Fractional design: An alternative paradigm for late-onset toxicities in oncology dose-finding studies.

ABSTRACT: Late-onset (LO) toxicities often arise in the new era of phase I oncology dose-finding trials with targeted agents or immunotherapies. The current LO toxicities modelling is often formulated in a weighted likelihood framework, where the time-to-event continual reassessment method (TITE-CRM) is commonly used. The TITE-CRM uses the patient exposure time as a weight for the censored observation, while there is large uncertainty on which weight function to be used. As an alternative, the fractional scheme formulates an efficient and robust paradigm to address LO toxicity issues in dose finding. We review the fractional continual reassessment method (fCRM) and compare its operating characteristics with those of the TITE-CRM as well as other competitive designs via extensive simulation studies b

SUBMITTER: Yin G 

PROVIDER: S-EPMC7451759 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature