PMID- 22415232
OWN - NLM
STAT- MEDLINE
DCOM- 20120511
LR  - 20240404
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Print)
IS  - 0007-0920 (Linking)
VI  - 106
IP  - 7
DP  - 2012 Mar 27
TI  - Safety of UFT/LV and S-1 as adjuvant therapy for stage III colon cancer in phase 
      III trial: ACTS-CC trial.
PG  - 1268-73
LID - 10.1038/bjc.2012.86 [doi]
AB  - BACKGROUND: The Adjuvant Chemotherapy Trial of TS-1 for Colon Cancer (ACTS-CC) is 
      a phase III trial designed to validate the non-inferiority of S-1 to 
      UFT/leucovorin (LV) as postoperative adjuvant chemotherapy for stage III colon 
      cancer. We report the results of a planned safety analysis. METHODS: Patients 
      aged 20-80 years with curatively resected stage III colon cancer were randomly 
      assigned to receive UFT/LV (UFT, 300 mg m(-2) per day as tegafur; LV, 75 mg per 
      day on days 1-28, every 35 days, 5 courses) or S-1 (80, 100, or 120 mg per day on 
      days 1-28, every 42 days, 4 courses). Treatment status and safety were evaluated. 
      RESULTS: Of 1535 enrolled patients, a total of 1504 (756 allocated to S-1 and 748 
      to UFT/LV) were analysed. The completion rate of protocol treatment was 77% in 
      the S-1 group and 73% in the UFT/LV group. The overall incidence of adverse 
      events (AEs) were 80% in S-1 and 74% in UFT/LV. Stomatitis, anorexia, 
      hyperpigmentation, and haematological toxicities were common in S-1, whereas 
      increased alanine aminotransferase and aspartate aminotransferase were common in 
      UFT/LV. The incidences of >/=grade 3 AEs were 16% and 14%, respectively. 
      CONCLUSION: Although AE profiles differed between the groups, feasibility of the 
      protocol treatment was good. Both S-1 and UFT/LV could be safely used as adjuvant 
      chemotherapy.
FAU - Mochizuki, I
AU  - Mochizuki I
AD  - Department of Gastroenterological Surgery, Iwate Central Prefectural Hospital, 
      1-4-1 Ueda, Morioka, Iwate 020-0066, Japan.
FAU - Takiuchi, H
AU  - Takiuchi H
FAU - Ikejiri, K
AU  - Ikejiri K
FAU - Nakamoto, Y
AU  - Nakamoto Y
FAU - Kinugasa, Y
AU  - Kinugasa Y
FAU - Takagane, A
AU  - Takagane A
FAU - Endo, T
AU  - Endo T
FAU - Shinozaki, H
AU  - Shinozaki H
FAU - Takii, Y
AU  - Takii Y
FAU - Takahashi, Y
AU  - Takahashi Y
FAU - Mochizuki, H
AU  - Mochizuki H
FAU - Kotake, K
AU  - Kotake K
FAU - Kameoka, S
AU  - Kameoka S
FAU - Takahashi, K
AU  - Takahashi K
FAU - Watanabe, T
AU  - Watanabe T
FAU - Watanabe, M
AU  - Watanabe M
FAU - Boku, N
AU  - Boku N
FAU - Tomita, N
AU  - Tomita N
FAU - Matsubara, Y
AU  - Matsubara Y
FAU - Sugihara, K
AU  - Sugihara K
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120313
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Drug Combinations)
RN  - 0 (UFT(R) drug)
RN  - 150863-82-4 (S 1 (combination))
RN  - 1548R74NSZ (Tegafur)
RN  - 56HH86ZVCT (Uracil)
RN  - 5VT6420TIG (Oxonic Acid)
RN  - Q573I9DVLP (Leucovorin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Chemotherapy, Adjuvant
MH  - Colonic Neoplasms/*drug therapy/surgery
MH  - Disease-Free Survival
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Leucovorin/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Oxonic Acid/*administration & dosage/adverse effects
MH  - Tegafur/*administration & dosage/adverse effects
MH  - Uracil/*administration & dosage/adverse effects
PMC - PMC3314794
EDAT- 2012/03/15 06:00
MHDA- 2012/05/12 06:00
PMCR- 2013/03/27
CRDT- 2012/03/15 06:00
PHST- 2012/03/15 06:00 [entrez]
PHST- 2012/03/15 06:00 [pubmed]
PHST- 2012/05/12 06:00 [medline]
PHST- 2013/03/27 00:00 [pmc-release]
AID - bjc201286 [pii]
AID - 10.1038/bjc.2012.86 [doi]
PST - ppublish
SO  - Br J Cancer. 2012 Mar 27;106(7):1268-73. doi: 10.1038/bjc.2012.86. Epub 2012 Mar 
      13.