Carboplatin plus vinorelbine, a new well-tolerated and active regimen for the treatment of extensive-stage small-cell lung cancer: a phase II study. Gruppo Oncologico Centro-Sud-Isole

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Cesare GridelliA R Bianco

Abstract

To evaluate the activity and toxicity of the combination carboplatin plus vinorelbine in extensive small-cell lung cancer (SCLC). A two-stage optimal Simon design was applied. To proceed after the first stage, responses from 8 of 11 treated patients were needed. Overall, 31 responses of 43 treated patients were required to comply with the design parameters. Inclusion criteria were cytohistologically proven SCLC; extensive disease; age of 70 years or less; Eastern Cooperative Oncology group performance status (ps ECOG) of 2 or less; normal cardiac, hepatic, renal, and bone marrow functions; and no previous chemotherapy. Patients were staged by physical examination; biochemistry; chest radiograph; brain, thoracic; and abdominal computed tomographic (CT) scans, and bone scan. All patients received carboplatin 300 mg/m2 intravenously (i.v.) day 1 and vinorelbine 25 mg/m2 i.v. on days 1 and 8 every 4 weeks up to six cycles. Of 43 enrolled patients, 36 were men and 7 women, with a median age of 63 years (range, 46 to 70 years). All patients were assessable for response and toxicity. We observed 32 (74%) objective responses, with 23% complete responses. Median time to progression was 25 weeks, and median survival was 37 weeks. The tre...Continue Reading

Citations

May 2, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nasser HannaAlan Sandler
Nov 4, 2000·Expert Opinion on Investigational Drugs·F P Worden, G P Kalemkerian
Dec 12, 2001·Critical Reviews in Oncology/hematology·M S AaproJ B Vermorken
Oct 1, 2010·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·David J StewartB Nebiyou Bekele
Oct 28, 2010·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·João Paulo S N LimaAndré Deeke Sasse

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