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

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...

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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
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cited_by cdi_FETCH-LOGICAL-c214t-142a876dbf0ac28d861630b35caf7ab4be2c0ee299d7bebb73308744044fe7b63
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container_issue 7
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container_title Clinical & translational oncology
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creator Cobo-Dols, M
Gil-Calle, S
Villar-Chamorro, E
Alés-Díaz, I
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Alcalde-García, J
Gutiérrez-Calderón, V
Montesa-Pino, A
Bretón-García, J J
Benavides-Orgaz, M
description 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.
doi_str_mv 10.1007/s12094-006-0052-6
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source Springer Link
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
title Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study
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