PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC).

摘要: CRA7510 Background: The PARAMOUNT trial investigated whether pem continuation maintenance therapy improves progression-free survival (PFS) after pem-cisplatin induction in patients (pts) with advanced nonsquamous NSCLC. Methods: In this double-blind, placebo-controlled trial, 939 pts participated the phase, specified as four cycles of (500 mg/m2) and cisplatin (75 on day 1 a 21-day cycle. Pts who had not progressed during an Eastern Cooperative Oncology Group performance status (PS) 0/1 (n=539; 57.4%) were randomized (2:1, stratified for disease stage, PS, response) to mg/m2 cycle) plus BSC (n=359) or placebo (n=180) until progression. All received vitamin B12, folic acid, dexamethasone. primary endpoint was PFS (target: HR=0.65, two-sided alpha=0.05; 90% power minimum 238 events). Results: Pt characteristics balanced between arms...