User login
SAN ANTONIO – Accelerated partial-breast brachytherapy, delivered as part of breast-conserving therapy for early breast cancer, was associated with twice the mastectomy rate when compared with standard whole-breast irradiation in a large study.
Moreover, accelerated partial-breast brachytherapy entailed substantially higher rates of both acute and late complications, Dr. Benjamin D. Smith said in a presentation of the study findings at the San Antonio Breast Cancer Symposium.
Investigators reviewed Medicare claims data for all 130,535 beneficiaries whose early breast cancer was treated with lumpectomy followed by adjuvant radiation during 2000-2007. The use of accelerated partial-breast brachytherapy in this population rose from less than 1% in 2000 to 13% in 2007.
The incidence of mastectomy during 5 years of follow-up was 4% in 7,291 brachytherapy recipients, compared with 2% after whole breast irradiation (P less than .001). Upon adjustment for the brachytherapy recipients’ older average age, more comorbid conditions, and lesser rate of positive axillary lymph nodes, brachytherapy was associated with a 2.2-fold increased risk of losing the treated breast within 5 years, reported Dr. Smith, a radiation oncologist at the University of Texas M.D. Anderson Cancer Center, Houston.
"When we adjusted for various clinical and sociodemographic factors, to our surprise brachytherapy was the variable that had the strongest correlation with the risk of subsequent mastectomy," he noted.
Partial-breast brachytherapy was also associated with significantly higher rates of postoperative wound infection and acute noninfectious complications as well as increased 5-year rates of fat necrosis and breast pain. Fat necrosis is considered a marker of tissue injury caused by surgery and/or radiotherapy.
Within 1 year of breast cancer diagnosis, infectious complications involving breast or surrounding skin or soft tissues occurred in 16% of women treated with brachytherapy vs. 10% of those who received standard whole breast radiation.
Noninfectious complications including surgical wound breakdown, postoperative bleeding, or seroma formation were twice as common with brachytherapy at 16% and 8%, respectively.
Five-year rates of fat necrosis (9% vs. 4%) and breast pain (15% vs. 12%) also were higher with brachytherapy.
Accelerated partial-breast brachytherapy was developed to address the shortcomings of whole-breast irradiation, the historic standard of care, which entails up to 7 weeks of daily Monday-through-Friday treatment. Whole-breast irradiation is inconvenient. Indeed, it’s such a hardship, especially for patients in rural areas distant from a radiotherapy center, that some women opt for mastectomy as a matter of convenience. Moreover, 15%-30% of women who undergo lumpectomy forgo prescribed radiation therapy, placing themselves at increased risk of local recurrence.
Accelerated partial-breast brachytherapy may improve patient compliance with radiotherapy. It shortens the treatment course to 1 week. It entails temporary placement of radioactive beads within the breast via a catheter system. This method delivers radiation only to breast tissue immediately adjacent to the lumpectomy. This technique is but one of several forms of partial breast irradiation, however; the new findings don’t apply to 3-D external beam radiation, for example.
Accelerated partial breast brachytherapy has boomed in popularity in recent years, especially in community practice. But these new data may put the brakes on that trend.
"This study has changed the way that I think about these two different treatment options, and it’s changed the way I practice," Dr. Smith said in an interview.
Dr. Jennifer A. Ligibel, who chaired a press conference where Dr. Smith presented his findings, said the study carries an important message: "Although observational data using a claims database are no substitute for a randomized trial with long-term follow-up, what we see in this study is that this technique was not as effective and it was also associated with a lot more complications. So if your argument in using this is that it’s sparing patients from additional problems, we’re not seeing that in this study.
"I think this study really does give pause to the incorporation of accelerated partial-breast brachytherapy into routine clinical practice. These results should make people wait for the results of the ongoing randomized trials before they offer this as a standard procedure for their patients," added Dr. Ligibel of Dana-Farber Cancer Center, Boston.
The major randomized trial underway is the National Surgical Breast and Bowel Project B-39/Radiation Therapy Oncology Group 0413 study. The NSABP B-39/RTOG 0413 trial has enrolled 4,000 of a planned 4,500 patients with early breast cancer. The emphasis is on patients under age 50, since they have a higher local recurrence risk than older women. Participants are randomized to whole-breast radiation or various forms of partial breast irradiation after lumpectomy. Mature results aren’t expected until mid-decade.
Dr. Smith and Dr. Ligibel declared having no relevant financial interests.
The American Society for Radiation Oncology has
issued a statement of concern regarding the potential for misinterpretation of
the accelerated partial-breast brachytherapy study. Brachytherapy is a faster,
more convenient alternative to standard whole-breast irradiation, and
brachytherapy technology has improved dramatically since the study years of
2000-2007. Moreover, this was not a randomized trial, and definitive results
from ongoing randomized trials comparing the safety and efficacy of
brachytherapy and standard whole-breast irradiation are still years off. In the
interim, it is appropriate to continue using brachytherapy outside of clinical
trials under selected circumstances as described in a 2009 ASTRO consensus
statement. The first author of the consensus statement was Dr. Benjamin D.
Smith, who presented the brachytherapy findings in San Antonio.
The ASTRO statement (J. Am.
Coll. Surg. 2009;209:269-77) was forged by a task force that conducted an
extensive literature review. Task force members defined a group suitable for
accelerated partial-breast brachytherapy outside of clinical trials based upon
the following characteristics: age 60 years or older, no BRCA mutations, tumor
size not more than 2 cm, T1, estrogen receptor-positive, unicentric and
unifocal, node-negative, no neoadjuvant therapy, no extensive intraductal
component of the breast cancer, and no pure ductal carcinoma in situ. The
consensus statement also defines other patient groups for whom caution must be
applied when considering brachytherapy outside of a clinical trial, as well as
a group for whom such therapy is unacceptable.
The new brachytherapy
study should provide an additional incentive for physicians to be cautious in choosing
which patients to recommend for accelerated partial-breast irradiation. For the
time being, physicians should continue to encourage enrollment in trials and
adhere to a conservative approach to accelerated partial-breast brachytherapy
as indicated in the ASTRO consensus panel statement.
Dr.
Bruce Haffty, a coauthor of the consensus statement, is professor and
chairman of radiation oncology at the Robert
Wood Johnson
Medical School
in New Brunswick, N.J.
The American Society for Radiation Oncology has
issued a statement of concern regarding the potential for misinterpretation of
the accelerated partial-breast brachytherapy study. Brachytherapy is a faster,
more convenient alternative to standard whole-breast irradiation, and
brachytherapy technology has improved dramatically since the study years of
2000-2007. Moreover, this was not a randomized trial, and definitive results
from ongoing randomized trials comparing the safety and efficacy of
brachytherapy and standard whole-breast irradiation are still years off. In the
interim, it is appropriate to continue using brachytherapy outside of clinical
trials under selected circumstances as described in a 2009 ASTRO consensus
statement. The first author of the consensus statement was Dr. Benjamin D.
Smith, who presented the brachytherapy findings in San Antonio.
The ASTRO statement (J. Am.
Coll. Surg. 2009;209:269-77) was forged by a task force that conducted an
extensive literature review. Task force members defined a group suitable for
accelerated partial-breast brachytherapy outside of clinical trials based upon
the following characteristics: age 60 years or older, no BRCA mutations, tumor
size not more than 2 cm, T1, estrogen receptor-positive, unicentric and
unifocal, node-negative, no neoadjuvant therapy, no extensive intraductal
component of the breast cancer, and no pure ductal carcinoma in situ. The
consensus statement also defines other patient groups for whom caution must be
applied when considering brachytherapy outside of a clinical trial, as well as
a group for whom such therapy is unacceptable.
The new brachytherapy
study should provide an additional incentive for physicians to be cautious in choosing
which patients to recommend for accelerated partial-breast irradiation. For the
time being, physicians should continue to encourage enrollment in trials and
adhere to a conservative approach to accelerated partial-breast brachytherapy
as indicated in the ASTRO consensus panel statement.
Dr.
Bruce Haffty, a coauthor of the consensus statement, is professor and
chairman of radiation oncology at the Robert
Wood Johnson
Medical School
in New Brunswick, N.J.
The American Society for Radiation Oncology has
issued a statement of concern regarding the potential for misinterpretation of
the accelerated partial-breast brachytherapy study. Brachytherapy is a faster,
more convenient alternative to standard whole-breast irradiation, and
brachytherapy technology has improved dramatically since the study years of
2000-2007. Moreover, this was not a randomized trial, and definitive results
from ongoing randomized trials comparing the safety and efficacy of
brachytherapy and standard whole-breast irradiation are still years off. In the
interim, it is appropriate to continue using brachytherapy outside of clinical
trials under selected circumstances as described in a 2009 ASTRO consensus
statement. The first author of the consensus statement was Dr. Benjamin D.
Smith, who presented the brachytherapy findings in San Antonio.
The ASTRO statement (J. Am.
Coll. Surg. 2009;209:269-77) was forged by a task force that conducted an
extensive literature review. Task force members defined a group suitable for
accelerated partial-breast brachytherapy outside of clinical trials based upon
the following characteristics: age 60 years or older, no BRCA mutations, tumor
size not more than 2 cm, T1, estrogen receptor-positive, unicentric and
unifocal, node-negative, no neoadjuvant therapy, no extensive intraductal
component of the breast cancer, and no pure ductal carcinoma in situ. The
consensus statement also defines other patient groups for whom caution must be
applied when considering brachytherapy outside of a clinical trial, as well as
a group for whom such therapy is unacceptable.
The new brachytherapy
study should provide an additional incentive for physicians to be cautious in choosing
which patients to recommend for accelerated partial-breast irradiation. For the
time being, physicians should continue to encourage enrollment in trials and
adhere to a conservative approach to accelerated partial-breast brachytherapy
as indicated in the ASTRO consensus panel statement.
Dr.
Bruce Haffty, a coauthor of the consensus statement, is professor and
chairman of radiation oncology at the Robert
Wood Johnson
Medical School
in New Brunswick, N.J.
SAN ANTONIO – Accelerated partial-breast brachytherapy, delivered as part of breast-conserving therapy for early breast cancer, was associated with twice the mastectomy rate when compared with standard whole-breast irradiation in a large study.
Moreover, accelerated partial-breast brachytherapy entailed substantially higher rates of both acute and late complications, Dr. Benjamin D. Smith said in a presentation of the study findings at the San Antonio Breast Cancer Symposium.
Investigators reviewed Medicare claims data for all 130,535 beneficiaries whose early breast cancer was treated with lumpectomy followed by adjuvant radiation during 2000-2007. The use of accelerated partial-breast brachytherapy in this population rose from less than 1% in 2000 to 13% in 2007.
The incidence of mastectomy during 5 years of follow-up was 4% in 7,291 brachytherapy recipients, compared with 2% after whole breast irradiation (P less than .001). Upon adjustment for the brachytherapy recipients’ older average age, more comorbid conditions, and lesser rate of positive axillary lymph nodes, brachytherapy was associated with a 2.2-fold increased risk of losing the treated breast within 5 years, reported Dr. Smith, a radiation oncologist at the University of Texas M.D. Anderson Cancer Center, Houston.
"When we adjusted for various clinical and sociodemographic factors, to our surprise brachytherapy was the variable that had the strongest correlation with the risk of subsequent mastectomy," he noted.
Partial-breast brachytherapy was also associated with significantly higher rates of postoperative wound infection and acute noninfectious complications as well as increased 5-year rates of fat necrosis and breast pain. Fat necrosis is considered a marker of tissue injury caused by surgery and/or radiotherapy.
Within 1 year of breast cancer diagnosis, infectious complications involving breast or surrounding skin or soft tissues occurred in 16% of women treated with brachytherapy vs. 10% of those who received standard whole breast radiation.
Noninfectious complications including surgical wound breakdown, postoperative bleeding, or seroma formation were twice as common with brachytherapy at 16% and 8%, respectively.
Five-year rates of fat necrosis (9% vs. 4%) and breast pain (15% vs. 12%) also were higher with brachytherapy.
Accelerated partial-breast brachytherapy was developed to address the shortcomings of whole-breast irradiation, the historic standard of care, which entails up to 7 weeks of daily Monday-through-Friday treatment. Whole-breast irradiation is inconvenient. Indeed, it’s such a hardship, especially for patients in rural areas distant from a radiotherapy center, that some women opt for mastectomy as a matter of convenience. Moreover, 15%-30% of women who undergo lumpectomy forgo prescribed radiation therapy, placing themselves at increased risk of local recurrence.
Accelerated partial-breast brachytherapy may improve patient compliance with radiotherapy. It shortens the treatment course to 1 week. It entails temporary placement of radioactive beads within the breast via a catheter system. This method delivers radiation only to breast tissue immediately adjacent to the lumpectomy. This technique is but one of several forms of partial breast irradiation, however; the new findings don’t apply to 3-D external beam radiation, for example.
Accelerated partial breast brachytherapy has boomed in popularity in recent years, especially in community practice. But these new data may put the brakes on that trend.
"This study has changed the way that I think about these two different treatment options, and it’s changed the way I practice," Dr. Smith said in an interview.
Dr. Jennifer A. Ligibel, who chaired a press conference where Dr. Smith presented his findings, said the study carries an important message: "Although observational data using a claims database are no substitute for a randomized trial with long-term follow-up, what we see in this study is that this technique was not as effective and it was also associated with a lot more complications. So if your argument in using this is that it’s sparing patients from additional problems, we’re not seeing that in this study.
"I think this study really does give pause to the incorporation of accelerated partial-breast brachytherapy into routine clinical practice. These results should make people wait for the results of the ongoing randomized trials before they offer this as a standard procedure for their patients," added Dr. Ligibel of Dana-Farber Cancer Center, Boston.
The major randomized trial underway is the National Surgical Breast and Bowel Project B-39/Radiation Therapy Oncology Group 0413 study. The NSABP B-39/RTOG 0413 trial has enrolled 4,000 of a planned 4,500 patients with early breast cancer. The emphasis is on patients under age 50, since they have a higher local recurrence risk than older women. Participants are randomized to whole-breast radiation or various forms of partial breast irradiation after lumpectomy. Mature results aren’t expected until mid-decade.
Dr. Smith and Dr. Ligibel declared having no relevant financial interests.
SAN ANTONIO – Accelerated partial-breast brachytherapy, delivered as part of breast-conserving therapy for early breast cancer, was associated with twice the mastectomy rate when compared with standard whole-breast irradiation in a large study.
Moreover, accelerated partial-breast brachytherapy entailed substantially higher rates of both acute and late complications, Dr. Benjamin D. Smith said in a presentation of the study findings at the San Antonio Breast Cancer Symposium.
Investigators reviewed Medicare claims data for all 130,535 beneficiaries whose early breast cancer was treated with lumpectomy followed by adjuvant radiation during 2000-2007. The use of accelerated partial-breast brachytherapy in this population rose from less than 1% in 2000 to 13% in 2007.
The incidence of mastectomy during 5 years of follow-up was 4% in 7,291 brachytherapy recipients, compared with 2% after whole breast irradiation (P less than .001). Upon adjustment for the brachytherapy recipients’ older average age, more comorbid conditions, and lesser rate of positive axillary lymph nodes, brachytherapy was associated with a 2.2-fold increased risk of losing the treated breast within 5 years, reported Dr. Smith, a radiation oncologist at the University of Texas M.D. Anderson Cancer Center, Houston.
