PURPOSE: To assess the role of pathologic complete response (pCR) after neoadjuvant therapy as surrogate end point of disease-free survival (DFS) and @entity1349 ( @entity1349 ) in @entity1 with @entity0 , we performed a trial-based meta-regression of randomized studies comparing different neoadjuvant systemic treatments. METHODS: The systematic literature search included electronic databases and proceedings of oncologic meetings. Endocrine therapy trials were excluded. Treatment effects on DFS and @entity1349 were expressed as hazard ratios (HRs), and treatment effects on pCR were expressed as odds ratios (ORs). A weighted regression analysis was performed on log-transformed treatment effect estimates to test the association between treatment effects on the surrogate outcome and treatment effects on the clinical outcome. RESULTS: Twenty-nine trials, 59 arms, and 30 comparisons, for a total of 14,641 @entity1 , were included in the analysis. Using the complete set of data, the regression of either the log(HR) for DFS or the log(HR) for @entity1349 on the log(OR) for pCR demonstrated only weak associations (R (2) = 0.08; 95% CI, 0 to 0.47; and R(2) = 0.09; 95% CI, 0.01 to 0.41, respectively). Better associations were found in an exploratory analysis assessing a subset of trials comparing intensified/dose-dense chemotherapy versus standard-dose regimens (DFS: R(2) = 0.79; 95% CI, 0.26 to 0.95; P = .003; and @entity1349 : R(2) = 0.57; 95% CI, 0.19 to 0.93; P = .03). CONCLUSION: This meta-regression analysis of 29 heterogeneous neoadjuvant trials does not support the use of pCR as a surrogate end point for DFS and @entity1349 in @entity1 with @entity0 . However, pCR may potentially meet the criteria of surrogacy with specific systemic therapies.

Pathologic Complete Response As a Potential Surrogate for the Clinical Outcome in @entity1 With XXXX After Neoadjuvant Therapy: A Meta-Regression of 29 Randomized Prospective Studies.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['overall survival', 'OS']
@entity0 :: (MESH:D001943,Disease) :: ['Breast Cancer']
