at the University of Texas, San Antonio, outlined trends in surgical treatment of early-stage breast cancer as documented in a recent major retrospective study conducted in Tennessee of 1.2 million women treated at accredited U.S. breast cancer centers during 1998-2011.
The Tennessee investigators’ analysis points to a polarization in surgical therapy: The rate of unilateral mastectomy without reconstruction has dropped steadily since the beginning of the study period in 1998 among women eligible for breast-conserving surgery (BCS), while starting around 2006 the rate of bilateral mastectomy with reconstruction has surged. This increase in bilateral mastectomies with reconstruction resulted in an adjusted 34% jump in the overall mastectomy rate during 2004-2011 as compared with 1998-2003. As a result, in 2011 nearly 40% of women with early breast cancer underwent mastectomy. Meanwhile, the rate of BCS has been waning since 2006 (JAMA Surg. 2015 Jan;150[1]:9-16).
These disturbing trends have been fueled in part by at least eight published observational studies reporting improved survival with contralateral prophylactic mastectomy (CPM) as compared with unilateral mastectomy or BCS. But these were all observational studies and hence likely compromised by unmeasured confounders, according to Dr. Jatoi.
He presented highlights of his study of National Cancer Institute Surveillance, Epidemiology, and End Results data to support his recommendation that these observational studies be taken with a grain of salt.
His study included nearly 26,000 women who underwent CPM and more than 400,000 who did not. In a multivariate regression analysis adjusted for age, race, tumor stage, hormone receptor status, and histologic grade, CPM was associated with a statistically significant and impressive-sounding 16% reduction in the 5-year risk of breast cancer–specific mortality, a 17% reduction in overall mortality, and … a highly improbable 29% reduction in noncancer mortality (Breast Cancer Res Treat. 2014 Nov;148[2]:389-96).
“Obviously bilateral mastectomy is not going to reduce your risk of dying of heart attack or stroke or other noncancer causes. So even though we adjusted for everything possible in the SEER database, it suggests there were still unmeasured confounders. What this study shows is that it’s these unmeasured confounders that pose a threat to the validity of observational studies,” the surgeon said.
“Randomized data and observational studies consistently show that breast-conserving surgery is the optimal choice for most patients. It’s the safest choice, it’s cost effective, and it should remain in 2015 the optimal treatment for breast cancer,” he declared.
The cost-effectiveness of BCS was underscored during the symposium by means of a retrospective study presented by Dr. Benjamin D. Smith.
He and his coinvestigators analyzed costs and complication rates in the first 2 years following diagnosis of early-stage breast cancer in 44,344 patients under age 65 in the MarketScan database and almost 61,000 older women in the SEER-Medicare database.
The 2-year complication rate related to local therapy in younger breast cancer patients ranged from 30% for lumpectomy plus whole breast irradiation to 56% for mastectomy plus reconstruction. In older patients, the complication rates were 38% for lumpectomy plus whole breast irradiation and 69% for mastectomy plus reconstruction.
Adding together procedural and complication costs, the most expensive therapy in younger women was mastectomy with reconstruction, at an average of $89,140, which was $23,421 more than for lumpectomy plus whole breast irradiation, according to Dr. Smith, a radiation oncologist at MD Anderson Cancer Center in Houston.
“When oncologists offer all appropriate therapy options to patients, some women may choose to avoid radiation and opt for mastectomy and reconstruction instead. This study is helpful to such patients because it provides them with information regarding the trade-offs involved in this choice,” he explained.
Dr. MacNeill noted that in addition to the increased financial cost and physical complication rate entailed by mastectomy plus reconstruction for early breast cancer, this more aggressive surgery has another important unwelcome consequence: it delays the start of adjuvant therapy, which is the intervention that truly affects outcome.
Many women who opt for CPM do so because they can’t face the prospect of going through chemotherapy again should cancer arise in the contralateral breast. What’s often overlooked, she continued, is that the greatest risks of death or need for further systemic treatment due to relapse arise from the index cancer.
