Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy

Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy

2008 Ann. Oncol

Italiano, A. | Massard, C. | Bahleda, R. | Vataire, A.L. | Deutsch, E. | Magne, N. | Pignon, J.P. | Vassal, G. | Armand, J.P. | Soria, J.C. | Volume: 19, Issue: 4, Pages: 787-792, Adult, adverse effects, Aged, Aged,80 and over, analysis, Antineoplastic Agents, Antineoplastic Agents,Hormonal, Clinical Trials,Phase I as Topic, diagnosis, Disease-Free Survival, drug therapy, epidemiology, Female, France, Humans, immunology, Immunotherapy, Kaplan-Meier Estimate, Male, methods, Middle Aged, mortality, Multivariate Analysis, Neoplasms, pharmacokinetics, pharmacology, radiotherapy, Risk, therapeutic use, therapy, toxicity, Treatment Outcome,

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 > or =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

https://www.doi.org/mdm548 [pii];10.1093/annonc/mdm548