摘要
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。
Objective To evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor（GIST） patients who had high risk of recurrence. Methods A prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CDll7 positive GIST, tumor size more than 5cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib （400 mg, once a day） for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated. Results From Aug. 16^th 2004 to Sep. 13^th2005, there were totally 74 patients screened and 57 patients （34 men, 23 women） enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50. 9%, the small intestine in 38. 6% and the colorectum in 10.5% of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat（ITT）, twelve patients finished the protocol（per protocol, PP）. The disease free survival was （268.3 ± 120.2） d in ITT analysis, and （396.7 ± 38.2） d in the PP analysis. The incidence of adverse effect was 44. 4%. The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits. Conclusion Imatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.
出处
《中华胃肠外科杂志》
CAS
2006年第5期383-387,共5页
Chinese Journal of Gastrointestinal Surgery
关键词
胃肠道间质瘤
外科手术
辅助治疗
伊马替尼
Gastrointestinal stromal tumor
Surgical procedures, operative
Adjuvant therapy
Imatinib
