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Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy
- Source :
- Annals of oncology : official journal of the European Society for Medical Oncology. 19(4)
- Publication Year :
- 2007
-
Abstract
- 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.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.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.Current phase I oncology trials are safe and are associated with clinical benefit in a substantial proportion of patients.
- Subjects :
- Oncology
Adult
Male
medicine.medical_specialty
Multivariate analysis
Antineoplastic Agents, Hormonal
MEDLINE
Antineoplastic Agents
Disease
Kaplan-Meier Estimate
Disease-Free Survival
Institut Gustave Roussy
Internal medicine
Neoplasms
medicine
Humans
Progression-free survival
Aged
Aged, 80 and over
Clinical Trials, Phase I as Topic
business.industry
Cancer
Hematology
Middle Aged
medicine.disease
Clinical trial
Treatment Outcome
Meta-analysis
Multivariate Analysis
Female
France
Immunotherapy
business
Subjects
Details
- ISSN :
- 15698041
- Volume :
- 19
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Accession number :
- edsair.doi.dedup.....194dfe8efc3866fdf06c43849a149f31