Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study

• Published in: Clinical & translational oncology 2006-07, Vol.8 (7), p.519-524
• Main Authors: Cobo-Dols, M, Gil-Calle, S, Villar-Chamorro, E, Alés-Díaz, I, Carabantes-Ocón, F, Alcalde-García, J, Gutiérrez-Calderón, V, Montesa-Pino, A, Bretón-García, J J, Benavides-Orgaz, M
• Format: Article
• Language: English
• Subjects: Adult; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Cisplatin - administration & dosage; Female; Humans; Infusions, Intravenous; Lung Neoplasms - drug therapy; Male; Maximum Tolerated Dose; Middle Aged; Survival Analysis; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives
• ISSN: 1699-048X; 1699-3055
• DOI: 10.1007/s12094-006-0052-6

In this Phase I/II trial, the maximumtolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC. The dose of cisplatin was 100 mg/m(2) in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable for response and toxicity. The MTD was 8 mg/m(2) bolus followed by a continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median survival was 11 months (95% CI: 5-20 months). The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 mg/m(2) per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination.