2182P - Patient involvement to improve prospective follow-up: Quality of life data after cancer immunotherapy from the PRAISE study

Background

The PRAISE cohort evaluates the incidence, severity and consequences of secondary autoimmune events, OASI (Opportunistic Autoimmunity Secondary to cancer Immunotherapy) or IRAE (Immune-Related Adverse Events). This analysis presents the methodology to involve patients in improving follow-up and tolerability as well as initial Quality of Life (QoL) data.

Methods

PRAISE is a French, longitudinal, observational, prospective, multicentre (59 sites) e-cohort of patients initiating ipilimumab and/or nivolumab cancer immunotherapy using patient-reported outcomes. QoL assessment was designed collaboratively with volunteers from the e-cohort. A literature review and two video conferences with 27 patients guided the choice of QoL questionnaires based on completion time, dimensions, items, and wording.

Results

As of 22/01/2022, monthly patient follow-up forms included a mandatory general QoL questionnaire (EQ-5D-5L) and an optional specific questionnaire (EORTC QLQ-C30). Between 09/12/2019 and 21/04/2023, 861 patients (268 women [31.1%]) were included (age = 66.1 ± 10.9 yrs). Most had lung (SCLC, n=256), kidney (ccRCC, n=204) or melanoma (n=202) cancers and 674 (78.3%) were treated at a metastatic stage. QoL data was available for 409 patients, with 1-month data available for 218 (83.5%) of the 261 patients included after 22/01/22. Of these, 188 (72.0%) completed the EORTC QLQ-C30. The EQ-5D-5L VAS score (67.7 ± 19.9), EQ-5D index (0.66 ± 0.31), and EORTC QLQ-C30 global health score (64.5 ± 21.6) and function scores were significantly worse than in the general population except for emotional functioning (p<0.01). Table: 2182P

1-month QoL sub-scores

* Significant difference with general population: EQ-5D-5L: Chi-Squared, p<0.01, comparison values from Gautier et al. 2023. EORTC-QLQ-C30: Double-sided t-test, p<0.01, comparison values from Scott et al. 2008

Conclusions

Patient implication contributed to high response rates to selected QoL questionnaires which show that patients’ QoL and functioning are significantly impaired. Integrating these data in the prospective follow-up of this study will provide a more detailed analysis of cancer immunotherapy and potential OASI on patients.

Clinical trial identification

NCT03849131.

Editorial acknowledgement

Legal entity responsible for the study

Hôpitaux Universitaires de Strasbourg.

Funding

Bristol Myers Squibb.

Disclosure

J. Gottenberg: Financial Interests, Personal, Financially compensated role: AbbVie, MSD, Janssen, Pfizer, UCB, and Lilly; Financial Interests, Personal and Institutional, Funding: Bristol Myers Squibb and Roche; Financial Interests, Institutional, Funding: Pfizer and Bristol Myers Squibb. C. Chouaid: Financial Interests, Personal, Advisory Board: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen; Financial Interests, Institutional, Funding: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen. P. Barthelemy: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck, Pfizer, Ipsen, Bayer, Janssen Cilag, Astellas, Novartis, Amgen, Gilead; Financial Interests, Personal, Invited Speaker: AstraZeneca, Seagen. S. Oudard: Financial Interests, Personal, Advisory Role: Astellas and Janssen, Bayer, Bristol Myers Squibb, Eisai, Merck, Sharp & Dohme, Novartis, and Pfizer; Financial Interests, Institutional, Funding: Ipsen; Financial Interests, Personal and Institutional, Funding: Sanofi. All other authors have declared no conflicts of interest.