Article Abstract

Surrogate study endpoints in the era of cancer immunotherapy

Authors: Tsuyoshi Hamada, Keisuke Kosumi, Yousuke Nakai, Kazuhiko Koike


The choice of a primary endpoint is a matter of ongoing debate in the design of clinical oncology trials testing new treatment regimens. Overall survival (OS) time of patients serves as a gold-standard endpoint in phase III clinical trials testing first-line chemotherapy for cancers, because this outcome variable ultimately represents survival benefits from chemotherapy regimens and has minimal measurement errors.