A phase II study of docetaxel plus nedaplatin in patients with metastatic non-small-cell lung cancer

Purpose Nedaplatin is a cisplatin derivative, which has similar activity to cisplatin in non-small-cell lung cancer (NSCLC) when combined with vindesine, and causes less nausea/vomiting and nephrotoxicity compared with cisplatin. The aim of this study was to evaluate the efficacy and safety of combination chemotherapy with docetaxel plus nedaplatin in patients with metastatic NSCLC. Methods Patients with metastatic stage IIIB excluding locally advanced diseases or stage IV NSCLC were enrolled between March 2004 and March 2006. They were treated with docetaxel (60 mg/m 2 ) and nedaplatin (80 mg/m 2 ) on day 1 every 3–4 weeks until progression or intolerable toxicity for up to 4 cycles. Results Forty-four patients (mean age, 65 years; range, 40–79 years) received a total of 140 treatment cycles. Responses could be assessed in all patients (complete response, 0; partial response, 22; stable disease, 11; and progressive disease, 11). Response rate was 50.0 % (95 % confidence interval [CI], 35.2–64.8 %) with a disease control rate of 75.0 % (95 % CI, 62.2–87.8 %). A high response rate was achieved in patients with squamous cell carcinoma (66.7 %) compared with that in patients with adenocarcinoma (41.4 %). Median survival time from the start of the combination chemotherapy was 13.0 months, and the progression-free survival time was 7.4 months. Grade 3 or 4 hematologic toxicities included leukopenia (28.6 %) and neutropenia (61.4 %). Nonhematologic toxicities were mild. Conclusion The combination of docetaxel plus nedaplatin was well tolerated and demonstrated potent activity in patients with metastatic NSCLC, particularly squamous cell carcinoma of the lung.