Docetaxel has shown promising single-agent activity in non-small cell lung cancer (NSCLC) and ist activity can be anhanced by the addition of platinum compounds. Several studies indicate that carboplatin may be as effective as carboplatin but with better tolerability. A phase II study was performed to investigate the safety and efficacy of combination chemotherapy with docetaxel and carboplatin in patients with advanced NSCLC. 30 chemotherapy-naive patients with stage IIIB (7 patients) and IV (23 patients) NSCLC were treated with docetaxel 90mg/m2 over 1 hour, followed by carboplatin administrated according to a targed area under the curve of 5 (Calvert formula). Treatment was repeated every 3 weeks and a total of 6 cycles. Myelosuppression was the predominant toxity. Grade 3 or 4 granulocytopenia occurred in 77% of patients. Granulocyte colony-stimulating factor (G-CSF) was not used and no neutropenic fevers were observed. Grade 3 or 4 nail disorder developed in 27% of the patients. Other non-haematological toxicities, including pulmonary edema, were mild to moderate. The objective response rate was 30%, the median time to progression was 24 weeks and median survival 57 weeks. One-year, two-years and three-years survival was 56%, 20% and 6,6% respectly. The largest observed survival was 4 years and 6 weeks. |