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Comment & Response
March 2017

Adoption of Pathologic Complete Response as a Surrogate End Point in Neoadjuvant Trials in HER2-Positive Breast Cancer Still an Open Question

Author Affiliations
  • 1International Drug Development Institute, Louvain-la-Neuve, Belgium
  • 2Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Belgium
  • 3Dendrix Research, Sao Paulo, Brazil
  • 4International Drug Development Institute, San Francisco, California
JAMA Oncol. 2017;3(3):416. doi:10.1001/jamaoncol.2016.3941

To the Editor The meta-analysis presented by Broglio et al1 is an attempt to extend a previously reported pooled analysis by Cortazar et al.2 Cortazar et al2 estimated an individual-level association between pathologic complete response (pCR) and event-free survival (EFS), and a trial-level association between the effects of anti–human epidermal growth factor receptor 2 (HER2) therapies on pCR and EFS. Their results clearly demonstrated that there is a strong individual-level association between pCR and EFS, but virtually no association between treatment effects on these end points, which implies that no reliable prediction can be made about the effect that a new treatment will have on EFS, based on the effect of this treatment on pCR. These results applied to breast cancer in general, but doubts remained in HER2-positive disease, of which there were only few trials.

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