Gen Hirano1, Akitaka Makiyama1, Chinatsu Makiyama1, Taito Esaki2, Hisanobu Oda2, Keita Uchino3, Masato Komoda3, Risa Tanaka4, Yuzo Matsushita4, Kenji Mitsugi4, Yoshihiro Shibata5, Hozumi Kumagai6, Shuji Arita7, Hiroshi Ariyama6, Hitoshi Kusaba6, Koichi Akashi6, Eishi Baba8. 1. Department of Hematology and Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan. 2. Department of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan. 3. Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 4. Department of Oncology, Hamanomachi Hospital, Fukuoka, Japan. 5. Department of Chemotherapy, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan. 6. Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan. 7. Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan. 8. Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan e-baba@c-oncology.med.kyushu-u.ac.jp.
Abstract
BACKGROUND: Salvage-line regorafenib monotherapy exhibited a marked survival benefit for metastatic colorectal cancer (mCRC). However, the toxicity of this regimen has resulted in the clinical use of a reduced dose of regorafenib. PATIENTS AND METHODS: Thirty-two Japanese mCRC patients (median age=61 years) who had been treated with regorafenib were retrospectively examined. RESULTS: Best objective response rate was 0% and stable disease (SD) was 31%. Median progression-free survival was 81 days and median overall survival was 233 days. Adverse events of any grade were observed in all patients: 17 (53%) patients suffered grade 3 or 4 adverse events including fatigue (13%), anorexia (13%), hand-foot skin reaction (22%) and elevations of alanine aminotransferase/aspartate aminotransferase (19%/16%). One patient with grade 5 liver dysfunction was identified (3%). Twenty-nine (91%) patients required treatment dose reduction or a delay in treatment. The relative dose intensity was 59%. Regorafenib treatments were terminated because of disease progression (59%) or adverse events (34%). CONCLUSION: Despite a decrease in the intensity of regorafenib treatment, because of severe adverse events, a fairly favorable efficacy was achieved in Japanese patients. Copyright
BACKGROUND: Salvage-line regorafenib monotherapy exhibited a marked survival benefit for metastatic colorectal cancer (mCRC). However, the toxicity of this regimen has resulted in the clinical use of a reduced dose of regorafenib. PATIENTS AND METHODS: Thirty-two Japanese mCRC patients (median age=61 years) who had been treated with regorafenib were retrospectively examined. RESULTS: Best objective response rate was 0% and stable disease (SD) was 31%. Median progression-free survival was 81 days and median overall survival was 233 days. Adverse events of any grade were observed in all patients: 17 (53%) patients suffered grade 3 or 4 adverse events including fatigue (13%), anorexia (13%), hand-foot skin reaction (22%) and elevations of alanine aminotransferase/aspartate aminotransferase (19%/16%). One patient with grade 5 liver dysfunction was identified (3%). Twenty-nine (91%) patients required treatment dose reduction or a delay in treatment. The relative dose intensity was 59%. Regorafenib treatments were terminated because of disease progression (59%) or adverse events (34%). CONCLUSION: Despite a decrease in the intensity of regorafenib treatment, because of severe adverse events, a fairly favorable efficacy was achieved in Japanese patients. Copyright
Authors: Riccardo Giampieri; Michela Del Prete; Tiziana Prochilo; Marco Puzzoni; Valeria Pusceddu; Fabiana Pani; Elena Maccaroni; Roberta Mascia; Maria Giuditta Baleani; Tania Meletani; Rossana Berardi; Anna Maria Lanzillo; Stefano Mariotti; Alberto Zaniboni; Stefano Cascinu; Mario Scartozzi Journal: Sci Rep Date: 2017-04-05 Impact factor: 4.379