[Efficacy of gefitinib on Chinese patients with locally advanced or metastatic non-small cell lung cancer: a clinical trial].

作者：Zhong Zhen Guan, L. Zhang, Long Yun Li, Guo Liang Jiang, Xu Yi Liu, Da-Tong Chu, Hong Yun Zhao, Wei Li · 发表于：PubMed · 年份：2005 · 被引用次数：15 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Research Studies、Colorectal Cancer Treatments and Studies

BACKGROUND & OBJECTIVE: Gefitinib, a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, has been approved to be used in treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in many countries. This study, a multicenter clinical trial, was designed to evaluate the efficacy of gefitinib on Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy, and explore its safety. METHODS: A total of 159 pathologically-confirmed NSCLC patients were enrolled. Gefitinib was orally administered 250 mg once daily until disease progression or the occurrence of intolerable toxicity. RESULTS: The objective response rate was 27.0%; the disease control rate was 54.1%. The median progression-free survival time was 97 days; the median overall survival time was 10.0 months; the 1-year survival rate was 44%. The most common drug-related adverse events were rash (44.0%), pruritus (15.7%), and diarrhea (10.1%), and most of them were grade 1-2 events with no need of further treatment. CONCLUSION: Gefitinib is effective and safe in treating Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy.