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- Title
Phase I trials involving radiation therapy, quantifying the risks.
- Authors
Lawrence, Yaacov Richard; Glass, Charles; Symon, Zvi; Dicker, Adam P.; Den, Robert B.
- Abstract
Introduction Over one third of cancer patients receive radiation therapy ( RT) at some point. Our purpose was to quantify the risks to patients associated with enrolment onto RT-based phase I trials. Methods All phase I and phase I/ II clinical trials involving RT published in English between 2001 and 2010 were identified via a PubMed search. For pragmatic reasons, we focused on trials from 2001, 2005 and 2009. For each trial we calculated a 'toxicity ratio' equal to the number of grade 3/4/5 toxic events divided by the number of patients in the trial. Linear regression was used to determine which variables were associated with higher toxicity ratios. Results There were a total of 33 treatment-related deaths, and 1812 acute grade 3/4 toxicities among the 2994 subjects in 98 trials. The median toxicity ratio over 98 trials was 0.46 (95% confidence interval ( CI) 0.34 to 0.58). Multivariate regression analysis showed that toxicity ratios were significantly higher in trials with chemotherapy ( P = 0.002) and in trials for cancers of the head-and-neck ( P < 0.001). The median toxicity ratio in chemotherapy trials was 0.60 (95% CI: 0.48 to 0.72) compared with trials without chemotherapy 0.08 (95% CI: 0.03 to 0.13). Conclusions Although the risk of grade 5 toxicity is low, the risk of major toxicity is significant in phase I RT trials. These values are comparable to published risk estimates for phase I non- RT trials.
- Subjects
RADIOTHERAPY; CLINICAL trials; DRUG toxicity; ONCOLOGY; REGRESSION analysis
- Publication
Journal of Medical Imaging & Radiation Oncology, 2013, Vol 57, Issue 6, p719
- ISSN
1754-9477
- Publication type
Article
- DOI
10.1111/1754-9485.12082