FIRST-LINE TREATMENT OF ADVANCED NON-SMALL-CELL LUNG-CANCER WITH DOCETAXEL AND CISPLATIN - A MULTICENTER PHASE-II STUDY

Purpose: To evaluate the efficacy and safety of the docetaxelcisplatin combination in patients with advanced non-small-cell lung cancer (NSC LC). Patients and methods: Chemotherapy-naive patients with histologic ally confirmed, measurable stage IIIB or IV NSCLC, a World Health Orga nization (WHO) performance status of 0-2 and adequate bone marrow rena l, hepatic and cardiac function were eligible for the study. Patients received docetaxel (100 mg/m(2)) as an one-hour infusion on day 1 and cisplatin (80 mg/m(2)) as a 30-min infusion with appropriate hydration on day 2. Granulocyte colony-stimulating factor (G-CSF; 150 mu g/m(2) , SC) was given on days 3 to 13. Treatment was repeated every three we eks. Results. Fifty-three patients were enrolled (25 with stage IIIB a nd 25 with stage IV). One complete and 23 partial responses were obser ved (overall response rate (OR): 45%; 95% CI: 34.1%-61.8%). The respon se rate was 57% and 32% in patients with stages IIIB and IV disease (P = NS). The median time to progression was 36 weeks and the median sur vival 45 weeks; the one-year survival was 48%. Grade 3-4 neutropenia o ccurred in 23 patients, 15 of whom were hospitalized for neutropenic f ever; two patients died of sepsis. Grade 2 neurotoxicity was observed in six patients and grade 3 in five patients; grade 3 fatigue occurred in seven patients, grade 3-4 mucositis in four patients and grade 3-4 diarrhea in six patients. Mild allergic reactions and oedema were obs erved in five and four patients, respectively. The median dose intensi ty was 30 mg/m(2)/week for docetaxel and 24 mg/m(2)/week for cisplatin , corresponding to 91% and 89% of the specified protocol doses, respec tively. Conclusions: The docetaxel-cisplatin combination is an active regimen in advanced NSCLC, but hematologic toxicity remains high despi te the prophylactic use of G-CSE.