PMID- 30679316
OWN - NLM
STAT- MEDLINE
DCOM- 20200630
LR  - 20200630
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 24
IP  - 6
DP  - 2019 Jun
TI  - Phase II Study of the Triple Combination Chemotherapy of SOXIRI 
      (S-1/Oxaliplatin/Irinotecan) in Patients with Unresectable Pancreatic Ductal 
      Adenocarcinoma.
PG  - 749-e224
LID - 10.1634/theoncologist.2018-0900 [doi]
AB  - LESSONS LEARNED: The triple combination chemotherapy of SOXIRI 
      (S-1/oxaliplatin/irinotecan) in patients with unresectable pancreatic ductal 
      adenocarcinoma was an effective treatment that appeared to be better tolerated 
      than the widely used FOLFIRINOX regimen.SOXIRI regimen may provide an alternative 
      approach for advanced pancreatic cancer. BACKGROUND: In our previous phase I 
      study, we determined the recommended dose of a biweekly S-1, oxaliplatin, and 
      irinotecan (SOXIRI) regimen in patients with unresectable pancreatic ductal 
      adenocarcinoma (PDAC). This phase II study was conducted to assess the safety and 
      clinical efficacy in patients with unresectable PDAC. METHODS: Patients with 
      previously untreated metastatic and locally advanced PDAC were enrolled. The 
      primary endpoint was response rate (RR). Secondary endpoints were adverse events 
      (AEs), progression-free survival (PFS), and overall survival (OS). Patients 
      received 80 mg/m(2) of S-1 twice a day for 2 weeks in alternate-day 
      administration, 150 mg/m(2) of irinotecan on day 1, and 85 mg/m(2) of oxaliplatin 
      on day 1 of a 2-week cycle. RESULTS: Thirty-five enrolled patients received a 
      median of six (range: 2-15) treatment cycles. The RR was 22.8% (95% confidence 
      interval [CI]: 10.4-40.1); median OS, 17.7 months (95% CI: 9.8-22.0); and median 
      PFS, 7.4 months (95% CI: 4.2-8.4). Furthermore, the median OS in patients with 
      distant metastasis was 10.1 months, whereas that in patients with locally 
      advanced PDAC was 22.6 months. Major grade 3 or 4 toxicity included neutropenia 
      (54%), anemia (17%), febrile neutropenia (11%), anorexia (9%), diarrhea (9%), and 
      nausea (9%). There were no treatment-related deaths. CONCLUSION: SOXIRI is 
      considered a promising and well-tolerated regimen in patients with unresectable 
      PDAC.
CI  - (c) AlphaMed Press; the data published online to support this summary are the 
      property of the authors.
FAU - Akahori, Takahiro
AU  - Akahori T
AD  - Department of Surgery, Nara Medical University, Nara, Japan.
FAU - Sho, Masayuki
AU  - Sho M
AD  - Department of Surgery, Nara Medical University, Nara, Japan 
      akahorin@naramed-u.ac.jp.
FAU - Yanagimoto, Hiroaki
AU  - Yanagimoto H
AD  - Department of Surgery, Kansai Medical University, Osaka, Japan.
FAU - Satoi, Sohei
AU  - Satoi S
AD  - Department of Surgery, Kansai Medical University, Osaka, Japan.
FAU - Nagai, Minako
AU  - Nagai M
AD  - Department of Surgery, Nara Medical University, Nara, Japan.
FAU - Nishiwada, Satoshi
AU  - Nishiwada S
AD  - Department of Surgery, Nara Medical University, Nara, Japan.
FAU - Nakagawa, Kenji
AU  - Nakagawa K
AD  - Department of Surgery, Nara Medical University, Nara, Japan.
FAU - Nakamura, Kota
AU  - Nakamura K
AD  - Department of Surgery, Nara Medical University, Nara, Japan.
FAU - Yamamoto, Tomohisa
AU  - Yamamoto T
AD  - Department of Surgery, Kansai Medical University, Osaka, Japan.
FAU - Hirooka, Satoshi
AU  - Hirooka S
AD  - Department of Surgery, Kansai Medical University, Osaka, Japan.
FAU - Yamaki, So
AU  - Yamaki S
AD  - Department of Surgery, Kansai Medical University, Osaka, Japan.
FAU - Ikeda, Naoya
AU  - Ikeda N
AD  - Department of Surgery, Nara Medical University, Nara, Japan.
LA  - eng
SI  - UMIN-CTR/UMIN000014339
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20190124
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Drug Combinations)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 150863-82-4 (S 1 (combination))
RN  - 1548R74NSZ (Tegafur)
RN  - 5VT6420TIG (Oxonic Acid)
RN  - 7673326042 (Irinotecan)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/pathology
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carcinoma, Pancreatic Ductal/*drug therapy/pathology
MH  - Cohort Studies
MH  - Drug Combinations
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Irinotecan/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Oxaliplatin/administration & dosage
MH  - Oxonic Acid/administration & dosage
MH  - Pancreatic Neoplasms/*drug therapy/pathology
MH  - Prognosis
MH  - Tegafur/administration & dosage
PMC - PMC6656520
EDAT- 2019/01/27 06:00
MHDA- 2020/07/01 06:00
PMCR- 2019/01/24
CRDT- 2019/01/26 06:00
PHST- 2018/08/25 00:00 [received]
PHST- 2018/12/17 00:00 [accepted]
PHST- 2019/01/27 06:00 [pubmed]
PHST- 2020/07/01 06:00 [medline]
PHST- 2019/01/26 06:00 [entrez]
PHST- 2019/01/24 00:00 [pmc-release]
AID - theoncologist.2018-0900 [pii]
AID - ONCO12816 [pii]
AID - 10.1634/theoncologist.2018-0900 [doi]
PST - ppublish
SO  - Oncologist. 2019 Jun;24(6):749-e224. doi: 10.1634/theoncologist.2018-0900. Epub 
      2019 Jan 24.