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Hypothesis: Axillaryrelapseinnode-negativepatientsstaged with sentinel lymph node (SLN) biopsy alone is no more fre- quent than in patients treated with standard axillary dissec- tion. Morbidity is less for patients who had SLN biopsy. Design, Setting, and Patients: Between October 14, 1997, and August 31, 2001, 1253 consecutive women with primary invasive breast cancer were prospectively en- tered into an SLN biopsy database. Completion axillary dissection was performed in 164 patients after SLN bi- opsy as part of a training protocol. Interventions: Patients were contacted by question- naire or telephone to determine breast cancer relapse; pres- ence of arm lymphedema, arm pain, axillary infection, or seroma formation; and tumor recurrence or death. Main Outcome Measures: 2 or Fisher exact tests and Wilcoxon rank sum tests were used to analyze categori- cal and continuous variables. Logistic regression was used to analyze morbidity. Results: Of 1253 women, 894 (71%) were node nega- tive by SLN biopsy alone (n=730 (82%)) or SLN biopsy and completion axillary dissection (n=164 (18%)). Ques- tionnaires were completed by 776 patients (87%). Mean±SD follow-up was 2.4±0.9 years. Patients with ax- illary dissections reported a significantly higher occur- rence of arm lymphedema (34%), arm pain (38%), se- roma formation (24%), and infection (9%) vs SLN biopsy- only patients (6%, 14%, 7%, and 3%, respectively). One axillary relapse (0.1%) occurred during follow-up of 685 women who underwent SLN biopsy only. Conclusions: With intermediate-term follow-up, there was 1 axillary recurrence in 685 SLN node-negative women, supporting use of SLN biopsy as an accurate method for staging breast cancer. Biopsy of the SLN was associated with significantly less morbidity than comple- tion axillary dissection.

Relapse and Morbidity in Patients Undergoing Sentinel Lymph Node Biopsy Alone or With Axillary Dissection for Breast Cancer