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Pemetrexed improved survival in patients with NSCLC

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Patients with non–small cell lung cancer who received maintenance therapy with pemetrexed had improved PFS and OS, and the drug was well-tolerated.

In this phase-3 study, researchers randomly assigned 441 patients to 500 mg/m² of pemetrexed (Alimta, Eli Lilly) plus best supportive care and 222 patients to placebo plus best supportive care until disease progression. All patients had stage IIIb or stage IV disease and had not progressed during four 21-day cycles of platinum-based chemotherapy.

The median PFS was 4.3 months in the therapy group vs. 2.6 months in the placebo group (HR=0.50; 95% CI, 0.42-0.61). The median OS was also longer in the therapy group (13.4 months) compared with the placebo group (10.6 months; HR=0.79; 95% CI, 0.65-0.95).

Five percent of patients who received pemetrexed discontinued treatment due to drug-related toxicity compared with 1% in the placebo group. Overall, the drug-related grade-3 or -4 toxic effects rate was higher in the treatment group (16%) than in the placebo group (4%; P<.0001), particularly for fatigue (P=.001) and neutropenia (P=.006).

Fifty-one percent of patients in the treatment group and 67% of patients in the placebo group received systemic post-discontinuation therapy (P=.0001). There were no drug-related deaths during the study, according to researchers.

“For patients who have a response or stable disease with first-line chemotherapy, who tolerated platinum-based therapy without limiting toxicity while maintaining a good performance status, and who desire to continue therapy, maintenance therapy is an appealing consideration,” Thomas E. Stinchcombe, MD, assistant professor at Lineberger Comprehensive Cancer Center at the University of North Carolina in Chapel Hill, N.C., and Howard L. West, MD, oncology physician at the Swedish Cancer Institute in Seattle, wrote in an accompanying editorial.

“However, if patients have had substantial toxicity with first-line therapy or desire a treatment-free interval, close monitoring and starting timely second-line therapy at disease progression remains an appropriate alternative,” they added.

Ciuleanu T. Lancet. 2009;doi:10.1016/S0140-6736(09)61497-5.

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