安罗替尼联合伊立替康三线治疗转移性食管癌的临床研究

摘要/Abstract

摘要：

目的探讨安罗替尼联合伊立替康三线治疗转移性食管癌的临床疗效及不良反应。方法选取2018年10月至2019年10月安徽省六安市中医院收治的,既往接受标准同步放化疗后发生远处转移,给予二线化疗失败的转移性食管癌患者52例,采用随机数字表法分为试验组和对照组,每组各26例。对照组给予伊立替康单药静脉化疗;试验组给予口服安罗替尼联合伊立替康静脉化疗。治疗2周期后评价两组患者的临床疗效及不良反应发生情况。结果治疗前,试验组和对照组Karnofsky功能状态(KPS)评分差异无统计学意义(76.15±7.52vs.74.62±8.59,t=-0.137,P=0.892);治疗后两组差异亦无统计学意义(70.77±6.28vs.72.69±8.74,t=-1.761,P=0.084);但试验组治疗后KPS评分较治疗前有所下降(t=3.035,P=0.006);对照组治疗前后KPS评分差异无统计学意义(t=1.000,P=0.327)。两组患者不良反应主要为1~2级,试验组1~2级骨髓抑制和腹泻发生率分别为61.5%(16/26)、46.2%(12/26),明显高于对照组的19.2%(5/26)、19.2%(5/26),差异均有统计学意义(χ²=9.665,P=0.002;χ²=4.282,P=0.039)。试验组疾病控制率为73.1%(19/26),明显高于对照组的46.2%(12/26),两组差异有统计学意义(χ²=3.914,P=0.048);试验组和对照组患者中位无进展生存期分别为52 d和45 d,差异具有统计学意义(χ²=4.692,P=0.032)。结论安罗替尼联合伊立替康三线治疗转移性食管癌疗效明显,但一定程度增加了1~2级骨髓抑制、腹泻不良反应发生率,且KPS评分较治疗前有所下降。

关键词:食管肿瘤,安罗替尼,伊立替康

Abstract:

ObjectiveTo investigate the clinical efficacy and adverse reactions of anlotinib combined with irinotecan in the third line treatment of metastatic esophageal cancer.MethodsFrom October 2018 to October 2019, 52 patients with metastatic esophageal cancer who had developed distant metastasis after receiving standard concurrent chemoradiotherapy and failed second-line chemotherapy were selected from Lu'an Hospital of Traditional Chinese Medicine of Anhui Province. The patients were divided into experimental group and control group by random number table method, with 26 cases in each group. The control group was given intravenous chemotherapy with irinotecan. The experimental group was treated with oral erlotinib combined with intravenous chemotherapy of irinotecan. The clinical efficacy and adverse reactions of the two groups were evaluated after 2 cycles of treatment.ResultsBefore treatment, there was no significant difference in Karnofsky performance status (KPS) score between the experimental group and the control group (76.15±7.52vs.74.62±8.59, t=-0.137, P=0.892). After treatment, there was no significant difference between the two groups (70.77±6.28vs.72.69±8.74,t=-1.761,P=0.084). However, after treatment, the KPS score in the experimental group was lower than that before treatment (t=3.035,P=0.006). There was no statistical significance in the KPS scores of the control group before and after treatment (t=1.000,P=0.327). Adverse reactions in the two groups were mainly grade 1-2. The incidences of grade 1-2 myelosuppression and diarrhea in the experimental group were 61.5% (16/26) and 46.2% (12/26), which were significantly higher than those in the control group (19.2%, 5/26 and 19.2%, 5/26), with statistically significant differences (χ²=9.665,P=0.002;χ²=4.282,P=0.039). The disease control rate of the experimental group was 73.1% (19/26), which was significantly higher than that of the control group (46.2%, 12/26), and there was a statistically significant difference between the two groups (χ²=3.914,P=0.048). The median progression-free survival of the experimental group and the control group was 52 days and 45 days, respectively, and there was a statistically significant difference (χ²=4.692,P=0.032).ConclusionAnlotinib combined with irinotecan in the third-line treatment of metastatic esophageal cancer has obvious efficacy, but to a certain extent, it increases the incidence of grade 1-2 myelosuppression and diarrhea, and the KPS score is lower compared with before treatment.

Key words:Esophageal neoplasms,Anlotinib,Irinotecan

赵慧娟, 丁美钱, 陈文婷. 安罗替尼联合伊立替康三线治疗转移性食管癌的临床研究[J]. 国际肿瘤学杂志, 2021, 48(8): 479-483.

Zhao Huijuan, Ding Meiqian, Chen Wenting. Clinical study of anlotinib combined with irinotecan in the third line treatment of metastatic esophageal cancer[J]. Journal of International Oncology, 2021, 48(8): 479-483.

图/表4

临床特征	试验组 (n=26)	对照组 (n=26)	t/χ²值	P值
年龄(岁)	55.68±11.76	53.72±9.81	0.723	0.417
性别
男	20	22	0.495	0.482
女	6	4
初始KPS评分(分)
60~70	10	12	0.315	0.575
80~90	16	14
既往化疗方案
氟尿嘧啶+铂类	18	14
卡培他滨+铂类	8	12	1.300	0.522
紫杉醇+铂类	26	26

表1

组别	治疗前	治疗后	t值	P值
试验组(n=26)	76.15±7.52	70.77±6.28	3.035	0.006
对照组(n=26)	74.62±8.59	72.69±8.74	1.000	0.327
t值	-0.137	-1.761
P值	0.892	0.084

表2

表3

两组晚期转移性食管癌患者不良反应比较[例(%)]"

不良反应	试验组(n=26)			对照组(n=26)			Z值	P值
不良反应	0级	1~2级	3~4级	0级	1~2级	3~4级	Z值	P值
骨髓抑制	8(30.8)	16(61.5)	2(7.7)	21(80.8)	5(19.2)	0(0)	-3.651	<0.001
肝功能损伤	21(80.8)	5(19.2)	0(0)	23(88.5)	3(11.5)	0(0)	-0.761	0.446
蛋白尿	16(61.5)	9(34.6)	1(3.8)	17(65.4)	9(34.6)	0(0)	-0.382	0.703
腹泻	12(46.2)	12(46.2)	2(7.7)	21(80.8)	5(19.2)	0(0)	-2.650	0.008
甲状腺功能异常	16(61.5)	8(30.8)	2(7.7)	18(69.2)	7(26.9)	1(3.8)	-0.636	0.525
高血压	13(50.0)	11(42.3)	2(7.7)	14(53.8)	11(42.3)	1(3.8)	-0.382	0.702
消化道出血	24(92.3)	2(7.7)	0(0)	26(100)	0(0)	0(0)	-1.428	0.153
口咽黏膜反应	18(69.2)	8(30.8)	0(0)	17(65.4)	9(34.6)	0(0)	-0.293	0.770
手足综合征	13(50.0)	13(50.0)	0(0)	13(50.0)	12(46.2)	1(3.8)	-0.136	0.892
甘油三酯升高	14(53.8)	11(42.3)	1(3.8)	15(57.7)	10(38.5)	1(3.8)	-0.262	0.793
胆固醇升高	21(80.8)	5(19.2)	0(0)	20(76.9)	6(21.2)	0(0)	-0.336	0.737

表3

图1

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