PMID- 24744162
OWN - NLM
STAT- MEDLINE
DCOM- 20140918
LR  - 20220311
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Print)
IS  - 0344-5704 (Linking)
VI  - 73
IP  - 6
DP  - 2014 Jun
TI  - Safety analysis of two different regimens of uracil-tegafur plus leucovorin as 
      adjuvant chemotherapy for high-risk stage II and III colon cancer in a phase III 
      trial comparing 6 with 18 months of treatment: JFMC33-0502 trial.
PG  - 1253-61
LID - 10.1007/s00280-014-2461-5 [doi]
AB  - PURPOSE: The JFMC33-0502 trial is a phase III clinical study designed to 
      determine the most appropriate duration of postoperative adjuvant chemotherapy 
      with uracil-tegafur (UFT) plus leucovorin in patients with stage IIB or III colon 
      cancer. We report the interim results of preplanned safety analyses. METHODS: 
      Patients with stage IIB or III colon cancer who had undergone curative resection 
      were randomly assigned to receive UFT (300 mg/m(2)) plus leucovorin (75 mg/day) 
      for 6 months (control group, 4 weeks of treatment followed by a 1-week rest, five 
      courses) or for 18 months (study group, 5 days of treatment followed by a 2-day 
      rest, 15 courses). Treatment status and safety were evaluated. RESULTS: A total 
      of 1,071 patients were enrolled, and 1,063 were included in safety analyses. 
      Treatment completion rate at 6 months was 74.0 % in the control group and 76.7 % 
      in the study group. Treatment completion rate in the study group at 18 months was 
      56.0 %. The overall incidence of adverse events (AEs) was 75.3 % in the control 
      group and 77.6 % in the study group. The incidences of grade 3 or higher AEs were 
      low in both groups. During the first 6 months, the incidences of the subjective 
      AEs were significantly lower in the study group. CONCLUSIONS: Oral UFT plus 
      leucovorin given by either dosage schedule is a very safe regimen for adjuvant 
      chemotherapy. In particular, 5 days of treatment followed by a 2-day rest was a 
      useful treatment option from the viewpoint of toxicity even when given for longer 
      than 6 months.
FAU - Tsuchiya, Takashi
AU  - Tsuchiya T
AD  - Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, 983-0824, 
      Japan, tsuchiya@openhp.or.jp.
FAU - Sadahiro, Sotaro
AU  - Sadahiro S
FAU - Sasaki, Kazuaki
AU  - Sasaki K
FAU - Kondo, Ken
AU  - Kondo K
FAU - Katsumata, Kenji
AU  - Katsumata K
FAU - Nishimura, Genichi
AU  - Nishimura G
FAU - Kakeji, Yoshihiro
AU  - Kakeji Y
FAU - Baba, Hideo
AU  - Baba H
FAU - Morita, Takayuki
AU  - Morita T
FAU - Koda, Keiji
AU  - Koda K
FAU - Sato, Seiji
AU  - Sato S
FAU - Matsuoka, Junji
AU  - Matsuoka J
FAU - Yamaguchi, Yoshiyuki
AU  - Yamaguchi Y
FAU - Usuki, Hisashi
AU  - Usuki H
FAU - Hamada, Chikuma
AU  - Hamada C
FAU - Kodaira, Susumu
AU  - Kodaira S
FAU - Saji, Shigetoyo
AU  - Saji S
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140418
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 1548R74NSZ (Tegafur)
RN  - 56HH86ZVCT (Uracil)
RN  - Q573I9DVLP (Leucovorin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/*adverse 
      effects
MH  - Chemotherapy, Adjuvant
MH  - Colonic Neoplasms/*drug therapy/pathology/surgery
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Leucovorin/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Risk Factors
MH  - Tegafur/administration & dosage/adverse effects
MH  - Uracil/administration & dosage/adverse effects
PMC - PMC4032639
EDAT- 2014/04/20 06:00
MHDA- 2014/09/19 06:00
PMCR- 2014/04/18
CRDT- 2014/04/19 06:00
PHST- 2014/02/25 00:00 [received]
PHST- 2014/03/23 00:00 [accepted]
PHST- 2014/04/19 06:00 [entrez]
PHST- 2014/04/20 06:00 [pubmed]
PHST- 2014/09/19 06:00 [medline]
PHST- 2014/04/18 00:00 [pmc-release]
AID - 2461 [pii]
AID - 10.1007/s00280-014-2461-5 [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2014 Jun;73(6):1253-61. doi: 
      10.1007/s00280-014-2461-5. Epub 2014 Apr 18.