阿帕替尼联合卡瑞利珠单抗治疗既往接受过治疗的晚期胆管癌患者的疗效和安全性：一项前瞻性临床研究。
The Efficacy and Safety of Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer: A Prospective Clinical Study.
作者信息
Wang Dongxu, Yang Xu, Long Junyu, Lin Jianzhen, Mao Jinzhu, Xie Fucun, Wang Yunchao, Wang Yanyu, Xun Ziyu, Bai Yi, Yang Xiaobo, Guan Mei, Pan Jie, Seery Samuel, Sang Xinting, Zhao Haitao
机构信息
Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare Disease, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出版信息
Front Oncol. 2021 Apr 12;11:646979. doi: 10.3389/fonc.2021.646979. eCollection 2021.
BACKGROUND
PD-1/L1 inhibitor-based immunotherapy is currently under investigation in biliary tract cancer (BTC). Apatinib combined with camrelizumab has achieved promising results in various tumor types. The aim of this study was to assess the safety and efficacy of apatinib plus camrelizumab for advanced biliary tract cancer patients who have received previously treatments.
METHODS
This prospective, non-randomized, open-label trial was conducted at Peking Union Medical College Hospital (PUMCH). All included patients received apatinib orally at 250 mg per a day and camrelizumab intravenously at 200 mg every three weeks until disease progression or intolerable toxicity occurred. Efficacy was evaluated based on the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1). Adverse events (AEs) were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
RESULTS
A total of 22 patients were consecutively enrolled from 1st December, 2018 until 1st August, 2020. Among 21 patients for whom we could conduct efficacy evaluations, no patients achieved a complete response (CR), 4 patients (19%) achieved partial response (PR), and 11 patients had stable disease with a disease control rate of 71.4%. The median overall survival was 13.1 months (95% CI, 8.1-18.2), and the median progression-free survival was 4.4 months (95% CI, 2.4-6.3). All patients experienced treatment related AEs, and grade 3 or 4 AEs occurred in 14 (63.6%) of 22 patients. No treatment related deaths were observed.
CONCLUSIONS
This is the first report focusing on the efficacy and safety of camrelizumab plus apatinib in pretreated biliary tract cancer patients. The finding suggests this regimen has favorable therapeutic effects with relatively manageable toxicity. Further trials with a control arm are required to investigate.
CLINICAL TRIAL REGISTRATION
identifier NCT04642664.
背景
基于程序性死亡受体1（PD-1）/程序性死亡配体1（PD-L1）抑制剂的免疫疗法目前正在胆管癌（BTC）中进行研究。阿帕替尼联合卡瑞利珠单抗在多种肿瘤类型中取得了有前景的结果。本研究的目的是评估阿帕替尼联合卡瑞利珠单抗对先前接受过治疗的晚期胆管癌患者的安全性和疗效。
方法
这项前瞻性、非随机、开放标签试验在北京协和医院（PUMCH）进行。所有纳入的患者每天口服250mg阿帕替尼，每三周静脉注射200mg卡瑞利珠单抗，直至疾病进展或出现无法耐受的毒性。根据实体瘤疗效评价标准（RECIST）1.1版评估疗效。不良事件（AE）通过美国国立癌症研究所不良事件通用术语标准（CTCAE 4.0版）进行评估。
结果
从2018年12月1日至2020年8月1日，共连续纳入22例患者。在我们能够进行疗效评估的21例患者中，无患者达到完全缓解（CR），4例患者（19%）达到部分缓解（PR），11例患者疾病稳定，疾病控制率为71.4%。中位总生存期为13.1个月（95%CI，8.1 - 18.2），中位无进展生存期为4.4个月（95%CI，2.4 - 6.3）。所有患者均经历了与治疗相关的AE，22例患者中有14例（63.6%）发生3级或4级AE。未观察到与治疗相关的死亡。
结论
这是首篇关注卡瑞利珠单抗联合阿帕替尼在经治胆管癌患者中的疗效和安全性的报告。该研究结果表明该方案具有良好的治疗效果，且毒性相对可控。需要进一步开展有对照臂的试验进行研究。
临床试验注册
标识符NCT04642664。
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