Cisplatin and weekly docetaxel as first-line therapy in patients with advanced non-small cell lung cancer a phase II study |
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Authors: | Tartarone Alfredo Romano Gianpiero Iodice Giovanni Capobianco Alba Coccaro Mariarosa Bochicchio Annamaria Di Leo Pasquale Ardito Raffaele Di Renzo Nicola |
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Affiliation: | Division of Medical Oncology and Hematology, Centro di Riferimento Oncologico della Basilicata (CROB), Rionero in Vulture (PZ), Italy. tarta1@virgilio.it |
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Abstract: | BACKGROUND: Based on the results of previous phase I studies, in the current phase II trial we evaluated the efficacy and toxicity of cisplatin plus weekly docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: The eligibility criteria for the study included newly diagnosed stage IIIB/IV NSCLC, age < or = 75 years, Eastern Cooperative Oncology Group performance status of 0-2, adequate organ functions, and signed informed consent. The chemotherapy regimen consisted of cisplatin, 80 mg/m2 on day 1, and docetaxel, 25 mg/m2 on days 1, 8 and 15 every 4 weeks. RESULTS: Between January 2002 and December 2003, 31 patients with NSCLC were enrolled in the study. An objective response rate of 40% (95% CI, 21-60) was obtained in 27 assessable patients. The median time to progression was 6.4 months (range, 2.5-26.3) and median overall survival was 10.01 months (range, 5-28.3). The regimen was well tolerated with no grade 4 toxicity. CONCLUSIONS: Cisplatin plus weekly docetaxel is an effective and well-tolerated regimen in chemo-naive patients with advanced NSCLC. A phase III study of weekly versus the conventional regimen of every three weeks should be conducted to compare the survival benefits, toxicity profile and quality of life. |
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