PMID- 33994125
OWN - NLM
STAT- MEDLINE
DCOM- 20220201
LR  - 20220201
IS  - 1878-3562 (Electronic)
IS  - 1590-8658 (Linking)
VI  - 53
IP  - 7
DP  - 2021 Jul
TI  - FOLFIRINEC: a randomized phase II trial of mFOLFIRINOX vs platinum-etoposide for 
      metastatic neuroendocrine carcinoma of gastroenteropancreatic or unknown origin.
PG  - 824-829
LID - S1590-8658(21)00201-2 [pii]
LID - 10.1016/j.dld.2021.04.016 [doi]
AB  - BACKGROUND: Poorly differentiated neuroendocrine carcinomas (NEC) are rare 
      diseases with a poor prognosis. Platinum-etoposide (PE) has been the recommended 
      first-line treatment for decades. FOLFIRINEC (NCT04325425) is a national 
      multicenter randomized phase II study which aims to challenge this standard 
      regimen. METHODS: The primary objective is to compare the median progression-free 
      survival (PFS) under mFOLFIRINOX versus PE. The secondary objectives are to 
      evaluate the objective response rates (ORR), median overall survival (OS), safety 
      and quality of life. The associated real-time translational study will establish 
      a molecular profile for each patient enrolled. MAIN INCLUSION CRITERIA ARE: NEC 
      of gastroenteropancreatic (GEP) or unknown origin, metastatic and RECIST 1.1 
      evaluable disease, tumor sample available and no contraindication to 
      chemotherapy. Patients will be randomized 1:1 between PE every 21 days for 6-8 
      cycles and mFOLFIRINOX every 14 days for up to 12 cycles and stratified according 
      to center, performance status, Ki67 and pathological subtype. This trial will 
      randomize 218 patients (24 months of follow-up) to have 80% power to detect an 
      improvement of the median PFS from 5 months under PE to 7.5 months under 
      mFOLFIRINOX (HR of 0.67, alpha =5%, two-sided). An intermediate analysis is planned 
      at 50% of events. Recruitment started on October 20, 2020.
CI  - Copyright (c) 2021 Editrice Gastroenterologica Italiana S.r.l. Published by 
      Elsevier Ltd. All rights reserved.
FAU - Hadoux, Julien
AU  - Hadoux J
AD  - Endocrine oncology, Imaging department, Gustave Roussy, 114 rue Edouard Vaillant, 
      Villejuif F-94805, France. Electronic address: Julien.hadoux@gustaveroussy.fr.
FAU - Afchain, Pauline
AU  - Afchain P
AD  - Department of Oncology, Saint Antoine Hospital, Paris, France.
FAU - Walter, Thomas
AU  - Walter T
AD  - Department of Oncology, ENETS Centre of Excellence, Hospices Civils de Lyon and 
      Lyon University, Lyon, France.
FAU - Tougeron, David
AU  - Tougeron D
AD  - Department of Hepato-gastroenterology, Poitiers University Hospital; University 
      of Poitiers, Poitiers, France.
FAU - Hautefeuille, Vincent
AU  - Hautefeuille V
AD  - Department of Hepato-gastroenterology, Amiens University Hospital, Amiens, 
      France.
FAU - Monterymard, Carole
AU  - Monterymard C
AD  - FFCD EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche-Comte, Dijon, 
      France.
FAU - Lorgis, Veronique
AU  - Lorgis V
AD  - Department of Oncology, Cancerology institut of Bourgogne GRReCC, Dijon, France.
FAU - Thuillier, Frederic
AU  - Thuillier F
AD  - Department of Oncology, Limoges University Hospital, Limoges, France.
FAU - Baudin, Eric
AU  - Baudin E
AD  - Endocrine oncology, Imaging department, Gustave Roussy, 114 rue Edouard Vaillant, 
      Villejuif F-94805, France.
FAU - Scoazec, Jean Yves
AU  - Scoazec JY
AD  - Pathology, Biopathology department, Gustave Roussy, Villejuif, F-94805, France.
FAU - Lepage, Come
AU  - Lepage C
AD  - FFCD EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche-Comte, Dijon, 
      France; Department of digestive oncology University hospital Dijon, University of 
      Burgundy and Franche Comte, Dijon, France.
FAU - Desgrippes, Romain
AU  - Desgrippes R
AD  - Hepato-gastroenterology department, Centre Hospitalier de Saint-Malo, Saint-Malo 
      F-35403, France.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210512
PL  - Netherlands
TA  - Dig Liver Dis
JT  - Digestive and liver disease : official journal of the Italian Society of 
      Gastroenterology and the Italian Association for the Study of the Liver
JID - 100958385
RN  - 0 (Biomarkers)
RN  - 0 (Platinum Compounds)
RN  - 0 (folfirinox)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 6PLQ3CP4P3 (Etoposide)
RN  - 7673326042 (Irinotecan)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
RN  - Gastro-enteropancreatic neuroendocrine tumor
SB  - IM
MH  - Adult
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
MH  - Biomarkers/analysis
MH  - Carcinoma, Neuroendocrine/*drug therapy
MH  - Etoposide/*administration & dosage
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Humans
MH  - Intestinal Neoplasms/*drug therapy
MH  - Irinotecan/administration & dosage
MH  - Leucovorin/administration & dosage
MH  - Male
MH  - Neoplasm Metastasis
MH  - Neoplasms, Unknown Primary/*drug therapy
MH  - Neuroendocrine Tumors/*drug therapy
MH  - Oxaliplatin/administration & dosage
MH  - Pancreatic Neoplasms/*drug therapy
MH  - Platinum Compounds/*administration & dosage
MH  - Progression-Free Survival
MH  - Prospective Studies
MH  - Quality of Life
MH  - Stomach Neoplasms/*drug therapy
MH  - Survival Rate
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chemotherapy
OT  - FOLFIRINOX
OT  - Gastroenteropancreatic
OT  - Neuroendocrine carcinoma
COIS- Declaration of Competing Interest None
EDAT- 2021/05/18 06:00
MHDA- 2022/02/02 06:00
CRDT- 2021/05/17 05:44
PHST- 2021/03/04 00:00 [received]
PHST- 2021/04/11 00:00 [revised]
PHST- 2021/04/12 00:00 [accepted]
PHST- 2021/05/18 06:00 [pubmed]
PHST- 2022/02/02 06:00 [medline]
PHST- 2021/05/17 05:44 [entrez]
AID - S1590-8658(21)00201-2 [pii]
AID - 10.1016/j.dld.2021.04.016 [doi]
PST - ppublish
SO  - Dig Liver Dis. 2021 Jul;53(7):824-829. doi: 10.1016/j.dld.2021.04.016. Epub 2021 
      May 12.