PMID- 18711189
OWN - NLM
STAT- MEDLINE
DCOM- 20080902
LR  - 20240322
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 26
IP  - 24
DP  - 2008 Aug 20
TI  - Performing nondiagnostic research biopsies in irradiated tissue: a review of 
      scientific, clinical, and ethical considerations.
PG  - 3987-94
LID - 10.1200/JCO.2008.16.9896 [doi]
AB  - 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.
FAU - Brown, Aaron P
AU  - Brown AP
AD  - Radiation Oncology Branch, National Cancer Institute, 10 CRC, B2-3500, Bethesda, 
      MD 20892, USA.
FAU - Wendler, David S
AU  - Wendler DS
FAU - Camphausen, Kevin A
AU  - Camphausen KA
FAU - Miller, Franklin G
AU  - Miller FG
FAU - Citrin, Deborah
AU  - Citrin D
LA  - eng
GR  - Z01 BC010849-01/ImNIH/Intramural NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
MH  - Biopsy/adverse effects/*ethics/*methods
MH  - Clinical Trials as Topic/*ethics/*methods
MH  - Humans
MH  - Neoplasms/*pathology/*radiotherapy
MH  - Radiotherapy/adverse effects
PMC - PMC2587354
MID - NIHMS48055
EDAT- 2008/08/20 09:00
MHDA- 2008/09/03 09:00
PMCR- 2009/08/20
CRDT- 2008/08/20 09:00
PHST- 2008/08/20 09:00 [pubmed]
PHST- 2008/09/03 09:00 [medline]
PHST- 2008/08/20 09:00 [entrez]
PHST- 2009/08/20 00:00 [pmc-release]
AID - 26/24/3987 [pii]
AID - 69896 [pii]
AID - 10.1200/JCO.2008.16.9896 [doi]
PST - ppublish
SO  - J Clin Oncol. 2008 Aug 20;26(24):3987-94. doi: 10.1200/JCO.2008.16.9896.