(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.