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Performing Nondiagnostic Research Biopsies in Irradiated Tissue: A Review of Scientific, Clinical, and Ethical Considerations

Aaron P. Brown, David S. Wendler, Kevin A. Camphausen, Franklin G. Miller, Deborah Citrin

From the Radiation Oncology Branch, Section of Imaging and Molecular Therapeutics, Center for Cancer Research, National Cancer Institute; and Department of Bioethics, the National Institutes of Health Clinical Center, and Clinical Research Training Program, Office of the Director, National Institutes of Health, Bethesda, MD

Corresponding author: Deborah Citrin, MD, Radiation Oncology Branch, National Cancer Institute, 10 CRC, B2-3500, Bethesda, MD 20892; e-mail: citrind{at}mail.nih.gov

Purpose Recent development of drugs that target specific pathways in tumors has increased scientific interest in studying drug effects on tumor tissue. As a result, biopsies have become an important part of many early-phase clinical trials. Performing nondiagnostic tumor biopsies raises technical and ethical concerns mostly related to the use of a potentially harmful procedure with no potential benefit to the patient. This issue is complicated by uncertainty about whether performing biopsies in irradiated fields adds significant risk. This article reviews the clinical, scientific, and ethical considerations involved in performing nondiagnostic tumor biopsies in competent adults for research purposes, with a focus on biopsies performed in the setting of therapeutic irradiation.

Methods Clinical trials that performed biopsies during or within 4 months of the completion of radiotherapy were identified with a literature review.

Results Twenty-nine studies with 2,160 patients were identified. Sixteen of 29 studies reported adverse events (AEs) but did not report active evaluation for biopsy complications. Ten studies did not mention AEs within the study report. At least three studies actively evaluated patients for biopsy complications. Taking this into consideration, 17 (>1%) of 2,160 patients were reported to have biopsy complications, although reporting of AEs was suboptimal in most studies.

Conclusion Limited data suggest that biopsies can be performed in irradiated tissues without clinically significant excess risk. Ongoing and future trials including nondiagnostic research biopsies should record and report AEs related to this procedure to provide additional data on safety and toxicity.

Supported by the Intramural Research Program of the National Institutes of Health, National Cancer Institute, Office of the Director, and the National Institutes of Health Clinical Center. A.P.B.'s research year was made possible through the Clinical Research Training Program, a public-private partnership supported jointly by the National Institutes of Health and Pfizer Inc (via a grant to the Foundation for National Institutes of Health from Pfizer Inc).

Disclaimer: The opinions expressed are those of the authors and do not reflect the position or policy of the National Institutes of Health, the Public Health Service, or the United States 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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