Surv-CRM-12: A Bayesian phase I/II survival CRM for right-censored toxicity endpoints with competing disease progression.

ABSTRACT: The growing interest in new classes of anti-cancer agents, such as molecularly-targeted therapies and immunotherapies with modes of action different from those of cytotoxic chemotherapies, has changed the dose-finding paradigm. In this setting, the observation of late-onset toxicity endpoints may be precluded by treatment and trial discontinuation due to disease progression, defining a competing event to toxicity. Trial designs where dose-finding is modeled in the framework of a survival competing risks model appear particularly well-suited. We aim to provide a phase I/II dose-finding design that allows dose-limiting toxicity (DLT) outcomes to be delayed or unobserved due to competing progression within the possibly long observation window. The proposed design named the Survival-continual

SUBMITTER: Andrillon A 

PROVIDER: S-EPMC9691552 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature