Corey J. Langer, MD, Professor of Medicine, Director, Thoracic Oncology, Abramson Cancer Center, University of Pennsylvania, explains the PARAMOUNT study, which initially consisted of 939 patients with advanced nonsquamous non–small cell lung cancer (NSCLC) that were first given 4 courses of first-line pemetrexed (Alimta) and cisplatin. The 539 patients from the initial group that did not demonstrate disease progression were randomized into two arms, one receiving maintenance pemetrexed and the other receiving a placebo. Read more about the trial >>> Pemetrexed Maintenance Improves Progression-Free Survival in Patients With NSCLC.

The trial adequately justified that continuation maintenance with pemetrexed improves progression-free survival (PFS) in patients who received pemetrexed as part of their initial chemotherapy regimen.

Langer remains unconvinced of the drug's efficacy because an overall survival (OS) benefit was not shown. If the PFS does not translate into OS then consideration needs to be taken as to whether the benefits outweigh the toxicity.

The main concern Langer voices regarding this trial is similar to his concern for the JMEN trial that also studied maintenance pemetrexed. (Dr. Langer Discusses the JMEN Maintenance Pemetrexed Trial ) The main criticism of this trial was the mandatory crossover from the control arm to the pemetrexed arm.