Cumulative Toxicity in Targeted Therapies: What to Expect at the Recommended Phase II Dose.

ABSTRACT: BACKGROUND:In the era of molecularly targeted agents (MTAs), it is recommended to account for toxicity over several cycles to identify the recommended phase II dose (RP2D). We investigated the relationship between the risk of toxicity at cycle 1 and the cumulative incidence of toxicity over subsequent cycles in trials of single MTAs. METHODS:On individual patient data from 26 phase I clinical trials of single MTAs provided by the National Cancer Institute, we estimated the probability of first-severe toxicity per treatment cycle as well as the cumulative incidence at, below, and above the maximum tolerated dose (MTD). Toxicity was further subclassified into nonhematologic and hematologic. A prediction table was developed to estimate the cumulative incidence up to six cycles based on the to

SUBMITTER: Altzerinakou MA 

PROVIDER: S-EPMC6855968 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature