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Annals of Oncology Advance Access originally published online on November 27, 2007
Annals of Oncology 2008 19(4):787-792; doi:10.1093/annonc/mdm548
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© The Author 2007. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

phase I and pharmacokinetics

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

A. Italiano1, C. Massard1, R. Bahleda1, A.-L. Vataire2, E. Deutsch3, N. Magné3, J.-P. Pignon2, G. Vassal4, J.-P. Armand1,5 and J.-C. Soria1,*

1 Department of Medicine
2 Department of Biostatistics and Epidemiology
3 Department of Radiotherapy
4 Clinical and Translational Research Division, Institut Gustave Roussy, Villejuif
5 Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France

* Correspondence to: Dr J.-C. Soria, Department of Medicine, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif Cedex, France. Tel: +33-1-42-11-43-39; Fax: +33-1-42-11-50-38; E-mail: soria{at}igr.fr

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.

Key words: anticancer drugs, early clinical trials, oncology, phase I trials, targeted therapies

Received for publication September 25, 2007. Revision received October 29, 2007. Accepted for publication October 30, 2007.


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