Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre phase II study

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2002-06, Vol.36 (3), p.327-332
• Main Authors: Gridelli, Cesare, Rossi, Antonio, Barletta, Emiddio, Panza, Nicola, Brancaccio, Luigi, Cioffi, Riccardo, Pedicini, Tonino, Ianniello, Giovanni Pietro, Piazza, Elena, Rossi, Nestore, Iaffaioli, Rosario Vincenzo, Maione, Paolo, Maio, Massimo Di, Gallo, Ciro, Perrone, Francesco
• Format: Article
• Language: English
• Subjects: Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Carboplatin; Carboplatin - administration & dosage; Carcinoma, Small Cell - drug therapy; Carcinoma, Small Cell - pathology; Chemotherapy; Disease Progression; Elderly; Female; Granulocyte Colony-Stimulating Factor - administration & dosage; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Phase II study; Small-cell lung cancer; Survival Analysis; Treatment Outcome; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Vinorelbine
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/S0169-5002(02)00003-X

Purpose and methods: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m 2 days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. Results: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5–59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3–6.7). Median survival was 7.9 months (95% CI: 4.8–14.4). Conclusion: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.