摘要
目的比较依维莫司与阿昔替尼二线治疗转移性肾细胞癌(metastatic renal cell carcinoma,mRCC)的临床疗效及不良反应。方法回顾性分析2008年5月至2018年10月复旦大学附属中山医院收治的44例一线靶向药物(舒尼替尼)治疗后疾病进展(或不耐受)的mRCC患者的临床资料。所有患者均有病理诊断,其中透明细胞癌34例,非透明细胞癌10例。根据二线治疗方案,将患者分成依维莫司组(依维莫司10 mg,qd,n=25)及阿昔替尼组(阿昔替尼5 mg,bid,n=19)。比较两组的疗效和药物不良反应。结果两组一般资料比较差异无统计学意义。最长随访时间为40.0个月,中位随访时间为7.5个月。依维莫司组无进展生存时间(progression-free survival,PFS)为2.0~40.0个月,中位PFS为7.0个月;阿昔替尼组PFS为2.0~11.0个月,中位PFS为4.4个月,差异有统计学意义(P=0.032)。依维莫司组总生存时间(overall survival,OS)为2.0~40.0个月,中位OS为9.0个月;阿昔替尼组OS为2.0~11.0个月,中位OS为5.6个月,差异有统计学意义(P=0.029)。客观反应率(objective response rate,ORR):依维莫司组12.0%(3/25),阿昔替尼组15.7%(3/19),差异无统计学意义(P=0.717)。疾病控制率(disease control rate,DCR):依维莫司组88.0%(22/25),阿昔替尼组78.9%(15/19),差异无统计学意义(P=0.416)。依维莫司组常见不良反应为口腔炎及乏力,3/4级不良反应有3例(肺炎及贫血各1例,暴发性肝炎1例);阿昔替尼组常见不良反应为腹泻及肝功能损害,3/4级不良反应有1例(慢性肾功能不全),差异无统计学意义(P=0.721)。结论依维莫司治疗mRCC在疗效上优于阿昔替尼,不良反应上两者相当,故在二线治疗mRCC上依维莫司比阿昔替尼有优势。
Objective To compare the clinical efficacy and adverse reaction between Everolimus and Axitinib as the second-line treatment of metastatic renal cell carcinoma(mRCC). Methods From May2008 to Oct. 2018,44 consecutive mRCC patients were retrospectively analyzed who had disease progression(or drug intolerance)after the first-line targeted therapy(Sunitinib)in Zhongshan Hospital,Fudan University. All patients’ diagnoses were confirmed by pathology,including 34 cases of clear cell carcinoma and 10 cases of non-clear cell carcinoma. According to the different second-line treatment,the patients were divided into Everolimus group(Everolimus 10 mg,qd,n=25)and Axitinib group(Axitinib 5 mg,bid,n=19). The clinical efficacy and adverse reaction were compared. Results There was no statistical difference in general data between the two groups.The longest follow-up time was 40.0 months,the median follow-up time was 7.5 months.The progression-free survival(PFS)was 2.0-40.0 months in Everolimus group with the median PFS of 7.0 months. The PFS was 2.0-11.0 months in Axitinib group with the median PFS of 4.4 months(P=0.032). The overall survival(OS) was 2.0-40.0 months in Everolimus group with the median OS of 9.0 months.The OS was 2.0-11.0 months in Axitinib group with the median OS of 5.6 months(P=0.029). The objective response rate(ORR) was 12.0%(3/25) in Everolimus group,while 15.7%(3/19)in Axitinib group(P=0.717). The disease control rate(DCR)in Everolimus group was 88.0%(22/25),while 78.9%(15/19)in Axitinib group(P=0.416).The infrequent adverse reactions of Everolimus were stomatitis and fatigue,and there were 3 cases of 3/4 adverse reactions(1 case of pneumonia,1 case of anemia and 1 case of fulminant hepatic failure).The infrequent adverse reactions of Axitinib were diarrhea and liver function damage,and there was 1 case of 3/4 adverse reactions(chronic renal insufficiency)(P=0.721). Conclusions The clinical efficacy of Everolimus was better than Axitinib.The adverse reactions of Axitinib was similar with Everolimus.Everol
作者
赖鹏
胡骁轶
郭剑明
LAI Peng;HU Xiao-yi;GUO Jian-ming(Department of Urology,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Urology,Xiamen Branch,Zhongshan Hospital,Fudan University,Xiamen 361000,Fujian Province,China)
出处
《复旦学报（医学版）》
CAS
CSCD
北大核心
2020年第1期37-41,共5页
Fudan University Journal of Medical Sciences
基金
复旦大学附属中山医院厦门医院孵化项目(2018ZSXMWK10)~~
