Different-dose docetaxel plus cisplatin as first-line chemotherapy and then maintenance therapy with single-agent docetaxel for advanced non-small cell lung cancer (TFINE study, C-TONG 0904).

8015 Background: Docetaxel (75 mg/m2) has been reported as first-line and maintenance treatment for Western population with advanced NSCLC. Different doses of docetaxel (60 mg/m2) are currently delivered in Asian population. Pharmacogenomics alterations in taxanes disposition in different ethnic groups may explain this difference. TFINE study was to evaluate the efficacy, safety, and tolerability of docetaxel in the maintenance setting, and to identify the preferable dose of docetaxel in Asian population. Methods: Previously untreated patients, aged between 18 and 75 years, histologically or cytologically confirmed advanced NSCLC with PS of 0-1 were included. Patients were initially randomized (R1, 1:1) to receive cisplatin (75 mg/m2) plus docetaxel of 75 mg/m2 or 60 mg/m2 for 4 cycles. Patients with disease control after the initial treatment were subsequently randomized (R2, 1:2) to best supportive care (BSC) or maintenance docetaxel of 60 mg/m2 for up to 6 cycles. Genomic DNA was prospectively collecte...