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 (NSCLC). Patients and methods: Chemotherapy-naive patients with histologically confirmed, measurable stage IIIB or IV NSCLC, a World Health Organization (WHO) performance status of 0-2 and adequate bone marrow renal, 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 weeks. Results. Fifty-three patients were enrolled (25 with stage IIIB and 25 with stage IV). One complete and 23 partial responses were observed (overall response rate (OR): 45%; 95% CI: 34.1%-61.8%). The response 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 survival 45 weeks; the one-year survival was 48%. Grade 3-4 neutropenia occurred in 23 patients, 15 of whom were hospitalized for neutropenic fever; 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 observed in five and four patients, respectively. The median dose intensity 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, respectively. Conclusions: The docetaxel-cisplatin combination is an active regimen in advanced NSCLC, but hematologic toxicity remains high despite the prophylactic use of G-CSE.