Practical Application of the Continual Reassessment Method to a Phase I Dose-Finding Trial in Advanced Breast Cancer

摘要

The continual reassessment method (CRM) is a study design and analytical method for dose-finding studies. Since its proposal by O'Quigley et al. (l),the CRM has been used increasingly in phase I dose-finding studies in cancer patients as an alternative to a conventional 3 + 3 cohort design. In 3 + 3 design, patients are treated in cohorts of three, and the dose administered in each successive cohort of three patients is determined by the number of toxicities observed in three patients treated in the previous cohort.