Front-Line Treatment of Advanced Non–Small-Cell Lung Cancer With Docetaxel and Gemcitabine: A Multicenter Phase II Trial

Author:

Georgoulias Vassilis1,Kouroussis Charalambos1,Androulakis Nikos1,Kakolyris Stelios1,Dimopoulos Meletios-Athanasios1,Papadakis Emmanuel1,Bouros Dimosthenis1,Apostolopoulou Fotini1,Papadimitriou Christos1,Agelidou Athina1,Hatzakis Kostas1,Kalbakis Kostas1,Kotsakis Athanasios1,Vardakis Nikos1,Vlachonicolis John1

Affiliation:

1. From the Departments of Medical Oncology, Pulmonary Medicine, and Biostatistics, School of Medicine, University of Crete, Heraklion, Crete; Department of Clinical Therapeutics, School of Medicine, University of Athens, Athens; First Department of Pulmonary Medicine, General Hospital for Pulmonary Diseases, Athens; and Second Department of Pulmonary Medicine, Sismanoglion General Hospital, Athens, Greece.

Abstract

PURPOSE: To evaluate the tolerance and efficacy of the combination of docetaxel and gemcitabine in patients with advanced non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Fifty-one chemotherapy-naive patients with NSCLC were treated with gemcitabine 900 mg/m2 intravenously on days 1 and 8 and docetaxel 100 mg/m2 intravenously on day 8 with granulocyte colony-stimulating factor (150 μg/m2, subcutaneously) support from day 9 to day 15. Treatment was repeated every 3 weeks. RESULTS: The patients' median age was 64 years. The World Health Organization performance status was 0 to 1 in 39 patients and 2 in 12 patients. Fifteen patients (29%) had stage IIIB disease, and 36 (71%) had stage IV; histology was mainly squamous cell carcinoma (59%). A partial response was achieved in 19 patients (37.5%; 95% confidence interval, 24% to 50%); stable disease and progressive disease were each observed in 16 patients (31.4%). The median duration of response and the time to tumor progression were 5 and 6 months, respectively. The median survival was 13 months, and the actuarial 1-year survival was 50.7%. Grade 4 anemia and thrombocytopenia were rare (2%). Four patients (8%) developed grade 3 or 4 neutropenia, and all were complicated with fever; there was no treatment-related death. Grade 3 or 4 diarrhea occurred in three patients (6%), grade 2 or 3 neurotoxicity in four patients (8%), grade 2 or 3 asthenia in 10 patients (20%), and grade 2 or 3 edema in 10 patients (20%). CONCLUSION: The combination of docetaxel/gemcitabine is well tolerated, can be used for outpatients, and is active for the treatment of advanced NSCLC. This treatment merits further comparison with other cisplatin- or carboplatin-based combinations.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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