Annals of Oncology 1:175-181, 1990
© 1990 European Society for Medical Oncology

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research-article


Responses and toxic deaths in Phase I clinical trials*
G. Decoster1,, G. Stein2 and E. E. Holdener1
1Department of Clinical Research, Division of Oncology, F. Hoffmann-LaRoche Ltd CH-4002 Basle, Switzerland
2Statistics for Research, SFR Ltd CH-4051 Basle, Switzerland

Correspondence to: Genevieve Decoster, M.D. Department of Clinical Research-Oncology F. Hoffmann-LaRoche Ltd Grenzacherstrasse 124 CH-4002 Basle, Switzerland


This review analysis consists of the antitumor activity and toxic deaths reported in single agent Phase I clinical trials using cytotoxic compounds published from 1972 to 1987. A total of 6639 patients with a variety of solid tumors and hematological malignancies were accrued in 211 trials studying 87 compounds. The median number of patients per trial was 28 (range: 7–111) and the median of the median ages reported in the individual trial was 56 (range of individual age: 2 to 93 years). Ten percent of the trials enrolled pediatric patients (< 18 years), but the exact numbers of children were not always given or separated from the adult patients.

http://annonc.oxfordjournals.org/cgi...stract/1/3/175