PMID- 28078540
OWN - NLM
STAT- MEDLINE
DCOM- 20170919
LR  - 20181202
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Print)
IS  - 1341-9625 (Linking)
VI  - 22
IP  - 3
DP  - 2017 Jun
TI  - Preplanned safety analysis of the JFMC37-0801 trial: a randomized phase III study 
      of six months versus twelve months of capecitabine as adjuvant chemotherapy for 
      stage III colon cancer.
PG  - 494-504
LID - 10.1007/s10147-016-1083-9 [doi]
AB  - BACKGROUND: Six months of adjuvant chemotherapy is regarded as the standard of 
      care for patients with stage III colon cancer. However, whether longer treatment 
      can improve prognosis has not been fully investigated. We conducted a phase III 
      study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage 
      III colon cancer, and report here the results of our preplanned safety analysis. 
      METHODS: Patients aged 20-79 years with curatively resected stage III colon 
      cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles 
      (12 months) of capecitabine (2500 mg/m(2)/day on days 1-14 of each 21-day cycle). 
      Treatment exposure and adverse events (AEs) were evaluated. RESULTS: A total of 
      1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were 
      analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, 
      neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 
      12-month group than in the 6-month group. HFS was the only grade >/=3 AE to have a 
      significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The 
      completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 
      46% in the 12-month group. HFS was the most common AE requiring dose reduction 
      and treatment discontinuation. CONCLUSIONS: Twelve months of adjuvant 
      capecitabine demonstrated a higher cumulative incidence of HFS compared to the 
      standard 6-month treatment period, while toxicities after 12 months of 
      capecitabine were clinically acceptable. TRIAL REGISTRATION: UMIN-CTR, 
      UMIN000001367.
FAU - Suto, Takeshi
AU  - Suto T
AD  - Department of Gastroenterological Surgery, Yamagata Prefectural Central Hospital, 
      1800 Aoyagi, Yamagata-shi, Yamagata, 990-2214, Japan.
FAU - Ishiguro, Megumi
AU  - Ishiguro M
AD  - Department of Translational Oncology, Tokyo Medical and Dental University, 1-5-45 
      Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
FAU - Hamada, Chikuma
AU  - Hamada C
AD  - Graduate School of Engineering, Tokyo University of Science, 6-3-1 Niijuku, 
      Katsushika-ku, Tokyo, 125-8585, Japan.
FAU - Kunieda, Katsuyuki
AU  - Kunieda K
AD  - Department of Surgery, Gifu Prefectural General Medical Center, 4-6-1 Noishiki, 
      Gifu-shi, Gifu, 500-8717, Japan.
FAU - Masuko, Hiroyuki
AU  - Masuko H
AD  - Department of Surgery, Nikko Memorial Hospital, 1-5-13 Shintomi-cho, Muroran-shi, 
      Hokkaido, 051-8501, Japan.
FAU - Kondo, Ken
AU  - Kondo K
AD  - Department of Surgery, National Hospital Organization Nagoya Medical Center, 
      4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan.
FAU - Ishida, Hideyuki
AU  - Ishida H
AD  - Department of Digestive Tract and General Surgery, Saitama Medical Center, 
      Saitama Medical University, 1981 Kamoda, Kawagoe-shi, Saitama, 350-8550, Japan.
FAU - Nishimura, Genichi
AU  - Nishimura G
AD  - Department of Surgery, Kanazawa Red Cross Hospital, 2-251 Mimma, Kanazawa-shi, 
      Ishikawa, 921-8162, Japan.
FAU - Sasaki, Kazuaki
AU  - Sasaki K
AD  - Department of Surgery, Otaru Ekisaikai Hospital, 1-10-17 Ironai, Otaru-shi, 
      Hokkaido, 047-0031, Japan.
FAU - Morita, Takayuki
AU  - Morita T
AD  - Department of Surgery, Aomori Prefectural Central Hospital, 2-1-1 
      Higashitsukurimichi, Aomori-shi, Aomori, 030-8553, Japan.
FAU - Hazama, Shoichi
AU  - Hazama S
AD  - Department of Digestive Surgery and Surgical Oncology, Yamaguchi University 
      Graduate School of Medicine, 1-1-1 Minamikogushi, Ube-shi, Yamaguchi, 755-8505, 
      Japan.
FAU - Maeda, Koutarou
AU  - Maeda K
AD  - Department of Lower Gastrointestinal Surgery, Fujita Health University, 1-98 
      Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi, 470-1192, Japan.
FAU - Mishima, Hideyuki
AU  - Mishima H
AD  - Cancer Center, Aichi Medical University, 1-1 Yazakokarimata, Nagakute-shi, Aichi, 
      480-1195, Japan.
FAU - Ike, Hideyuki
AU  - Ike H
AD  - Department of Surgery, Saiseikai Yokohama Southern Hospital, 3-2-10 Konandai, 
      Konan-ku, Yokohama-shi, Kanagawa, 234-8503, Japan.
FAU - Sadahiro, Sotaro
AU  - Sadahiro S
AD  - Department of Surgery, Tokai University School of Medicine, 143 Shimokasuya, 
      Isehara-shi, Kanagawa, 259-1193, Japan.
FAU - Sugihara, Kenichi
AU  - Sugihara K
AD  - Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, 
      Japan.
FAU - Okajima, Masazumi
AU  - Okajima M
AD  - The Second Department of Surgery, Hiroshima University School of Medicine, 7-33 
      Motomachi, Naka-ku, Hiroshima-shi, Hiroshima, 730-8518, Japan.
FAU - Saji, Shigetoyo
AU  - Saji S
AD  - Japanese Foundation for Multidisciplinary Treatment of Cancer, 1-28-6 Kameido, 
      Koto-ku, Tokyo, 136-0071, Japan.
FAU - Sakamoto, Junichi
AU  - Sakamoto J
AD  - Japanese Foundation for Multidisciplinary Treatment of Cancer, 1-28-6 Kameido, 
      Koto-ku, Tokyo, 136-0071, Japan.
FAU - Tomita, Naohiro
AU  - Tomita N
AD  - Division of Lower Gastrointestinal Surgery, Department of Surgery, Hyogo College 
      of Medicine, 1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo, 663-8501, Japan. 
      ntomita@hyo-med.ac.jp.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170111
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 6804DJ8Z9U (Capecitabine)
SB  - IM
EIN - Int J Clin Oncol. 2017 Aug;22(4):805-806. PMID: 28608229
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Capecitabine/administration & dosage/*adverse effects/*therapeutic use
MH  - Chemotherapy, Adjuvant/adverse effects/methods
MH  - Colonic Neoplasms/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Hand-Foot Syndrome/etiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC5486458
OTO - NOTNLM
OT  - Adjuvant chemotherapy
OT  - Adverse events
OT  - Capecitabine
OT  - Colon cancer
OT  - Hand-foot syndrome
OT  - Treatment duration
COIS- MI has received consulting fees from Taiho Pharmaceutical; honoraria from Taiho, 
      Yakult Honsha, and Merck Serono; research funding from Taiho Pharmaceutical and 
      Yakult Honsha. SH has received research funding from Toyo-Kohan and NEC 
      Corporation. HMi has received honoraria from Chugai and Merck Serono; research 
      funding from Chugai, Taiho, Yakult, and Daiichi-Sankyo. KSu has received 
      honoraria from Chugai Pharmaceutical Co., Taiho Pharmaceutical Co., Merk Serono 
      Co., Bayer Yakuhin Ltd., and Eli Lilly Co. as well as research funding from 
      Chugai Pharmaceutical Co. and Taiho Pharmaceutical Co. JS has received honoraria 
      from Yakult Honsha Co. Ltd, and consultancy fee from Takeda Co. Ltd. All 
      remaining authors have declared no conflict of interest.
EDAT- 2017/01/13 06:00
MHDA- 2017/09/20 06:00
PMCR- 2017/01/11
CRDT- 2017/01/13 06:00
PHST- 2016/11/02 00:00 [received]
PHST- 2016/12/23 00:00 [accepted]
PHST- 2017/01/13 06:00 [pubmed]
PHST- 2017/09/20 06:00 [medline]
PHST- 2017/01/13 06:00 [entrez]
PHST- 2017/01/11 00:00 [pmc-release]
AID - 10.1007/s10147-016-1083-9 [pii]
AID - 1083 [pii]
AID - 10.1007/s10147-016-1083-9 [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2017 Jun;22(3):494-504. doi: 10.1007/s10147-016-1083-9. Epub 
      2017 Jan 11.