“We overestimate our patients’ contralateral risk, we underestimate the risk of dying from relapse of the index cancer, and we very often fail to consider other competing health risks from smoking, obesity, age, and other factors,” according to Dr. MacNeill.
“It’s not as if additional surgery is risk-free. A bilateral mastectomy carries bilateral complications. Our patients expect a perfect outcome because that’s what they see on television, but the reality is that for some women the results can be absolutely disastrous. Whilst women may not regret their choice for bilateral mastectomy with reconstruction because they think it’s lifesaving, the psychosexual impact is phenomenal,” she said.
That being said, Dr. MacNeill continued, “the elephant in the room” regarding BCS is that re-excision rates of up to 40% are common. This high rate of repeat surgery is a huge issue because of the resultant increased costs, morbidity, poor cosmesis, increased risk of mastectomy, and delay to adjuvant therapy.
High re-excision rates aren’t due to surgical incompetence, Dr. MacNeill stressed, but rather to the difficulty in defining microscopic disease intraoperatively. But help is on the way. Several novel approaches that facilitate lower re-excision rates and more breast conservation show considerable promise.
For example, investigators at Yale University have recently demonstrated in a randomized controlled trial that routine intraoperative cavity shave margins taken circumferentially halved the re-excision rate, from 21% to 10% (N Engl J Med. 2015 Aug 6;373[6]:503-10).
A meta-analysis of studies that included nearly 9,000 breast cancer patients who underwent BCS alone or BCS with oncoplastic breast conservation techniques concluded that the re-excision rate was just 4.3% in women who underwent oncoplastic breast conservation, compared with 14.6% with BCS alone (Ann Plast Surg. 2014 Feb;72[2]:145-9).
“This is going to be a driver for many breast cancer units to look at how they can use oncoplastic breast conservation to bring down their resection rates,” Dr. MacNeill predicted.
Neoadjuvant chemotherapy or endocrine therapy, a strategy in which surgery becomes adjuvant therapy, is likely to play an important role in facilitating breast conservation in the future. In the CALGB 40603 trial, for example, neoadjuvant chemotherapy in women with triple-negative breast cancer resulted in an absolute 14% increase in eligibility for BCS. Moreover, BCS was successful with no re-excision in 93% of treated patients (Ann Surg. 2015 Sep;262[3]:434-9).
The ‘less is more’ movement in breast cancer surgery may in the future mean no surgery at all in certain cases. Now underway in the United Kingdom is LORIS (the Low Risk DCIS Trial), in which women with low-risk DCIS are being randomized to surgery or 10 years of monitoring via annual mammograms.
“I’m suggesting that surgery may not exist in the longer term,” Dr. MacNeill said.
She, Dr. Jatoi, and Dr. Smith reported having no financial conflicts regarding their presentations. Dr. Smith’s study was supported by the Cancer Prevention and Research Institute of Texas, the Conquer Cancer Foundation, and the American Society for Radiation Oncology.
SAN ANTONIO – The worldwide upsurge in bilateral mastectomy for unilateral breast cancer in the last decade came under withering fire from prominent breast surgeons at the San Antonio Breast Cancer Symposium.
“It seems crazy, doesn’t it, that we’re spending all this time trying to conserve the breast, yet we’re facing a tsunami of requests for bilateral mastectomy,” observed Dr. Fiona MacNeill, chairman of the education and training committee of the Royal College of Surgeons of England.
“A contralateral risk–reducing prophylactic mastectomy undoubtedly will reduce the risk of contralateral breast cancer, since you’re removing the breast, but this is overtreatment for the vast majority of women who request it. At 20 years we haven’t been able to demonstrate that it offers a significant survival advantage. I think a lot of what’s driving bilateral mastectomy is fear and ignorance, a failure to understand risk by patients and often by health professionals,” said Dr. MacNeill, a breast surgeon at Royal Marsden Hospital in London.
In an invited special lecture titled, “Less is more: minimizing breast cancer surgery,” Dr. MacNeill began by observing, “Only a surgeon could give this talk, because only a surgeon can tell you why we’re doing too much surgery.”
