Caicun Zhou1, Yi-Long Wu2, Gongyan Chen2, Xiaoqing Liu2, Yunzhong Zhu2, Shun Lu2, Jifeng Feng2, Jianxing He2, Baohui Han2, Jie Wang2, Guoliang Jiang2, Chunhong Hu2, Hao Zhang2, Gang Cheng2, Xiangqun Song2, You Lu2, Hongming Pan2, Wenjuan Zheng2, Anny-Yue Yin2. 1. Caicun Zhou, Shanghai Pulmonary Hospital, Tongji University School of Medicine; Shun Lu and Baohui Han, Shanghai Chest Hospital; Guoliang Jiang, Fudan University Shanghai Cancer Center; Wenjuan Zheng and Anny-Yue Yin, Roche (China) Holding Ltd, Shanghai; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, National Clinical Research Center for Respiratory Disease, State Key Laboratory of Respiratory Disease, Guangzhou; Gongyan Chen, Harbin Medical University Cancer Hospital, Harbin; Xiaoqing Liu, Academy of Military Medical Sciences Affiliated Hospital (307 Hospital of People's Liberation Army); Yunzhong Zhu, Beijing Chest Hospital; Jie Wang, Beijing Cancer Hospital; Gang Cheng, Beijing Hospital of Ministry of Health, Beijing; Jifeng Feng, Jiangsu Cancer Hospital, Nanjing; Chunhong Hu, The Second Xiangya Hospital of Central South University, Changsha; Hao Zhang, Cancer Hospital of Shantou University Medical College, Shantou; Xiangqun Song, Affiliated Cancer Hospital of Guangxi Medical University, Nanning; You Lu, West China Hospital, Sichuan University, Chengdu; and Hongming Pan, Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, China. caicunzhoudr@163.com. 2. Caicun Zhou, Shanghai Pulmonary Hospital, Tongji University School of Medicine; Shun Lu and Baohui Han, Shanghai Chest Hospital; Guoliang Jiang, Fudan University Shanghai Cancer Center; Wenjuan Zheng and Anny-Yue Yin, Roche (China) Holding Ltd, Shanghai; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, National Clinical Research Center for Respiratory Disease, State Key Laboratory of Respiratory Disease, Guangzhou; Gongyan Chen, Harbin Medical University Cancer Hospital, Harbin; Xiaoqing Liu, Academy of Military Medical Sciences Affiliated Hospital (307 Hospital of People's Liberation Army); Yunzhong Zhu, Beijing Chest Hospital; Jie Wang, Beijing Cancer Hospital; Gang Cheng, Beijing Hospital of Ministry of Health, Beijing; Jifeng Feng, Jiangsu Cancer Hospital, Nanjing; Chunhong Hu, The Second Xiangya Hospital of Central South University, Changsha; Hao Zhang, Cancer Hospital of Shantou University Medical College, Shantou; Xiangqun Song, Affiliated Cancer Hospital of Guangxi Medical University, Nanning; You Lu, West China Hospital, Sichuan University, Chengdu; and Hongming Pan, Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, China.
Abstract
PURPOSE: The phase III BEYOND trial was undertaken to confirm in a Chinese patient population the efficacy seen with first-linebevacizumab plus platinum doublet chemotherapy in globally conducted studies. PATIENTS AND METHODS: Patients age ≥ 18 years with locally advanced, metastatic, or recurrent advanced nonsquamous non-small-cell lung cancer (NSCLC) were randomly assigned to receive carboplatin (area under the curve, 6) intravenously and paclitaxel (175 mg/m(2)) intravenously (CP) on day 1 of each 3-week cycle, for ≤ six cycles, plus placebo (Pl+CP) or bevacizumab (B+CP) 15 mg/kg intravenously, on day 1 of each cycle, until progression, unacceptable toxicity, or death. The primary end point was progression-free survival (PFS); secondary end points were objective response rate, overall survival, exploratory biomarkers, safety. RESULTS:A total of 276 patients were randomly assigned, 138 to each arm. PFS was prolonged with B+CP versus Pl+CP (median, 9.2 v 6.5 months, respectively; hazard ratio [HR], 0.40; 95% CI, 0.29 to 0.54; P < .001). Objective response rate was improved with B+CP compared with Pl+CP (54% v 26%, respectively). Overall survival was also prolonged with B+CP compared with Pl+CP (median, 24.3 v 17.7 months, respectively; HR, 0.68; 95% CI, 0.50 to 0.93; P = .0154). Median PFS was 12.4 months with B+CP and 7.9 months with Pl+CP (HR, 0.27; 95% CI, 0.12 to 0.63) in EGFR mutation-positive tumors and 8.3 and 5.6 months, respectively (HR, 0.33; 95% CI, 0.21 to 0.53), in wild-type tumors. Safety was similar to previous studies of B+CP in NSCLC; no new safety signals were observed. CONCLUSION: The addition to bevacizumab to carboplatin/paclitaxel was well tolerated and resulted in a clinically meaningful treatment benefit in Chinese patients with advanced nonsquamous NSCLC.
RCT Entities:
PURPOSE: The phase III BEYOND trial was undertaken to confirm in a Chinese patient population the efficacy seen with first-line bevacizumab plus platinum doublet chemotherapy in globally conducted studies. PATIENTS AND METHODS: Patients age ≥ 18 years with locally advanced, metastatic, or recurrent advanced nonsquamous non-small-cell lung cancer (NSCLC) were randomly assigned to receive carboplatin (area under the curve, 6) intravenously and paclitaxel (175 mg/m(2)) intravenously (CP) on day 1 of each 3-week cycle, for ≤ six cycles, plus placebo (Pl+CP) or bevacizumab (B+CP) 15 mg/kg intravenously, on day 1 of each cycle, until progression, unacceptable toxicity, or death. The primary end point was progression-free survival (PFS); secondary end points were objective response rate, overall survival, exploratory biomarkers, safety. RESULTS: A total of 276 patients were randomly assigned, 138 to each arm. PFS was prolonged with B+CP versus Pl+CP (median, 9.2 v 6.5 months, respectively; hazard ratio [HR], 0.40; 95% CI, 0.29 to 0.54; P < .001). Objective response rate was improved with B+CP compared with Pl+CP (54% v 26%, respectively). Overall survival was also prolonged with B+CP compared with Pl+CP (median, 24.3 v 17.7 months, respectively; HR, 0.68; 95% CI, 0.50 to 0.93; P = .0154). Median PFS was 12.4 months with B+CP and 7.9 months with Pl+CP (HR, 0.27; 95% CI, 0.12 to 0.63) in EGFR mutation-positive tumors and 8.3 and 5.6 months, respectively (HR, 0.33; 95% CI, 0.21 to 0.53), in wild-type tumors. Safety was similar to previous studies of B+CP in NSCLC; no new safety signals were observed. CONCLUSION: The addition to bevacizumab to carboplatin/paclitaxel was well tolerated and resulted in a clinically meaningful treatment benefit in Chinese patients with advanced nonsquamous NSCLC.