PMID- 29340058
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 1949-2553 (Electronic)
IS  - 1949-2553 (Linking)
VI  - 8
IP  - 67
DP  - 2017 Dec 19
TI  - A multicenter prospective phase II study of first-line modified FOLFIRINOX for 
      unresectable advanced pancreatic cancer.
PG  - 111346-111355
LID - 10.18632/oncotarget.22795 [doi]
AB  - BACKGROUND: FOLFIRINOX (FX) has been reported as an effective treatment for 
      unresectable advanced pancreatic cancer. However, FX is associated with a high 
      incidence of adverse events (AEs). A previous phase II study in Japan showed high 
      incidences of hematological AEs, including febrile neutropenia (22.2%). A 
      modified FX regimen (mFX) may decrease the rates of AEs and be more effective 
      than FX by improving the treatment compliance. AIMS: To assess the safety and 
      efficacy of first-line mFX for unresectable advanced pancreatic cancer. PATIENTS 
      AND METHODS: This was as a multicenter prospective phase II study in 
      chemotherapy-naive Japanese patients with pathologically confirmed unresectable 
      advanced pancreatic adenocarcinoma or adenosquamous carcinoma. Treatment with mFX 
      (85 mg/m2 oxaliplatin, 150 mg/m2 irinotecan, and 200 mg/m2 l-leucovorin, followed 
      by 46-h continuous infusion of 2400 mg/m2 5-fluorouracil) was administered every 
      2 weeks. The primary endpoint was the response rate. The secondary endpoints were 
      overall survival, progression-free survival, and safety. RESULTS: Thirty-one 
      patients (18 men; median age, 64 years) were enrolled. A median of 13 treatment 
      cycles were administered during a median follow-up period of 14.2 months. The 
      response rate, median overall survival, and median progression-free survival were 
      38.7%, 14.9 months, and 7.0 months, respectively. Grade 3 or 4 AEs included 
      neutropenia (83.9%), febrile neutropenia (16.1%), peripheral sensory neuropathy 
      (9.7%), thrombocytopenia (6.5%), diarrhea (6.5%), anorexia (6.5%), and vomiting 
      (3.2%). CONCLUSION: Compared to FX, mFX may result in fewer Grade 3 or 4 
      non-hematological AEs, with a comparable response rate. However, further efforts 
      might be required to reduce hematological AEs.
FAU - Yoshida, Kensaku
AU  - Yoshida K
AD  - First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
FAU - Iwashita, Takuji
AU  - Iwashita T
AD  - First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
FAU - Uemura, Shinya
AU  - Uemura S
AD  - First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
FAU - Maruta, Akinori
AU  - Maruta A
AD  - First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
FAU - Okuno, Mitsuru
AU  - Okuno M
AD  - First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
FAU - Ando, Nobuhiro
AU  - Ando N
AD  - Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, 
      Japan.
FAU - Iwata, Keisuke
AU  - Iwata K
AD  - Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, 
      Japan.
FAU - Kawaguchi, Junji
AU  - Kawaguchi J
AD  - Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
FAU - Mukai, Tsuyoshi
AU  - Mukai T
AD  - Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
FAU - Shimizu, Masahito
AU  - Shimizu M
AD  - First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
LA  - eng
PT  - Journal Article
DEP - 20171130
PL  - United States
TA  - Oncotarget
JT  - Oncotarget
JID - 101532965
PMC - PMC5762326
OTO - NOTNLM
OT  - adverse events
OT  - biliary drainage
OT  - dose modification
OT  - febrile neutropenia
OT  - risk factor
COIS- CONFLICTS OF INTEREST Kensaku Yoshida, Takuji Iwashita, Shinya Uemura, Akinori 
      Maruta, Mitsuru Okuno, Nobuhiro Ando, Keisuke Iwata, Jyunji Kawaguchi, Tsuyoshi 
      Mukai, Masahito Shimizu have nothing to declare.
EDAT- 2018/01/18 06:00
MHDA- 2018/01/18 06:01
PMCR- 2017/12/19
CRDT- 2018/01/18 06:00
PHST- 2017/08/24 00:00 [received]
PHST- 2017/11/13 00:00 [accepted]
PHST- 2018/01/18 06:00 [entrez]
PHST- 2018/01/18 06:00 [pubmed]
PHST- 2018/01/18 06:01 [medline]
PHST- 2017/12/19 00:00 [pmc-release]
AID - 22795 [pii]
AID - 10.18632/oncotarget.22795 [doi]
PST - epublish
SO  - Oncotarget. 2017 Nov 30;8(67):111346-111355. doi: 10.18632/oncotarget.22795. 
      eCollection 2017 Dec 19.