She stressed three main points: surgery is, as she put it, “a medieval treatment in a molecular era.” Overwhelming evidence shows that breast cancer outcomes are determined by disease biology, burden, and response to systemic therapy and not by the extent of surgery. And since there is no survival benefit for more aggressive surgery, the surgeon’s goal must be to optimize breast and axillary conservation.
In a separate presentation, Dr. Ismail Jatoi, professor and chief of surgical oncology at the University of Texas, San Antonio, outlined trends in surgical treatment of early-stage breast cancer as documented in a recent major retrospective study conducted in Tennessee of 1.2 million women treated at accredited U.S. breast cancer centers during 1998-2011.
The Tennessee investigators’ analysis points to a polarization in surgical therapy: The rate of unilateral mastectomy without reconstruction has dropped steadily since the beginning of the study period in 1998 among women eligible for breast-conserving surgery (BCS), while starting around 2006 the rate of bilateral mastectomy with reconstruction has surged. This increase in bilateral mastectomies with reconstruction resulted in an adjusted 34% jump in the overall mastectomy rate during 2004-2011 as compared with 1998-2003. As a result, in 2011 nearly 40% of women with early breast cancer underwent mastectomy. Meanwhile, the rate of BCS has been waning since 2006 (JAMA Surg. 2015 Jan;150[1]:9-16).
These disturbing trends have been fueled in part by at least eight published observational studies reporting improved survival with contralateral prophylactic mastectomy (CPM) as compared with unilateral mastectomy or BCS. But these were all observational studies and hence likely compromised by unmeasured confounders, according to Dr. Jatoi.
He presented highlights of his study of National Cancer Institute Surveillance, Epidemiology, and End Results data to support his recommendation that these observational studies be taken with a grain of salt.
His study included nearly 26,000 women who underwent CPM and more than 400,000 who did not. In a multivariate regression analysis adjusted for age, race, tumor stage, hormone receptor status, and histologic grade, CPM was associated with a statistically significant and impressive-sounding 16% reduction in the 5-year risk of breast cancer–specific mortality, a 17% reduction in overall mortality, and … a highly improbable 29% reduction in noncancer mortality (Breast Cancer Res Treat. 2014 Nov;148[2]:389-96).
“Obviously bilateral mastectomy is not going to reduce your risk of dying of heart attack or stroke or other noncancer causes. So even though we adjusted for everything possible in the SEER database, it suggests there were still unmeasured confounders. What this study shows is that it’s these unmeasured confounders that pose a threat to the validity of observational studies,” the surgeon said.
“Randomized data and observational studies consistently show that breast-conserving surgery is the optimal choice for most patients. It’s the safest choice, it’s cost effective, and it should remain in 2015 the optimal treatment for breast cancer,” he declared.
The cost-effectiveness of BCS was underscored during the symposium by means of a retrospective study presented by Dr. Benjamin D. Smith.
He and his coinvestigators analyzed costs and complication rates in the first 2 years following diagnosis of early-stage breast cancer in 44,344 patients under age 65 in the MarketScan database and almost 61,000 older women in the SEER-Medicare database.
The 2-year complication rate related to local therapy in younger breast cancer patients ranged from 30% for lumpectomy plus whole breast irradiation to 56% for mastectomy plus reconstruction. In older patients, the complication rates were 38% for lumpectomy plus whole breast irradiation and 69% for mastectomy plus reconstruction.
Adding together procedural and complication costs, the most expensive therapy in younger women was mastectomy with reconstruction, at an average of $89,140, which was $23,421 more than for lumpectomy plus whole breast irradiation, according to Dr. Smith, a radiation oncologist at MD Anderson Cancer Center in Houston.
“When oncologists offer all appropriate therapy options to patients, some women may choose to avoid radiation and opt for mastectomy and reconstruction instead. This study is helpful to such patients because it provides them with information regarding the trade-offs involved in this choice,” he explained.
Dr. MacNeill noted that in addition to the increased financial cost and physical complication rate entailed by mastectomy plus reconstruction for early breast cancer, this more aggressive surgery has another important unwelcome consequence: it delays the start of adjuvant therapy, which is the intervention that truly affects outcome.
Many women who opt for CPM do so because they can’t face the prospect of going through chemotherapy again should cancer arise in the contralateral breast. What’s often overlooked, she continued, is that the greatest risks of death or need for further systemic treatment due to relapse arise from the index cancer.
“We overestimate our patients’ contralateral risk, we underestimate the risk of dying from relapse of the index cancer, and we very often fail to consider other competing health risks from smoking, obesity, age, and other factors,” according to Dr. MacNeill.
“It’s not as if additional surgery is risk-free. A bilateral mastectomy carries bilateral complications. Our patients expect a perfect outcome because that’s what they see on television, but the reality is that for some women the results can be absolutely disastrous. Whilst women may not regret their choice for bilateral mastectomy with reconstruction because they think it’s lifesaving, the psychosexual impact is phenomenal,” she said.
That being said, Dr. MacNeill continued, “the elephant in the room” regarding BCS is that re-excision rates of up to 40% are common. This high rate of repeat surgery is a huge issue because of the resultant increased costs, morbidity, poor cosmesis, increased risk of mastectomy, and delay to adjuvant therapy.
High re-excision rates aren’t due to surgical incompetence, Dr. MacNeill stressed, but rather to the difficulty in defining microscopic disease intraoperatively. But help is on the way. Several novel approaches that facilitate lower re-excision rates and more breast conservation show considerable promise.
For example, investigators at Yale University have recently demonstrated in a randomized controlled trial that routine intraoperative cavity shave margins taken circumferentially halved the re-excision rate, from 21% to 10% (N Engl J Med. 2015 Aug 6;373[6]:503-10).
A meta-analysis of studies that included nearly 9,000 breast cancer patients who underwent BCS alone or BCS with oncoplastic breast conservation techniques concluded that the re-excision rate was just 4.3% in women who underwent oncoplastic breast conservation, compared with 14.6% with BCS alone (Ann Plast Surg. 2014 Feb;72[2]:145-9).
“This is going to be a driver for many breast cancer units to look at how they can use oncoplastic breast conservation to bring down their resection rates,” Dr. MacNeill predicted.
Neoadjuvant chemotherapy or endocrine therapy, a strategy in which surgery becomes adjuvant therapy, is likely to play an important role in facilitating breast conservation in the future. In the CALGB 40603 trial, for example, neoadjuvant chemotherapy in women with triple-negative breast cancer resulted in an absolute 14% increase in eligibility for BCS. Moreover, BCS was successful with no re-excision in 93% of treated patients (Ann Surg. 2015 Sep;262[3]:434-9).
The ‘less is more’ movement in breast cancer surgery may in the future mean no surgery at all in certain cases. Now underway in the United Kingdom is LORIS (the Low Risk DCIS Trial), in which women with low-risk DCIS are being randomized to surgery or 10 years of monitoring via annual mammograms.
“I’m suggesting that surgery may not exist in the longer term,” Dr. MacNeill said.
She, Dr. Jatoi, and Dr. Smith reported having no financial conflicts regarding their presentations. Dr. Smith’s study was supported by the Cancer Prevention and Research Institute of Texas, the Conquer Cancer Foundation, and the American Society for Radiation Oncology.
SAN ANTONIO – The worldwide upsurge in bilateral mastectomy for unilateral breast cancer in the last decade came under withering fire from prominent breast surgeons at the San Antonio Breast Cancer Symposium.
“It seems crazy, doesn’t it, that we’re spending all this time trying to conserve the breast, yet we’re facing a tsunami of requests for bilateral mastectomy,” observed Dr. Fiona MacNeill, chairman of the education and training committee of the Royal College of Surgeons of England.
