Originally published as JCO Early Release 10.1200/JCO.2008.18.1420 on November 24 2008

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Self-Reported Practices and Attitudes of US Oncologists Regarding Off-Protocol Therapy

Jeffrey Peppercorn, Harold Burstein, Franklin G. Miller, Eric Winer, Steve Joffe

From the Duke Comprehensive Cancer Center, Durham, NC; Dana-Farber Cancer Institute, Boston, MA; and the National Institutes of Health, Bethesda, MD

Corresponding author: Jeffrey Peppercorn, MD, MPH, Division of Medical Oncology, Duke University Medical Center, Box 3446, Durham, NC 27710; e-mail: jeffrey.peppercorn{at}duke.edu

Purpose Investigational cancer therapies being tested in clinical trials may be available outside of trials, or off-protocol (OPRx). We evaluated the practices and attitudes among US oncologists with regard to this controversial practice.

Methods We mailed an anonymous survey to a random sample of US medical oncologists evaluating frequency and prevalence of OPRx and evaluated the correlation between demographic factors, attitudes, and practice.

Results One hundred forty-six (31%) of 471 oncologists responded. Ninety-three percent reported ever discussing and 81% ever prescribing OPRx. Academic oncologists were more likely than community oncologists to have ever provided OPRx (89% v 75%; P = .06), to discuss OPRx at least once/month (41% v 19%; P = .0004), and to deny requests for OPRx at least once/month (16% v 2%; P = .004). While 61% of oncologists believed that patients should be discouraged from OPRx, only 31% felt it should not be available. With regard to trial recruitment, 53% felt that informed consent requires discussion of OPRx, 34% disagree, and 26% feel that patients should be provided OPRx on request, while 56% disagree. There was lack of consensus on access to OPRx in scenarios based on open trials at the time of the survey, such as adjuvant trastuzumab, which 41% would provide, 59% would not.

Conclusion US oncologists report common discussion and use of OPRx, but attitudes and practices may vary substantially. There is need for greater debate regarding OPRx in oncology, further definition of the ethical and clinical issues at stake, and development of guidelines in this area.

published online ahead of print at www.jco.org on November 24, 2008

Supported by the American Society of Clinical Oncology Foundation (J.P.), Breast Cancer Research Foundation (J.P.), and by the Greenwall Foundation Faculty Scholars Program in Bioethics (J.P.).

The opinions expressed are those of the author and do not reflect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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