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Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy fornon-small-cell lung cancer
- Source :
- Annals of Oncology. 15:38-44
- Publication Year :
- 2004
- Publisher :
- Elsevier BV, 2004.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 15
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....c76a55a94c7bb648a7ead93bbb422dd4