Treating non-responders: pitfalls and implications for cancer immunotherapy trial design.

ABSTRACT:

Background

Conventional trial design and analysis strategies fail to address the typical challenge of immune-oncology (IO) studies: only a limited percentage of treated patients respond to the experimental treatment. Treating non-responders, we hypothesize, would in part drive non-proportional hazards (NPH) patterns in Kaplan-Meier curves that violates the proportional hazards (PH) assumption required by conventional strategies. Ignoring such violation incurred from treating non-responders in the design and analysis strategy may result in underpowered or even falsely negative studies. Hence, designing innovative IO trials to address such pitfall becomes essential.

Methods

We empirically tested the hypothesis that treating non-responders in studies of inadequate size is suffi

SUBMITTER: Xu Z 

PROVIDER: S-EPMC7071722 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature