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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Published in:Biomedicines 2022-05, Vol.10 (5), p.1211
Main Authors: Evrard, Camille, Aparicio, Thomas, Soularue, Emilie, Le Malicot, Karine, Desramé, Jérôme, Botsen, Damien, El Hajbi, Farid, Gonzalez, Daniel, Lepage, Come, Bouché, Olivier, Tougeron, David, On Behalf Of The Durigast-Prodige Investigators/Collaborators
Format: Article
Language:English
Subjects:
Adenocarcinoma
Cancer
Chemotherapy
Convulsions & seizures
Epilepsy
Gastric cancer
gastro-oesophageal junction adenocarcinoma
Hyperthyroidism
Immune checkpoint inhibitors
irinotecan
Metastases
Metastasis
Neuroimaging
Neutropenia
Ostomy
Patients
Safety
safety run-in
Seizures
Tumors
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Summary: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.
ISSN:2227-9059
2227-9059
DOI:10.3390/biomedicines10051211