Ryugo Teranishi1, Tsuyoshi Takahashi2, Toshirou Nishida3, Seiichi Hirota4, Yukinori Kurokawa1, Takuro Saito1, Kazuyoshi Yamamoto1, Kotaro Yamashita1, Koji Tanaka1, Tomoki Makino1, Masaaki Motoori5, Takeshi Omori6, Kiyokazu Nakajima1, Hidetoshi Eguchi1, Yuichiro Doki1. 1. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita-City, Osaka, 565-0871, Japan. 2. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita-City, Osaka, 565-0871, Japan. ttakahashi2@gesurg.med.osaka-u.ac.jp. 3. Department of Surgery, Japan Community Health Care Organization Osaka Hospital, 4-2-78, Fukushima-ku, Osaka City, Osaka, 553-0003, Japan. 4. Department of Surgical Pathology, Hyogo College of Medicine, Hyogo, Japan. 5. Department of Surgery, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka City, Osaka, 558-8558, Japan. 6. Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka City, Osaka, 541-8567, Japan.
Abstract
BACKGROUND: Regorafenib is an oral multi-kinase inhibitor that has been established as third-line treatment for patients after the failure of imatinib and sunitinib. However, since clinical data of regorafenib in the Japanese population are still lacking, the management of regorafenib is mainly based on the clinical experience of each oncologist. The aim of this study was to evaluate the efficacy and safety of regorafenib in a Japanese population. METHODS: Thirty-three patients treated with regorafenib for metastatic and recurrent gastrointestinal stromal tumors were retrospectively enrolled. This study investigated the anti-tumor effect, including overall survival, progression-free survival, and safety, which was evaluated based on the incidence of adverse events. RESULTS: The median overall survival of patients treated with regorafenib was 23.8 months and the 1-year overall survival rate was 80.0%, the median progression-free survival was 7.1 months and the 1-year progression-free survival rate was 40.2%. The responses to regorafenib were partial response in 3 cases (9.1%), stable disease in 17 (51.5%), progressive disease in 10 (30.3%), and non-evaluable in 3 (9.1%). The disease control rate was 54.0%. Treatment-related adverse events were reported in all patients, with the most common being hand-foot syndrome (72.7%), followed by liver damage (36.4%) and diarrhea (27.3%), and six patients (20.0%) were discontinued due to adverse events. CONCLUSION: This is the first report of Japanese patients with gastrointestinal stromal tumors treated with regorafenib. Regorafenib showed efficacy and a manageable safety profile in Japanese patients with advanced gastrointestinal stromal tumors, which was comparable with previous studies.
BACKGROUND: Regorafenib is an oral multi-kinase inhibitor that has been established as third-line treatment for patients after the failure of imatinib and sunitinib. However, since clinical data of regorafenib in the Japanese population are still lacking, the management of regorafenib is mainly based on the clinical experience of each oncologist. The aim of this study was to evaluate the efficacy and safety of regorafenib in a Japanese population. METHODS: Thirty-three patients treated with regorafenib for metastatic and recurrent gastrointestinal stromal tumors were retrospectively enrolled. This study investigated the anti-tumor effect, including overall survival, progression-free survival, and safety, which was evaluated based on the incidence of adverse events. RESULTS: The median overall survival of patients treated with regorafenib was 23.8 months and the 1-year overall survival rate was 80.0%, the median progression-free survival was 7.1 months and the 1-year progression-free survival rate was 40.2%. The responses to regorafenib were partial response in 3 cases (9.1%), stable disease in 17 (51.5%), progressive disease in 10 (30.3%), and non-evaluable in 3 (9.1%). The disease control rate was 54.0%. Treatment-related adverse events were reported in all patients, with the most common being hand-foot syndrome (72.7%), followed by liver damage (36.4%) and diarrhea (27.3%), and six patients (20.0%) were discontinued due to adverse events. CONCLUSION: This is the first report of Japanese patients with gastrointestinal stromal tumors treated with regorafenib. Regorafenib showed efficacy and a manageable safety profile in Japanese patients with advanced gastrointestinal stromal tumors, which was comparable with previous studies.
Authors: George D Demetri; Allan T van Oosterom; Christopher R Garrett; Martin E Blackstein; Manisha H Shah; Jaap Verweij; Grant McArthur; Ian R Judson; Michael C Heinrich; Jeffrey A Morgan; Jayesh Desai; Christopher D Fletcher; Suzanne George; Carlo L Bello; Xin Huang; Charles M Baum; Paolo G Casali Journal: Lancet Date: 2006-10-14 Impact factor: 79.321
Authors: Jaap Verweij; Paolo G Casali; John Zalcberg; Axel LeCesne; Peter Reichardt; Jean-Yves Blay; Rolf Issels; Allan van Oosterom; Pancras C W Hogendoorn; Martine Van Glabbeke; Rossella Bertulli; Ian Judson Journal: Lancet Date: 2004 Sep 25-Oct 1 Impact factor: 79.321
Authors: George D Demetri; Margaret von Mehren; Charles D Blanke; Annick D Van den Abbeele; Burton Eisenberg; Peter J Roberts; Michael C Heinrich; David A Tuveson; Samuel Singer; Milos Janicek; Jonathan A Fletcher; Stuart G Silverman; Sandra L Silberman; Renaud Capdeville; Beate Kiese; Bin Peng; Sasa Dimitrijevic; Brian J Druker; Christopher Corless; Christopher D M Fletcher; Heikki Joensuu Journal: N Engl J Med Date: 2002-08-15 Impact factor: 91.245
Authors: Michael C Heinrich; Christopher L Corless; George D Demetri; Charles D Blanke; Margaret von Mehren; Heikki Joensuu; Laura S McGreevey; Chang-Jie Chen; Annick D Van den Abbeele; Brian J Druker; Beate Kiese; Burton Eisenberg; Peter J Roberts; Samuel Singer; Christopher D M Fletcher; Sandra Silberman; Sasa Dimitrijevic; Jonathan A Fletcher Journal: J Clin Oncol Date: 2003-12-01 Impact factor: 44.544