Randomised phase III trial of docetaxel/carboplatin vs MIC/MVP chemotherapy in advanced non-small cell lung cancer (NSCLC) - final results of a British Thoracic Oncology Group (BTOG) trial

7066 Background: Phase III studies suggest higher response rates and better survival in patients with NSCLC treated with a combination of cisplatin and docetaxel (DC) compared to older cisplatin based regimens. We report the final results of a randomised phase III study of docetaxel and carboplatin versus MIC/MVP in patients with advanced NSCLC. Methods: 432 patients with biopsy proven stage III-IV NSCLC not suitable for curative surgery or radiotherapy and PS 0–2 were randomised to receive either 4 cycles of DC (docetaxel 75mg/m2, carboplatin AUC 6) or 4 cycles of either MIC (mitomycin 6mg/m2, ifosfamide 3gm/m2, cisplatin 50 mg/m2) or MVP (mitomycin 6mg/m2, vinblastine 6mg/m2, cisplatin 50mg/m2), 3 weekly. The primary end-point was 1-year survival, secondary endpoints were response rates, toxicity and QOL (EORTC QLQ-C30, HADS and LC13). Results: 419 patients were eligible and 87 (21%) were of PS2. There were less stage IV (48 v 54%, p=0.26) and PS2 patients (18 v 23%, p=0.28) in the DC arm. The radiologi...