切换至 "中华医学电子期刊资源库"

中华危重症医学杂志(电子版) ›› 2021, Vol. 14 ›› Issue (02) : 127 -132. doi: 10.3877/cma.j.issn.1674-6880.2021.02.006

所属专题: 文献

论著

卡瑞利珠单抗治疗复发或晚期子宫恶性肿瘤患者的疗效和安全性评价
张雨馨1, 楼寒梅1, 吕晓娟1, 殷卓敏1, 徐小仙1, 李莉1, 倪镌1,()   
  1. 1. 310022 杭州,中国科学院大学附属肿瘤医院(浙江省肿瘤医院)妇瘤放疗科、中国科学院基础医学与肿瘤研究所
  • 收稿日期:2020-12-29 出版日期:2021-04-30
  • 通信作者: 倪镌
  • 基金资助:
    浙江省公益技术应用社会发展项目(LGF19H160009); 浙江省医药卫生科技项目(2020KY056)

Efficacy and safety of camrelizumab in patients with recurrent or advanced cervical cancer and endometrial cancer

Yuxin Zhang1, Hanmei Lou1, Xiaojuan Lyu1, Zhuomin Yin1, Xiaoxian Xu1, Li Li1, Juan Ni1,()   

  1. 1. Department of Gynecologic Tumor Radiotherapy, Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou 310022, China
  • Received:2020-12-29 Published:2021-04-30
  • Corresponding author: Juan Ni
引用本文:

张雨馨, 楼寒梅, 吕晓娟, 殷卓敏, 徐小仙, 李莉, 倪镌. 卡瑞利珠单抗治疗复发或晚期子宫恶性肿瘤患者的疗效和安全性评价[J/OL]. 中华危重症医学杂志(电子版), 2021, 14(02): 127-132.

Yuxin Zhang, Hanmei Lou, Xiaojuan Lyu, Zhuomin Yin, Xiaoxian Xu, Li Li, Juan Ni. Efficacy and safety of camrelizumab in patients with recurrent or advanced cervical cancer and endometrial cancer[J/OL]. Chinese Journal of Critical Care Medicine(Electronic Edition), 2021, 14(02): 127-132.

目的

评估程序性死亡1(PD-1)抑制剂(卡瑞利珠单抗)治疗复发或晚期子宫恶性肿瘤的疗效及安全性。

方法

收集2019年8月至2020年7月在浙江省肿瘤医院接受过PD-1抑制剂(卡瑞利珠单抗)治疗的31例复发或晚期子宫恶性肿瘤患者,主要观察指标为客观缓解率(ORR)和疾病控制率(DCR),次要观察指标为无进展生存时间(PFS)和不良反应发生率。

结果

纳入31例复发或晚期的妇科恶性肿瘤患者中,宫颈癌24例,子宫内膜癌7例。免疫单药治疗4例,免疫联合治疗27例。总ORR为45.16%(14/31),DCR为70.97%(22/31)。随访时间为2.9 ~ 14.6个月,中位PFS尚未达到。不良反应发生率为58.06%(18/31),主要不良反应包括骨髓抑制、反应性皮肤毛细血管增生症及甲状腺功能异常,并未发生≥ 3级的不良反应。

结论

PD-1抑制剂卡瑞利珠单抗在复发或晚期子宫恶性肿瘤患者具有一定的疗效和安全性。

Objective

To evaluate the efficacy and safety of programmed death-1 (PD-1) inhibitor (camrelizumab) in the treatment of patients with recurrent or advanced cervical cancer and endometrial cancer.

Methods

Thirty-one patients with recurrent or advanced cervical cancer and endometrial cancer who had received PD-1 inhibitor (camrelizumab) at the Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) from August 2019 to July 2020 were collected. The primary end points were objective response rate (ORR) and disease control rate (DCR); the secondary end points were progression-free survival (PFS) and incidence of adverse reactions.

Results

Among the 31 patients, 24 had cervical cancer and 7 had endometrial cancer. Four patients were treated with immune monotherapy, while 27 were treated with combination immunotherapy. The ORR was 45.16% (14/31), and the DCR was 70.97% (22/31) in all patients. The follow-up time was 2.9 to 14.6 months, and the median PFS was not reached. The incidence of adverse reactions was 58.06% (18/31). The main adverse reactions were myelosuppression, reactive cutaneous capillary endothelial proliferation and thyroid dysfunction, and no adverse reactions of grade ≥ 3 in combination immunotherapy were observed.

Conclusion

The PD-1 inhibitor camrelizumab has certain efficacy and safety in the treatment of patients with recurrent or advanced cervical cancer and endometrial cancer.

