Axillary dissection vs no axillary dissection in XXXX with @entity0 and sentinel node @entity3 : a randomized clinical trial.

@entity1 @entity43560 @entity3018 @entity0 @entity5 @entity1711 @entity1600 @entity1710 @entity3
CONTEXT: @entity1600 ( @entity1600 ) accurately identifies nodal @entity3 of early @entity0 , but it is not clear whether further nodal dissection affects survival. OBJECTIVE: To determine the effects of complete @entity1600 ( @entity1600 ) on survival of @entity1 with @entity1600 ( @entity1600 ) @entity3 of @entity0 . DESIGN, SETTING, AND @entity1 : The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling @entity1 from May 1999 to December 2004. @entity1 were @entity1 with clinical T1-T2 @entity0 , no palpable @entity3018 , and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or @entity1710 - @entity1711 staining on permanent section. Targeted enrollment was 1900 @entity1 with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. INTERVENTIONS: All @entity1 underwent lumpectomy and tangential whole-breast irradiation. Those with @entity1600 metastases identified by @entity1600 were randomized to undergo @entity1600 or no further axillary treatment. Those randomized to @entity1600 underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. MAIN OUTCOME MEASURES: Overall survival was the primary end point, with a noninferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that @entity1600 alone is noninferior to @entity1600 . Disease-free survival was a secondary end point. RESULTS: Clinical and @entity5 characteristics were similar between 445 @entity1 randomized to @entity1600 and 446 randomized to @entity1600 alone. However, the median number of nodes removed was 17 with @entity1600 and 2 with @entity1600 alone. At a median follow-up of 6.3 years (last follow-up, @entity43560 , 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%) with @entity1600 and 92.5% (95% CI, 90.0%-95.1%) with @entity1600 alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with @entity1600 and 83.9% (95% CI, 80.2%-87.9%) with @entity1600 alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy. CONCLUSION: Among @entity1 with limited @entity1600 metastatic @entity0 treated with breast conservation and systemic therapy, the use of @entity1600 alone compared with @entity1600 did not result in inferior survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003855.
