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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 III study
The Lancet, 10/26/09

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 undertaken in 83 centres in 20 countries.
663 patients with stage IIIB or IV disease who had not progressed on 4 cycles of platinum-based chemotherapy randomly assigned (2:1 ratio) to receive pemetrexed (500 mg/m2, day 1) plus best supportive care or placebo plus best supportive care in 21-day cycles until disease progression
Treatment randomised with Simon and Pocock minimisation method
Patients and investigators were masked to treatment
All patients received vitamin B12, folic acid, and dexamethasone
Primary endpoint of progression-free survival and the secondary endpoint of overall survival analysed by intention to treat

Results

All randomly assigned participants analysed
Pemetrexed significantly improved progression-free survival (4·3 months vs 2·6 months ; 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) compared with placebo
Treatment discontinuations due to drug-related toxic effects higher in pemetrexed group than in placebo group (21 [5%] vs three [1%])
Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo (70 [16%] vs nine [4%]), specifically fatigue (22 [5%] vs one [1%]) and neutropenia (13 [3%] vs 0)
No pemetrexed-related deaths occurred
Relatively fewer patients in pemetrexed group than in placebo group received systemic post-discontinuation therapy