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Incorporating Toxicity Grade Information in Up-and-Down Design

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Author:
No author available
Journal Title:
JOURNAL OF BIOMATHEMATICS
Issue:
1
DOI:
10.3969/j.issn.1001-9626.2007.01.001
Key Word:
剂量响应;毒性研究;Ⅰ期试验;最大耐受剂量;Dose-response;Toxicity study;Phase Ⅰtrial;Maximum tolerated dose(MTD)

Abstract: For phase Ⅰ cancer clinical trials, toxicity is a major concern. Commonly, toxicity is categorized with five levels of severity. A simple sequential design that addresses these ethical concerns is the up-and-down designs (BCD Ⅰ, BCD Ⅱ, k-in-a-row, Narayana, improved Narayana). However, in the up-and-down designs family, the severity level of graded toxicity of a previous patient's response would not be a differentiated factor for "the next dose level assignment and doses that are too toxic may also be recommended. In this study, we extend the up-and-down procedure incorporating the idea on the assessments of graded toxicity in the dose escalation. We investigate the operating characteristics of this approach under a variety of dose-toxicity associations and comparison with up-and-down family shows that it can achieve significant improvements to the doses recommended during the phase Ⅰtrial.

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