The time has come to change the algorithm for the surgical management of early breast cancer.

HYPOTHESIS If the sentinel lymph nodes (SNs) draining a primary invasive breast cancer are free of tumor, then axillary lymph node dissection is not necessary for management of disease. DESIGN AND INTERVENTION In July 2000, we reported our initial experience of a small cohort of patients who underwent axillary lymph node dissection only if their SNs were involved with metastases. We now report outcome data for all patients who underwent breast conservation and sentinel lymph node dissection without completion axillary lymph node dissection between October 1, 1995, and April 30, 1999. SETTING Tertiary breast referral center. PATIENTS Two hundred thirty-eight patients whose SN staining results were negative for tumor by both hematoxylin-eosin and imunohistochemical stains. Median age was 58.4 years. Most patients (85%) had a T1 tumor; 15% had a T2 tumor. Most (86%) had infiltrating ductal carcinoma with or without extensive ductal carcinoma in situ; 10% had invasive lobular cancer. RESULTS At a median follow-up of 38.9 months (range, 6-69 months), we found no axillary recurrences, and 98.3% of patients are alive without evidence of disease. Three patients have died of causes not related to breast cancer. Four patients are alive with metastatic disease but have not developed axillary recurrences. CONCLUSIONS Sentinel lymph node dissection is a safe and efficacious treatment option for patients with early breast cancer. It provides excellent regional control and is associated with excellent survival. A multicenter trial such as the American College of Surgeons Oncology Group Z0010 is needed to corroborate findings of this single-institution study.