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Sentinel lymph node biopsy is now accepted as the initial approach for women with early stage breast cancer with clinically node-negative disease. We performed a pooled analysis of trials comparing axillary lymph node dissection to sentinel lymph node biopsy in patients with early stage breast cancer and pathologically negative sentinel lymph node analysis. A systematic MEDLINE review identified four randomized trials of axillary dissection versus sentinel lymph node biopsy in lymph node-negative early stage breast cancer patients. A meta-analysis was performed for survival and relapse. The combined analyses of these four trials found no significant difference in overall survival (relative risk [RR] 1.15; P=0.16; 95% CI: 0.95-1.39), breast cancer-specific (RR 1.03; P=0.85; 95% CI: 0.75- 1.43) and disease-free survival (RR 1.07; P=0.3; 95% CI: 0.94-1.21), distant metastases (RR 1; P=0.98; 95% CI: 0.76-1.32), and ipsilateral breast recurrence (RR 1.64; P=0.34; 95% CI: 0.60-4.47) associated with sentinel lymph node biopsy. In particular, a similar rate of nodal recurrences was seen after sentinel lymph node biopsy (RR 1.74; P=0.13; 95% CI: 0.86- 3.53). Axillary dissection does not confer a survival benefit nor prevent further nodal relapses in the setting of early stage, pathologically lymph node-negative breast cancer.
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