PMID- 29249584
OWN - NLM
STAT- MEDLINE
DCOM- 20190401
LR  - 20190401
IS  - 1938-0674 (Electronic)
IS  - 1533-0028 (Linking)
VI  - 17
IP  - 2
DP  - 2018 Jun
TI  - Planned Safety Analysis of the ACTS-CC 02 Trial: A Randomized Phase III Trial of 
      S-1 With Oxaliplatin Versus Tegafur and Uracil With Leucovorin as Adjuvant 
      Chemotherapy for High-Risk Stage III Colon Cancer.
PG  - e153-e161
LID - S1533-0028(17)30161-5 [pii]
LID - 10.1016/j.clcc.2017.10.015 [doi]
AB  - BACKGROUND: This trial was designed to verify the superiority of 6 months of 
      postoperative adjuvant chemotherapy with SOX (S-1 with oxaliplatin) with UFT 
      (tegafur and uracil) with LV (leucovorin) in terms of disease-free survival in 
      patients with high-risk stage III colon cancer. We report the results of a 
      planned safety analysis. PATIENTS AND METHODS: Patients who underwent curative 
      resection for high-risk stage III colon cancer (any T, N2, or positive nodes 
      around the origin of the feeding arteries) were randomly assigned to receive 
      either UFT/LV (300-600 mg/d UFT with 75 mg/d LV on days 1-28, every 35 days, for 
      5 cycles) or SOX (100 mg/m(2) of oxaliplatin on day 1 with 80-120 mg/d S-1 on 
      days 1-14, every 21 days, for 8 cycles). Treatment status and safety were 
      evaluated. RESULTS: A total of 966 patients were enrolled, and 932 patients were 
      included in safety analyses. The planned 6-month protocol treatment was received 
      by 76.9% of the patients in the UFT/LV group and 65.8% of those in the SOX group. 
      The overall incidence of any Grade adverse events (AEs) were 91.3% in the UFT/LV 
      group and 98.7% in the SOX group, and those of Grade >/= 3 AEs were 16.1% and 
      36.1%, respectively. As for Grade >/= 3 AEs, leukopenia, neutropenia, 
      thrombocytopenia, and sensory neuropathy were more common in the SOX group. The 
      incidence of Grade >/= 3 sensory peripheral neuropathy was 4.6% in the SOX group. 
      CONCLUSION: The completion rate of adjuvant SOX and its incidence of AEs were 
      acceptable in patients with colon cancer.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Kusumoto, Tetsuya
AU  - Kusumoto T
AD  - Department of Gastroenterological Surgery and Clinical Research Institute Cancer 
      Research Division, National Kyushu Medical Center, Fukuoka, Japan. Electronic 
      address: kusumoto-t@kyumed.jp.
FAU - Sunami, Eiji
AU  - Sunami E
AD  - Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.
FAU - Ota, Mitsuyoshi
AU  - Ota M
AD  - Gastroenterological Center, Yokohama City University Medical Center, Yokohama, 
      Japan.
FAU - Yoshida, Kazuhiro
AU  - Yoshida K
AD  - Department of Surgical Oncology, Gifu University Graduate School of Medicine, 
      Gifu, Japan.
FAU - Sakamoto, Yoshiyuki
AU  - Sakamoto Y
AD  - Department of Gastroenterological Surgery, Hirosaki University Graduate School of 
      Medicine, Hirosaki, Japan.
FAU - Tomita, Naohiro
AU  - Tomita N
AD  - Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, 
      Hyogo, Japan.
FAU - Maeda, Atsuyuki
AU  - Maeda A
AD  - Department of Surgery, Ogaki Municipal Hospital, Gifu, Japan.
FAU - Mochizuki, Izumi
AU  - Mochizuki I
AD  - Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, 
      Iwate, Japan.
FAU - Okabe, Michio
AU  - Okabe M
AD  - Department of General Surgery, Kurashiki Central Hospital, Okayama, Japan.
FAU - Kunieda, Katsuyuki
AU  - Kunieda K
AD  - Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.
FAU - Yamauchi, Junichiro
AU  - Yamauchi J
AD  - Department of Surgery, Sendai Kousei Hospital, Miyagi, Japan.
FAU - Itabashi, Michio
AU  - Itabashi M
AD  - Department of Surgery 2, Tokyo Women's Medical University, Tokyo, Japan.
FAU - Kotake, Kenjiro
AU  - Kotake K
AD  - Department of Surgery, Tochigi Cancer Center, Tochigi, Japan.
FAU - Takahashi, Keiichi
AU  - Takahashi K
AD  - Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center, 
      Komagome Hospital, Tokyo, Japan.
FAU - Baba, Hideo
AU  - Baba H
AD  - Department of Gastroenterological Surgery, Graduate School of Medical Sciences, 
      Kumamoto University, Kumamoto, Japan.
FAU - Boku, Narikazu
AU  - Boku N
AD  - Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 
      Tokyo, Japan.
FAU - Aiba, Keisuke
AU  - Aiba K
AD  - Department of Internal Medicine, Division of Clinical Oncology/Hematology, The 
      Tokyo Jikei University School of Medicine, Tokyo, Japan.
FAU - Ishiguro, Megumi
AU  - Ishiguro M
AD  - Department of Translational Oncology, Tokyo Medical and Dental University, Tokyo, 
      Japan.
FAU - Morita, Satoshi
AU  - Morita S
AD  - Department of Biomedical Statistics and Bioinformatics, Graduate School of 
      Medicine, Kyoto University, Kyoto, Japan.
FAU - Sugihara, Kenichi
AU  - Sugihara K
AD  - Tokyo Medical and Dental University, Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171101
PL  - United States
TA  - Clin Colorectal Cancer
JT  - Clinical colorectal cancer
JID - 101120693
RN  - 0 (Drug Combinations)
RN  - 04ZR38536J (Oxaliplatin)
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/*adverse effects/*methods
MH  - Colorectal Neoplasms/*drug therapy/mortality
MH  - Disease-Free Survival
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Leucovorin/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Oxaliplatin/administration & dosage/adverse effects
MH  - Oxonic Acid/administration & dosage/adverse effects
MH  - Tegafur/administration & dosage/adverse effects
MH  - Uracil/administration & dosage/adverse effects
OTO - NOTNLM
OT  - Adverse events
OT  - L-OHP
OT  - Oral fluorouracil
OT  - Sensory peripheral neuropathy
OT  - Tegafur/gimeracil/oteracil
EDAT- 2017/12/19 06:00
MHDA- 2019/04/02 06:00
CRDT- 2017/12/19 06:00
PHST- 2017/04/21 00:00 [received]
PHST- 2017/10/17 00:00 [revised]
PHST- 2017/10/25 00:00 [accepted]
PHST- 2017/12/19 06:00 [pubmed]
PHST- 2019/04/02 06:00 [medline]
PHST- 2017/12/19 06:00 [entrez]
AID - S1533-0028(17)30161-5 [pii]
AID - 10.1016/j.clcc.2017.10.015 [doi]
PST - ppublish
SO  - Clin Colorectal Cancer. 2018 Jun;17(2):e153-e161. doi: 
      10.1016/j.clcc.2017.10.015. Epub 2017 Nov 1.