Is there a role of surgery in patients with recurrent or metastatic gastrointestinal stromal tumours responding to imatinib: A prospective randomised trial in China

被引:93
作者
Du, Chun-Yan [1 ,2 ]
Zhou, Ye [1 ,2 ]
Song, Chun [3 ]
Wang, Yong-Peng [3 ]
Jie, Zhi-Gang [4 ]
He, Yu-Long [5 ]
Liang, Xiao-Bo [6 ]
Cao, Hui [7 ]
Yan, Zhong-Shu [8 ]
Shi, Ying-Qiang [1 ,2 ]
机构
[1] Fudan Univ, Ctr Canc, Dept Gastr Canc & Soft Tissue Surg, Shanghai 200433, Peoples R China
[2] Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai 200433, Peoples R China
[3] Liaoning Canc Hosp & Inst, Dept Colorectal Surg, Shenyang, Liaoning, Peoples R China
[4] Nanchang Univ, Affiliated Hosp 1, Dept Gen Surg, Nanchang, Peoples R China
[5] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Colon & Rectal Surg, Guangzhou 510275, Guangdong, Peoples R China
[6] Shanxi Canc Hosp, Dept Colorectal Surg, Taiyuan, Shanxi, Peoples R China
[7] Shanghai Jiao Tong Univ, Sch Med, Ren Ji Hosp, Dept Gen Surg, Shanghai 200030, Peoples R China
[8] Cent S Univ, Xiangya Hosp, Dept Gastrointestinal Surg, Changsha, Hunan, Peoples R China
关键词
Gastrointestinal stromal tumours; Imatinib mesylate; Surgery; TERM-FOLLOW-UP; PROGNOSTIC-FACTORS; SURGICAL-MANAGEMENT; ACQUIRED-RESISTANCE; RESIDUAL DISEASE; TYROSINE-KINASE; MESYLATE; THERAPY; GIST; RESECTION;
D O I
10.1016/j.ejca.2014.03.280
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objectives: For advanced gastrointestinal stromal tumour (GIST) patients who are responding to imatinib mesylate, the role of surgery has not been formally demonstrated. This multicenter randomised controlled trial was designed to assess whether surgery to treat residual disease for patients with recurrent/metastatic GISTs responding to imatinib mesylate (IM) improved progression free survival (PFS) compared with IM treatment alone. Methods: Between 3 and 12 months after starting IM for recurrent/metastatic GISTs, eligible patients were randomised to two arms: Arm A (surgery for residual disease) and Arm B (IM treatment alone). In Arm A (19 pts), surgery was performed to remove residual macroscopic lesions as completely as possible, and IM treatment continued after surgery. In Aim B (22 pts), IM was given alone at a dose of 400 mg per day until disease progression. The primary end-point was PFS measured from the date IM started. This study was registered in the ChiCTR registry with the ID number ChiCTR-TRC-00000244. Results: This randomised trial was closed early due to poor accrual. Only 41 patients were enrolled as opposed to 210 patients planned. 2-year PFS was 88.4% in the surgery arm and 57.7% in the IM-alone arm (P = 0.089). Median overall survival (mOS) was not reached in the surgery arm and 49 months in patients with IM-alone arm (P = 0.024). Conclusions: While no significant differences were observed in the two arms, this study suggests that surgical removal of the metastatic lesion may improve the outcome of advanced GIST patients and should stimulate additional research on this topic. (C) 2014 Elsevier Ltd. All rights reserved.
引用
收藏
页码:1772 / 1778
页数:7
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