国际肿瘤学杂志

国际肿瘤学杂志 ›› 2020, Vol. 47 ›› Issue (4): 193-198.doi: 10.3760/cma.j.cn371439-20190731-00001

• 论著 •    下一篇

PD-1抑制剂单药治疗与联合化疗/靶向治疗晚期恶性肿瘤的疗效及安全性比较

侯莉娜1, 迪娜·索力提肯2, 郭智3, 陈晓3, 任骅4,5()   

  1. 1 国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院深圳医院医务部,深圳 518116
    2 国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院深圳医院肿瘤内科,深圳 518116
    3 国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院深圳医院血液肿瘤科,深圳 518116
    4 国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院放疗科,北京 100021
    5 国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院深圳医院放疗科,深圳 518116
  • 收稿日期:2019-07-31 修回日期:2020-01-10 出版日期:2020-04-08 发布日期:2020-05-26
  • 通讯作者: 任骅
    侯莉娜和迪娜·索力提肯对本文有同等贡献 E-mail:renhua2009@hotmail.com

Comparison of efficacy and safety of PD-1 inhibitor monotherapy and combined with chemotherapy/targeted therapy in advanced malignant tumors

Hou Lina1, Dina Suolitiken2, Guo Zhi3, Chen Xiao3, Ren Hua4,5()   

  1. 1 Department of Medical Administration, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, China
    2 Department of Medical Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, China
    3 Department of Hematology Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, China
    4 Department of Radiation Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
    5 Department of Radiation Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, China
  • Received:2019-07-31 Revised:2020-01-10 Online:2020-04-08 Published:2020-05-26
  • Contact: Ren Hua
    Hou Lina and Dina Suolitiken are contributed equally to the artide E-mail:renhua2009@hotmail.com

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摘要：

目的 比较程序性死亡蛋白-1(PD-1)抑制剂单药治疗及联合化疗/靶向治疗晚期恶性肿瘤的疗效和安全性。方法 分析2017年1月至2018年8月在中国医学科学院协和医学院肿瘤医院深圳医院接受PD-1抑制剂治疗的52例晚期恶性肿瘤患者的临床资料。根据治疗方案的不同将患者分为单药治疗组(n=23)和联合治疗组(n=29),其中单药治疗组仅接受PD-1抑制剂单药治疗,联合治疗组接受PD-1抑制剂联合化疗/靶向治疗,比较两组患者的治疗疗效和不良反应。结果 52例患者中,38例根据影像学结果完成疗效评价,其中单药治疗组15例,联合治疗组23例。单药治疗组与联合治疗组总反应率分别为33.33%(5/15)和34.78%(8/23),差异无统计学意义(P=0.604)。单药治疗组与联合治疗组疾病控制率分别为80.00%(12/15)和73.91%(17/23),差异无统计学意义(P=0.490)。单药治疗组中位总生存期(OS)为6.0个月,联合治疗组中位OS为5.0个月,差异无统计学意义(χ 2=0.790,P=0.374);单药治疗组中位无进展生存期(PFS)为6.0个月,联合治疗组中位PFS为5.0个月,差异无统计学意义(χ 2=0.371,P=0.542)。单药治疗组腹痛腹泻的发生率[1~2级为8.7%(2/23);≥3级为0]比联合治疗组低[1~2级为27.59%(8/29),≥3级为6.90%(2/29);Z=2.211,P=0.027]。两组患者治疗期间骨髓抑制、恶心呕吐、皮疹、肝肾功能损害、治疗相关肺炎的发生率差异均无统计学意义(均P>0.05)。结论 对于晚期恶性肿瘤患者,无论单独使用还是联合使用PD-1抑制剂,OS及PFS均无明显差异,但单药治疗腹痛腹泻发生率低于联合治疗。

关键词: 免疫抑制剂, 抗肿瘤联合化疗方案, 治疗结果, 不良反应

Abstract:

Objective To compare the efficacy and safety of programmed death-1 (PD-1) inhibitors monotherapy and combined with chemotherapy/targeted therapy in the treatment of advanced malignant tumors. Methods The clinical data of 52 patients with advanced malignant tumors treated with PD-1 inhibitors from January 2017 to August 2018 in Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College were analyzed. All the patients were divided into monotherapy group (n=23) and combined therapy group (n=29) according to the therapeutic regimen. The monotherapy group received only PD-1 inhibitors and the combined therapy group received PD-1 inhibitors combined with chemotherapy/targeted therapy. The therapeutic effects and adverse reactions of the two groups were compared. Results Of the 52 patients, 38 were evaluated according to the imaging results, including 15 in the monotherapy group and 23 in the combined therapy group. The overall response rates of the monotherapy group and combined therapy group were 33.33% (5/15) and 34.78% (8/23) respectively, with no significant difference (P=0.604). The disease control rates of the monotherapy group and combined therapy group were 80.00% (12/15) and 73.91% (17/23), with no significant difference (P=0.490). The median overall survival (OS) of the monotherapy group was 6.0 months, and that of the combined therapy group was 5.0 months, with no significant difference (χ 2=0.790, P=0.374). The median progression-free survival (PFS) of the monotherapy group was 6.0 months, and that of the combined therapy group was 5.0 months, with no significant difference (χ 2=0.371, P=0.542). The incidence of abdominal pain and diarrhea was lower in the monotherapy group [grade 1-2: 8.7% (2/23), grade 3 and above: 0] than that in the combined therapy group [grade 1-2: 27.59% (8/29), grade 3 and above: 6.90% (2/29); Z=2.211, P=0.027]. There were no significant differences in the incidence of bone marrow suppression, nausea and vomiting, rash, liver and kidney function impairment or treatment-related pneumonia between the two groups (all P>0.05). Conclusion For patients with advanced malignant tumors, there is no significant difference in OS and PFS whether PD-1 inhibitors are taken separately or together, but the incidence of abdominal pain and diarrhea in patients treated with PD-1 inhibitors alone is lower than that in patients treated with combined therapy.

Key words: Immunosuppressive agents, Antineoplastic combined chemotherapy protocols, Treatment outcome, Adverse effects