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Radiotherapy showed similar control rates, fewer side effects than dissection
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CHICAGO — Five-year survival outcomes were similar for axillary radiotherapy and axillary lymph node dissection in a cohort of women with primary breast cancer, according to study results presented at the ASCO Annual Meeting.
Emiel J. Rutgers, MD, surgical oncologist at the Netherlands Cancer Institute in Amsterdam, and colleagues hypothesized that axillary radiotherapy may provide comparable regional control than axillary lymph node dissection, but with fewer adverse events.
Eligibility criteria for the noninferiority AMAROS trial included women with cT1E2N0 primary disease. After a positive sentinel node biopsy, patients were randomly assigned axillary radiotherapy or lymph node dissection.
Accrual occurred between 2001 and 2010. Baseline characteristics for the 4,806 patients enrolled were comparable.
Five-year axillary recurrence rate served as the primary endpoint. OS, DFS, quality of life, shoulder movement, and lymphedema at 1 and 5 years served as the secondary endpoints.
A positive biopsy was observed in 681 women in the radiation arm and 744 women in the dissection arm. Sixty percent of those patients had a macrometastasis.
Results at a median of 6.1 years of follow-up indicated that the 5-year axillary recurrence rate after a positive biopsy was 1.03% after radiation and 0.54% after dissection.
The researchers noted an unexpectedly low number of events, which, in turn, failed to generate the statistical power necessary for a noninferiority test.
After a negative biopsy, axillary recurrence occurred in 0.8% of the cohort.
The estimated 5-year OS was 92.52% for radiation and 93.27% for dissection (P=.3386), which was not a significant difference. Researchers also reported no significant difference in 5-year DFS rates (82.65% in the radiation group vs. 86.9% in the dissection group; P=.1788).
Significantly more lymphedema was observed after dissection than radiation. At 1 year, the lymphedema rate was 40% for dissection and 22% for radiation (P<.0001); at 5 years, the rate was 28% for dissection and 14% for radiation (P<.0001).
Radiation was associated with a nonsignificant trend toward early shoulder movement impairment.
Results of the quality-of-life analysis indicated that radiation yielded improvements in swelling and dissection yielded improvements in movements. Otherwise, quality of life was comparable in both groups.
“I am sure these findings will lead to many doctors re-thinking their strategy for treating patients who have a positive sentinel node biopsy,” Rutgers said. “Lymphedema is a serious concern for patients and a side effect that can affect their quality of life indefinitely.”
For more information:
Rutgers EJ. Abstract# LBA1001. Presented at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Clifford A. Hudis, MD
This is a really long-awaited clinical trial from our European colleagues. Rutgers et al looked at what we do in patients who have a positive sentinel node from invasive breast cancer. The specific question they asked in a randomized fashion was whether a complete axillary dissection was necessary or whether radiation therapy would be sufficient. The takeaway point for most of us was that the rate of local recurrences was very, very low no matter which way you went. The rates of some of the toxicities of the two therapies varied a bit, but fundamentally the results of this study do not make it necessary to go ahead and radiate, nor do they make it necessary to go ahead and do an axillary dissection. Based on the results of this study, either approach can be defended.
Perspective
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Andrew D. Seidman, MD
While some controversy continues regarding the role of complete axillary lymph node surgery, this trial presents an important nonsurgical option for selected patients to reduce breast cancer recurrence under the arm and substantially reduce the risk of arm swelling, which is too common and often debilitating for our patients.
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