Yan Sun1, Jin Wan Wang1, Yong Yu Liu2, Qi Tao Yu3, Yi Ping Zhang4, Kai Li5, Li Yan Xu6, Su Xia Luo7, Feng Zhan Qin8, Zheng Tang Chen9, Wen Chao Liu10, Qing Hua Zhou11, Qiang Chen12, Ke Jun Nan13, Xiao Qing Liu14, Wei Liu15, Hou Jie Liang16, Hui Shan Lu17, Xiu Wen Wang18, Jie Jun Wang19, Shu Ping Song20, Yuan Rong Tu21, Jing Min Zhou22, Wei Lian Li23, Chen Yao24. 1. Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China. 2. Liaoning Provincial Cancer Hospital, Shenyang, China. 3. Cancer Hospital, Guangxi Medical University, Nanning, Guangxi, China. 4. Zhejiang Provincial Cancer Hospital, Hengzhou, China. 5. Tianjin Cancer Hospital, Tianjin, China. 6. Thoracic Tumor Hospital, Beijing, China. 7. Henan Provincial Cancer Hospital, Zhengzhou, China. 8. Anhai Provincial Cancer Hospital, Hefei, China. 9. Xianqiao Hospital, 3rd PLA Medical University, Chongqing, China. 10. Xijing Hospital, 4th PLA Medical University, Xi'an, China. 11. Huaxi Hospital, Sichun University, Chengdu, China. 12. Fujian Medical University Cancer Hospital, Fuzhou, China. 13. First Hospital of Xian Communication University, Xian, China. 14. 307 Hospital, Chinese Academy of Military Medical Sciences, Beijing, China. 15. Hebei Provincial Cancer Hospital, Shijiazhuang, China. 16. Xinan Hospital, 3rd PLA Medical University, Chongqing, China. 17. Fujian Medical University Union Hospital, Fuzhou, China. 18. Qilu Hospital, Shandong University, Jinan, China. 19. Changzheng Hospital, 2nd PLA Medical University, Shanghai, China. 20. Shandong Provincial Cancer Hospital, Jinan, China. 21. Fujian Medical University 1st Hospital, Fuzhou, China. 22. Tianjin Chest Hospital, Tianjin, China. 23. Tianjin 2nd Hospital, Tianjin, China. 24. Peking University First Hospital, Beijing, China.
Abstract
BACKGROUND: : Phase II-III trials in patients with untreated and previously treated locally advanced or non-small cell lung cancer (NSCLC) suggested that Endostar was able to enhance the effect of platinum-based chemotherapy (NP regimen) with tolerable adverse effects. METHODS:Four hundred and eighty six patients were randomized into two arms: study arm A: NP plus Endostar (n = 322; vinorelbine, cisplatin, Endostar), and study arm B: NP plus placebo (n = 164; vinorelbine, cisplatin, 0.9% sodium chloride). Patients were treated every third week for two to six cycles. RESULTS: : Overall response rates were 35.4% in arm A and 19.5% in arm B (P = 0.0003). The median time to progression was 6.3 months for arm A and 3.6 months for B, respectively (P < 0.001). The clinical benefit rates were 73.3% in arm A and 64.0% in arm B (P = 0.035). Grade 3/4 neutropenia, anemia, and nausea/vomiting were 28.5%, 3.4%, and 8.0%, respectively, in Arm A compared with 28.2%, 3.0%, and 6.6%, respectively, in Arm B (P > 0.05). There were two treatment related deaths in arm A and one in arm B (P > 0.05). The median overall survival was longer in arm A than in arm B (P < 0.0001). CONCLUSION: : Long-term follow-up revealed that the addition of Endostar to an NP regimen can result in a significant clinical and survival benefit in advanced NSCLC patients, compared with NP alone.
RCT Entities:
BACKGROUND: : Phase II-III trials in patients with untreated and previously treated locally advanced or non-small cell lung cancer (NSCLC) suggested that Endostar was able to enhance the effect of platinum-based chemotherapy (NP regimen) with tolerable adverse effects. METHODS: Four hundred and eighty six patients were randomized into two arms: study arm A: NP plus Endostar (n = 322; vinorelbine, cisplatin, Endostar), and study arm B: NP plus placebo (n = 164; vinorelbine, cisplatin, 0.9% sodium chloride). Patients were treated every third week for two to six cycles. RESULTS: : Overall response rates were 35.4% in arm A and 19.5% in arm B (P = 0.0003). The median time to progression was 6.3 months for arm A and 3.6 months for B, respectively (P < 0.001). The clinical benefit rates were 73.3% in arm A and 64.0% in arm B (P = 0.035). Grade 3/4 neutropenia, anemia, and nausea/vomiting were 28.5%, 3.4%, and 8.0%, respectively, in Arm A compared with 28.2%, 3.0%, and 6.6%, respectively, in Arm B (P > 0.05). There were two treatment related deaths in arm A and one in arm B (P > 0.05). The median overall survival was longer in arm A than in arm B (P < 0.0001). CONCLUSION: : Long-term follow-up revealed that the addition of Endostar to an NP regimen can result in a significant clinical and survival benefit in advanced NSCLCpatients, compared with NP alone.