“A contralateral risk–reducing prophylactic mastectomy undoubtedly will reduce the risk of contralateral breast cancer, since you’re removing the breast, but this is overtreatment for the vast majority of women who request it. At 20 years we haven’t been able to demonstrate that it offers a significant survival advantage. I think a lot of what’s driving bilateral mastectomy is fear and ignorance, a failure to understand risk by patients and often by health professionals,” said Dr. MacNeill, a breast surgeon at Royal Marsden Hospital in London.
In an invited special lecture titled, “Less is more: minimizing breast cancer surgery,” Dr. MacNeill began by observing, “Only a surgeon could give this talk, because only a surgeon can tell you why we’re doing too much surgery.”
She stressed three main points: surgery is, as she put it, “a medieval treatment in a molecular era.” Overwhelming evidence shows that breast cancer outcomes are determined by disease biology, burden, and response to systemic therapy and not by the extent of surgery. And since there is no survival benefit for more aggressive surgery, the surgeon’s goal must be to optimize breast and axillary conservation.
In a separate presentation, Dr. Ismail Jatoi, professor and chief of surgical oncology at the University of Texas, San Antonio, outlined trends in surgical treatment of early-stage breast cancer as documented in a recent major retrospective study conducted in Tennessee of 1.2 million women treated at accredited U.S. breast cancer centers during 1998-2011.
The Tennessee investigators’ analysis points to a polarization in surgical therapy: The rate of unilateral mastectomy without reconstruction has dropped steadily since the beginning of the study period in 1998 among women eligible for breast-conserving surgery (BCS), while starting around 2006 the rate of bilateral mastectomy with reconstruction has surged. This increase in bilateral mastectomies with reconstruction resulted in an adjusted 34% jump in the overall mastectomy rate during 2004-2011 as compared with 1998-2003. As a result, in 2011 nearly 40% of women with early breast cancer underwent mastectomy. Meanwhile, the rate of BCS has been waning since 2006 (JAMA Surg. 2015 Jan;150[1]:9-16).
These disturbing trends have been fueled in part by at least eight published observational studies reporting improved survival with contralateral prophylactic mastectomy (CPM) as compared with unilateral mastectomy or BCS. But these were all observational studies and hence likely compromised by unmeasured confounders, according to Dr. Jatoi.
He presented highlights of his study of National Cancer Institute Surveillance, Epidemiology, and End Results data to support his recommendation that these observational studies be taken with a grain of salt.
His study included nearly 26,000 women who underwent CPM and more than 400,000 who did not. In a multivariate regression analysis adjusted for age, race, tumor stage, hormone receptor status, and histologic grade, CPM was associated with a statistically significant and impressive-sounding 16% reduction in the 5-year risk of breast cancer–specific mortality, a 17% reduction in overall mortality, and … a highly improbable 29% reduction in noncancer mortality (Breast Cancer Res Treat. 2014 Nov;148[2]:389-96).
“Obviously bilateral mastectomy is not going to reduce your risk of dying of heart attack or stroke or other noncancer causes. So even though we adjusted for everything possible in the SEER database, it suggests there were still unmeasured confounders. What this study shows is that it’s these unmeasured confounders that pose a threat to the validity of observational studies,” the surgeon said.
“Randomized data and observational studies consistently show that breast-conserving surgery is the optimal choice for most patients. It’s the safest choice, it’s cost effective, and it should remain in 2015 the optimal treatment for breast cancer,” he declared.
The cost-effectiveness of BCS was underscored during the symposium by means of a retrospective study presented by Dr. Benjamin D. Smith.
He and his coinvestigators analyzed costs and complication rates in the first 2 years following diagnosis of early-stage breast cancer in 44,344 patients under age 65 in the MarketScan database and almost 61,000 older women in the SEER-Medicare database.
The 2-year complication rate related to local therapy in younger breast cancer patients ranged from 30% for lumpectomy plus whole breast irradiation to 56% for mastectomy plus reconstruction. In older patients, the complication rates were 38% for lumpectomy plus whole breast irradiation and 69% for mastectomy plus reconstruction.
