Maintenance Therapy for Advanced Non–Small-Cell Lung Cancer

Summary and Comment |
July 26, 2013

Maintenance Therapy for Advanced Non–Small-Cell Lung Cancer

  1. Anne Tsao, MD

Continuation pemetrexed was superior to placebo.

  1. Anne Tsao, MD

Pemetrexed maintenance therapy has been shown to improve survival in patients with advanced non–small-cell lung cancer (NSCLC) that did not progress after induction therapy with a non–pemetrexed-containing platinum doublet regimen (Lancet 2009; 374:1432).

To describe the efficacy of pemetrexed maintenance after induction with a pemetrexed-containing regimen, investigators report final results of the industry-supported, phase III, randomized PARAMOUNT trial, involving 939 patients with stage IIIB to IV nonsquamous NSCLC. After receiving four cycles of induction with pemetrexed and cisplatin, 539 nonprogressors were randomized 2:1 to maintenance pemetrexed (500 mg/m2 intravenously on day 1 of 21-day cycles) or placebo.

Progression-free survival (the primary endpoint) was superior with pemetrexed maintenance versus placebo (hazard ratio, 0.60; P<0.001), similar to prior results (Lancet Oncology 2012; 13:247). After a median follow-up of 24.3 months, median overall survival (OS) was superior with pemetrexed (13.9 vs. 11.0 months; HR, 0.78; P=0.0195). The OS benefit was also observed from the start of induction therapy (16.9 vs. 14 months) and was consistent across all patient subgroups. Rates of posttrial salvage therapy were similar between the two study arms. Grade 3 to 4 anemia, fatigue, and neutropenia were more common with pemetrexed.


These findings demonstrate that pemetrexed maintenance is beneficial for nonsquamous NSCLC patients who achieve a response or stable disease after induction therapy with pemetrexed and cisplatin. This result was expected, and the approach has already been adopted into standard practice. Other trials have also demonstrated a consistent PFS benefit, as well as some OS benefit, of maintenance therapy with pemetrexed and other newer agents, including bevacizumab and erlotinib. The benefit is indisputable and is associated with both continuation- and switch-maintenance therapy. The challenge that remains is to identify the optimal induction and maintenance regimens for molecularly unselected patients. Also, additional studies such as E5508will evaluate whether dual maintenance therapy is superior to monotherapy maintenance.

Editor Disclosures at Time of Publication

  • Disclosures for Anne Tsao, MD at time of publication Consultant / advisory board Medimmune, Genentech, Roche, GSK


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