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  11. Improving The Clinical Meaning Of Surrogate Endpoints: An Empirical Assessment Of Clinical Progression In Phase Iii Oncology Trials

Improving the clinical meaning of surrogate endpoints: An empirical assessment of clinical progression in phase III oncology trials

Alexander D Sherry1, Timothy A Lin2, Zachary R McCaw3,4

  • 1Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

International Journal of Cancer
|August 14, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

Clinical progression, more meaningful to patients than radiologic measures, is underutilized in metastatic solid tumor trials. Genitourinary cancer trials more frequently incorporate clinical progression criteria.

Area of Science:

  • Oncology
  • Clinical Trials
  • Biostatistics
Keywords:
clinical progressionphase III: Randomized controlled trialsquality of lifesurrogate endpoints

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Background:

  • Radiologic measures commonly define disease progression in clinical trials.
  • Clinical progression, reflecting patient experience and treatment changes, may occur independently of radiologic findings.

Purpose of the Study:

  • To assess the inclusion and utilization of clinical progression criteria in phase III trials for metastatic solid tumors.

Main Methods:

  • Systematic review of primary manuscripts and protocols for 216 phase III trials (2006-2020).
  • Analysis of whether clinical events (e.g., pain, bleeding, neurologic compromise) defined progression.
  • Univariable logistic regression to identify factors associated with clinical progression criteria.

Main Results:

  • Only 13% of trials included major clinical status changes in progression criteria, often as secondary endpoints.
  • Distinct clinical progression outcomes were reported in only 59% of trials that included them.
  • Genitourinary cancer trials showed significantly higher utilization of clinical progression definitions (48% vs. 6%).

Conclusions:

  • Clinical progression events are infrequently incorporated into trial endpoints for metastatic solid tumors.
  • Increased focus on clinical progression could enhance the relevance and applicability of surrogate endpoints for patients.
  • Genitourinary trials represent an exception, with greater adoption of clinical progression criteria.