Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (gefitinib) In China With Advanced Non-small Cell Lung Cancer Patients In The Efficacy And Safety Studies And Clinical Efficacy Predictors

Background Lung cancer is a common fatal disease with highest mobidity and motality rate among tumors in urban China. With the development of standard platinum-based chemotherapy regimens and Docetaxel-based second-line regimen, the 5-year survival remains poor in non-small cell lung cancer (NSCLC). Gefitinib, which targeted epidermal growth factor receptor (EGFR) - tyrosin kinase provides a novel treatment for advanced NSCLC. Methods It is an open, uncontrolled phase II clinical trial. 100 patients with advanced NSCLC who were failed of platinum-based chemotherapy were administrated gefitinib orally at the dose of 250 mg/day. The objective tumor response was evaluated with RECIST criteria. The impact of treatment on symptoms and quality of life (QoL) was evaluated with Chinese version of EORTC QLQ-C30 and QLQ-LC13. Results Tumor response rate was 28%. Disease control rate, which included both tumor responses and stable disease, was 64%. The improvement rates of five functional scales and global scales in QLQ-C30 were over 60%, the improvement rates of general symptoms and lung cancer related symptoms were over 35%. The improvements of QoL and symptoms were correlated with objective tumor response. The mean score of each functioning scale and global scale increased significantly, While the mean score of each disease-related symptom decreased significantly in responders. The improvement rates of QoL and symptoms in responders were over 89% and 60% respectively. The 250mg/day dose of gefitinib was well tolerated by patients. The majority of adverse events were grade 1 or grade 2 skin rash and diarrhea, which were manageable and reversible. Conclusion Gefitinib offers a new treatment option providing meaningful tumor control and symptom relief with tolerable side effect for some patients with advanced NSCLC.