A Comparative Study of Model-Based Dose-Finding Methods for Two-Agent Combination Trials

Akihiro Hirakawa () and Hiroyuki Sato ()
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Akihiro Hirakawa: The University of Tokyo, Department of Biostatistics and Bioinformatics, Graduate School of Medicine
Hiroyuki Sato: Pharmaceuticals and Medical Devices Agency, Biostatistics Group, Office of New Drug V

A chapter in Frontiers of Biostatistical Methods and Applications in Clinical Oncology, 2017, pp 37-52 from Springer

Abstract: Abstract Little is known about the relative relationships of the operating characteristics for rival model-based dose-finding methods for two-agent combination phase I trialsPhase I trial . In this chapter, we focus on the model-based dose-finding methods that have been recently developed. We compare the recommendation rates for true maximum tolerated dose combinations (MTDCs) and over dose combinations (ODCs) among these methods under 16 scenarios with 3 × 3, 4 × 4, 2 × 4, and 3 × 5 dose combination matrices through comprehensive simulationSimulation studies. We found that the operating characteristics of the dose-finding methods varied depending on (1) whether the dose combination matrix is square or not, (2) whether the true MTDCs exist within the same group consisting of the diagonals of the dose combination matrix, and (3) the number of true MTDCs. We also discuss the details of the operating characteristics and the advantages and disadvantages of the dose-finding methods compared.

Keywords: Combination of two agents; Dose-finding design; Phase I trial; Oncology (search for similar items in EconPapers)
Date: 2017
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DOI: 10.1007/978-981-10-0126-0_4

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