title: Phase I study of sunitinib plus modified FOLFOX6 in Japanese patients with treatment-naive colorectal cancer.
abstract: OBJECTIVE
  This phase I study evaluated sunitinib plus modified FOLFOX6 (mFOLFOX6: 5-fluorouracil, leucovorin and oxaliplatin) in Japanese patients with treatment-naïve metastatic colorectal cancer.
  
  
  METHODS
  Sunitinib was administered orally (37.5 mg/day, 4 weeks on, 2 weeks off [Schedule 4/2; arm A] or 50 mg/day, 2 weeks on, 2 weeks off [Schedule 2/2; arm B]) with mFOLFOX6.
  
  
  RESULTS
  In arms A/B, respectively (n=6 each): median relative dose intensity was 50.4%/89.1% for sunitinib and 39.2-69.8%/73.0-80.5% for mFOLFOX6 components. Most adverse events were grade 1/2. The most frequent grade 3/4 adverse events were neutropenia, thrombocytopenia, and leukopenia. No significant drug-drug interactions were detected. Four patients had objective responses in each arm.
  
  
  CONCLUSIONS
  Sunitinib plus mFOLFOX6 had acceptable tolerability, with the Schedule 2/2 combination being generally more manageable than the Schedule 4/2. Based on two global trials and the present study, sunitinib on Schedule 2/2 combined with chemotherapy may be considered, if further first-line trials are planned.
authors.affiliation: 6-5-1, Kashiwanoha, National Cancer Center Hospital East, Department of Gastroenterology and Gastrointestinal Oncology, Kashiwa, Chiba 277-8577, Japan. tyoshino@east.ncc.go.jp
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hamaguchi
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yasui
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Maria Jose
authors.initials: MJ
authors.lastname: Lechuga
authors.forename: Tomoko
authors.initials: T
authors.lastname: Hirohashi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Shibata
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hashigaki
authors.forename: Yinhua
authors.initials: Y
authors.lastname: Li
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007211:Indoles / Q000008:administration & dosage; D007564:Japan; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D000077150:Oxaliplatin; D011758:Pyrroles / Q000008:administration & dosage; D000077210:Sunitinib
chemical_list: D007211:Indoles; D009944:Organoplatinum Compounds; D011758:Pyrroles; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil; D000077210:Sunitinib