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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

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 I...

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Autores principales: Evrard, Camille, Aparicio, Thomas, Soularue, Emilie, Le Malicot, Karine, Desramé, Jérôme, Botsen, Damien, El Hajbi, Farid, Gonzalez, Daniel, Lepage, Come, Bouché, Olivier, Tougeron, David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9138589/
https://www.ncbi.nlm.nih.gov/pubmed/35625947
http://dx.doi.org/10.3390/biomedicines10051211
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author Evrard, Camille
Aparicio, Thomas
Soularue, Emilie
Le Malicot, Karine
Desramé, Jérôme
Botsen, Damien
El Hajbi, Farid
Gonzalez, Daniel
Lepage, Come
Bouché, Olivier
Tougeron, David
author_facet Evrard, Camille
Aparicio, Thomas
Soularue, Emilie
Le Malicot, Karine
Desramé, Jérôme
Botsen, Damien
El Hajbi, Farid
Gonzalez, Daniel
Lepage, Come
Bouché, Olivier
Tougeron, David
author_sort Evrard, Camille
collection PubMed
description 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.
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spelling pubmed-91385892022-05-28 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 Evrard, Camille Aparicio, Thomas Soularue, Emilie Le Malicot, Karine Desramé, Jérôme Botsen, Damien El Hajbi, Farid Gonzalez, Daniel Lepage, Come Bouché, Olivier Tougeron, David Biomedicines Article 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. MDPI 2022-05-23 /pmc/articles/PMC9138589/ /pubmed/35625947 http://dx.doi.org/10.3390/biomedicines10051211 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Evrard, Camille
Aparicio, Thomas
Soularue, Emilie
Le Malicot, Karine
Desramé, Jérôme
Botsen, Damien
El Hajbi, Farid
Gonzalez, Daniel
Lepage, Come
Bouché, Olivier
Tougeron, David
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9138589/
https://www.ncbi.nlm.nih.gov/pubmed/35625947
http://dx.doi.org/10.3390/biomedicines10051211
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