Dose escalation with overdose control using a quasi-continuous toxicity score in cancer Phase I clinical trials.

Contemporary Clinical Trials
Zhengjia ChenJeanne Kowalski

Abstract

Escalation with overdose control (EWOC) is a Bayesian adaptive design for selecting dose levels in cancer Phase I clinical trials while controlling the posterior probability of exceeding the maximum tolerated dose (MTD). EWOC has been used by clinicians to design many cancer Phase I clinical trials, see e.g. [1-4]. However, this design treats the toxicity response as a binary indicator of dose limiting toxicity (DLT) and does not account for the number and specific grades of toxicities experienced by patients during the trial. Chen et al. (2010) proposed a novel toxicity score system to fully utilize all toxicity information using a normalized equivalent toxicity score (NETS). In this paper, we propose to incorporate NETS into EWOC using a quasi-Bernoulli likelihood approach to design cancer Phase I clinical trials. We call the design escalation with overdose control using normalized equivalent toxicity score (EWOC-NETS). Simulation results show that this design has good operating characteristics and improves the accuracy of MTD, trial efficiency, therapeutic effect, and overdose control relative to EWOC which is used as a representative of designs treating toxicity response as a binary indicator of DLT. We illustrate the perfo...Continue Reading

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Citations

Apr 12, 2014·Annals of Behavioral Medicine : a Publication of the Society of Behavioral Medicine·Corrine I VoilsJonathan A Shaffer
May 1, 2013·Statistics in Medicine·Yun Shi, Guosheng Yin
Jun 12, 2016·Journal of Medical Ethics·Nir Eyal
Sep 1, 2017·Journal of Biopharmaceutical Statistics·Mourad TighiouartAndré Rogatko
Dec 22, 2020·Statistics in Medicine·Zahra S RazaeeAndré Rogatko

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