Removing additional axillary (underarm) lymph nodes ? a procedure called sentinel node biopsy (SNB) – to look for more breast cancer cells in women with limited disease spread in the sentinel node does not improve survival, according to results from a Phase III study. These findings are important because many physicians routinely opt for axillary node dissection in women with metastases in the sentinel lymph node. The results of the Phase III study were reported at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from June 4 – 8 in Chicago, Illinois (USA).

?Axillary lymph node removal has been the standard approach for women with micro- and macrometastases in the sentinel node,? said lead author Armando E. Giuliano, MD, director of the John Wayne Cancer Institute Breast Center in Santa Monica, Calif. ?Our findings suggest that there may not be a benefit to removing more lymph nodes than the sentinel node only, and that women can avoid the risk of additional side effects that come with more extensive lymph node removal. Axillary lymph node dissection will still be needed in some cases, but these findings show it may be necessary for far fewer women.?

Effects on survival controversial
When cancer is detected in the sentinel lymph node (the first node cancer cells would spread to from a tumor), the usual practice is to surgically remove more lymph nodes under the arm to look for additional cancer cells. While this procedure, axillary lymph node dissection (ALND), has been shown to help control the disease locally, its effect on survival has been controversial. ALND can also cause significant side effects, including pain, discomfort and swelling (lymphedema) of the affected arm.

Clinical study
In the largest Phase III study of axillary node dissection for sentinel node-positive women to date, 991 women who had lumpectomy, radiation therapy and a positive sentinel node were randomly assigned to no ALND (446 women ) or ALND with removal of 10 or more additional axillary lymph nodes (445 patients). All were followed for local/regional recurrence and overall survival.

After a median follow-up of nearly six years, the researchers found no survival advantage to having more lymph nodes removed, despite the fact that some of these lymph nodes had cancer in them.. The five-year overall survival in patients undergoing ALND was 91.9% compared to 92.5% for those who had sentinel node biopsy alone. The ALND group had a disease-free survival of 82.2 percent, versus 83.8% for those who did not have ALND. The rate of local/regional recurrence was 4.3% among women who had ALND and 3.4 percent among those who had only sentinel node biopsy. None of these differences was statistically significant.

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Oral Abstract Session: Local, Regional and Adjuvant Therapy
Lead Author: Armando Giuliano, MD, John Wayne Cancer Institute, Santa Monica, CA
Date: Monday, June 7, 2010, 10:00-10:15 AM CDT
Location: N Hall B1
Abstract: CRA 506
Title: ACOSOG Z0011: A randomized trial of axillary node dissection in women with clinical T1-2 N0 M0 breast cancer who have a positive sentinel node.
Authors: A. E. Giuliano, L. M. McCall, P. D. Beitsch, P. W. Whitworth, M. Morrow, P. W. Blumencranz, A. M. Leitch, S. Saha, K. Hunt, K. V. Ballman.

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