Surgical Oncology

Axillary lymph node dissection can be skipped in some early-stage breast cancer patients with minimal sentinel node involvement, as well as in those with negative findings on sentinel node biopsy, according to revised clinical practice guidelines issued by the National Comprehensive Cancer Network.

The recommendation that no further axial surgery be considered for certain patients with only one or two involved sentinel lymph nodes reflects an upgrade of the National Comprehensive Cancer Network (NCCN) guideline on sentinel node biopsy to a category 1 recommendation.

The change is based on the findings of recent prospective studies. In particular, the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, found no survival difference between early-stage breast cancer patients who underwent axillary lymph node dissection [ALND] and those who did not after one or two sentinel nodes were determined to be positive on biopsy (JAMA 2011;305:569-75).

The revised recommendation extends only to those patients with early-stage disease (tumor grades 1 or 2) who undergo breast-conserving surgery and whole-breast radiation and who have not received neoadjuvant chemotherapy, according to the guidelines. A primary objective is to reduce the risk of lymphedema associated with axillary lymph node dissection.

"In the absence of definitive data demonstrating superior survival from the performance of axillary lymph node dissection, patients who have particularly favorable tumors, patients for whom the selection of adjuvant systemic therapy is unlikely to be affected, for the elderly or those with serious comorbid conditions, the performance of axillary lymph node dissection may be considered optional," the guidelines advise.

The update was presented at the NCCN annual meeting in Hollywood, Fla. The Breast Cancer Panel lists potential conflict of interest disclosures on the NCCN website.

Axillary lymph node dissection can be skipped in some early-stage breast cancer patients with minimal sentinel node involvement, as well as in those with negative findings on sentinel node biopsy, according to revised clinical practice guidelines issued by the National Comprehensive Cancer Network.

The recommendation that no further axial surgery be considered for certain patients with only one or two involved sentinel lymph nodes reflects an upgrade of the National Comprehensive Cancer Network (NCCN) guideline on sentinel node biopsy to a category 1 recommendation.

The change is based on the findings of recent prospective studies. In particular, the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, found no survival difference between early-stage breast cancer patients who underwent axillary lymph node dissection [ALND] and those who did not after one or two sentinel nodes were determined to be positive on biopsy (JAMA 2011;305:569-75).

The revised recommendation extends only to those patients with early-stage disease (tumor grades 1 or 2) who undergo breast-conserving surgery and whole-breast radiation and who have not received neoadjuvant chemotherapy, according to the guidelines. A primary objective is to reduce the risk of lymphedema associated with axillary lymph node dissection.

"In the absence of definitive data demonstrating superior survival from the performance of axillary lymph node dissection, patients who have particularly favorable tumors, patients for whom the selection of adjuvant systemic therapy is unlikely to be affected, for the elderly or those with serious comorbid conditions, the performance of axillary lymph node dissection may be considered optional," the guidelines advise.

The update was presented at the NCCN annual meeting in Hollywood, Fla. The Breast Cancer Panel lists potential conflict of interest disclosures on the NCCN website.

Axillary lymph node dissection can be skipped in some early-stage breast cancer patients with minimal sentinel node involvement, as well as in those with negative findings on sentinel node biopsy, according to revised clinical practice guidelines issued by the National Comprehensive Cancer Network.

The recommendation that no further axial surgery be considered for certain patients with only one or two involved sentinel lymph nodes reflects an upgrade of the National Comprehensive Cancer Network (NCCN) guideline on sentinel node biopsy to a category 1 recommendation.

The change is based on the findings of recent prospective studies. In particular, the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, found no survival difference between early-stage breast cancer patients who underwent axillary lymph node dissection [ALND] and those who did not after one or two sentinel nodes were determined to be positive on biopsy (JAMA 2011;305:569-75).

The revised recommendation extends only to those patients with early-stage disease (tumor grades 1 or 2) who undergo breast-conserving surgery and whole-breast radiation and who have not received neoadjuvant chemotherapy, according to the guidelines. A primary objective is to reduce the risk of lymphedema associated with axillary lymph node dissection.

"In the absence of definitive data demonstrating superior survival from the performance of axillary lymph node dissection, patients who have particularly favorable tumors, patients for whom the selection of adjuvant systemic therapy is unlikely to be affected, for the elderly or those with serious comorbid conditions, the performance of axillary lymph node dissection may be considered optional," the guidelines advise.

The update was presented at the NCCN annual meeting in Hollywood, Fla. The Breast Cancer Panel lists potential conflict of interest disclosures on the NCCN website.

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. "Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care," said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that "currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals," the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that "differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation" may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are "almost always" re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that "institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both" may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because "there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate." So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. "Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care," said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that "currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals," the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that "differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation" may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are "almost always" re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that "institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both" may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because "there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate." So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. "Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care," said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that "currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals," the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that "differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation" may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are "almost always" re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that "institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both" may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because "there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate." So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

SAN ANTONIO – Contralateral prophylactic mastectomy – in comparison to unilateral mastectomy – was associated with a significantly increased rate of major postoperative surgical complications in a 470-patient study.

