期刊
ANNALS OF ONCOLOGY
卷 19, 期 4, 页码 787-792出版社
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdm548
关键词
anticancer drugs; early clinical trials; oncology; phase I trials; targeted therapies
类别
Background: The oncology community usually perceives phase I oncology trials as associated with poor or limited benefits and substantial risks. There is scarce data concerning outcome and survival of patients enrolled in current phase I oncology trials. Patients and methods: We reviewed all phase I oncology trials conducted by investigators from the Adult Phase I Unit at Institut Gustave Roussy from 2003 to 2006. We report data concerning patient demographics, treatment outcome, toxicity, survival and type of care after trial exit. Results: We analyzed 10 trials involving 180 participants. The overall response rate was 7.2%. Disease control (objective response plus stable disease) was achieved in 48.2% of patients. The rate of toxic death was 0.5%. In all, 38% of patients had at least one episode of grade 3 or 4 toxic events. The median progression-free survival and the median overall survival (OS) were 2.3 and 8.7 months, respectively. On multivariate analysis, a time between diagnosis of disease and inclusion in the phase I trial >= 24 months and evidence of disease control were statistically significant predictors of improved OS. Conclusion: Current phase I oncology trials are safe and are associated with clinical benefit in a substantial proportion of patients.
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