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Pemetrexed plus erlotinib improved PFS in nonsquamous NSCLC
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Combination treatment with pemetrexed and erlotinib significantly extended PFS in never-smokers with nonsquamous NSCLC compared with either agent alone, according to results of a phase 2 study.
The randomized, controlled trial included 240 patients (65% women) with ECOG performance status ≤2. Ninety-three percent of patients had ECOG performance status of 0 or 1, and all patients had failed one prior chemotherapy regimen.
Researchers assigned patients to one of three treatment regimens:
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pemetrexed (Alimta, Lilly) 500 mg/m2 on day 1 plus erlotinib (Tarceva; Genentech, Astellas Pharma) 150 mg daily on days 2-14;
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erlotinib 150 mg daily; or
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pemetrexed 500 mg/m2 on day 1 of each 21-day cycle.
PFS served as the primary endpoint.
Researchers reported a statistically significant improvement in PFS among patients assigned to the combination regimen compared with pemetrexed alone (HR=0.58; 95% CI, 0.39-0.85) and erlotinib alone (HR=0.57; 95% CI, 0.40-0.81). Median PFS was 7.4 months in the combination arm, compared with 4.4 months among patients assigned to pemetrexed alone and 3.8 months among patients assigned to erlotinib alone.
The incidence of drug-related grade 3-4 toxicity associated with the combination regimen (60%) was higher than that for pemetrexed alone (28.9%) or erlotinib alone (12%); however, the toxicities were clinically manageable, according to researchers. The most common grade 3-4 adverse events were neutropenia, anemia, rash and diarrhea.
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