Taking a Measured Approach to Toxicity Data in Phase I Oncology Clinical Trials

Clin Cancer Res. 2016 Feb 1;22(3):527-9. doi: 10.1158/1078-0432.CCR-15-2005. Epub 2015 Oct 14.

Abstract

The standard categorical system for assessing attribution of toxicity to study drug(s) in phase I trials is cumbersome and uninformative. Although a binary system ("related" vs. "unrelated") would be sufficient to define maximum tolerated dose (MTD), a probability estimation would better support dose selection for randomized dose-ranging phase II trials.

Publication types

  • Research Support, N.I.H., Extramural
  • Comment

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Clinical Trials, Phase I as Topic
  • Dose-Response Relationship, Drug*
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Maximum Tolerated Dose*
  • Research Design

Substances

  • Antineoplastic Agents