Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents

• Published in: British journal of cancer 2003-10, Vol.89 (7), p.1166-1171
• Main Authors: Han, C, Braybrooke, J P, Deplanque, G, Taylor, M, Mackintosh, D, Kaur, K, Samouri, K, Ganesan, T S, Harris, A L, Talbot, D C
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Biological and medical sciences; Biomarkers, Tumor - metabolism; Biomedical and Life Sciences; Biomedicine; Cancer Research; Chemotherapy; Clinical; Clinical Trials, Phase I as Topic; Disease-Free Survival; Drug Resistance; Epidemiology; Female; Humans; Male; Medical sciences; Middle Aged; Molecular Medicine; Neoplasms - diagnosis; Neoplasms - drug therapy; Neoplasms - mortality; Oncology; Pharmacology. Drug treatments; Prognosis; Retrospective Studies; Risk Factors; Survival Rate
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6601218

The aims of this study were to identify prognostic variables for toxicity and survival in patients with cancer participating in phase I clinical trials and compare characteristics of those treated with cytotoxic chemotherapy (CT) and non-cytotoxic drugs (non-CT). Data were collected from 420 (114 CT, 306 non-CT) patients enrolled in 16 phase I trials (five CT and 11 non-CT trials) in one cancer centre. Analyses of all patients were used to compare treatment groups, identify predictive variables for toxicity and to estimate prognostic factors in overall survival (OS). These were used to develop a prognostic index (PI). Multivariate analysis found those patients with better performance status, fewer sites of metastases, baseline Hb>12 g dl −1 and WBC or LDH in the normal range had significantly better OS. Male gender, platelet count