No Efficacy Increase Found for Pemetrexed-Cetuximab Combination in NSCLC

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(CHICAGO, IL) – Adding cetuximab to regimens containing pemetrexed does not improve survival rates in patients with recurrent or progressive non-small cell lung cancer (NSCLC) after platinum-based therapy, according to the results of the Phase 3 SELECT trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

SELECT investigated whether the addition of cetuximab to standard chemotherapy improved progression-free survival (PFS) in patients with recurrent or progressive NSCLC after failure of platinum-based therapy, explained lead author Edward S. Kim, MD, of the University of Texas M.D. Anderson Cancer Center, Houston.

In this multicenter, open-label, randomized Phase 3 trial, patients received either pemetrexed (500mg/m2; n=605) or docetaxel (75mg/m2; n=333) on Day 1 and were then randomized within each group to chemotherapy plus cetuximab (400/250mg/m2) or chemotherapy alone. Therapy was administered in 6 three-week cycles. Patients were followed until the primary endpoint of PFS for pemetrexed plus cetuximab (PC) vs. pemetrexed was reached; secondary endpoints were overall survival (OS), objective response rate (ORR), and duration of response (DOR).

Median PFS was not different: 2.89 months for the PC-arm vs. 2.76 months for pemetrexed arm (HR=1.03 [95% CI=0.87–1.21]; P=0.76). Median OS for PC was 6.93 months vs. 7.79 months for pemetrexed (HR=1.01 [95% CI=0.86–1.20]; P=0.86). ORR for PC was 6.6% vs. 4.3% for pemetrexed (odds ratio=1.59 [95% CI=0.78–3.26]; P=0.20). Median DOR for PC was 4.17 months vs. 6.93 months for pemetrexed (HR=1.58 [95% CI=0.74–3.36]; P=0.24). No patient from either study arm exhibited a complete response, Dr. Kim and colleagues noted.

More drug-related adverse events and serious adverse events were observed in the PC arm, with differences mainly attributable to skin toxicities, gastrointestinal events (e.g., diarrhea, stomatitis), and hypomagnesemia; 31% of patients in the PC arm developed acneiform rash, Dr. Kim said.

Dr. Kim and colleagues concluded that addition of cetuximab to pemetrexed did not improve efficacy in this patient population.

Abstract

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