COMBINATION CHEMOTHERAPY WITH DOCETAXEL, VINORELBINE AND CISPLATIN ASFIRST-LINE TREATMENT OF ADVANCED NON-SMALL-CELL LUNG-CANCER - A MULTICENTER PHASE-II STUDY OF THE GREEK COOPERATIVE GROUP FOR LUNG-CANCER

Vinorelbine, docetaxel and cisplatin have documented single-agent acti vity in non-small-cell lung cancer (NSCLC); a multicenter phase II tri al was initiated in order to evaluate the tolerance and efficacy of th eir combination. A total of 24 chemotherapy-naive patients with measur able stage III, or IV NSCLC and performance status (PS; WHO) 0-2 enter ed the study. Vinorelbine (20 mg/m(2) i.v.) was given on days 1 and 15 , cisplatin (60 mg/m(2)) on day 1, and docetaxel (100 mg/m(2)) on day 16, in cycles of 28 days. Recombinant human granulocyte colony-stimula ting factor (150 mu g/m(2) s.c.) was administered prophylactically fro m day 17 to day 27. One pathological complete (4%) and six partial res ponses (25%) were documented (overall response 29%; 95% CI 11.6-49.2%) . A total of five patients (21%) had stable and 12 (50%) progressive d isease. The median duration of response was 28 weeks and the median ti me to tumor progression 36 weeks; the median survival was 20 weeks. Gr ade 3-4 neutropenia occurred in 16 patients (67%) while 13 of them (54 %) developed febrile neutropenia. Grade 4 mucositis occurred in two pa tients (8%) and one of them also presented grade 4 diarrhea. There wer e four treatment-related deaths: two from sepsis, one from massive hem optysis due to a pulmonary abscess and one from acute myocardial ische mia 7 days post-chemotherapy. In conclusion, the high incidence of neu tropenic episodes and treatment-related deaths led to an early discont inuation of patient enrollment. This combination, in the schedule and the doses used, could not be recommended for off protocol treatment of patients with advanced NSCLC. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.