福沙匹坦预防儿童肿瘤患者高致吐化疗药物相关恶心呕吐有效性和安全性评估

doi:10.12372/jcp.2023.22e0483

Abstract

Abstract:

Objective To investigate the clinical efficacy and safety of fosaprepitant in preventing nausea and vomiting caused by highly emetogenic chemotherapy (HEC) in children with cancer. Methods Pediatric cancer patients who received fosaprepitant to manage HEC-induced nausea and vomiting in the Department of Hematology and Oncology of Shanghai Children's Medical Center between July 2021 and November 2021 were enrolled into this study. The patients treated with fosaprepitant+ondansetron+dexamethasone were included in the fosaprepitant group, and the patients treated with ondansetron+dexamethasone were included in the control group. The clinical efficacy was evaluated by the difference of complete response (CCR, no vomiting/rescue medication) of acute, delayed and overall phase vomiting between the two groups. The safety assessment was carried out using the Common Terminology Criteria for Adverse Events v4.0 (National Cancer Institute). Results 107 patients were enrolled in this study (55 in the fosaprepitant group and 52 in the control group). There were 51 males and 56 females, with a median age of 3.5 (1.42-7.33) years. CCR rates were higher in the fosaprepitant group comparing that in the control group during the acute, delayed vomiting and overall phases, a lower proportion of children with mild and moderate vomiting, and no children with severe vomiting. Adverse reactions occurred in 25 cases (45.5%) in the fosaprepitant group, with a lower incidence rate than that in the control group (34 cases, 65.4%), and the difference was statistically significant (P<0.05). No severe adverse event was observed in this study. The difference in the incidence of headache, anorexia, malaise and other adverse reactions between the two groups of children was not statistically significant (P>0.05). Conclusion Fosaprepitant combined with ondansetron and dexamethasone is effective and safe in preventing related nausea and vomiting in children with cancer.

Key words: NK-1 receptor antagonist, fosaprepitant, highly emetogenic chemotherapy drugs, security, effectiveness

YU Liting, SHEN Xingwei, WANG Zhuo, ZHANG Shunguo, GAO Yijin. Efficacy and safety of fosaprepitant in the prevention of highly emetogenic chemotherapy-related nausea and vomiting in pediatric patients with cancer[J].Journal of Clinical Pediatrics, 2023, 41(8): 604-609.

Figures/Tables 4

References 23

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项目	福沙匹坦组(n=55)	对照组(n=52)	统计量	P
年龄[M(P₂₅~P₇₅)]/岁	3.3(1.4~4.9)	3.8(1.8~7.8)	Z =1.09	0.278
男性[n(%)]	30(54.5)	21(40.4)	χ²=2.15	0.143
体重[M(P₂₅~P₇₅)]/kg	13.3(10.7~18.2)	15.3(11.4~21.2)	Z =0.33	0.739
接受过化疗[n(%)]	46(83.6)	44(84.6)	χ²=0.02	0.896
诊断[n(%)]			-	0.509¹⁾
神经母细胞瘤	16(29.1)	10(19.2)
肝母细胞瘤	10(18.2)	7(13.5)
髓母细胞瘤	4(7.3)	1(1.9)
横纹肌肉瘤	11(20.0)	12(23.1)
尤文氏肉瘤	5(9.1)	9(17.3)
肾上腺皮质癌	2(3.6)	0(0.0)
淋巴母细胞瘤	3(5.5)	5(9.6)
生殖细胞瘤	1(1.8)	2(3.9)
肾母细胞瘤	0(0.0)	1(1.9)
肺母细胞瘤	3(5.5)	4(7.7)
急性淋巴细胞性白血病	0(0.0)	1(1.9)

呕吐类型	福沙匹坦组(n=55)	对照组(n=52)	Z值	P
急性呕吐
无呕吐(CR)	53(96.4)	37(71.2)	12.70	<0.001
轻度	2(3.6)	12(23.1 )
中度	0(0.0)	3(5.8)
严重	0(0.0)	0(0.0)
延迟性呕吐
无呕吐(CR)	44(80.0)	32(61.5)	4.42	0.035
轻度	10(18.2)	14(26.9)
中度	1(1.8)	4(7.7)
严重	0(0.0)	2(3.8)
整体呕吐
无呕吐(CR)	42(76.4)	17(32.7)	20.60	<0.001
轻度	12(21.8)	26(50.0)
中度	1(1.8)	7(13.5)
严重	0(0.0)	2(3.9)

不良反应	福沙匹坦组(n=55)	对照组(n=52)	χ²值	P
头晕	1(1.8)	1(1.9)	-	1.000¹⁾
发热	2(3.6)	6(11.5)	-	0.154¹⁾
厌食	21(38.2)	15(28.8)	1.04	0.307
腹部不适	1(1.8)	2(3.8)	-	0.611¹⁾
咳嗽	4(7.3)	5(9.6)	-	0.737¹⁾
腹泻	4(7.3)	2(3.8)	-	0.679¹⁾
便秘	5(9.1)	5(9.6)	-	1.000¹⁾
中性粒细胞减少1、2级	18(32.7)	18(34.6)	0.04	0.836
中性粒细胞减少3、4级	5(9.1)	7(13.5)	0.51	0.474
WBC减少1、2级	23(41.8)	24(46.2)	0.41	0.520
WBC减少3、4级	8(14.5)	10(19.2)	0.20	0.652
血小板减少	1(1.8)	4(7.7)	-	0.197¹⁾
乏力	6(10.9)	2(3.8)	-	0.272¹⁾
恶心	3(5.5)	10(19.2)	3.55	0.067
牙痛	1(1.8)	0(0.0)	-	1.000¹⁾
喉咙痛	1(1.8)	0(0.0)	-	1.000¹⁾
烦躁	1(1.8)	0(0.0)	-	1.000¹⁾

Efficacy and safety of fosaprepitant in the prevention of highly emetogenic chemotherapy-related nausea and vomiting in pediatric patients with cancer

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