PMID- 26475356
OWN - NLM
STAT- MEDLINE
DCOM- 20170111
LR  - 20201209
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Linking)
VI  - 21
IP  - 3
DP  - 2016 Jun
TI  - Multicenter randomized phase II clinical trial of oxaliplatin reintroduction as a 
      third- or later-line therapy for metastatic colorectal cancer-biweekly versus 
      standard triweekly XELOX (The ORION Study).
PG  - 566-72
LID - 10.1007/s10147-015-0911-7 [doi]
AB  - BACKGROUND: The aim of this multicenter, open-label, randomized phase II trial 
      was to evaluate the efficacy of a dose-dense capecitabine and oxaliplatin (XELOX) 
      regimen in patients with metastatic colorectal cancer (mCRC) for whom 
      reintroduction of oxaliplatin had been planned as a third- or later-line regimen. 
      METHODS: The patients with mCRC who had received prior chemotherapy including 
      oxaliplatin and were scheduled for reintroduction of oxaliplatin were randomized 
      to capecitabine (1,000 mg/m(2)) twice daily on days 1-14 and oxaliplatin 
      (130 mg/m(2)) on day 1 every 21 days (Q3W group) or capecitabine (2,000 mg/m(2)) 
      twice daily on days 1-7 and oxaliplatin (85 mg/m(2)) on day 1 every 14 days (Q2W 
      group). The primary endpoint was the time-to-treatment failure (TTF). Other 
      endpoints included overall survival (OS), progression-free survival (PFS) and 
      other adverse events (AEs). RESULTS: A total of 46 patients were enrolled in the 
      trial-22 patients were randomly assigned to the Q3W group and 23 to the Q2W 
      group. The median TTF was 3.4 months in both groups (hazard ratio [HR] 1.053; 
      p = 0.880). The median PFS and OS were 3.3 and 9.2 months in the Q2W group and 
      4.3 and 12.1 months in the Q3W group, respectively (HR 1.15; p = 0.153 and 0.672; 
      p = 0.836). The most common grade 3-4 AEs in the Q3W and Q2W groups were fatigue 
      (27.3 vs 21.7), neuropathy (9.1 vs 0 %) and diarrhea (9.1 vs 0 %), respectively. 
      CONCLUSION: There was no significant inter-group difference in any of the 
      efficacy and safety endpoints, including TTF, OS, RFS and AEs. The results of 
      this clinical trial were convincingly negative.
FAU - Matsuda, Chu
AU  - Matsuda C
AD  - Department of Surgery, Osaka General Medical Center, Osaka, Japan.
FAU - Honda, Michitaka
AU  - Honda M
AD  - Department of Gastroenterological Surgery, Gastroenterological Center, Cancer 
      Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, 
      Koto-ku, Tokyo, 135-8550, Japan. michitaka.honda@jfcr.or.jp.
FAU - Tanaka, Chihiro
AU  - Tanaka C
AD  - Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.
FAU - Fukunaga, Mutsumi
AU  - Fukunaga M
AD  - Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, 
      Japan.
FAU - Ishibashi, Keiichiro
AU  - Ishibashi K
AD  - Department of Surgery, Saitama Medical University, Saitama, Japan.
FAU - Munemoto, Yoshinori
AU  - Munemoto Y
AD  - Department of Surgery, Fukui Saiseikai Hospital, Fukui, Japan.
FAU - Hata, Taishi
AU  - Hata T
AD  - Department of Gastroenterological Surgery, Osaka University, Osaka, Japan.
FAU - Bando, Hiroyuki
AU  - Bando H
AD  - Department of Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, 
      Japan.
FAU - Oshiro, Mitsuru
AU  - Oshiro M
AD  - Department of Surgery, Toho University, Sakura Hospital, Sakura, Japan.
FAU - Kobayashi, Michiya
AU  - Kobayashi M
AD  - Department of Surgery, Kochi Medical School, Kochi University, Kochi, Japan.
FAU - Tokunaga, Yukihiko
AU  - Tokunaga Y
AD  - Department of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan.
FAU - Fujii, Akitomo
AU  - Fujii A
AD  - Department of Surgery, Rinku General Medical Center, Osaka, Japan.
FAU - Nagata, Naoki
AU  - Nagata N
AD  - Kitakyushu General Hospital, Kitakyushu, Japan.
FAU - Oba, Koji
AU  - Oba K
AD  - Department of Epidemiology & Biostatistics, University of Tokyo, Tokyo, Japan.
FAU - Mishima, Hideyuki
AU  - Mishima H
AD  - Clinical Cancer Center, Aichi Medical University, Nagakute, Aichi, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20151016
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Oxaloacetates)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - U3P01618RT (Fluorouracil)
RN  - XELOX
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse 
      effects
MH  - Capecitabine
MH  - Colorectal Neoplasms/*drug therapy/*pathology
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Diarrhea/chemically induced
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Fatigue/chemically induced
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects/*analogs & derivatives
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Nervous System Diseases/chemically induced
MH  - Organoplatinum Compounds/*administration & dosage/adverse effects
MH  - Oxaliplatin
MH  - Oxaloacetates
MH  - Retreatment
MH  - Survival Rate
OTO - NOTNLM
OT  - Metastatic colorectal cancer
OT  - Oxaliplatine
OT  - Reintroduction
EDAT- 2015/10/18 06:00
MHDA- 2017/01/12 06:00
CRDT- 2015/10/18 06:00
PHST- 2015/08/23 00:00 [received]
PHST- 2015/09/28 00:00 [accepted]
PHST- 2015/10/18 06:00 [entrez]
PHST- 2015/10/18 06:00 [pubmed]
PHST- 2017/01/12 06:00 [medline]
AID - 10.1007/s10147-015-0911-7 [pii]
AID - 10.1007/s10147-015-0911-7 [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2016 Jun;21(3):566-72. doi: 10.1007/s10147-015-0911-7. Epub 
      2015 Oct 16.