Continuous-infusion vinorelbine for the treatment of advanced non-small-cell lung cancer: a phase I/II study
| Autor: | Inmaculada Alés-Díaz, Esther Villar-Chamorro, Vanesa Gutiérrez-Calderón, Álvaro Montesa-Pino, Silvia Gil-Calle, Manuel Benavides-Orgaz, Julia Alcalde-García, Francisco Carabante-Ocôn, Manuel Cobo-Dols, Juan J. Bretón-García |
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| Rok vydání: | 2005 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male Mucositis Cancer Research medicine.medical_specialty Lung Neoplasms Neutropenia Adenocarcinoma Vinorelbine Vinblastine Gastroenterology Bolus (medicine) Internal medicine Carcinoma Non-Small-Cell Lung medicine Carcinoma Humans Lung cancer Infusions Intravenous Aged Neoplasm Staging Dose-Response Relationship Drug business.industry Middle Aged medicine.disease Antineoplastic Agents Phytogenic Confidence interval Treatment Outcome Oncology Anesthesia Asthenia Carcinoma Squamous Cell Carcinoma Large Cell Female business Constipation Febrile neutropenia medicine.drug |
| Zdroj: | Clinical lung cancer. 7(2) |
| ISSN: | 1525-7304 |
| Popis: | BACKGROUND: In this phase I/II trial, the maximum tolerated dose (MTD) and activity of vinorelbine administered in continuous infusion as first-line treatment for advanced non–small-cell lung cancer (NSCLC) was determined in 25 consecutive chemotherapy-naive patients with advanced NSCLC. PATIENTS AND METHODS: Vinorelbine was administered as an initial intravenous (I.V.) bolus of 8 mg/m 2 on day 1 followed by a 4-day continuous I.V. infusion at 5 different 24-hour dose levels to be repeated every 21 days. All 25 patients (159 cycles) were evaluable for response. The MTD was 8 mg/m 2 bolus followed by a continuous I.V. infusion of 11 mg/m 2 per day over 4 days. RESULTS: The dose-limiting toxicities were febrile neutropenia in 6 patients and grade 3 mucositis in 2 patients. There was less neurotoxicity and constipation and more mucositis compared with the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Treatment responses were observed in 6 patients: 1 complete response and 5 partial responses. The overall response rate was 24% (95% confidence interval [CI], 8%–40%). Median time to progression was 4 months (95% CI, 2-11 months), and median survival was 6 months (95% CI, 2-18 months). CONCLUSION: The results demonstrate that, in this setting of first-line treatment of NSCLC, vinorelbine administered as an 8 mg/m 2 bolus followed by a continuous infusion of 11 mg/m 2 per day over 4 days is the recommended schedule. Further trials are necessary to establish activity and possible benefits of combination with other agents. |
| Databáze: | OpenAIRE |
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