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

Sebbag, Gottenberg, Chouaid, et al. Poster 2182P. European Society for Medical Oncology. 2023.


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).


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.


(Poster) Sebbag E, Gottenberg JE, Chouaid C, et al. 2182P Patient involvement to improve prospective follow-up: Quality of life data after cancer immunotherapy from the PRAISE study. Annals of Oncology. 2023;34:S1130-S1131. doi:10.1016/j.annonc.2023.09.962


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