Axillary Lymph Node Dissection Unnecessary for Some Early-Stage Patients with Breast Cancer

TON - March/April 2011, VOL 4, NO 2 — April 11, 2011

Data published in the Journal of the American Medical As sociation in March indicate that for 20% of women with early-stage breast cancer, removing malignant lymph nodes from the armpit does not improve survival or prevent recurrence. Women in the phase 3 trial who underwent complete axillary lymph node dissection (ALND) had higher rates of lymphedema than those who had sentinel lymph node dissection (SLND) alone (P <.001). They also had higher rates of wound infection, axillary seromas, and paresthesias (70% vs 25%, respectively; P <.001).

The study, known as the American College of Surgeons Oncology Group Z0011 trial, was conducted at 115 sites from May 1999 to December 2004 to assess whether SLND was noninferior to ALND. In total, 891 women with similar clinical and disease characteristics were randomized to ALND or SLND and followed for a median of 6.3 years with regular physical examinations and annual mammograms.

All women enrolled in the study had stage T1-T2 noninvasive tumors (5 cm or less), with no more than 2 positive sentinel lymph nodes at biopsy, no palpable axillary nodes, and no metastatic spread. Initial treatment consisted of lumpectomy, and 605 underwent wholebreast radiation; women who had received neoadjuvant hormonal therapy or chemotherapy were ineligible. Following surgery, 403 women in the ALND group and 423 in the SLND-only arm received adjuvant systemic therapy, with the types of therapy given fairly well balanced between the study arms. Women in the ALND group had an average of 17 nodes removed compared with 2 in the SLND arm.

At a median of 6.3 years after enrollment, 52 women in the ALND group had died compared with 42 in the SLND group, for an unadjusted hazard ratio of 0.79 (90% confidence interval, 0.56- 1.10), which the authors said demonstrated the noninferiority of SLND alone (P = .008). The 5-year overall survival rates were also similar between the groups, at 92.5% in the SLND-only arm and 91.8% in the ALND group. No statistically significant difference in survival rates was observed when stratifying the patients according to estrogen- or progesterone- receptor status.

In the SLND-only arm, 83.9% of women had no recurrence at 5 years compared with 82.2% of women in the ALND group (P = .14). The 5-year rate of local recurrence was 1.6% in the SLND-only arm versus 3.1% in the ALND group, supporting the conclusion that ALND does not prevent recurrence.

The authors concluded that “the only rationale for ALND in these patients would be if the finding of additional nodal metastases would result in changes in systemic therapy.” Because current treatment guidelines generally call for the same adjuvant therapy regimen regardless of nodal status, the authors said “ALND does not appear to be warranted in this patient population.”

For women with early-stage breast cancer similar to the women in this study, foregoing ALND offers the potential to improve quality of life significantly. Armando E. Giuliano, MD, chief of surgical oncology at the John Wayne Cancer Institute at St. John’s Health Center, Santa Monica, Cali fornia, was lead author of the study. He presented preliminary findings last year at the annual meeting of the American Society of Clinical Oncology and noted then that it might be hard for some physicians to abandon ALND, which has been standard practice for at least a century.

Additional studies will need to determine whether women with more than 2 positive sentinel nodes or matted nodes can safely forego ALND.

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