Efficacy and safety of camrelizumab combined with albumin paclitaxel as second-line therapy for advanced esophageal squamous cell carcinoma

doi:10.3760/cma.j.cn371439-20210409-00129

Abstract

Abstract:

Objective To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel in second-line treatment of advanced esophageal squamous cell carcinoma (ESCC). Methods Seventy-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. Results The 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 (χ ²=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 (χ ²=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 (χ ²=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 (χ ²=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 (χ ²=4.799, P=0.028). Conclusion Camrelizumab 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

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.

Figures/Tables 4

References 17

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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)

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)