Physicians therefore must provide appropriate information about these risks to patients who are considering the contralateral procedure, according to lead investigator Allison C. Stover, M.P.H. Major complications often require numerous unplanned procedures, which increase patient burden and treatment costs.

To assess the impact of the contralateral procedure on surgical outcomes, Ms. Stover of the University of California, San Francisco, and her colleagues identified patients who underwent unilateral or bilateral mastectomy with immediate reconstruction at her institution between 2005 and 2010. A minimum of 1 year of follow-up data was available for each study participant. Patients with bilateral cancer or bilateral prophylactic surgery were excluded from the analysis.

The investigators grouped the patients by unilateral or contralateral mastectomy status. They also prospectively captured complications, including infection with use of oral or intravenous antibiotics; implant exposure, loss, or removal; seroma; hematoma; delayed wound healing; necrosis; readmission; and return to the operating room.

Among the 470 patients (665 breasts) who met the study criteria, the mean follow-up time was 22 months. There were no differences between the groups in tumor grade, stage, follow-up time, smoking history, or radiation, either prior to or post surgery, Ms. Stover said in a poster presentation at the San Antonio Breast Cancer Symposium.

Significant between-group differences were observed in age and the number of skin-sparing mastectomies, she said, noting that the contralateral group was younger than the unilateral group (mean age 46.04 years vs. 50.55 years, respectively), and had a larger proportion of skin-sparing mastectomies.

The rate of any major complication was 1.5 times higher in the contralateral group compared with the unilateral group, Ms. Stover stated. "There were significant between-group differences in the number of severe infections requiring IV antibiotics and return to the operating room, as well as the overall rate of any major complication," she said.

A comparison of the complication rate by index vs. prophylactic breast within the contralateral group showed a significantly higher rate of implant loss in the index breast, but no significant differences in any other measure, Ms. Stover noted.

Because many contralateral cases are not at sufficiently high risk for a second breast cancer to meet clinical criteria for prophylactic surgery, the increased complication rate should be taken into consideration when counseling women who are contemplating contralateral mastectomy, Ms. Stover said, adding that they should also be incorporated into guidelines and clinical recommendations.

The poster discussant, Dr. Ismail Jatoi of the University of Texas Health Sciences Center in San Antonio, pointed out that the study’s mean follow-up of 22 months may be insufficient to adequately compare the complication rates. "There are long-term implications that may increase the value [of the contralateral procedure]. For example, patients who undergo the procedure no longer undergo mammograms and thus are not subject to false-positive reports and the subsequent associated testing. They may have lower morbidity over time," he said. "The long-term impact may be less dire than the short-term impact."

It is also possible that the results could be attributed to a "multiplicity of testing," Dr. Jatoi said. "When you test for a lot of bad outcomes, you’re likely to find one."

Despite these concerns, "there clearly are some risks, which point to the need for proper, thorough informed consent," said Dr. Jatoi. "The possible increased complication risks are definitely points to be made when we provide informed consent."

Ms. Stover and Dr. Jatoi reported that they had no relevant financial conflicts.

SAN ANTONIO – Contralateral prophylactic mastectomy – in comparison to unilateral mastectomy – was associated with a significantly increased rate of major postoperative surgical complications in a 470-patient study.

Physicians therefore must provide appropriate information about these risks to patients who are considering the contralateral procedure, according to lead investigator Allison C. Stover, M.P.H. Major complications often require numerous unplanned procedures, which increase patient burden and treatment costs.

To assess the impact of the contralateral procedure on surgical outcomes, Ms. Stover of the University of California, San Francisco, and her colleagues identified patients who underwent unilateral or bilateral mastectomy with immediate reconstruction at her institution between 2005 and 2010. A minimum of 1 year of follow-up data was available for each study participant. Patients with bilateral cancer or bilateral prophylactic surgery were excluded from the analysis.

The investigators grouped the patients by unilateral or contralateral mastectomy status. They also prospectively captured complications, including infection with use of oral or intravenous antibiotics; implant exposure, loss, or removal; seroma; hematoma; delayed wound healing; necrosis; readmission; and return to the operating room.

Among the 470 patients (665 breasts) who met the study criteria, the mean follow-up time was 22 months. There were no differences between the groups in tumor grade, stage, follow-up time, smoking history, or radiation, either prior to or post surgery, Ms. Stover said in a poster presentation at the San Antonio Breast Cancer Symposium.

Significant between-group differences were observed in age and the number of skin-sparing mastectomies, she said, noting that the contralateral group was younger than the unilateral group (mean age 46.04 years vs. 50.55 years, respectively), and had a larger proportion of skin-sparing mastectomies.

