Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy fornon-small-cell lung cancer
| Autor: | Didier Debieuvre, J.-L. Breton, Bernard Lebeau, P. Clouet, Bernard Milleron, Fabien Vaylet, Gérard Zalcman, Alain Depierre, J. M. Brechot, D. Moro-Sibilot, A. Vergnenegre, Etienne Lemarié, E. Quoix, J.L. Pujol, A. Ducolone |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.medical_specialty Lung Neoplasms Neutropenia Time Factors Randomization medicine.medical_treatment Phases of clinical research Docetaxel Gastroenterology Carcinoma Non-Small-Cell Lung Internal medicine medicine Humans Treatment Failure Infusions Intravenous Lung cancer Aged Chemotherapy Dose-Response Relationship Drug business.industry Respiratory disease Hematology Middle Aged medicine.disease Antineoplastic Agents Phytogenic Survival Analysis Confidence interval Surgery Treatment Outcome Oncology Disease Progression Female Taxoids Neoplasm Recurrence Local Safety business medicine.drug |
| Zdroj: | Annals of Oncology. 15:38-44 |
| ISSN: | 0923-7534 |
| Popis: | Background The survival benefit associated with first-line chemotherapy in advanced lung cancer led to the need for second-line chemotherapy. Docetaxel (Taxotere®) has proven efficacy in both settings. This study evaluated the safety and efficacy of two doses of docetaxel in patients with non-small-cell lung cancer who had failed first-line platinum-based chemotherapy. Patients and methods In total, 182 patients from 24 French centres were randomised and treated with either docetaxel 75 mg/m2 (arm A) or 100 mg/m2 (arm B) every 3 weeks. Baseline characteristics were well balanced, except more patients in arm A had metastatic disease (91.4% versus 78.7%) and therefore the median number of sites involved for arm A was three compared with two for arm B. Results Median time to treatment failure was 1.34 months [95% confidence interval (CI) 1.28–1.64] for arm A and 1.64 months (95% CI 1.34–2.62) for arm B. Median overall survival was 4.7 months (95% CI 3.8–5.9) for arm A versus 6.7 months (95% CI 4.8–7.1) for arm B. According to a blinded expert panel, disease control was achieved in 35 (43.8%) patients in arm A and 39 (49.4%) patients in arm B. More patients in arm B experienced grade 3–4 neutropenia (B: 72.7% versus A: 44.0%), asthenia (B: 20.2% versus A: 10.8%) and infection (B: 6.7% versus A: 2.2%). Three treatment-related deaths were reported in each arm. Conclusions The optimal docetaxel dosage in this second-line setting is 75 mg/m2, as it has a more favourable safety profile and on balance a similar efficacy to the 100 mg/m2 dose. |
| Databáze: | OpenAIRE |
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