Is there a role of surgery in patients with recurrent or metastatic gastrointestinal stromal tumours responding to imatinib: A prospective randomised trial in China |
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| Affiliation: | 1. Department of Gastric Cancer and Soft Tissue Surgery, Cancer Center, Fudan University, Shanghai, China;2. Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China;3. Department of Colorectal Surgery, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China;4. Department of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, China;5. Department of Colonic and Rectal Surgery, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China;6. Department of Colorectal Surgery, Shanxi Cancer Hospital, Taiyuan, Shanxi, China;7. Department of General Surgery, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China;8. Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China;1. The University of Toronto Sarcoma Group, Princess Margaret Hospital and Mount Sinai Hospital, Canada;2. Department of Surgery, University of Toronto, Canada;3. Department of Surgery, Adelaide and Meath Hospital, Dublin 24, Ireland;4. Department of Radiation Oncology, University of Toronto, Canada;5. The Peterborough Clinic, Peterborough, Canada;6. The R. S. McLaughlin Durham Regional Cancer Centre, Oshawa, Canada;1. Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield S10 2SJ, United Kingdom;2. Southampton NIHR Experimental Cancer Medicine Center and Southampton University Hospitals NHS Foundation, Southampton SO16 6YD, United Kingdom;3. Royal Marsden Hospital, London SW3 6JJ, United Kingdom;4. Guy’s and St. Thomas’ NHS Foundation Trust, London SE1 9RT, United Kingdom;5. Royal Devon and Exeter NHS Foundation Trust, Exeter EX2 5DW, United Kingdom;6. Royal Bournemouth Hospital, Bournemouth BH7 7DW, United Kingdom;7. Hull and East Yorkshire Hospitals NHS Trust, Hull HU16 5JQ, United Kingdom;8. Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, United Kingdom;9. Harrogate and District NHS Foundation Trust, Harrogate HG2 7SX, United Kingdom;10. Beatson West of Scotland Cancer Centre, Glasgow G12 0YN, United Kingdom;11. Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, United Kingdom;12. Velindre Cancer Centre, Cardiff CF14 2TL, United Kingdom;13. United Lincolnshire Hospitals NHS Trust, Lincoln LN2 5QY, United Kingdom;14. Newcastle upon Tyne NHS Foundation Trust, Newcastle NE7 7DN, United Kingdom;15. University College London Hospitals NHS Foundation Trust, London NW1 2PG, United Kingdom;1. Lund University, Department of Laboratory Medicine, Section of Clinical Chemistry, University Hospital Malmö, Malmö, Sweden;2. Lund University, Department of Laboratory Medicine, Section of Molecular Tumor Biology, Medicon Village, Lund, Sweden;3. Umeå University, Department of Surgical and Perioperative Sciences, Urology and Andrology, Umeå, Sweden;1. Department of Surgical Sciences, Uppsala University, Sweden;2. Regional Cancer Centre, Uppsala Örebro Region, Sweden;3. King’s College London, School of Medicine, Division of Cancer Studies, London, UK;4. Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden;5. Department of Surgical and Perioperative Sciences, Umeå University, Sweden;6. Department of Surgery, Urology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA;1. Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China;2. Department of Pulmonary and Critical Care Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;3. Department of Respiratory and Critical Care Medicine, Minhang Hospital, Fudan University, Shanghai, China;4. Department of Respiratory and Critical Medicine, Shanghai Tenth People''s Hospital, Shanghai, China;5. Department of Respiratory Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China;6. Department of Medical Management, Zhoupu Hospital of Pudong New District, Shanghai, China;7. Department of Respiratory Medicine, Shanghai Pudong New Area People''s Hospital, Shanghai, China;8. Department of Pulmonary and Critical Care Medicine, Gongli Hospital, Shanghai, China;9. Department of Infectious Disease, Shanghai Nanhua Hospital of Pudong New District, Shanghai, China;10. Department of Respiratory and Critical Care Medicine, Songjiang Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;11. Department of Respiratory Medicine, Baoshan Branch of Renji Hospital, Shanghai, China;12. Department of Respiratory Medicine, Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China;13. Department of Respiratory Medicine Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai, China;14. Department of Respiratory Medicine, Shanghai Punan Hospital of Pudong New District, Shanghai, China;15. Department of Respiratory and Critical Care Medicine, Jiading Center Hospital, Shanghai University of Medicine & Health Sciences, Shanghai, China;p. Department of Respiratory and Critical Care Medicine, Shanghai Eighth People''s Hospital, Shanghai, China;q. Department of Respiratory and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China;r. Department of Respiratory Medicine, Chongming Branch of Xin Hua Hospital Affiliated to School of Medicine, Jiaotong University, Shanghai, China;s. Department of Respiratory and Critical Care Medicine, Yangpu Hospital, Tongji University, Shanghai, China;t. Department of Respiratory Medicine, Xuhui District Central Hospital, Shanghai, China;u. Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai, China;v. Department of Respiratory Medicine, Jing''an District Centre Hospital of Shanghai, Shanghai, China;w. Department of Respiratory Medicine, Shanghai Fourth People''s Hospital, Shanghai, China;x. Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China;y. Shanghai Public Health Clinical Center, Shanghai, China;z. Clinical Research Unit, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China;11. Department of Respiratory and Critical Care Medicine, Shanghai Fifth People''s Hospital, Fudan University, Shanghai, China;1. Department of Engineering Mechanics, Chongqing University, Chongqing 400044, China;2. School of Aeronautic Science and Engineering, Beihang University, Beijing 100191, China;3. Center for Composite Materials, Harbin Institute of Technology, Harbin 150080, China |
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| Abstract: | ObjectivesFor 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.MethodsBetween 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 Arm 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.ResultsThis 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).ConclusionsWhile 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. |
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| Keywords: | Gastrointestinal stromal tumours Imatinib mesylate Surgery |
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