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Carboplatin plus pemetrexed increased OS in advanced NSCLC
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The addition of pemetrexed to first-line carboplatin chemotherapy significantly improved OS in patients with advanced non–small cell lung cancer, according to results of a randomized phase 3 trial.
The multicenter trial, conducted across eight centers in Brazil and one in the United States, included 205 patients.
Patients had advanced NSCLC, an ECOG performance status of 2 and adequate organ function, and they had not undergone prior chemotherapy.
Researchers randomly assigned 103 patients to carboplatin plus pemetrexed (Alimta, Eli Lilly) 500 mg/m² every 3 weeks for four cycles. The other 102 patients received pemetrexed alone.
OS served as the primary outcome measure.
Researchers reported longer median PFS (5.8 months vs. 2.8 months; HR=0.46; 95% CI, 0.35-0.63) and median OS (9.3 months vs. 5.3 months; HR=0.62; 95% CI, 0.46-0.83) among patients who received carboplatin plus pemetrexed.
One-year survival rates were 40.1% in the combination arm and 21.9% in the pemetrexed alone arm.
Rates of grade 3-4 anemia (11.7% vs. 3.9%), neutropenia (6.8% vs. 1%) and thrombocytopenia (1% vs. 0) were higher in the combination arm, according to researchers.
Four treatment-associated deaths occurred in the combination arm.
“The question of single-agent versus combination chemotherapy in patients with advanced NSCLC and an ECOG performance status of 2 has persisted unanswered for more than a decade,” the researchers wrote. “Although concerns about safety and benefit are appropriate, the advent of better supportive care, along with more effective and tolerable carboplatin-based doublets, has allowed us to revisit this question in a more modern light … Our study provides strong evidence that combination chemotherapy is superior to single-agent therapy in all relevant clinical endpoints.”
Disclosure: The researchers report research funding/honoraria and consultant/advisory roles with Bristol-Myers Squibb, Eli Lilly, Pfizer and Roche.
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