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 radiological response rate was 33% for both arms (PR=32%, CR=1%). 32% of MIC/MVP and 29% of DC patients had stable disease. 1 and 2 year survival for DC were 32% and 12% and for MIC/MVP were 37% and 9% (p=0.26). Grade 3/4 neutropenia (66 v 40%, p<0.005), infection (19 v 10%, p=0.02), mucositis (8 v 3%, p=0.03) and peripheral neuropathy (8 v 3%, p=0.05) were more common with DC than MIC/MVP. The MIC/MVP arm had significantly worsening overall EORTC score and global health status whereas the DC arm showed no significant change in these.
CONCLUSIONS
The combination of DC had similar efficacy to MIC/MVP but QOL was better maintained. [Table: see text].