Xingsheng Hu1, Baohui Han2, Aiqin Gu2, Yiping Zhang3, Shun Chang Jiao4, Chang-Li Wang5, Jintao He6, Xueke Jia7, Li Zhang8, Jiewen Peng9, Meina Wu10, Kejing Ying11, Junye Wang12, Kewei Ma13, Shucai Zhang14, Changxuan You15, Fenlai Tan16, Yinxiang Wang16, Lieming Ding16, Yan Sun17. 1. Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China. 2. Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. 3. Department of Chemotherapy, Zhejiang Cancer Hospital, Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou, China. 4. General Hospital of People's Liberation Army, Beijing, China. 5. Department of Lung Cancer, Cancer Institute and Hospital, Tianjin Medical University, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China. 6. Sichuan Cancer Hospital and Institute, Chengdu, China. 7. Baoding Hengxing Medicine Integrative Hospital, Baoding, China. 8. Department of Respiratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China. 9. Department of Medical Oncology, Zhongshan City Pepole's Hospital, Zhongshan, China. 10. Department of Thoracic Medical Oncology Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing, China. 11. Zhejiang Sir Run Run Shaw Hospital, Department of Medicine, Zhejiang University, Hangzhou, China. 12. State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China. 13. Cancer Center of the First Hospital of Jilin University, Changchun, China. 14. Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China. 15. Department of Medical Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, China. 16. Betta Pharmaceuticals Co., Ltd, Hangzhou, China. 17. Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China. Electronic address: suny@csco.org.cn.
Abstract
BACKGROUND: The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. METHODS: This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. RESULTS: Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. CONCLUSIONS: The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting.
BACKGROUND: The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. METHODS: This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLCpatients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. RESULTS: Between August, 2011 and August, 2012, a total of 6087 advanced NSCLCpatients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. CONCLUSIONS: The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting.