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

doi:10.3877/cma.j.issn.1674-6880.2021.02.006

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。

关键词: 子宫内膜肿瘤, 宫颈肿瘤, 卡瑞利珠单抗, 免疫治疗

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.

Key words: Endometrial neoplasms, Uterine crvical neoplasms, Camrelizumab, Immunotherapy

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

自变量		例数	赋值方法
年龄
	≤ 60岁	22	否= 0
	>60岁	9	是=1
ECOG评分
	0分	23	否= 0
	1分	8	是=1
复发与末次治疗间隔时间
	≤ 6个月	22	否= 0
	>6个月	9	是=1
联合放射治疗
	否	26	否= 0
	是	5	是=1
联合化学治疗
	否	11	否= 0
	是	20	是= 1
联合靶向治疗
	否	18	否= 0
	是	13	是= 1

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

自变量		例数	赋值方法
年龄
	≤ 60岁	22	否= 0
	>60岁	9	是=1
ECOG评分
	0分	23	否= 0
	1分	8	是=1
复发与末次治疗间隔时间
	≤ 6个月	22	否= 0
	>6个月	9	是=1
联合放射治疗
	否	26	否= 0
	是	5	是=1
联合化学治疗
	否	11	否= 0
	是	20	是= 1
联合靶向治疗
	否	18	否= 0
	是	13	是= 1

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

变量	回归系数	标准误	Wald值	P值	RR值	95%CI
年龄> 60岁	-1.718	1.052	2.667	0.102	0.179	0.023 ~ 1.411
ECOG评分1分	-0.186	0.700	0.071	0.790	0.830	0.211 ~ 3.271
复发与末次治疗间隔时间> 6个月	-0.349	0.681	0.262	0.609	0.705	0.186 ~ 2.681
联合放射治疗	-0.857	1.050	0.666	0.414	0.424	0.054 ~ 3.324
联合化学治疗	-0.088	0.628	0.020	0.888	0.916	0.267 ~ 3.135
联合靶向治疗	0.016	0.615	0.001	0.979	1.016	0.304 ~ 3.392

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

变量	回归系数	标准误	Wald值	P值	RR值	95%CI
年龄> 60岁	-1.718	1.052	2.667	0.102	0.179	0.023 ~ 1.411
ECOG评分1分	-0.186	0.700	0.071	0.790	0.830	0.211 ~ 3.271
复发与末次治疗间隔时间> 6个月	-0.349	0.681	0.262	0.609	0.705	0.186 ~ 2.681
联合放射治疗	-0.857	1.050	0.666	0.414	0.424	0.054 ~ 3.324
联合化学治疗	-0.088	0.628	0.020	0.888	0.916	0.267 ~ 3.135
联合靶向治疗	0.016	0.615	0.001	0.979	1.016	0.304 ~ 3.392

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

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