国际肿瘤学杂志

国际肿瘤学杂志 ›› 2022, Vol. 49 ›› Issue (5): 276-281.doi: 10.3760/cma.j.cn371439-20220111-00051

• 论著 • 上一篇    下一篇

卡瑞利珠单抗联合阿帕替尼及化疗二线或以上治疗HER-2阴性晚期胃癌的临床疗效及安全性

唐琳1, 相明月2, 张建波3, 王丽丽4, 巩合义2, 韩大力2()   

  1. 1山东第一医科大学（山东省医学科学院）研究生院,山东第一医科大学附属肿瘤医院肿瘤内科,济南 250117
    2山东第一医科大学附属肿瘤医院放疗科,济南 250117
    3山东第一医科大学附属肿瘤医院病理科,济南 250117
    4山东第一医科大学附属肿瘤医院介入科,济南 250117
  • 收稿日期:2022-01-11 修回日期:2022-03-10 出版日期:2022-05-08 发布日期:2022-05-31
  • 通讯作者: 韩大力,孔春燕 E-mail:dalihan_sdch@163.com

Clinical efficacy and safety of camrelizumab combined with apatinib and chemotherapy as second-line or later therapy in the treatment of HER-2 negative advanced gastric cancer

Tang Lin1, Xiang Mingyue2, Zhang Jianbo3, Wang Lili4, Gong Heyi2, Han Dali2()   

  1. 1School of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences; Department of Oncology, Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan 250117, China
    2Department of Radiation Oncology, Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan 250117, China
    3Department of Pathology, Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan 250117, China
    4Department of Intervention Therapy, Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan 250117, China
  • Received:2022-01-11 Revised:2022-03-10 Online:2022-05-08 Published:2022-05-31
  • Contact: Han Dali E-mail:dalihan_sdch@163.com

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摘要：

目的 探讨卡瑞利珠单抗联合阿帕替尼及化疗二线或以上治疗人表皮生长因子受体-2（HER-2）阴性晚期胃癌的疗效及安全性。方法 选取2018年3月至2021年9月山东第一医科大学附属肿瘤医院收治的一线治疗失败的HER-2阴性晚期胃癌患者66例,根据治疗方案不同将患者分为研究组（n=22例）和对照组（n=44例）,研究组采用卡瑞利珠单抗联合阿帕替尼及化疗方案治疗,对照组采用单纯化疗治疗。比较两组患者近期疗效、无进展生存期（PFS）、总生存期（OS）和不良反应发生情况,Cox回归分析患者预后的影响因素。结果 治疗至少2~4个周期后,研究组和对照组患者的客观缓解率（ORR）分别为9.1%（2/22）、0（0/44）,差异无统计学意义（P=0.108）;DCR分别为77.3%（17/22）、45.5%（20/44）,差异有统计学意义（χ2=6.03,P=0.014）。研究组患者未达到中位OS,对照组患者中位OS为11.7个月,差异无统计学意义（χ2=1.59,P=0.207）;研究组患者未达到中位PFS,对照组患者中位PFS为3.2个月,差异有统计学意义（χ2=10.13,P=0.001）。多因素Cox回归分析结果显示,治疗方法是HER-2阴性晚期胃癌患者PFS的独立影响因素（HR=0.33,95%CI为0.15~0.75,P=0.008）。在不良反应方面,研究组与对照组患者谷丙转氨酶升高发生率差异有统计学意义[31.8%（7/22） vs. 6.8%（3/44）,χ2=5.32,P=0.021]。两组患者均无不良反应相关的死亡。结论 与单纯化疗比较,卡瑞利珠单抗联合阿帕替尼及化疗二线或以上治疗HER-2阴性晚期胃癌,可延长患者PFS,提高DCR,但谷丙转氨酶升高发生率显著增加。

关键词: 胃肿瘤, 药物疗法,联合, 卡瑞利珠单抗, 阿帕替尼

Abstract:

Objective To explore the clinical efficacy and safety of the camrelizumab combined with apatinib and chemotherapy as second-line or later therapy in human epidermal growth factor receptor-2 （HER-2） negative advanced gastric cancer. Methods A total of 66 patients with HER-2 negative advanced gastric cancer and first-line treatment failure in Shandong Cancer Hospital Affiliated to Shandong First Medical University from March 2018 to September 2021 were selected. They were divided into study group （n=22） and control group （n=44） according to the different treatment regimens. The patients in the study group were treated with camrelizumab combined with apatinib and chemotherapy, and the patients in the control group were treated with chemotherapy alone. The short-term efficacy, progression-free survival （PFS）, overall survival （OS） and the occurrence of adverse reactions were compared, and Cox regression analysis was used to analyze the influencing factors of prognosis. Results After at least 2-4 cycles of treatment, the ORR in the study group and the control group were 9.1% （2/22） and 0 （0/44） respectively, with no statistically significant difference （P=0.108）. DCR in the two groups were 77.3% （17/22） and 45.5% （20/44） respectively, with a statistically significant difference （χ2=6.03, P=0.014）. The study group didn’t reach median OS and the median OS in the control group was 11.7 months, with no statistically significant difference （χ2=1.59, P=0.207）. The study group didn’t reach median PFS and the median PFS in the control group was 3.2 months, with a statistically significant difference （χ2=10.13, P=0.001）. Multivariate Cox regression analysis showed that treatment method was an independent influencing factor for PFS in patients with HER-2 negative advanced gastric cancer （HR=0.33, 95%CI： 0.15-0.75, P=0.008）. In terms of adverse reactions, there was a statistically significant difference in the incidence of elevated alanine aminotransferase between the study group and the control group [31.8% （7/22） vs. 6.8% （3/44）, χ2=5.32, P=0.021]. There were no adverse-related deaths in both groups. Conclusion Compared with chemotherapy alone, camrelizumab combined with apatinib and chemotherapy as a second-line or later therapy in HER-2 negative advanced gastric cancer can prolong PFS and improve DCR, but the incidence of elevated alanine aminotransferase increases significantly.

Key words: Stomach neoplasms, Drug therapy,combination, Camrelizumab, Apatinib