PMID- 35625947
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2227-9059 (Print)
IS  - 2227-9059 (Electronic)
IS  - 2227-9059 (Linking)
VI  - 10
IP  - 5
DP  - 2022 May 23
TI  - Safety of FOLFIRI + Durvalumab +/- Tremelimumab in Second Line of Patients with 
      Advanced Gastric Cancer: A Safety Run-In from the Randomized Phase II Study 
      DURIGAST PRODIGE 59.
LID - 10.3390/biomedicines10051211 [doi]
LID - 1211
AB  - Efficacy of immune checkpoint inhibitors (ICI) as monotherapy in 2nd line 
      treatment for gastric or gastro-oesophageal junction (GEJ) adenocarcinoma is low, 
      with no evaluation of efficacy and safety of ICI combined with chemotherapy. The 
      DURIGAST PRODIGE 59 study is a randomised, multicentre, phase II study designed 
      to assess the efficacy and safety of the combination of FOLFIRI + Durvalumab +/- 
      Tremelimumab as 2nd line treatment of patients with advanced gastric/GEJ 
      adenocarcinoma. Here, we report data from the safety run-in phase with FOLFIRI 
      Durvalumab (arm A) or FOLFIRI Durvalumab and Tremelimumab (arm B). Among the 11 
      patients included, 63.6% experienced at least one grade 3-4 adverse events (AEs) 
      related to the treatment, most frequently neutropenia (36.4%). There was only one 
      immune-related AE (grade 2 hyperthyroidism). Ten serious AEs were described among 
      six patients, but only two were related to the treatment, due to the 
      chemotherapy. One seizure epilepsy related to a brain metastasis was observed, 
      but was not related by the investigator to the treatment. However, the 
      Independent Data Monitoring Committee recommended brain imaging at inclusion. 
      This safety run-in phase demonstrates an expected safety profile of FOLFIRI with 
      Durvalumab +/- Tremelimumab combination allowing the randomised phase II.
FAU - Evrard, Camille
AU  - Evrard C
AD  - Service d'Oncologie Medicale, Centre Hospitalo-Universitaire de Poitiers, 86000 
      Poitiers, France.
FAU - Aparicio, Thomas
AU  - Aparicio T
AUID- ORCID: 0000-0001-8834-6927
AD  - Service d'Hepato Gastro-Enterologie et de Cancerologie Digestive, Hopital Saint 
      Louis, 75010 Paris, France.
FAU - Soularue, Emilie
AU  - Soularue E
AD  - Service d'Oncologie Medicale, Institute Mutualiste Montsouris, 75014 Paris, 
      France.
FAU - Le Malicot, Karine
AU  - Le Malicot K
AD  - Federation Francophone de Cancerologie Digestive, EPICAD INSERM LNC-UMR 1231, 
      Universite de Bourgogne Franche-Comte, 21000 Dijon, France.
FAU - Desrame, Jerome
AU  - Desrame J
AD  - Institut de Cancerologie, Hopital Prive Jean Mermoz, 69008 Lyon, France.
FAU - Botsen, Damien
AU  - Botsen D
AD  - Service d'Hepato Gastro-Enterologie et de Cancerologie Digestive, Hopital 
      Universitaire de Reims, 51100 Reims, France.
FAU - El Hajbi, Farid
AU  - El Hajbi F
AD  - Service d'Hepato Gastro-Enterologie et de Cancerologie Digestive, Centre Oscar 
      Lambret, 59000 Lille, France.
FAU - Gonzalez, Daniel
AU  - Gonzalez D
AD  - Federation Francophone de Cancerologie Digestive, EPICAD INSERM LNC-UMR 1231, 
      Universite de Bourgogne Franche-Comte, 21000 Dijon, France.
FAU - Lepage, Come
AU  - Lepage C
AD  - Federation Francophone de Cancerologie Digestive, EPICAD INSERM LNC-UMR 1231, 
      Universite de Bourgogne Franche-Comte, 21000 Dijon, France.
AD  - Service d'Hepato Gastro-Enterologie, Hopital Universitaire de Dijon, 21000 Dijon, 
      France.
FAU - Bouche, Olivier
AU  - Bouche O
AUID- ORCID: 0000-0002-8284-3743
AD  - Service d'Hepato Gastro-Enterologie et de Cancerologie Digestive, Hopital 
      Universitaire de Reims, 51100 Reims, France.
FAU - Tougeron, David
AU  - Tougeron D
AUID- ORCID: 0000-0002-8065-9635
AD  - Service d'Hepato Gastro-Enterologie, Hopital Universitaire de Poitiers, 86000 
      Poitiers, France.
AD  - Faculte de Medecine et de Pharmacie, Universite de Poitiers, 86000 Poitiers, 
      France.
FAU - On Behalf Of The Durigast-Prodige Investigators/Collaborators
AU  - On Behalf Of The Durigast-Prodige Investigators/Collaborators
LA  - eng
GR  - none/Federation Francophone de Cancerologie Digestive/
GR  - none/AstraZeneca (France)/
PT  - Journal Article
DEP - 20220523
PL  - Switzerland
TA  - Biomedicines
JT  - Biomedicines
JID - 101691304
PMC - PMC9138589
OTO - NOTNLM
OT  - gastric cancer
OT  - gastro-oesophageal junction adenocarcinoma
OT  - immune checkpoint inhibitors
OT  - irinotecan
OT  - safety run-in
COIS- David Tougeron has served in a consulting/advisory role for Astra Zeneca. Other 
      authors declare no conflict of interests related to this work. The funders had no 
      role in the design of the study; in the collection, analyses, or interpretation 
      of data; in the writing of the manuscript, or in the decision to publish the 
      results.
EDAT- 2022/05/29 06:00
MHDA- 2022/05/29 06:01
PMCR- 2022/05/23
CRDT- 2022/05/28 01:08
PHST- 2022/04/12 00:00 [received]
PHST- 2022/05/13 00:00 [revised]
PHST- 2022/05/19 00:00 [accepted]
PHST- 2022/05/28 01:08 [entrez]
PHST- 2022/05/29 06:00 [pubmed]
PHST- 2022/05/29 06:01 [medline]
PHST- 2022/05/23 00:00 [pmc-release]
AID - biomedicines10051211 [pii]
AID - biomedicines-10-01211 [pii]
AID - 10.3390/biomedicines10051211 [doi]
PST - epublish
SO  - Biomedicines. 2022 May 23;10(5):1211. doi: 10.3390/biomedicines10051211.