Adding together procedural and complication costs, the most expensive therapy in younger women was mastectomy with reconstruction, at an average of $89,140, which was $23,421 more than for lumpectomy plus whole breast irradiation, according to Dr. Smith, a radiation oncologist at MD Anderson Cancer Center in Houston.
“When oncologists offer all appropriate therapy options to patients, some women may choose to avoid radiation and opt for mastectomy and reconstruction instead. This study is helpful to such patients because it provides them with information regarding the trade-offs involved in this choice,” he explained.
Dr. MacNeill noted that in addition to the increased financial cost and physical complication rate entailed by mastectomy plus reconstruction for early breast cancer, this more aggressive surgery has another important unwelcome consequence: it delays the start of adjuvant therapy, which is the intervention that truly affects outcome.
Many women who opt for CPM do so because they can’t face the prospect of going through chemotherapy again should cancer arise in the contralateral breast. What’s often overlooked, she continued, is that the greatest risks of death or need for further systemic treatment due to relapse arise from the index cancer.
“We overestimate our patients’ contralateral risk, we underestimate the risk of dying from relapse of the index cancer, and we very often fail to consider other competing health risks from smoking, obesity, age, and other factors,” according to Dr. MacNeill.
“It’s not as if additional surgery is risk-free. A bilateral mastectomy carries bilateral complications. Our patients expect a perfect outcome because that’s what they see on television, but the reality is that for some women the results can be absolutely disastrous. Whilst women may not regret their choice for bilateral mastectomy with reconstruction because they think it’s lifesaving, the psychosexual impact is phenomenal,” she said.
That being said, Dr. MacNeill continued, “the elephant in the room” regarding BCS is that re-excision rates of up to 40% are common. This high rate of repeat surgery is a huge issue because of the resultant increased costs, morbidity, poor cosmesis, increased risk of mastectomy, and delay to adjuvant therapy.
High re-excision rates aren’t due to surgical incompetence, Dr. MacNeill stressed, but rather to the difficulty in defining microscopic disease intraoperatively. But help is on the way. Several novel approaches that facilitate lower re-excision rates and more breast conservation show considerable promise.
For example, investigators at Yale University have recently demonstrated in a randomized controlled trial that routine intraoperative cavity shave margins taken circumferentially halved the re-excision rate, from 21% to 10% (N Engl J Med. 2015 Aug 6;373[6]:503-10).
A meta-analysis of studies that included nearly 9,000 breast cancer patients who underwent BCS alone or BCS with oncoplastic breast conservation techniques concluded that the re-excision rate was just 4.3% in women who underwent oncoplastic breast conservation, compared with 14.6% with BCS alone (Ann Plast Surg. 2014 Feb;72[2]:145-9).
“This is going to be a driver for many breast cancer units to look at how they can use oncoplastic breast conservation to bring down their resection rates,” Dr. MacNeill predicted.
Neoadjuvant chemotherapy or endocrine therapy, a strategy in which surgery becomes adjuvant therapy, is likely to play an important role in facilitating breast conservation in the future. In the CALGB 40603 trial, for example, neoadjuvant chemotherapy in women with triple-negative breast cancer resulted in an absolute 14% increase in eligibility for BCS. Moreover, BCS was successful with no re-excision in 93% of treated patients (Ann Surg. 2015 Sep;262[3]:434-9).
The ‘less is more’ movement in breast cancer surgery may in the future mean no surgery at all in certain cases. Now underway in the United Kingdom is LORIS (the Low Risk DCIS Trial), in which women with low-risk DCIS are being randomized to surgery or 10 years of monitoring via annual mammograms.
“I’m suggesting that surgery may not exist in the longer term,” Dr. MacNeill said.
She, Dr. Jatoi, and Dr. Smith reported having no financial conflicts regarding their presentations. Dr. Smith’s study was supported by the Cancer Prevention and Research Institute of Texas, the Conquer Cancer Foundation, and the American Society for Radiation Oncology.
EXPERT ANALYSIS FROM SABCS 2015
