手术联合伊马替尼与单纯伊马替尼治疗复发或转移胃肠道.doc

Combined Operation Modality vs. Imatinib Mesylate Alonefor Patients with Recurrent or Metastatic GastrointestinalStromal Tumors: the Randomized COMVIA Trial DU Chunyam, ZHOU Ye】，SONG Chun2, WANG Yongpeng2, JIE Zhigang3,LIANG Xiaobos HE Yulongs CAO Huie, YAN Zhongshu?, SHI Yingqiangi(1 ? Department of Gastric Cancer and Soft Tissue Surgery, Cancer Ccnle几 Fudan University,ShangHai 200237; Department of Colorectal Surgery, Liaoning Cancer Hospital Institute, Shen Yang 110()42; Department of General Surgery, the First Affiliated Hospital of Nanchang University,NanChang 300006; Department of Colorectal Cancer, Sha nxi Cancer Hospital, Tai Yuan 030013; 5? Department of Gastrointestinal Panceatic Surgery, the First Affiliated HospitaL Sun Yat-senUniversity, GuangZhou 510080; 6. Depailmenl of General Surgery, Renji Hospital, Shanghai Jiaolong University School ofMedicine, ShangHai 200127; 7. Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University,ChangSha 410008) Abstract: Objectives:Gaslrointeslinal Stromal Tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. For advanced GIST patients who are responding to imatinib mesylate, the role of surgery has not been formally demonstrated. Therefore, this multicenter, randomized, con trolled trial was designed to assess whether surgeries to treat residual disease for patients with recurrent/metastatic GISTs responding to imatinib mesylate (IM) improves progression free survival (PFS) compared with IM treatment alone? Methods: Between 3 and 12 months after starting molecular-targeted therapy with IM for recurven〔/me{as【alic GISTs, eligible patients were ran do mi zed to two arms: Arm A (surgery for residual disease) and Arm B (IM treatment alone )? In Arm A (19 pts), surgery was periormed to remove residual macroscopic lesions as completely as possible, and IM treatmenl continued after surgery. In Arm B (22 pls), IM was given alone at a dose of 400mg per day until