表1 子宫恶性肿瘤复发或晚期患者发生疾病进展影响因素的自变量赋值方法
表2 子宫恶性肿瘤复发或晚期患者发生疾病进展影响因素的COX回归分析
1
金碧霞,孔为民.《国际妇产科联盟(FIGO)2018癌症报告:子宫内膜癌诊治指南》解读[J].中国临床医生杂志,2019,47(10):1155-1158.
2
Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy[J]. Nat Rev Cancer, 2012, 12 (4): 252-264.
3
周晖,白守民,林仲秋.《2019 NCCN宫颈癌临床实践指南(第1版)》解读[J].中国实用妇科与产科杂志,2018,34(9):54-61.
4
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) [J]. Eur J Cancer, 2009, 45 (2): 228-247.
5
Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics[J]. Lancet Oncol, 2017, 18 (3): e143-e152.
6
National Cancer Institute. Common terminology criteria for adverse events (CTCAE)[EB/OL]. (2017-11-27) [2021-01-24].

URL    
7
Cohen PA, Jhingran A, Oaknin A, et al. Cervical cancer[J]. Lancet, 2019, 393 (10167): 169-182.
8
Landoni F, Colombo A, Milani R, et al. Randomized study between radical surgery and radiotherapy for the treatment of stage ⅠB-ⅡA cervical cancer: 20-year update[J]. J Gynecol Oncol, 2017, 28 (3): e34.
9
Waggoner SE. Cervical cancer[J]. Lancet, 2003, 361(9376): 2217-2225.
10
Tewari KS, Sill MW, Penson RT, et al. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)[J]. Lancet, 2017, 390 (10103): 1654-1663.
11
Soumerai TE, Donoghue MTA, Bandlamudi C, et al. Clinical utility of prospective molecular characterization in advanced endometrial cancer[J]. Clin Cancer Res, 2018, 24 (23): 5939-5947.
12
Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage Ⅲ melanoma[J]. N Engl J Med, 2018, 378 (19): 1789-1801.
13
Mok TSK, Wu YL, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial[J]. Lancet, 2019, 393 (10183): 1819-1830.
14
Doi T, Piha-Paul SA, Jalal SI, et al. Safety and anti-tumor activity of the anti-programmed death-1 antibody pembrolizumab in patients with advanced esophageal carcinoma[J]. J Clin Oncol, 2018, 36 (1): 61-67.
15
Qin Y, Ekmekcioglu S, Forget MA, et al. Cervical cancer neoantigen landscape and immune activity is associated with human papillomavirus master regulators[J]. Front Immunol, 2017 (8): 689.
16
Vanderstraeten A, Luyten C, Verbist G, et al. Mapping the immunosuppressive environment in uterine tumors: implications for immunotherapy[J]. Cancer Immunol Immunother, 2014, 63 (6): 545-557.
17
Frenel JS, Le Tourneau C, O'Neil B, et al. Safety and efficacy of pembrolizumab in advanced, programmed death ligand 1-positive cervical cancer: results from the phase Ⅰb KEYNOTE-028 trial[J]. J Clin Oncol, 2017, 35 (36): 4035-4041.
18
Ott PA, Bang YJ, Berton-Rigaud D, et al. Safety and antitumor activity of pembrolizumab in advanced programmed death ligand 1-positive endometrial cancer: results from the KEYNOTE-028 study[J]. J Clin Oncol, 2017, 35 (22): 2535-2541.
19
Chung HC, Ros W, Delord JP, et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase Ⅱ KEYNOTE-158 study[J]. J Clin Oncol, 2019, 37 (17): 1470-1478.
20
Naumann RW, Hollebecque A, Meyer T, et al. Safety and efficacy of nivolumab monotherapy in recurrent or metastatic cervical, vaginal, or vulvar carcinoma: results from the phase Ⅰ/Ⅱ checkmate 358 trial[J]. J Clin Oncol, 2019, 37 (31): 2825-2834.
