Mingming He, Zhiqiang Wang, Jin Lu, Yuxian Bai, Teng Mao, Jun Wang, Qingxia Fan, Yiping Zhang, Kuaile Zhao, Zhendong Chen, Shegan Gao, Jiancheng Li, Zhichao Fu, Kangsheng Gu, Zhihua Liu, Lin Wu, Xiaodong Zhang, Jifeng Feng, Zuoxing Niu, Yi Ba, Helong Zhang, Ying Liu, Li Zhang, Xuhong Min, Jing Huang, Ying Cheng, Dong Wang, Zhen Sheng, Wanqin Zeng, Li Song, Rui-Hua Xu, Huiyan Luo
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引用次数: 0
Abstract
Background: The interim analysis of the randomized phase 3 ESCORT-1st study demonstrated significantly longer overall survival (OS) and progression-free survival (PFS) for camrelizumab-chemotherapy than placebo-chemotherapy in untreated advanced/metastatic esophageal squamous cell carcinoma (ESCC). Here, we present the final analysis of this study and investigate potential indicators associated with OS.
Methods: Patients were randomized 1:1 to receive camrelizumab (200 mg) or placebo, both in combination with up to six cycles of paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). All treatments were administered intravenously every 3 weeks. The co-primary endpoints were OS and PFS assessed by the independent review committee.
Findings: As of April 30, 2022, the median OS was significantly longer in the camrelizumab-chemotherapy group compared to the placebo-chemotherapy group (15.6 [95% confidence interval (CI): 14.0-18.4] vs. 12.6 months [95% CI 11.2-13.8]; hazard ratio [HR]: 0.70 [95% CI 0.58-0.84]; one-sided p < 0.0001), with 3-year OS rates of 25.6% and 12.8% in the two groups, respectively. The 2-year PFS rates were 20.4% in the camrelizumab-chemotherapy group and 3.4% in the placebo-chemotherapy group. Adverse events were consistent with those reported in the interim analysis. Higher PD-L1 expression correlated with extended OS, and multivariate analysis identified sex and prior history of radiotherapy as independent indicators of OS.
Conclusions: The sustained and significant improvement in efficacy with camrelizumab-chemotherapy compared to placebo-chemotherapy, along with the absence of accumulating or delayed toxicities, supports the long-term use of camrelizumab-chemotherapy as a standard therapy in untreated advanced/metastatic ESCC.
Funding: This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd.
研究背景随机3期ESCORT-1st研究的中期分析显示，在未经治疗的晚期/转移性食管鳞状细胞癌（ESCC）中，康瑞珠单抗化疗的总生存期（OS）和无进展生存期（PFS）明显长于安慰剂化疗。在此，我们将介绍这项研究的最终分析结果，并调查与OS相关的潜在指标：患者按 1:1 随机分配接受坎瑞珠单抗（200 毫克）或安慰剂治疗，两种药物均与紫杉醇（175 毫克/平方米）和顺铂（75 毫克/平方米）最多 6 个周期的联合治疗。所有治疗均采用静脉给药，每3周一次。共同主要终点是由独立审查委员会评估的OS和PFS：截至2022年4月30日，康瑞珠单抗化疗组的中位OS明显长于安慰剂化疗组（15.6个月[95% 置信区间（CI）：14.0-18.4] vs. 12.6个月[95% CI 11.2-13.8]；危险比[HR]：0.70 [95% CI]：0.70 [95% CI 0.58-0.84]；单侧 p 结论：与安慰剂化疗相比，康瑞珠单抗化疗的疗效得到了持续、显著的改善，且无蓄积性或延迟性毒性反应，支持将康瑞珠单抗化疗作为标准疗法长期用于未经治疗的晚期/转移性ESCC：本研究由江苏恒瑞医药股份有限公司资助。
期刊介绍：
Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically.
Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.
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