Patient selection for oncology phase I trials: a multi-institutional study of prognostic factors

Olmos, D. et al. (2012) Patient selection for oncology phase I trials: a multi-institutional study of prognostic factors. Journal of Clinical Oncology, 30(9), pp. 996-1004. (doi: 10.1200/JCO.2010.34.5074)

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<p><b>Purpose:</b> 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.</p> <p><b>Patients and Methods:</b> 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.</p> <p><b>Results:</b> 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.</p> <p><b>Conclusion:</b> 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.</p>

Item Type:Articles
Glasgow Author(s) Enlighten ID:Evans, Professor Jeff
Authors: Olmos, D., A'Hern, R.P., Marsoni, S., Morales, R., Gomez-Roca, C., Verweij, J., Voest, E.E., Schoffski, P., Ang, J.E., Penel, N., Schellens, J.H., del Conte, G., Brunetto, A.T., Evans, T.R.J., Wilson, R., Gallerani, E., Plummer, R., Tabernero, J., Soria, J.-C., and Kaye, S.B.
College/School:College of Medical Veterinary and Life Sciences > School of Cancer Sciences
Journal Name:Journal of Clinical Oncology

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