The rate of any major complication was 1.5 times higher in the contralateral group compared with the unilateral group, Ms. Stover stated. "There were significant between-group differences in the number of severe infections requiring IV antibiotics and return to the operating room, as well as the overall rate of any major complication," she said.

A comparison of the complication rate by index vs. prophylactic breast within the contralateral group showed a significantly higher rate of implant loss in the index breast, but no significant differences in any other measure, Ms. Stover noted.

Because many contralateral cases are not at sufficiently high risk for a second breast cancer to meet clinical criteria for prophylactic surgery, the increased complication rate should be taken into consideration when counseling women who are contemplating contralateral mastectomy, Ms. Stover said, adding that they should also be incorporated into guidelines and clinical recommendations.

The poster discussant, Dr. Ismail Jatoi of the University of Texas Health Sciences Center in San Antonio, pointed out that the study’s mean follow-up of 22 months may be insufficient to adequately compare the complication rates. "There are long-term implications that may increase the value [of the contralateral procedure]. For example, patients who undergo the procedure no longer undergo mammograms and thus are not subject to false-positive reports and the subsequent associated testing. They may have lower morbidity over time," he said. "The long-term impact may be less dire than the short-term impact."

It is also possible that the results could be attributed to a "multiplicity of testing," Dr. Jatoi said. "When you test for a lot of bad outcomes, you’re likely to find one."

Despite these concerns, "there clearly are some risks, which point to the need for proper, thorough informed consent," said Dr. Jatoi. "The possible increased complication risks are definitely points to be made when we provide informed consent."

Ms. Stover and Dr. Jatoi reported that they had no relevant financial conflicts.

SAN ANTONIO – Contralateral prophylactic mastectomy – in comparison to unilateral mastectomy – was associated with a significantly increased rate of major postoperative surgical complications in a 470-patient study.

Physicians therefore must provide appropriate information about these risks to patients who are considering the contralateral procedure, according to lead investigator Allison C. Stover, M.P.H. Major complications often require numerous unplanned procedures, which increase patient burden and treatment costs.

To assess the impact of the contralateral procedure on surgical outcomes, Ms. Stover of the University of California, San Francisco, and her colleagues identified patients who underwent unilateral or bilateral mastectomy with immediate reconstruction at her institution between 2005 and 2010. A minimum of 1 year of follow-up data was available for each study participant. Patients with bilateral cancer or bilateral prophylactic surgery were excluded from the analysis.

The investigators grouped the patients by unilateral or contralateral mastectomy status. They also prospectively captured complications, including infection with use of oral or intravenous antibiotics; implant exposure, loss, or removal; seroma; hematoma; delayed wound healing; necrosis; readmission; and return to the operating room.

Among the 470 patients (665 breasts) who met the study criteria, the mean follow-up time was 22 months. There were no differences between the groups in tumor grade, stage, follow-up time, smoking history, or radiation, either prior to or post surgery, Ms. Stover said in a poster presentation at the San Antonio Breast Cancer Symposium.

Significant between-group differences were observed in age and the number of skin-sparing mastectomies, she said, noting that the contralateral group was younger than the unilateral group (mean age 46.04 years vs. 50.55 years, respectively), and had a larger proportion of skin-sparing mastectomies.

The rate of any major complication was 1.5 times higher in the contralateral group compared with the unilateral group, Ms. Stover stated. "There were significant between-group differences in the number of severe infections requiring IV antibiotics and return to the operating room, as well as the overall rate of any major complication," she said.

A comparison of the complication rate by index vs. prophylactic breast within the contralateral group showed a significantly higher rate of implant loss in the index breast, but no significant differences in any other measure, Ms. Stover noted.

Because many contralateral cases are not at sufficiently high risk for a second breast cancer to meet clinical criteria for prophylactic surgery, the increased complication rate should be taken into consideration when counseling women who are contemplating contralateral mastectomy, Ms. Stover said, adding that they should also be incorporated into guidelines and clinical recommendations.

The poster discussant, Dr. Ismail Jatoi of the University of Texas Health Sciences Center in San Antonio, pointed out that the study’s mean follow-up of 22 months may be insufficient to adequately compare the complication rates. "There are long-term implications that may increase the value [of the contralateral procedure]. For example, patients who undergo the procedure no longer undergo mammograms and thus are not subject to false-positive reports and the subsequent associated testing. They may have lower morbidity over time," he said. "The long-term impact may be less dire than the short-term impact."

It is also possible that the results could be attributed to a "multiplicity of testing," Dr. Jatoi said. "When you test for a lot of bad outcomes, you’re likely to find one."

Despite these concerns, "there clearly are some risks, which point to the need for proper, thorough informed consent," said Dr. Jatoi. "The possible increased complication risks are definitely points to be made when we provide informed consent."

Ms. Stover and Dr. Jatoi reported that they had no relevant financial conflicts.