Pemetrexed maintenance extends survival in advanced NSCLC
MedWire News: In patients with advanced non-small-cell lung cancer (NSCLC), continuation of pemetrexed after four cycles of induction pemetrexed-cisplatin improves progression-free survival relative to placebo and is well tolerated, research shows.
"Before this study, whether there would be clinical benefit when pemetrexed was continued as maintenance therapy after a pemetrexed-containing induction regimen was unknown," Luis Paz-Ares (University Hospital Virgen del Rocio, Seville, Spain) and colleagues comment in The Lancet Oncology.
Three-quarters of patients with NSCLC have locally advanced (stage IIIB) or metastatic (stage IV) disease at the time of diagnosis. Pemetrexed combined with cisplatin is known to be efficacious in a first-line setting for nonsquamous NSCLC, but has not been studied as a maintenance treatment.
To address this question, Paz-Ares et al designed the PARAMOUNT double-blind, multicentre, phase III, randomized placebo-controlled study. Following an induction phase comprising four cycles of pemetrexed (500 mg/m²) plus cisplatin (75 mg/m²), 539 patients achieved stable disease without progression. Of these, 359 patients were then randomly assigned to receive continuation with pemetrexed plus best supportive care, and 180 were given placebo plus best supportive care.
Among the 359 patients randomized to continuation maintenance with pemetrexed, there was a significant reduction in the risk for disease progression over the placebo group (hazard ratio [HR]=0.62).
The median progression-free survival, measured from randomisation, was 4.1 months for pemetrexed and 2.8 months for placebo.
The most common grade 3-4 adverse events in the pemetrexed group were anemia (16 [4%] of 359 patients), neutropenia (13 [4%]), and fatigue (15 [4%]). In the placebo group, these adverse events were less common: anemia (one [<1%] of 180 patients), neutropenia (none), and fatigue (one [<1%]).
"These data give doctors and patients a new option, showing that there are additional benefits to patients with the continuation of pemetrexed after four cycles of induction pemetrexed-cisplatin therapy in this setting," Paz-Ares et al comment.
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By Andrew Czyzewski