甲磺酸阿帕替尼治疗转移性肾癌的临床观察

摘要/Abstract

摘要：

目的评估甲磺酸阿帕替尼治疗转移性肾癌的有效性及安全性。方法收集2018年10月至2020年4月,湖北省十堰市人民医院、太和医院、国药东风总医院肿瘤科收治的接受甲磺酸阿帕替尼治疗(500 mg/次,1次/d)的转移性肾癌患者32例,主要研究终点是无进展生存期(PFS),次要研究终点是客观缓解率(ORR)、疾病控制率(DCR)及安全性,采用Cox回归进行PFS多因素分析。结果中位随访时间6.5(2~10)个月,32例患者均可进行疗效评估。疗效评价完全缓解0例,部分缓解14例(43.75%),疾病稳定10例(31.25%),疾病进展8例(25.00%),ORR 43.75%(14/32),DCR 75.00%(24/32)。患者的PFS与性别、年龄、病理类型和既往手术无显著相关性(均P>0.05),与转移部位显著相关(HR=0.032,95%CI为0.003~0.411,P=0.008)。所有患者中位PFS为9.5个月(8.3~10.7个月),其中肺转移(n=21)和其他部位转移患者(n=11)的中位PFS差异有统计学意义(9.5个月vs.6.2个月,χ²=14.812,P<0.001)。不良反应主要为高血压(37.50%,12/32)、手足综合征(31.25%,10/32)、蛋白尿(18.75%,6/32)、中性粒细胞减少症(25.00%,8/32)、贫血(28.13%,9/32)、血小板减少症(18.75%,6/32)、恶心/呕吐(15.63%,5/32)、转氨酶升高(15.63%,5/32),多数为1级或2级,3级不良反应发生率为28.13%(9/32),无4级不良反应,经过减量及对症治疗后,症状均可控制。结论甲磺酸阿帕替尼能够有效延长转移性肾癌患者的PFS,且具有良好的安全性,可作为转移性肾癌的治疗选择。

关键词:肾肿瘤,甲磺酸盐类,治疗结果

Abstract:

ObjectiveTo assess the efficacy and safety of apatinib mesylate in the treatment of metastatic renal carcinoma.MethodsBetween October 2018 and April 2020, 32 patients with metastatic renal carcinoma were enrolled in the Department of Oncology of Shiyan People's Hospital of Hubei Province, Taihe Hospital and Sinopharm Dongfeng General Hospital. Apatinib mesylate was administered at an initial dose of 500 mg once daily. The main research end point was progression-free survival (PFS), secondary study destination included objective response rate (ORR), disease control rate (DCR) and safety. Multivariate analysis of PFS was carried out by Cox regression.ResultsThe median follow-up time was 6.5 months (from 2 to 10). All 32 patients could be evaluated for efficacy. Efficacy evaluation showed 0 cases of complete remission, 14 cases (43.75%) of partial remission, 10 cases (31.25%) of stable disease, 8 cases (25.00%) of progressive disease, the ORR was 43.75% (14/32), and DCR was 75.00% (24/32). The PFS of patients had no significant correlation with gender, age, pathological type and previous surgery (allP>0.05), but was significantly correlated with the site of metastasis (HR=0.032, 95%CI: 0.003-0.411,P=0.008). The median PFS for all patients was 9.5 months (8.3-10.7 months), and there was a significant difference in the median PFS between patients with lung metastasis (n=21) and those with other sites (n=11) (9.5 monthsvs. 6.2 months,χ²=14.812,P<0.001). The main adverse reactions were hypertension (37.50%, 12/32), hand-foot syndrome (31.25%, 10/32), proteinuria (18.75%, 6/32), neutropenia (25.00%, 8/32), anemia (28.13%, 9/32), thrombocytopenia (18.75%, 6/32), nausea/vomiting (15.63%, 5/32) and elevated transaminase (15.63%, 5/32), most of which were grade 1 or 2. The incidence of grade 3 adverse reactions was 28.13% (9/32), without grade 4 adverse reactions. After dosage reduction and symptomatic treatment, the symptoms could be controlled.ConclusionApatinib mesylate can effectively prolong PFS in metastatic renal carcinoma patients with good safety, and can be used as a treatment option for metastatic renal carcinoma.

Key words:Kidney neoplasms,Mesylates,Treatment outcome

吴光, 俞远东, 陈萍. 甲磺酸阿帕替尼治疗转移性肾癌的临床观察[J]. 国际肿瘤学杂志, 2021, 48(11): 655-659.

Wu Guang, Yu Yuandong, Chen Ping. Clinical observation of apatinib mesylate in the treatment of metastatic renal carcinoma[J]. Journal of International Oncology, 2021, 48(11): 655-659.

图/表4

变量	HR值	95%CI	P值
性别(女/男)	0.876	0.089~8.590	0.910
年龄(≤60岁/>60岁)	2.839	0.526~15.324	0.225
病理类型(透明细胞癌/ 非透明细胞癌)	0.271	0.019~3.963	0.340
转移部位(肺/其他部位)	0.032	0.003~0.411	0.008
治疗前手术切除(是/否)	1.526	0.243~9.605	0.652

表1

图1

图2

不良反应	1级	2级	3级	4级	合计
高血压	7(21.88)	3(9.38)	2(6.25)	0(0)	12(37.50)
手足综合征	6(18.75)	3(9.38)	1(3.13)	0(0)	10(31.25)
蛋白尿	4(12.50)	2(6.25)	0(0)	0(0)	6(18.75)
中性粒细胞减少症	4(12.50)	2(6.25)	2(6.25)	0(0)	8(25.00)
贫血	5(15.63)	3(9.38)	1(3.13)	0(0)	9(28.13)
血小板减少症	4(12.50)	1(3.13)	1(3.13)	0(0)	6(18.75)
恶心/呕吐	2(6.25)	1(3.13)	2(6.25)	0(0)	5(15.63)
转氨酶升高	3(9.38)	2(6.25)	0(0)	0(0)	5(15.63)

表2

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