阿帕替尼片治疗晚期实体瘤患者的临床研究  

Clinical trial of apatinib tablets in the treatment of advanced solid tumors

作　　者：黄莹莹[1] 郑子恢[2] 张帅[1] 胡雪晴[1] 朱捷[3] 杜俊[4] HUANG Ying-ying;ZHENG Zi-hui;ZHANG Shuai;HU Xue-qing;ZHU Jie;DU Jun(Department of Internal Oncology;Department of Pharmacy,Beijing Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Radiology,Beijing Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Pathology,Beijing Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院/国家老年医学中心肿瘤内科,北京100730 [2]北京医院/国家老年医学中心药学部,北京100730 [3]北京医院/国家老年医学中心放射科,北京100730 [4]北京医院/国家老年医学中心病理科,北京100730

出　　处：《中国临床药理学杂志》2021年第12期1498-1500,共3页The Chinese Journal of Clinical Pharmacology

基　　金：中国临床肿瘤学会基金资助项目(Y-HR2016-050)。

摘　　要：目的研究阿帕替尼片治疗晚期实体瘤的有效性和安全性。方法将42例晚期实体瘤患者,至少经过标准二线治疗进展后接受阿帕替尼治疗,按使用剂量分为高剂量组(500850 mg·d^(-1))9例和低剂量组(125250 mg·d^(-1))33例。比较2组治疗1个月时的客观缓解率(ORR)、无疾病进展期(PFS)和总生存期(OS)。结果高剂量组有2例在用药后1个月内死亡。低剂量组和高剂量组的ORR分别为27.27%(9例/33例)和14.29%(1例/7例),DCR分别为87.88%(29例/33例)和100.00%(7例/7例),差异均无统计学意义(均P>0.05)。低剂量组和高剂量组的PFS分别为5.0(3.46.6)和5.0(010.8)个月,OS分别为19.0(11.926.1)和17.0(040.4)个月,差异均无统计学意义(均P>0.05)。低剂量组和高剂量组的手足综合征发生率分别为69.69%和100.00%,声嘶分别为54.55%和88.89%,高血压分别为54.55%和77.78%,皮肤色素减退分别为45.46%和55.56%,蛋白尿分别为33.33%和88.89%。结论低剂量组和高剂量组相比生存获益相当,低剂量组的ORR较高剂量组升高,而且在低剂量组患者耐受性更好。Objective To investigate the clinical efficacy and safety of apatinib in the treatment of advanced malignant tumors.Methods Forty-two patients with advanced solid tumor were treated with apatinib after2 lines standard treatment.According to the dose,they were divided into high-dose group(500-850 mg,n=9)and low-dose group(125-250 mg,n=33).The objective response rate(ORR)in one month,progression-free survival(PFS)and overall survival(OS)were compared between two groups.Results In the high-dose group,2cases died within 1 month after administration.The ORR of low-dose and high-dose groups were 27.27%(9 cases/33 cases)and 14.29%(1 case/7 cases),the DCR were 87.88%(29 cases/33 cases)and100.00%(7 cases/7 cases),the differences were statistically significant(all P>0.05).The PFS of low-dose and high-dose groups were 5.0(3.4-6.6)and 5.0(0-10.8)months,the OS were 19.0(11.9-26.1)and 17.0(0-40.4)months,the differences were statistically significant(all P>0.05).The incidences of hand-foot syndrome in low-dose and high-dose groups were 69.69%and100.00%,the incidences of hoarseness were 54.55%and 88.89%,the incidences of hypopigmentation were 54.55%and 77.78%,the incidences of skin hypopigmentation were 45.46%and 55.56%,the incidences of proteinuria were 33.33%and 88.89%,respectively.Conclusin Although no significant survival benefits between the low-dose group and high-dose group,the patients in the low-dose group achieved more objective response and less adverse event than that in high-dose group.

关 键 词：阿帕替尼片 有效性 安全性 实体瘤 低剂量 

分 类 号：R979.1[医药卫生—药品]