A trial, conducted by Canadian researchers, determined whether the epidermal growth factor receptor ( EGFR ) inhibitor Tarceva ( Erlotinib ) prolongs survival in non–small-cell lung cancer after the failure of first-line or second-line chemotherapy.

Patients with stage IIIB or IV non–small-cell lung cancer, with performance status from 0 to 3, were eligible if they had received one or two prior chemotherapy regimens. The patients were randomly assigned in a 2:1 ratio to receive oral Erlotinib, at a dose of 150 mg daily, or placebo.

The median age of the 731 patients who underwent randomization was 61.4 years; 49 percent had received two prior chemotherapy regimens, and 93 percent had received platinum-based chemotherapy.

The response rate was 8.9 percent in the Erlotinib group and less than 1 percent in the placebo group ( P<0.001 ); the median duration of the response was 7.9 months and 3.7 months, respectively.
Progression-free survival was 2.2 months and 1.8 months, respectively ( hazard ratio, HR=0.61; P<0.001 ).
Overall survival was 6.7 months and 4.7 months, respectively (HR=0.70; P<0.001 ), in favor of Erlotinib.

Five percent of patients discontinued Erlotinib because of toxic effects.

The results of these study showed Erlotinib can prolong survival in patients with non–small-cell lung cancer after first-line or second-line chemotherapy.

Source: The New England Journal of Medicine, 2005


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