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[Dose finding methods for targeted agents: new perspectives].

X Paoletti1, S Postel-Vinay, V Servois

  • 1Service de biostatistique, Inserm U900, Institut Curie, 26, rue d'Ulm, Paris, France. xavier.paoletti@curie.net

Bulletin Du Cancer
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Summary
This summary is machine-generated.

Determining the optimal dose for molecularly targeted therapies requires moving beyond the Maximum Tolerated Dose (MTD). New methods incorporating sensitive endpoints are crucial for effective phase II trial dose selection.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trial Design

Background:

  • Traditional cytotoxic drug dosing relies on Maximum Tolerated Dose (MTD) determined by severe toxicity.
  • Molecularly Targeted Therapies (MTA) may have different dose-activity-toxicity relationships.
  • Relevance of MTD in MTA era requires re-evaluation.

Purpose of the Study:

  • To review potential outcomes for optimal dose definition in MTA.
  • To present innovative statistical dose-finding methodologies.
  • To assess the suitability of MTD for MTA dose selection.

Main Methods:

  • Review of relevant endpoints for dose determination.
  • Exploration of advanced statistical dose-finding methods.
  • Consideration of longitudinal data (tumor growth, toxicity) and continuous outcomes.

Main Results:

  • MTD identification remains important for Phase I trials.
  • MTD alone is insufficient for recommending Phase II trial doses.
  • Novel, sensitive, and discriminatory endpoints are needed for dose ranking.

Conclusions:

  • Phase I dose-finding for MTA should identify MTD but incorporate other endpoints for Phase II recommendations.
  • Endpoints need to be sensitive and discriminatory for ranking doses, not necessarily surrogates of clinical benefit.
  • Lessons from other medical specialties' dose-ranging trials could inform MTA strategies.