舒尼替尼治疗伊马替尼耐药的胃肠间质瘤初步分析  

Preliminary Research on Sunitinib for Patients with Gastrointestinal Stromal Tumor after Imatinib Treatment Failure

作　　者：刘星[1] 池畔[1] 卢辉山[2] 官国先[1] 蒋伟忠[1] 陈致奋[1] 

机构地区：[1]福建医科大学附属协和医院结直肠外科,福州350001 [2]福建医科大学附属协和医院胃外科,福州350001

出　　处：《福建医科大学学报》2012年第4期272-276,共5页Journal of Fujian Medical University

基　　金：福建省卫生厅青年科研课题(2011-02-09)

摘　　要：目的探讨舒尼替尼治疗伊马替尼耐药的胃肠间质瘤(GIST)的疗效及安全性。方法以27例对伊马替尼耐药的GIST患者为研究对象,予以舒尼替尼50mg/d服药4周、停药2周("50mg方案")或37.5mg/d连续口服("37.5mg方案")治疗,对其生存情况及副作用进行回顾性分析。结果 (1)27例接受中位时间为64周(7～153周)的舒尼替尼治疗,其中9例采用"50mg方案",18例采用"37.5mg方案"。所有患者治疗后随访中位时间为72周(14～164周)。(2)按Choi标准进行最佳疗效评估:完全缓解1例(1/27),部分缓解7例(7/27),疾病稳定10例(10/27),疾病进展9例(9/27),客观有效率达8/27。(3)随访过程中,进展21例,死亡15例。1年生存率为17/27;中位无进展生存时间(PFS)为40周,中位总生存时间(OS)为84周。按既往伊马替尼日最高剂量分为400mg组和>400mg组分析,PFS为46周vs 33周(P=0.047),即400mg组的PFS优于>400mg组;但OS为89周vs 71周(P=0.259)。(4)主要的不良反应有手足综合症(15/27),食欲减退(13/27),皮肤脱色(9/27),恶心呕吐(9/27),疲乏(9/27),腹泻(8/27),其中大多数是1/2级。按给药剂量分组,"50mg方案"组腹泻及手足综合症的发生率(5/9及7/9)均高于"37.5mg方案"组(3/18及8/18),差别有统计学意义(P<0.05)。结论舒尼替尼治疗伊马替尼耐药的GIST的疗效可靠,安全性良好。采用"37.5mg方案"患者更容易耐受。Objective To report the preliminary results of the efficacy and safety of sunitinib in the management of gastrointestinal stromal tumors（GIST） patients with imatinib resistance.Methods27 patients with imatinib treatment failure were enrolled to be treated with sunitinib from May.2008 to Jun.2011 in the Union Hospital of Fujian Medical University.The patients were administered 50 mg（4 weeks on and 2 weeks off） or 37.5 mg continuously of sunitinib.The survival rates and adverse effects were analyzed retrospectively.Results The median duration of sunitinib administration of all the 27 patients was 64 weeks（7 weeks to 153 weeks）.9 patients were treated with sunitinib by 50 mg group,and 18 patients by 37.5 mg group.The mean follow-up time was 72 weeks（14 weeks to 164 weeks）.The response rate was 8/27,including 1 case with complete response（CR）,7 cases with partial response（PR）,and 10 cases with stationary disease（SD）.And all cases were evaluated by Choi criteria.21 patients progressed in different degrees and 15 died during follow-up.And 1-year survival rate was 18/27.The median PFS and OS were 40 weeks and 84 weeks,respectively.The median PFS of patients previously treated by imatinib 400 mg/d and 〉400 mg/d were 46 weeksand 33 weeks,respectively（P=0.047）.OS of two groups were 89 weeks and 71weeks,respectively（P=0.259）.Hand-foot syndrome was the most common adverse effect（15/27）,followed by anorexia（13/27）,epichrosis（9/27）,nausea and vomiting（9/27）,fatigue（9/27）,diarrhea（8/27）,and most of them were 1/2 grade.The sub-group analysis showed that the incidence rate of diarrhea was higher in 50 mg group than in 37.5 mg group,resulting in 5/9 and 3/18（P=0.036）.The incidence rate of hand-foot syndrome of the 50 mg group was also higher than the 37.5 mg group（7/9 vs 8/18,P=0.048）.With regards to other adverse effects,there was no significant difference in the two groups.Conclusions Sunitinib appears to be effective and safe for GISTs with imatinib resistanc

关 键 词：胃肠道间质肿瘤 药物耐受性 哌嗪类 嘧啶类 

分 类 号：R735[医药卫生—肿瘤] R971.92[医药卫生—临床医学]