卡瑞利珠单抗联合白蛋白紫杉醇二线治疗晚期食管鳞状细胞癌的疗效和安全性

摘要/Abstract

摘要：

目的评价卡瑞利珠单抗联合白蛋白紫杉醇二线治疗晚期食管鳞状细胞癌(ESCC)患者的疗效和安全性。方法研究对象为2019年5月12日至2020年8月20日皖西卫生职业学院附属医院肿瘤科收治的一线治疗失败的晚期或转移性ESCC患者72例,根据患者意愿分别给予卡瑞利珠单抗联合白蛋白紫杉醇(试验组,n=45)或二线化疗(多西他赛或伊立替康,对照组,n=27)。分析患者的客观缓解率(ORR)、疾病控制率(DCR)、不良事件发生率、总生存期(OS)、无进展生存期(PFS)。结果试验组和对照组ORR分别为26.7%(12/45)、7.4%(2/27),差异有统计学意义(χ²=3.996,P=0.046);DCR分别为48.9%(22/45)、29.6%(8/27),差异无统计学意义(χ²=2.575,P=0.109)。在不良事件方面,试验组患者耐受性更好,3级及以上不良事件发生率更低[28.9%(13/45)vs. 55.6%(15/27)],较对照组减少了48%,差异有统计学意义(χ²=5.049,P=0.025)。对照组有1例患者发生了与治疗相关的死亡。试验组中位OS为8.9个月(95%CI为7.9~9.8),对照组中位OS为6.5个月(95%CI为5.6~7.3),差异有统计学意义(χ²=5.068,P=0.024)。试验组中位PFS为2.2个月(95%CI为1.6~2.7),对照组中位PFS为1.8个月(95%CI为1.5~2.0),差异有统计学意义(χ²=4.799,P=0.028)。结论卡瑞利珠单抗联合白蛋白紫杉醇二线治疗晚期ESCC患者的疗效确切,安全性可耐受,可能成为晚期ESCC二线治疗的潜在方案。

关键词:食管肿瘤,卡瑞利珠单抗,治疗结果

Abstract:

ObjectiveTo evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel in second-line treatment of advanced esophageal squamous cell carcinoma (ESCC).MethodsSeventy-two patients with advanced or metastatic ESCC who had failed first-line treatment admitted to the Department of Oncology of the Affiliated Hospital of West Anhui Health Vocational College from May 12, 2019 to August 20, 2020 were enrolled. The patients were given camrelizumab combined with albumin paclitaxel (the experimental group,n=45) or second-line chemotherapy (docetaxel or irinotecan, the control group,n=27) according to patients' preference. Besides, the objective response rate (ORR), disease control rate (DCR), incidence of adverse events, overall survival (OS) and progress free survival (PFS) were assessed.ResultsThe ORR of the experimental group and the control group were 26.7% (12/45) and 7.4% (2/27) respectively, with a statistically significant difference (χ²=3.996,P=0.046). The DCR of the two groups were 48.9% (22/45) and 29.6% (8/27) respectively, with no statistically significant difference (χ²=2.575,P=0.109). In terms of adverse events, the experimental group was better tolerated, and the incidence of grade 3 or above adverse events was lower [28.9% (13/45)vs. 55.6% (15/27)], which was 48% lower than that of the control group, with a statistically significant difference (χ²=5.049,P=0.025). One patient in the control group had a treatment-related death. The median OS was 8.9 months (95%CI: 7.9-9.8) in the experimental group and 6.5 months (95%CI: 5.6-7.3) in the control group, with a statistically significant difference (χ²=5.068,P=0.024). The median PFS was 2.2 months (95%CI: 1.6-2.7) in the experimental group and 1.8 months (95%CI: 1.5-2.0) in the control group, with a statistically significant difference (χ²=4.799,P=0.028).ConclusionCamrelizumab combined with albumin paclitaxel in second-line treatment of advanced ESCC patients has proven efficacy and tolerable safety, which may be a potential second-line treatment for advanced ESCC.

