You Position: Home > Paper
Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence: interim analysis from a multicenter prospective clinical trial
( views:553, downloads:522 )
- Author:
- No author available
- Journal Title:
- CHINESE JOURNAL OF GASTROINTESTINAL SURGERY
- Issue:
- 5
- DOI:
- 10.3760/cma.j.issn.1671-0274.2006.05.006
- Key Word:
- 胃肠道间质瘤;外科手术;辅助治疗;伊马替尼
Abstract： 目的 评价具复发转移高风险的胃肠间质瘤(GIST)患者术后予以伊马替尼(imatinib,IM)辅助治疗的安全性和疗效.方法 2004年8月16日至2005年12月15日期间,国内16家医院共同参加的多中心前瞻性临床研究.选择18岁以上、肿瘤最大径在5 cm及以上、病理核分裂相在5/50个高倍视野及以上、CD117阳性、肿瘤能作完整切除的GIST患者,手术后4周内开始服用IM,每天400 mg;疗程持续12个月或以上.主要终点观察指标为术后1、3年的肿瘤复发或转移率;次要终点指标为无病生存期、总生存期、不良事件和生活质量.按方案完成12个月或以上的IM治疗,且至少有1次主要终点指标评估者归入符合方案(PP)分析,至少服用过1次研究药物者归入意向治疗(ITT)分析.结果 符合入选标准者57例,其中男34例,年龄(50.6±12.2)岁;女23例,年龄(50.0±10.8)岁.肿瘤部位:胃50.9%,小肠38.6%,结直肠10.5%;全部接受根治性手术切除.归入PP分析者12例,归入ITT分析者57例.至中期报告随访期间,所有受试者均未发现肿瘤复发、转移和死亡;无病生存期ITT分析为(268.3±120.2)d,PP分析为(396.7±38.2)d;不良事件发生率44.4%.患者的生活质量与基线评估指标相比,差异无统计学意义(P＞0.05).结论 对于有高度恶性倾向的胃肠间质瘤完整切除术后患者,每天口服400 mg的IM可降低肿瘤的转移率和复发率;其不良反应是可以接受的.
- [1]M M, Oken,R H, Creech,D C, Tormey,etc.Toxicity and response criteria of the Eastern Cooperative Oncology Group.[J].1982,5.
- [2]Lasota J,Miettinen M,fip.osd.mil.Gastrointestinal stromal tumors--definition, clinical, histological, immunohistochemical, and molecular genetic features and differential diagnosis.[J].2001,438(1).
- [3]Dimitrijevic S,Eisenberg B,Joensuu H,etc.Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors.[J].2002,347(7).
- [4]Clary BM,DeMatteo RP,Lewis JJ,etc.Gastrointestinal stromal tumors and leiomyosarcoma of the abdomen and retroperitoneum: a clinical comparison.[J].2001,8(4).
- [5]S S, Mudan,K C, Conlon,J M, Woodruff,etc.Salvage surgery for patients with recurrent gastrointestinal sarcoma: prognostic factors to guide patient selection.[J].2000,88(1).
- [6]Dimitrijevic S,Demetri G,Fletcher C,etc.Management of malignant gastrointestinal stromal tumours.[J].2002,3(11).
- [7]Hodgson N,Franceschi D,Lee DJ,etc.Current incidence and outcomes of gastrointestinal mesenchymal tumors including gastrointestinal stromal tumors.[J].2006,202(4).
- [8]Benjamin RS,Eisenberg B,Blanke CD,etc.Management of gastrointestinal stromal tumors in the imatinib era: selected case studies.[J].2006,11(1).
- [9]Kumai K,Furukawa T,Otani Y,etc.Operative indications for relatively small (2-5 cm) gastrointestinal stromal tumor of the stomach based on analysis of 60 operated cases.[J].2006,139(4).
- [10]Ono K,Takifuji K,Nakatani Y,etc.Surgical management of small gastrointestinal stromal tumors of the stomach.[J].2006,30(1).
- [11]van den-Berg-E,Molenaar WM,Scheper RJ,etc.Soft tissue leiomyosarcomas and malignant gastrointestinal stromal tumors: differences in clinical outcome and expression of multidrug resistance proteins.[J].2000,18(18).
- [12]Gross TG,Neff G,Thomas MJ,etc.Liver transplantation for primary or metastatic sarcoma to the liver.[J].2006,6(2).