Abstract 1627TiP
Background
ICI transformed the prognosis of incurable cancers with lasting remissions. Their original mechanism of action causes side effects related to the immune response (irAEs). Patient Education (PE) could optimize detection, management of irAEs and improve quality of life. The aim of this study is to compare Grade≥3 irAEs in a group of educated patients vs standard care group.
Trial design
A prospective randomised controlled multicentre trial testing an educative program on patients with ICI was approved by the Ethics Committee. The same educational intervention using common tools (REPERE kit) is used in the experimental group (N=274), independent of the centre, versus the control group (N=137). Randomisation 2:1 with minimization on center, location, age, autoimmune disease, ICI combination with ICI/RT/chemotherapy/TKI is applied. Population: patients with cancer (Non-Small Cell Lung Cancer, Renal Cell Cancer, bladder cancer, Head and Neck Cancer, melanoma, cutaneous Squamous Cell Carcinomaand any new FDA approval) treated with ICI are enrolled in the trial. IrAES are analysed by Gustave Roussy’s Pharmacovigilance Unit and incremented in the REISAMIC database which is dedicated to the collection of immunotherapy severe adverse events (CTCAE Grade≥3). Since December 2019, 243 patients /411 were enrolled within 14 investigating centers. 238 patients were randomized, 158 in the experimental group and 80 in the control group.
Clinical trial identification
NCT03948724.
Editorial acknowledgement
Legal entity responsible for the study
Institut de Cancérologie de l’Ouest.
Funding
MSD, Novartis.
Disclosure
V.A. Berger: Non-Financial Interests, Institutional, Project Lead: Institut de Cancérologie de l’Ouest. C. Jubé: Non-Financial Interests, Institutional, Principal Investigator: Institut de Cancérologie de l’Ouest. A. Forestier: Non-Financial Interests, Institutional, Principal Investigator: Centre Oscar Lambret . C. Mitonneau: Non-Financial Interests, Institutional, Principal Investigator: CHD Vendée . S. Limouzin: Non-Financial Interests, Institutional, Principal Investigator: CHD Vendée . L. Morlière: Non-Financial Interests, Institutional, Principal Investigator: Centre léon Bérard. L. Geoffrois: Non-Financial Interests, Institutional, Principal Investigator: Institut de Cancérologie de Lorraine . M. Cabart: Non-Financial Interests, Institutional, Principal Investigator: Institut Bergonié . M. Bertholet: Non-Financial Interests, Institutional, Principal Investigator: CHU St Etienne. C. Llambrich-Molines: Non-Financial Interests, Institutional, Principal Investigator: Institut Curie. S. Breysse: Non-Financial Interests, Institutional, Principal Investigator: CH Emile Roux. S. Laghouati: Non-Financial Interests, Institutional, Pharmacovigilance Unit: Gustave Roussy. N. Beaumont: Non-Financial Interests, Institutional, Principal Investigator: Institut de Cancérologie de l’Ouest. All other authors have declared no conflicts of interest.