Measuring response in a post-RECIST world: from black and white to shades of grey

Laura C Michaelis1, Mark J Ratain

  • 1Section of Hematology/Oncology, University of Chicago, 5841 S. Maryland Avenue, MC 2115, Chicago, Illinois 60637, USA.

Nature Reviews. Cancer
|April 25, 2006
PubMed

Insights

The rapid advancement of cancer therapies necessitates new ways to measure drug effectiveness in early development. Traditional methods are inadequate, requiring more innovative trial designs for novel anticancer agents.

Area of Science:

  • Oncology
  • Drug Development
  • Clinical Trials

Background:

  • The rapid pace of therapeutic innovation in oncology challenges traditional methods for evaluating anticancer agent activity.
  • Current criteria for tumor response evaluation may be insufficient for assessing novel therapeutic agents.
  • There is a need to adapt early drug development strategies to the evolving landscape of cancer treatment.

Approach:

  • This analysis examines the historical context of current tumor response evaluation standards.
  • It explores the difficulties and pitfalls associated with using these traditional standards for newer anticancer agents.
  • The study advocates for revised outcome measurements and more imaginative early-phase trial designs.

Key Points:

  • Traditional endpoints for evaluating anticancer agent activity may no longer be adequate due to rapid therapeutic advancements.
  • The transition to new endpoints in early drug development faces significant challenges.
  • Existing criteria for tumor response evaluation present limitations when applied to novel anticancer agents.

Conclusions:

  • The current drug development environment demands different outcome measurements for anticancer agents.
  • More imaginative and rigorous early-phase trial designs are essential for accurately assessing novel therapies.
  • Adapting evaluation methods is crucial for effective oncology drug development.

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