PURPOSE: Pathologic complete response (pCR) to neoadjuvant chemotherapy reflects the cytotoxic efficacy of a drug, but @entity1 survival is influenced by many other factors. The purpose of this study was to assess the relationship between increased pCR rate and trial-level survival benefit in @entity0 ( @entity0 ). EXPERIMENTAL DESIGN: We used bootstrap resampling from a neoadjuvant trial to simulate trials with different pCR rates. We used estimates from Adjuvant!Online to simulate trial populations with different baseline prognosis and estimated survival improvements associated with changes in pCR rate. RESULTS: Assuming that survival is similar for @entity1 with pCR regardless of treatment arm, a linear relationship exists between increasing pCR rate and increasing recurrence-free survival (RFS). The slope is equal to the difference in survival between those with pCR and @entity66 , which in turn is influenced by (i) the baseline prognosis of the trial population, (ii) interactions between prognostic variables and pCR, and (iii) the efficacy of the postneoadjuvant therapies. For example, if the pCR rates are 30% and 60% (OR = 3.5) and the 10-year RFS of the control arm is 0.74, the trial would require 3,550 @entity1 per arm, whereas if the RFS is 0.54, the trial would require only 425 @entity1 per arm to detect significant survival benefit. CONCLUSIONS: We provide a framework for understanding the relationship between pCR and overall survival benefit that can help inform the design of neoadjuvant trials aiming to demonstrate improved survival from a regimen that results in higher pCR rate. Clin Cancer Res; 22(1); 1-8.   2015 AACR.See related commentary by Berry, p. 3.

Relationship between Complete Pathologic Response to Neoadjuvant Chemotherapy and Survival in Triple-Negative XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity0 :: ('MESH:D001943', 'Disease') :: ['triple-negative breast cancer', 'TNBC'] @entity66 :: ('MESH:D004194', 'Disease') :: ['residual disease']
@entity0 :: (MESH:D001943,Disease) :: ['Breast Cancer']
