Document Detail

Performing nondiagnostic research biopsies in irradiated tissue: a review of scientific, clinical, and ethical considerations.
MedLine Citation:
PMID:  18711189     Owner:  NLM     Status:  MEDLINE    
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.
Aaron P Brown; David S Wendler; Kevin A Camphausen; Franklin G Miller; Deborah Citrin
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  26     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-08-19     Completed Date:  2008-09-02     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3987-94     Citation Subset:  IM    
Radiation Oncology Branch, National Cancer Institute, 10 CRC, B2-3500, Bethesda, MD 20892, USA.
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MeSH Terms
Biopsy / adverse effects,  ethics*,  methods*
Clinical Trials as Topic / ethics*,  methods*
Neoplasms / pathology*,  radiotherapy*
Radiotherapy / adverse effects
Grant Support
Z01 BC010849-01/BC/NCI NIH HHS

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