"When we adjusted for various clinical and sociodemographic factors, to our surprise brachytherapy was the variable that had the strongest correlation with the risk of subsequent mastectomy," he noted.
Partial-breast brachytherapy was also associated with significantly higher rates of postoperative wound infection and acute noninfectious complications as well as increased 5-year rates of fat necrosis and breast pain. Fat necrosis is considered a marker of tissue injury caused by surgery and/or radiotherapy.
Within 1 year of breast cancer diagnosis, infectious complications involving breast or surrounding skin or soft tissues occurred in 16% of women treated with brachytherapy vs. 10% of those who received standard whole breast radiation.
Noninfectious complications including surgical wound breakdown, postoperative bleeding, or seroma formation were twice as common with brachytherapy at 16% and 8%, respectively.
Five-year rates of fat necrosis (9% vs. 4%) and breast pain (15% vs. 12%) also were higher with brachytherapy.
Accelerated partial-breast brachytherapy was developed to address the shortcomings of whole-breast irradiation, the historic standard of care, which entails up to 7 weeks of daily Monday-through-Friday treatment. Whole-breast irradiation is inconvenient. Indeed, it’s such a hardship, especially for patients in rural areas distant from a radiotherapy center, that some women opt for mastectomy as a matter of convenience. Moreover, 15%-30% of women who undergo lumpectomy forgo prescribed radiation therapy, placing themselves at increased risk of local recurrence.
Accelerated partial-breast brachytherapy may improve patient compliance with radiotherapy. It shortens the treatment course to 1 week. It entails temporary placement of radioactive beads within the breast via a catheter system. This method delivers radiation only to breast tissue immediately adjacent to the lumpectomy. This technique is but one of several forms of partial breast irradiation, however; the new findings don’t apply to 3-D external beam radiation, for example.
Accelerated partial breast brachytherapy has boomed in popularity in recent years, especially in community practice. But these new data may put the brakes on that trend.
"This study has changed the way that I think about these two different treatment options, and it’s changed the way I practice," Dr. Smith said in an interview.
Dr. Jennifer A. Ligibel, who chaired a press conference where Dr. Smith presented his findings, said the study carries an important message: "Although observational data using a claims database are no substitute for a randomized trial with long-term follow-up, what we see in this study is that this technique was not as effective and it was also associated with a lot more complications. So if your argument in using this is that it’s sparing patients from additional problems, we’re not seeing that in this study.
"I think this study really does give pause to the incorporation of accelerated partial-breast brachytherapy into routine clinical practice. These results should make people wait for the results of the ongoing randomized trials before they offer this as a standard procedure for their patients," added Dr. Ligibel of Dana-Farber Cancer Center, Boston.
The major randomized trial underway is the National Surgical Breast and Bowel Project B-39/Radiation Therapy Oncology Group 0413 study. The NSABP B-39/RTOG 0413 trial has enrolled 4,000 of a planned 4,500 patients with early breast cancer. The emphasis is on patients under age 50, since they have a higher local recurrence risk than older women. Participants are randomized to whole-breast radiation or various forms of partial breast irradiation after lumpectomy. Mature results aren’t expected until mid-decade.
Dr. Smith and Dr. Ligibel declared having no relevant financial interests.
FROM THE SAN ANTONIO BREAST CANCER SYMPOSIUM
Major Finding: Accelerated partial-breast brachytherapy had a twofold higher 5-year mastectomy rate than whole breast irradiation and substantially higher complication rates as well.
Data Source: An observational study of claims data for all of the more than 130,000 Medicare patients who underwent lumpectomy with adjuvant radiation in 2000-2007.
Disclosures: No financial conflicts were reported.