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Erlotinib no better than docetaxel in advanced NSCLC
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Erlotinib did not extend PFS or OS compared with docetaxel in epidermal growth factor receptor-unselected patients with advanced non–small cell lung cancer, according to results of a randomized phase 3 trial.
Tomoya Kawaguchi, MD, of the department of internal medicine in the National Hospital Organization of the Kinki-Chuo Chest Medical Center in Japan, and colleagues conducted the study to determine the efficacy of erlotinib (Tarceva, Genentech) compared with docetaxel in an EGFR-unselected cohort. All patients had undergone prior treatment, and they all had stage IIIB or IV NSCLC.
Researchers randomly assigned 150 patients to 150 mg daily erlotinib. The other 151 patients received 60 mg/m2 docetaxel every 3 weeks.
PFS served as the primary endpoint. Secondary outcome measures included OS, response rate, safety and analyses of EGFR wild-type tumors.
Overall, researchers reported median PFS of 2 months in the erlotinib arm and 3.2 months in the docetaxel arm (HR=1.22; 95% CI, 0.97-1.55). Researchers reported longer OS in the erlotinib arm (14.8 months vs. 12.2 months; HR=0.91; 95% CI, 0.68-1.22).
Researchers then analyzed outcomes of patients who had EGFR wild-type NSCLC. The analysis included 109 patients assigned erlotinib and 90 patients assigned docetaxel. Results showed patients assigned erlotinib experienced shorter PFS (1.3 months vs. 2.9 months; HR=1.45; 95% CI, 1.09-1.94) and OS (9 months vs. 10.1 months; HR=0.98; 95% CI, 0.69-1.39).
“This study has several limitations,” Kawaguchi and colleagues wrote. “First, we failed to detect a significant difference in PFS in the unselected population, which may have been a result of the small sample size. Second, the trial was nonblinded, and the primary end point of PFS was assessed by the individual investigator at each institution. Therefore, caution should be used when comparing our results with those of other studies in which PFS was centrally assessed.”
Disclosure: The researchers report honoraria from Chugai Pharmaceutical and Sanofi-Aventis, as well as research funding and stock ownership in Chugai Pharmaceutical.
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