title: Efficacy and Safety of Regorafenib or TAS-102 in Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies.
abstract: BACKGROUND
  Regorafenib and TAS-102 are novel antitumor agents for patients with metastatic colorectal cancer (mCRC) whose disease has progressed after standard therapies. In randomized trials, regorafenib and TAS-102 prolonged survival in patients with mCRC. However, the appropriate selection of regorafenib or TAS-102 in treatment strategy has not yet been established.
  
  
  METHODS
  We performed a retrospective analysis, between March 2013 and July 2015, on the efficacy and safety of regorafenib or TAS-102.
  
  
  RESULTS
  Thirty-seven patients with mCRC treated with regorafenib or TAS-102 were included. Of these 37 patients, 23 first received regorafenib and 14 received TAS-102. The median progression-free survival and overall survival were 3.0 and 5.8 months, respectively, in the regorafenib group and 2.1 and 6.3 months, respectively, in the TAS-102 group. Drug-related adverse events (AEs) and grade ≥3 AEs were 23 (100%) and 10 (43.5%), respectively, in the regorafenib group and 13 (92.9%) and 2 (14.3%), respectively, in the TAS-102 group. The most frequent grade ≥3 AEs were hepatotoxicity (17.4%) and hand-foot syndrome (13.0%) in the regorafenib group, and neutropenia (14.3%) in the TAS-102 group. In subgroup analysis, the median overall survival was 11.5 months in patients receiving crossover treatment with regorafenib to TAS-102, and 7.6 months in those receiving crossover treatment with TAS-102 to regorafenib.
  
  
  CONCLUSIONS
  Our results showed that regorafenib and TAS-102 have comparable efficacy but different toxicity profiles in patients with mCRC. Both are considered new salvage treatment options. Differences in the toxicity profiles between the two treatments will help in choosing regorafenib or TAS-102.
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Toshinori
authors.initials: T
authors.lastname: Sueda
authors.affiliation: Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Graduate School of Medicine, Osaka, Japan dsakai@cfs.med.osaka-u.ac.jp.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Sakai
authors.affiliation: Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kudo
authors.affiliation: Department of Medical Oncology, Saito Yukoukai Hospital, Osaka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sugiura
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Naotsugu
authors.initials: N
authors.lastname: Haraguchi
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Nishimura
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Taishi
authors.initials: T
authors.lastname: Hata
authors.affiliation: Department of Surgery, Saito Yukoukai Hospital, Osaka, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Mizushima
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.affiliation: Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Graduate School of Medicine, Osaka, Japan.
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011759:Pyrrolidines; D016032:Randomized Controlled Trials as Topic; D013941:Thymine; D016896:Treatment Outcome; D014271:Trifluridine / Q000008:administration & dosage* / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D004338:Drug Combinations; D010671:Phenylurea Compounds; D011725:Pyridines; D011759:Pyrrolidines; C000613803:trifluridine tipiracil drug combination; C559147:regorafenib; D014498:Uracil; D013941:Thymine; D014271:Trifluridine
keywords: Metastatic colorectal cancer; TAS-102; regorafenib