Key words:Esophageal neoplasms,Camrelizumab,Treatment outcome

张玉萍, 吴德平. 卡瑞利珠单抗联合白蛋白紫杉醇二线治疗晚期食管鳞状细胞癌的疗效和安全性[J]. 国际肿瘤学杂志, 2021, 48(11): 649-654.

Zhang Yuping, Wu Deping. Efficacy and safety of camrelizumab combined with albumin paclitaxel as second-line therapy for advanced esophageal squamous cell carcinoma[J]. Journal of International Oncology, 2021, 48(11): 649-654.

图/表4

表1

72例晚期食管鳞状细胞癌患者一般情况比较[例(%)]"

一般情况	试验组(n=45)	对照组(n=27)	χ²值	P值
年龄(岁)
≥65	31(68.9)	19(70.4)	0.017	0.895
<65	14(31.1)	8(29.6)
性别
男	41(91.1)	25(92.6)	<0.001	>0.999
女	4(8.9)	2(7.4)
ECOG评分
0	7(15.6)	3(11.1)	0.031	0.860
1	38(84.4)	24(88.8)
疾病分期
局部晚期	5(11.1)	2(7.4)	0.011	0.918
远处转移	40(88.9)	25(92.5)
转移器官数
1	21(46.7)	11(40.7)	0.240	0.624
≥2	24(53.3)	16(59.3)
既往治疗
手术	9(20.0)	7(25.9)
放疗	21(46.7)	14(51.8)	-	-
化疗	42(93.3)	27(100)

表1

表2

72例晚期食管鳞状细胞癌患者不良事件发生情况[例(%)]"

不良事件		试验组(n=45)										对照组(n=27)
不良事件		1~2级		3级	4级		5级			≥3级		1~2级	3级		4级	5级	≥3级
脱发	3(6.7)		0(0)			0(0)		0(0)	0(0)		3(11.1)			0(0)	0(0)	0(0)	0(0)
白细胞减少	6(13.3)		1(2.2)			0(0)		0(0)	1(2.2)		10(37.0)			3(11.1)	0(0)	0(0)	3(11.1)
中性粒细胞减少	5(11.1)		0(0)			0(0)		0(0)	0(0)		8(29.6)			2(7.4)	1(3.7)	0(0)	3(11.1)
血小板减少	2(4.4)		0(0)			0(0)		0(0)	0(0)		3(11.1)			0(0)	0(0)	0(0)	0(0)
贫血	5(11.1)		1(2.2)			0(0)		0(0)	1(2.2)		10(37.0)			2(7.4)	0(0)	0(0)	2(7.4)
纳差	6(13.3)		0(0)			0(0)		0(0)	0(0)		7(25.9)			2(7.4)	0(0)	0(0)	2(7.4)
恶心/呕吐	6(13.3)		0(0)			0(0)		0(0)	0(0)		11(40.7)			1(3.7)	0(0)	0(0)	1(3.7)
腹泻	1(2.2)		2(4.4)			0(0)		0(0)	2(4.4)		8(29.6)			1(3.7)	0(0)	0(0)	1(3.7)
疲劳/乏力	10(26.7)		2(4.4)			0(0)		0(0)	2(4.4)		9(33.3)			2(7.4)	0(0)	0(0)	2(7.4)
发热	5(11.1)		0(0)			0(0)		0(0)	0(0)		3(11.1)			0(0)	0(0)	0(0)	0(0)
肺炎	2(4.4)		2(4.4)			0(0)		0(0)	2(4.4)		0(0)			0(0)	0(0)	0(0)	0(0)
甲状腺功能减退	9(20.0)		3(6.7)			0(0)		0(0)	3(6.7)		0(0)			0(0)	0(0)	0(0)	0(0)
反应性毛细血管增生症	31(68.9)		2(4.4)			0(0)		0(0)	2(4.4)		0(0)			0(0)	0(0)	0(0)	0(0)
死亡	0(0)		0(0)			0(0)		0(0)	0(0)		0(0)			0(0)	0(0)	1(3.7)	1(3.7)

表2

图1

图2

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