中国药物警戒 ›› 2022, Vol. 19 ›› Issue (2): 164-168.
DOI: 10.19803/j.1672-8629.2022.02.11

• 基础与临床研究 • 上一篇    下一篇

信迪利单抗治疗晚期结直肠癌患者的疗效及安全性分析

蔡江霞1, 陈思颖2, 董凯3, 覃建萍1, 张跃1, 戚锐锋1, 叶银梅1,*   

  1. 1巴音郭楞蒙古自治州人民医院,新疆 库尔勒 841000;
    2西安交通大学第一附属医院药学部,陕西 西安 710061;
    3西安交通大学药学院,陕西 西安 710061
  • 收稿日期:2021-03-05 出版日期:2022-02-15 发布日期:2022-02-15
  • 通讯作者: *叶银梅,女,主任药师,临床药学。E-mail：1335233425@qq.com
  • 作者简介:蔡江霞,女,主管药师,硕士,临床药学。
  • 基金资助:
    国家自然科学基金资助项目（81502616、81803491）

Efficacy and safety of sintilimab in patients with advanced colorectal cancer

CAI Jiangxia1, CHEN Siying2, DONG Kai3, QIN Jianpin1, ZHANG Yue1, QI Ruifeng1, YE Yinmei1,*   

  1. 1The People's Hospital of Bayinguoleng Mongolian Autonomous Prefecture, Korla Xinjiang 841000, China;
    2Department of Pharmacy, the First Affiliated Hospital of Medical College, Xi'an Jiaotong University, Xi'an Shanxi 710061, China;
    3School of Pharmacy, Xi'an Jiaotong University, Xi'an Shanxi 710061, China
  • Received:2021-03-05 Online:2022-02-15 Published:2022-02-15

PDF (PC)

133

摘要： 目的 研究信迪利单抗联合化疗在晚期结直肠癌患者中的疗效及药品不良反应（adverse drug reaction,ADR）。方法 纳入2018年6月1日至2020年7月31日巴音郭楞蒙古自治州人民医院一线含奥沙利铂方案化疗失败的晚期结直肠癌患者82例,随机分为A、B两组,A组给予二线伊立替康+卡培他滨化疗方案（简称“XELIRI方案”）,B组给予信迪利单抗联合XELIRI化疗方案,对两组近期疗效、远期疗效及ADR进行对比研究。结果 截至2021年2月28日,82例晚期结直肠癌患者疗效均可评价,客观缓解率（objective response rate,ORR）A组20.00%,B组21.42%,疾病控制率（disease control rate, DCR）A组65.00%,B组71.43%,两组间ORR及DCR方面差异无统计学意义（P>0.05）;两组中位疾病无进展生存期（progression-free survival, PFS）比较,B组优于A组,差异有统计学意义（P<0.05）。ADR方面,血液毒性（中性粒细胞降低、血小板降低、贫血）、胃肠道反应（恶心呕吐、腹泻）及转氨酶升高方面两组无明显的差异（P>0.05）,但皮疹、甲减及蛋白尿ADR发生率方面信迪利单抗联合化疗组更高,主要以I~II度的轻度反应为主,考虑与信迪利单抗相关。有1例患者出现了III度皮疹反应,停药1月并经过对症治疗1周后皮疹彻底缓解,后续治疗未受影响。两组患者总体ADR均可耐受。结论 信迪利单抗联合二线XELIRI化疗方案在晚期结直肠癌患者中具有潜在获益,ADR总体可耐受,安全性可控。

关键词: 信迪利单抗, 结直肠癌, 疗效, 安全性

Abstract: Objective To study the efficacy and adverse reaction of sintilimab combined with chemotherapy in patients with advanced colorectal cancer. Methods 82 patients with advanced colorectal cancer who had failed first-line chemotherapy with oxaliplatin in Bayinguoleng Mongolian Autonomous Prefecture Hospital between January 1, 2018 and July 31, 2020 were randomly divided into group A and group B. Patients in group A underwent second-line chemotherapy involving irinotecan and capecitabine (referred to as XELIRI regimen), while those in group B were given sintilimab combined with XELIRI chemotherapy. The short-term efficacy, long-term efficacy and adverse reactions were compared between the two groups. Results As of February 28, 2021, the clinical efficacy among the 82 patients with advanced colorectal cancer could be evaluated. The Objective response rate (ORR) was 20.00% in group A and 21.42% in group B. The disease control rate (DCR) was 65.00% in group A and 71.43% in group B. There was no significant difference in ORR or DCR between the two groups (P>0.05). The median PFS of group B was superior to that of group A, with statistically significant significance (P<0.05). As for adverse reactions, there was no significant difference between the two groups in blood toxicity, gastrointestinal tract reactions (nausea/vomiting), diarrhea or elevation of transaminase (P > 0.05). However, the incidence of such adverse reactions (mainly mild reactions of grade I to II) as rash, hypothyroidism and proteinuria was higher in group B than in group A, which were considered to be related to sintilimab. One patient developed grade III rash reaction, but the rash was completely relieved one month after withdrawal and after one week of symptomatic treatment. Overall adverse reactions were tolerable in both groups. Conclusions intilimab combined with second-line XELIRI chemotherapy is of potential benefit for patients with advanced colorectal cancer, with generally tolerable adverse reactions and controllable safety.

Key words: sintilimab, colorectal cancer, curative effect, safety

中图分类号: