PMID- 29484450
OWN - NLM
STAT- MEDLINE
DCOM- 20181001
LR  - 20201209
IS  - 1432-1262 (Electronic)
IS  - 0179-1958 (Linking)
VI  - 33
IP  - 6
DP  - 2018 Jun
TI  - Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of 
      stage III colon cancer: phase II clinical study (The FACOS study).
PG  - 809-817
LID - 10.1007/s00384-018-2979-9 [doi]
AB  - PURPOSE: Adjuvant chemotherapy with oxaliplatin combined with a fluoropyrimidine 
      derivative is widely accepted as standard therapy for patients with stage III 
      colon cancer, since few clinical data are available for Japanese patients. The 
      FACOS trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) and 
      XELOX regimens in Japanese colon cancer patients. METHODS: Twelve cycles of 
      mFOLFOX6 or 8 cycles of XELOX were given to patients with eligibility: stage III 
      curatively resected colon cancer, performance status of 0-1, age from 20 to 
      75 years, and adequate organ function. The primary endpoint was 3-year 
      disease-free survival. Secondary endpoints were the incidence of adverse events 
      (AEs) and the completion rate of study therapy. RESULTS: From April 2010 to April 
      2014, a total of 132 patients were enrolled. Safety was analyzed in 130 patients, 
      with finalized data from 73 patients receiving mFOLFOX6 and 57 patients receiving 
      XELOX. A total of 130 patients (100%) experienced AEs (any grade), and 52 
      patients (40.0%) experienced AEs of grade >/= 3. No significant difference in the 
      frequency of grade >/= 3 AEs was observed between mFOLFOX6 and XELOX groups. 
      Continuation of the planned cycle rate of protocol treatment was 69.9% in the 
      mFOLFOX6 group and 68.4% in the XELOX group. Treatment was discontinued because 
      of AEs in 14 patients (19.2%) in the mFOLFOX6 group and 8 (14.0%) in the XELOX 
      group. Mean relative dose intensity for oxaliplatin was 78.0% in the mFOLFOX6 
      group and 82.8% in the XELOX group. CONCLUSION: As adjuvant chemotherapy for 
      stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.
FAU - Kosugi, Chihiro
AU  - Kosugi C
AUID- ORCID: 0000-0003-3719-6425
AD  - Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 
      Ichihara, Chiba, 299-0111, Japan. ckosugi0126@yahoo.co.jp.
FAU - Koda, Keiji
AU  - Koda K
AD  - Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 
      Ichihara, Chiba, 299-0111, Japan.
FAU - Ishibashi, Keiichiro
AU  - Ishibashi K
AD  - Department of Digestive Tract and General Surgery, Saitama Medical Center, 
      Saitama Medical University, Saitama, Japan.
FAU - Yoshimatsu, Kazuhiko
AU  - Yoshimatsu K
AD  - Department of Surgery, Medical Center East, Tokyo Women's Medical University, 
      Tokyo, Japan.
FAU - Tanaka, Soichi
AU  - Tanaka S
AD  - Department of Surgery, Matsuda Hospital, Sendai, Japan.
FAU - Kato, Ryouji
AU  - Kato R
AD  - Department of Surgery, Sakura Medical Center, School of Medicine, Faculty of 
      Medicine, Toho University, Tokyo, Japan.
FAU - Kato, Hiroyuki
AU  - Kato H
AD  - First Department of Surgery, Dokkyo Medical University, Mibu, Japan.
FAU - Oya, Masatoshi
AU  - Oya M
AD  - Department of Surgery, Koshigaya Hospital, Dokkyo Medical University, Mibu, 
      Japan.
FAU - Narushima, Kazuo
AU  - Narushima K
AD  - Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 
      Ichihara, Chiba, 299-0111, Japan.
FAU - Mori, Mikito
AU  - Mori M
AD  - Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 
      Ichihara, Chiba, 299-0111, Japan.
FAU - Shuto, Kiyohiko
AU  - Shuto K
AD  - Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 
      Ichihara, Chiba, 299-0111, Japan.
FAU - Ishida, Hideyuki
AU  - Ishida H
AD  - Department of Digestive Tract and General Surgery, Saitama Medical Center, 
      Saitama Medical University, Saitama, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20180227
PL  - Germany
TA  - Int J Colorectal Dis
JT  - International journal of colorectal disease
JID - 8607899
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Oxaloacetates)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
RN  - Folfox protocol
RN  - XELOX
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/*therapeutic use
MH  - Capecitabine
MH  - Chemotherapy, Adjuvant/adverse effects
MH  - Colonic Neoplasms/*drug therapy/pathology/*surgery
MH  - Deoxycytidine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Fluorouracil/adverse effects/*analogs & derivatives/therapeutic use
MH  - Follow-Up Studies
MH  - Humans
MH  - Leucovorin/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Organoplatinum Compounds/adverse effects/therapeutic use
MH  - Oxaloacetates
MH  - Withholding Treatment
OTO - NOTNLM
OT  - Adjuvant chemotherapy
OT  - Colon cancer
OT  - Stage III
OT  - XELOX
OT  - mFOLFOX6
EDAT- 2018/02/28 06:00
MHDA- 2018/10/03 06:00
CRDT- 2018/02/28 06:00
PHST- 2018/02/07 00:00 [accepted]
PHST- 2018/02/28 06:00 [pubmed]
PHST- 2018/10/03 06:00 [medline]
PHST- 2018/02/28 06:00 [entrez]
AID - 10.1007/s00384-018-2979-9 [pii]
AID - 10.1007/s00384-018-2979-9 [doi]
PST - ppublish
SO  - Int J Colorectal Dis. 2018 Jun;33(6):809-817. doi: 10.1007/s00384-018-2979-9. 
      Epub 2018 Feb 27.