Clin Cancer Res. 2021 May 01;27(9):2424-2429. doi: 10.1158/1078-0432.CCR-20-3868. Epub 2021 Feb 09.

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group.

Clinical cancer research : an official journal of the American Association for Cancer Research

Allison Magnuson, Suanna S Bruinooge, Harpreet Singh, Keith D Wilner, Shadia Jalal, Stuart M Lichtman, Paul G Kluetz, Gary H Lyman, Heidi D Klepin, Mark E Fleury, Brad Hirsch, Allen Melemed, Fernanda I Arnaldez, Upal Basu Roy, Caroline Schenkel, Shimere Sherwood, Elizabeth Garrett-Mayer

PMID: 33563633 PMCID: PMC8102305 DOI: 10.1158/1078-0432.CCR-20-3868

Abstract

PURPOSE: Performance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias.

EXPERIMENTAL DESIGN: A multidisciplinary working group of the American Society of Clinical Oncology and Friends of Cancer Research evaluated how PS eligibility criteria could be more inclusive. The working group recommendations are based on a literature search, review of trials, simulation study, and multistakeholder consensus. The working group prioritized inclusiveness and access to investigational therapies, while balancing patient safety and study integrity.

RESULTS: Broadening PS eligibility criteria may increase the number of potentially eligible patients for a given clinical trial, thus shortening accrual time. It may also result in greater participant diversity, potentially reduce trial participant and patient disparities, and enable clinicians to more readily translate trial results to patients with low-functioning PS. Potential impact on outcomes was explored through a simulation trial demonstrating that when the number of Eastern Cooperative Oncology Group PS2 participants was relatively small, the effect on the estimated HR and power was modest, even when PS2 patients did not derive a treatment benefit.

CONCLUSIONS: Expanding PS eligibility criteria to be more inclusive may be justified in many cases and could result in faster accrual rates and more representative trial populations.

©2021 American Association for Cancer Research.

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Publication Types

• Journal Article
• Research Support, N.I.H., Extramural

Grant support

• K76 AG064394/AG/NIA NIH HHS/United States
• P30 CA008748/CA/NCI NIH HHS/United States