Is there a role of surgery in patients with recurrent or metastatic gastrointestinal stromal tumours responding to imatinib: a prospective randomised trial in China.
OBJECTIVE
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 12months 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 (19pts), surgery was performed to remove residual macroscopic lesions as completely as possible, and IM treatment continued after surgery. In Arm B (22pts), IM was given alone at a dose of 400mg 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 49months 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.
Department of Gastric Cancer and Soft Tissue Surgery, Cancer Center, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Chun-Yan
CY
Du
Department of Gastric Cancer and Soft Tissue Surgery, Cancer Center, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Ye
Y
Zhou
Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China.
Chun
C
Song
Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China.
Yong-Peng
YP
Wang
Department of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, China.
Zhi-Gang
ZG
Jie
Department of Colonic and Rectal Surgery, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Yu-Long
YL
He
Department of Colorectal Surgery, Shanxi Cancer Hospital, Taiyuan, Shanxi, China.
Xiao-Bo
XB
Liang
Department of General Surgery, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Hui
H
Cao
Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Zhong-Shu
ZS
Yan
Department of Gastric Cancer and Soft Tissue Surgery, Cancer Center, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: yingqiangshi@126.com.
Ying-Qiang
YQ
Shi
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002681:China; D018450:Disease Progression; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D046152:Gastrointestinal Stromal Tumors / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary / Q000601:surgery*; D006801:Humans; D000068877:Imatinib Mesylate; D053208:Kaplan-Meier Estimate; D008297:Male; D059146:Metastasectomy / Q000009:adverse effects / Q000401:mortality; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local; D018365:Neoplasm, Residual; D018579:Patient Selection; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate
Gastrointestinal stromal tumours; Imatinib mesylate; Surgery