Efficacy and safety of erlotinib as monotherapy for advanced non-small cell lung cancer / 中国医学科学院学报

ABSTRACT

<p><b>OBJECTIVE</b>To explore the efficacy and safety of erlotinib monotherapy for advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Totally 50 patients with advanced NSCLC received oral erlotinib 150 mg/d treatment, and tumor specimen in 19 patients were collected for epidermal growth factor receptor (EGFR) gene mutation tests. Median survival (MS) was calculated using the Kaplan-Meier method.</p><p><b>RESULTS</b>The most common adverse events (AEs) were skin rash (96%) and diarrhea (32%). The overall survival (OS) of all patients was 21.8 months 95% confidential interval (CI) 17.1-26.4 months and the median progression-free survival (PFS) of all patients was 7.0 months (95% CI 3.9-10.1 months). EGFR mutation analysis showed gene mutation in 8 cases and wild type in 11 cases. The objective response rate in patients with or without EGFR gene mutations were 62.5% and 9.1%, respectively (chi(2)=6.631, P=0.036). PFS in patients with or without EGFR gene mutations were 16.330 (95% CI 2.803-29.857 months) and 5.570 months (95% CI 2.441-8.699 months), respectively (chi(2)=8.799, P=0.003).</p><p><b>CONCLUSION</b>Erlotinib monotherapy is safe and effective for some Chinese NSCLC patients after failure of prior chemotherapy.</p>