21
Lee L, Matulonis U. Immunotherapy and radiation combinatorial trials in gynecologic cancer: a potential synergy?[J]. Gynecol Oncol, 2019, 154 (1): 236-245.
22
Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage Ⅲ NSCLC[J]. N Engl J Med, 2018, 379 (24): 2342-2350.
23
Gadgeel S, Rodriguez-Abreu D, Speranza G, et al. Updated analysis from kEYNOTE-189: pembrolizumab or placebo plus pemetrexed and platinum for previously untreated metastatic nonsquamous non-small-cell lung cancer[J]. J Clin Oncol, 2020, 38 (14): 1505-1517.
24
Yasuda S, Sho M, Yamato I, et al. Simultaneous blockade of programmed death 1 and vascular endothelial growth factor receptor 2 (VEGFR2) induces synergistic anti-tumour effect in vivo[J]. Clin Exp Immunol, 2013, 172 (3): 500-506.
25
Fukumura D, Kloepper J, Amoozgar Z, et al. Enhancing cancer immunotherapy using antiangiogenics: opportunities and challenges[J]. Nat Rev Clin Oncol, 2018, 15 (5): 325-340.
26
Lan C, Shen J, Wang Y, et al. Camrelizumab plus apatinib in patients with advanced cervical cancer (CLAP): a multicenter, open-label, single-arm, phase Ⅱ trial[J]. J Clin Oncol, 2020, 38 (34): 4095-4106.
27
Naumann RW, Oaknin A, Meyer T, et al. Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: results from CheckMate 358[J]. Annals of Oncology, 2019, 30 (Suppl 5): v898-v899.
[1] 石皆春, 范子玉, 邢燕. 不同筛查方法预警宫颈原位腺癌的效能[J/OL]. 中华妇幼临床医学杂志(电子版), 2024, 20(05): 575-581.
[2] 唐丹, 姚晓曦, 杨博文, 薛绍龙, 李梦瑶, 韦柳杏, 郄明蓉. 双肾上腺皮质激素样激酶1对子宫内膜样腺癌患者临床特征的影响[J/OL]. 中华妇幼临床医学杂志(电子版), 2024, 20(05): 582-590.
[3] 梁孟杰, 朱欢欢, 王行舟, 江航, 艾世超, 孙锋, 宋鹏, 王萌, 刘颂, 夏雪峰, 杜峻峰, 傅双, 陆晓峰, 沈晓菲, 管文贤. 联合免疫治疗的胃癌转化治疗患者预后及术后并发症分析[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(06): 619-623.
[4] 林逸, 钟文龙, 李锴文, 何旺, 林天歆. 广东省医学会泌尿外科疑难病例多学科会诊(第15期)——转移性膀胱癌的综合治疗[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2024, 18(06): 648-652.
[5] 吴伟宙, 王琼仁, 詹雄宇, 郑明星, 李亚县. 广东省医学会泌尿外科疑难病例多学科会诊(第16期)——左肾肉瘤样癌[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2024, 18(05): 525-529.
[6] 李勇, 彭天明, 王倩倩, 陈育纯, 蒲小勇, 刘久敏. 基于失巢凋亡相关基因的膀胱癌预后模型构建及分析[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2024, 18(04): 331-339.
[7] 李飞, 郑灶松, 吴芃, 谭万龙. 广东省医学会泌尿外科疑难病例多学科会诊(第16期)——延胡索酸水合酶缺陷型晚期肾细胞癌[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2024, 18(04): 410-414.
[8] 陈旭, 牛凯, 孙建国. 放疗联合免疫治疗对驱动基因阴性NSCLC的困惑分析及应对策略[J/OL]. 中华肺部疾病杂志(电子版), 2024, 17(03): 341-348.
[9] 尹炳驿, 张楚楚, 刘艺, 林洪生. 益气清金汤加味治疗晚期非小细胞肺癌的临床分析[J/OL]. 中华肺部疾病杂志(电子版), 2024, 17(03): 462-465.
[10] 陈伟杰, 何小东. 胆囊癌免疫靶向治疗进展[J/OL]. 中华肝脏外科手术学电子杂志, 2024, 13(06): 763-768.
[11] 魏妙艳, 徐近. 合并远处转移胰腺癌系统性治疗的梳理和展望[J/OL]. 中华肝脏外科手术学电子杂志, 2024, 13(05): 644-650.
[12] 张燕, 许丁伟, 胡满琴, 李新成, 李翱, 黄洁. 胆囊癌免疫治疗的知识图谱可视化分析[J/OL]. 中华肝脏外科手术学电子杂志, 2024, 13(03): 319-327.
[13] 王昌前, 林婷婷, 宁雨露, 王颖杰, 谭文勇. 光免疫治疗在肿瘤领域的临床应用新进展[J/OL]. 中华临床医师杂志(电子版), 2024, 18(06): 575-583.
[14] 吴迪, 闫志风, 李明霞, 孟元光. 晚期子宫内膜癌免疫治疗的探索[J/OL]. 中华临床医师杂志(电子版), 2024, 18(03): 231-237.
[15] 黎璞, 生秀杰. 妊娠合并子宫颈癌的管理[J/OL]. 中华产科急救电子杂志, 2024, 13(04): 202-208.
阅读次数
全文


摘要


AI


AI小编
你好!我是《中华医学电子期刊资源库》AI小编,有什么可以帮您的吗?