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- Title
Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study.
- Authors
Cobo-Dols, Manuel; Gil-Calle, Silvia; Villar-Chamorro, Esther; Alés-Díaz, Inmaculada; Carabantes-Ocón, Francisco; Alcalde-García, Julia; Gutiérrez-Calderón, Vanesa; Montesa-Pino, Álvaro; Bretón-García, Juan; Benavides-Orgaz, Manuel
- Abstract
In this Phase I/II trial, the maximum-tolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous in-fusion 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/m2 in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m2 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/m2 bolus followed by a continuous iv infusion of 8 mg/m2 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/m2 bolus followed by a continuous infusion of 8 mg/m2 per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination.
- Publication
Clinical & Translational Oncology, 2006, Vol 8, Issue 7, p519
- ISSN
1699-048X
- Publication type
Article
- DOI
10.1007/s12094-006-0052-6