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Continual reassessment method for partial ordering.

Nolan A Wages1, Mark R Conaway, John O'Quigley

  • 1Department of Mathematics and Computer Science, Hampden-Sydney College, Hampden-Sydney, Virginia 23943, USA. nwages@hsc.edu

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Summary
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This study introduces a novel statistical method for phase 1 oncology trials with multiple agents. It addresses challenges with dose-toxicity curves, offering a more flexible approach for drug combination studies.

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Area of Science:

  • Oncology
  • Biostatistics
  • Clinical Trial Design

Background:

  • Phase 1 oncology trials typically use statistical methods assuming a single cytotoxic agent and monotonic dose-toxicity.
  • Estimating the maximally tolerated dose (MTD) is crucial but complicated by multiple agents and unknown toxicity orderings (partial ordering).

Purpose of the Study:

  • To propose a new two-dimensional dose-finding method for multi-agent phase 1 oncology trials.
  • To relax the assumption of a monotonic dose-toxicity curve in these complex trial settings.

Main Methods:

  • Developed a novel two-dimensional dose-finding method for multi-agent trials.
  • The method simplifies to the continual reassessment method (CRM) when dose-ordering is fully known.
  • Compared the proposed method with CRM and other partial order designs via simulations.

Main Results:

  • The proposed method accommodates situations with partial ordering of dose-toxicity probabilities.
  • It offers a viable alternative to traditional methods that assume full monotonicity.
  • Simulation results demonstrate the performance of the new approach.

Conclusions:

  • The new two-dimensional method provides a flexible framework for dose-finding in multi-agent oncology trials.
  • It effectively handles partial ordering of toxicities, a common scenario in drug combination studies.
  • This approach enhances the ability to estimate MTDs when monotonicity assumptions are uncertain.