title: Reduced dose of salvage-line regorafenib monotherapy for metastatic colorectal cancer in Japan.
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.
  
  
  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%).
  
  
  CONCLUSIONS
  Despite a decrease in the intensity of regorafenib treatment, because of severe adverse events, a fairly favorable efficacy was achieved in Japanese patients.
authors.affiliation: Department of Hematology and Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan.
authors.forename: Gen
authors.initials: G
authors.lastname: Hirano
authors.affiliation: Department of Hematology and Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan.
authors.forename: Akitaka
authors.initials: A
authors.lastname: Makiyama
authors.affiliation: Department of Hematology and Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan.
authors.forename: Chinatsu
authors.initials: C
authors.lastname: Makiyama
authors.affiliation: Department of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Taito
authors.initials: T
authors.lastname: Esaki
authors.affiliation: Department of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Hisanobu
authors.initials: H
authors.lastname: Oda
authors.affiliation: Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
authors.forename: Keita
authors.initials: K
authors.lastname: Uchino
authors.affiliation: Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Komoda
authors.affiliation: Department of Oncology, Hamanomachi Hospital, Fukuoka, Japan.
authors.forename: Risa
authors.initials: R
authors.lastname: Tanaka
authors.affiliation: Department of Oncology, Hamanomachi Hospital, Fukuoka, Japan.
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Matsushita
authors.affiliation: Department of Oncology, Hamanomachi Hospital, Fukuoka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Mitsugi
authors.affiliation: Department of Chemotherapy, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Shibata
authors.affiliation: Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Hozumi
authors.initials: H
authors.lastname: Kumagai
authors.affiliation: Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Arita
authors.affiliation: Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ariyama
authors.affiliation: Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kusaba
authors.affiliation: Department of Hematology and Oncology of Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Akashi
authors.affiliation: Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan e-baba@c-oncology.med.kyushu-u.ac.jp.
authors.forename: Eishi
authors.initials: E
authors.lastname: Baba
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D011725:Pyridines; C559147:regorafenib
keywords: Regorafenib; adverse events; chemotherapy; metastatic colorectal cancer