Erlotinib in Lung Cancer

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Abstract
Shepherd and colleagues (July 14 issue)1 report that erlotinib prolongs survival in non–small-cell lung cancer, as compared with placebo, after the failure of first-line or second-line chemotherapy. One disturbing aspect of this trial is that some patients underwent only one prior chemotherapy regimen before randomization. These same authors previously reported that docetaxel is superior to best supportive care after first-line chemotherapy.2 Subsequent studies have confirmed the efficacy of docetaxel and shown that pemetrexed achieves similar results.3 Did Shepherd and colleagues think that random assignment to placebo after the failure of first-line chemotherapy was ethically justifiable? The only patients for whom one could justify the assignment to placebo were those with a performance status of 3, who made up only 8.6 percent of all patients. Contrary to the authors' claim that inclusion of a placebo group was ethical, we believe that some patients were denied a therapeutic option known to be effective. Furthermore, the overall survival in the erlotinib group was inferior to that in published results with docetaxel and pemetrexed, suggesting that erlotinib should be used as third-line chemotherapy.

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