Optimal biological dose: a systematic review in cancer phase I clinical trials.

ABSTRACT:

Background

Classical phase 1 dose-finding designs based on a single toxicity endpoint to assess the maximum tolerated dose were initially developed in the context of cytotoxic drugs. With the emergence of molecular targeted agents and immunotherapies, the concept of optimal biological dose (OBD) was subsequently introduced to account for efficacy in addition to toxicity. The objective was therefore to provide an overview of published phase 1 cancer clinical trials relying on the concept of OBD.

Methods

We performed a systematic review through a computerized search of the MEDLINE database to identify early phase cancer clinical trials that relied on OBD. Relevant publications were selected based on a two-step process by two independent readers. Relevant information (phase, ty

SUBMITTER: Fraisse J 

PROVIDER: S-EPMC7805102 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature