贝伐珠单抗联合卡铂/紫杉醇对比安慰剂一线治疗晚期或复发性非鳞状非小细胞肺癌的随机、双盲、安慰剂对照、多中心 III 期临床研究（BEYOND 研究）
BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer.
机构信息
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.
出版信息
J Clin Oncol. 2015 Jul 1;33(19):2197-204. doi: 10.1200/JCO.2014.59.4424. Epub 2015 May 26.
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.
目的
III 期 BEYOND 试验旨在确认在全球开展的研究中，贝伐珠单抗联合一线含铂双药化疗在西方患者人群中观察到的疗效也同样适用于中国患者人群。
患者和方法
年龄≥18 岁的局部晚期、转移性或复发性晚期非鳞状非小细胞肺癌（NSCLC）患者按 1:1 比例随机分配，接受卡铂（曲线下面积 6）静脉输注和紫杉醇（175 mg/m2）静脉输注（CP），每 3 周为一个周期，最多 6 个周期，联合安慰剂（Pl+CP）或贝伐珠单抗（B+CP）15 mg/kg 静脉输注，每个周期第 1 天给药，直至疾病进展、无法耐受的毒性或死亡。主要终点是无进展生存期（PFS）；次要终点是客观缓解率、总生存期、探索性生物标志物、安全性。
结果
共 276 例患者随机分配，每组 138 例。与 Pl+CP 相比，B+CP 可延长 PFS（中位 PFS 分别为 9.2 个月和 6.5 个月；风险比[HR]，0.40；95%CI，0.29 至 0.54；P<0.001）。与 Pl+CP 相比，B+CP 可提高客观缓解率（分别为 54%和 26%）。与 Pl+CP 相比，B+CP 也可延长总生存期（中位总生存期分别为 24.3 个月和 17.7 个月；HR，0.68；95%CI，0.50 至 0.93；P=0.0154）。在 EGFR 突变阳性肿瘤中，B+CP 和 Pl+CP 的中位 PFS 分别为 12.4 个月和 7.9 个月（HR，0.27；95%CI，0.12 至 0.63），在野生型肿瘤中，分别为 8.3 个月和 5.6 个月（HR，0.33；95%CI，0.21 至 0.53）。安全性与贝伐珠单抗联合化疗治疗 NSCLC 的既往研究相似，未观察到新的安全性信号。
结论
在卡铂/紫杉醇基础上加用贝伐珠单抗在中国晚期非鳞状 NSCLC 患者中耐受性良好，并带来了有临床意义的治疗获益。
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