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Is more better? An analysis of toxicity and response outcomes from dose-finding clinical trials in cancer.


ABSTRACT:

Background

The overwhelming majority of dose-escalation clinical trials use methods that seek a maximum tolerable dose, including rule-based methods like the 3+3, and model-based methods like CRM and EWOC. These methods assume that the incidences of efficacy and toxicity always increase as dose is increased. This assumption is widely accepted with cytotoxic therapies. In recent decades, however, the search for novel cancer treatments has broadened, increasingly focusing on inhibitors and antibodies. The rationale that higher doses are always associated with superior efficacy is less clear for these types of therapies.

Methods

We extracted dose-level efficacy and toxicity outcomes from 115 manuscripts reporting dose-finding clinical trials in cancer between 2008 and 2014. We

SUBMITTER: Brock K 

PROVIDER: S-EPMC8256624 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature