Front-line treatment of advanced non-small-cell lung cancer with docetaxeland gemcitabine: A multicenter phase II trial

Purpose: To evaluate the tolerance and efficacy of the combination of docet axel 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/m(2) intravenously on days 1 and 8 and doc etaxel 100 mg/m(2) intravenously on day 8 with granulocyte colony-stimulati ng factor (150 mu g/m(2), subcutaneously) support from day 9 to day 15. Tre atment was repeated every 3 weeks. Results: The patients' median age was 64 years. The World Health Organizati on performance status was 0 to 1 in 39 patients and 2 in 12 patients. Fifte en patients (29%) had stage IIIB disease, and 36 (71%) had stage IV; histol ogy was mainly squamous cell carcinoma (59%). A partial response was achiev ed in 19 patients (37.5%; 95% confidence interval, 24% to 50%); stable dise ase 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 I-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 com plicated with fever; there was no treatment-related death. Grade 3 or 4 dia rrhea occurred in three patients (6%), grade 2 or 3 neurotoxicity in four p atients (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 carbopl atin based combinations. (C) 1999 by American Society of Clinical Oncology.