Effect of occult @entity3 on survival in node-negative XXXX .

@entity1 @entity0 @entity5 @entity982 @entity3 @entity204
BACKGROUND: Retrospective and observational analyses suggest that occult lymph-node @entity3 are an important prognostic factor for disease recurrence or survival among @entity1 with @entity0 . Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking. METHODS: We randomly assigned @entity1 with @entity0 to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. @entity982 -embedded tissue blocks of sentinel lymph nodes obtained from @entity1 with pathologically negative sentinel lymph nodes were centrally evaluated for occult @entity3 deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension. RESULTS: Occult @entity3 were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 @entity1 . Log-rank tests indicated a significant difference between @entity1 in whom occult @entity3 were detected and those in whom no occult @entity3 were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for @entity204 , any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among @entity1 in whom occult @entity3 were detected and those without detectable @entity3 were 94.6% and 95.8%, respectively. CONCLUSIONS: Occult @entity3 were an independent prognostic variable in @entity1 with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in @entity1 with @entity0 . (Funded by the National @entity5 Institute; ClinicalTrials.gov number, NCT00003830.).
