Title: Patient selection for oncology phase I trials: a multi-institutional study of prognostic factors
Authors: Olmos, David ×
A'hern, Roger P
Marsoni, Silvia
Morales, Rafael
Gomez-Roca, Carlos
Verweij, Jaap
Voest, Emile E
Schöffski, Patrick
Ang, Joo Ern
Penel, Nicolas
Schellens, Jan H
Del Conte, Gianluca
Brunetto, Andre T
Evans, T R Jeffry
Wilson, Richard
Gallerani, Elisa
Plummer, Ruth
Tabernero, Josep
Soria, Jean-Charles
Kaye, Stan B #
Issue Date: Mar-2012
Publisher: Grune & Stratton
Series Title: Journal of Clinical Oncology vol:30 issue:9 pages:996-1004
Abstract: PURPOSE The appropriate selection of patients for early clinical trials presents a major challenge. Previous analyses focusing on this problem were limited by small size and by interpractice heterogeneity. This study aims to define prognostic factors to guide risk-benefit assessments by using a large patient database from multiple phase I trials. PATIENTS AND METHODS Data were collected from 2,182 eligible patients treated in phase I trials between 2005 and 2007 in 14 European institutions. We derived and validated independent prognostic factors for 90-day mortality by using multivariate logistic regression analysis. Results The 90-day mortality was 16.5% with a drug-related death rate of 0.4%. Trial discontinuation within 3 weeks occurred in 14% of patients primarily because of disease progression. Eight different prognostic variables for 90-day mortality were validated: performance status (PS), albumin, lactate dehydrogenase, alkaline phosphatase, number of metastatic sites, clinical tumor growth rate, lymphocytes, and WBC. Two different models of prognostic scores for 90-day mortality were generated by using these factors, including or excluding PS; both achieved specificities of more than 85% and sensitivities of approximately 50% when using a score cutoff of 5 or higher. These models were not superior to the previously published Royal Marsden Hospital score in their ability to predict 90-day mortality. CONCLUSION Patient selection using any of these prognostic scores will reduce non-drug-related 90-day mortality among patients enrolled in phase I trials by 50%. However, this can be achieved only by an overall reduction in recruitment to phase I studies of 20%, more than half of whom would in fact have survived beyond 90 days.
ISSN: 0732-183X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Experimental Oncology
× corresponding author
# (joint) last author

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