(ChemotherapyAdvisor) – For patients with advanced nonsquamous non–small-cell lung cancer (NSCLC) with good performance status (PS) who have not progressed after induction therapy with pemetrexed plus cisplatin, continuation of pemetrexed as maintenance therapy significantly reduced risk of disease progression vs placebo and was well tolerated, according to a study published in The Lancet Oncology online February 16.
Of the 1022 patients enrolled in the double-blind, multicenter, phase 3 PARAMOUNT trial, 939 patients received four cycles of induction pemetrexed 500mg/m2 plus cisplatin 75mg/m2 on day 1 of a 21-day cycle. The 539 patients who did not progress and had an ECOG PS of 0 or 1 were randomly assigned 2:1 to maintenance therapy with either pemetrexed 500mg/m2 every 21 days plus best supportive care (BSC) (n=359) or placebo plus BSC (n=180) until disease progression. The primary end point was progression-free survival (PFS).
Patients in the pemetrexed plus BSC arm had a significant reduction in risk of disease progression compared with placebo plus BSC (P<0.0001). Median PFS was 4.1 months for the pemetrexed arm vs. 2.8 months for placebo.
Grade 3/4 adverse events that occurred most commonly in the pemetrexed group were anemia (4%), neutropenia (4%) and fatigue (4%) vs. <1%, none, and <1% for placebo, respectively. Most frequent serious AEs were anemia (2) in the pemetrexed arm vs. none in the placebo arm and febrile neutropenia, 1% vs none, respectively. Five percent of the patients in the pemetrexed group and 3% in the placebo group discontinued therapy due to drug-related AEs. One death possibly related to treatment occurred in each group.