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Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study
The Lancet - Early Online Publication, 09/24/09

Ciuleanu T et al. – Maintenance therapy with pemetrexed is well tolerated and offers improved progression-free and overall survival compared with placebo in patients with advanced non-small-cell lung cancer.

Methods

Randomised double-blind study
663 patients with stage IIIB or IV disease who had not progressed on four cycles of platinum-based chemotherapy were randomly assigned (2:1 ratio) to receive pemetrexed (500 mg/m2, day 1) plus best supportive care (n=441) or placebo plus best supportive care (n=222) in 21-day cycles until disease progression
All received vitamin B12, folic acid, and dexamethasone
The primary endpoint of progression-free survival
Secondary endpoint of overall survival analysed by intention to treat

Results

Pemetrexed significantly improved progression-free survival (4·3 months [95% CI 4·1—4·7] vs 2·6 months [1·7—2·8]; hazard ratio [HR] 0·50, 95% CI 0·42—0·61, p<0·0001) and overall survival (13·4 months [11·9—15·9] vs 10·6 months [8·7—12·0]; HR 0·79, 0·65—0·95, p=0·012) compared with placebo
Treatment discontinuations due to drug-related toxic effects were higher in pemetrexed group than placebo group (21 [5%] vs three [1%])
Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo vs nine specifically fatigue (22 [5%] vs one and neutropenia
No pemetrexed-related deaths
Relatively fewer patients in pemetrexed group than in placebo group received systemic post-discontinuation therapy

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