1852P - The use of patient-reported outcome measures to assess toxicities and quality of life associated with immune checkpoint inhibitor therapy: A systematic review

Background

Immune checkpoint inhibitors (ICI) are associated both with early (within 12 months) and late immune related adverse events (IRAEs), which can cause significant morbidity/mortality. Early recognition of IRAEs supports prompt management, however there is no consensus regarding optimum methods of monitoring. Patient Reported Outcome Measures (PROMs) yield promise; potentially improving both quality of life (QoL) and overall survival. This systematic review evaluates the PROMS used to identify toxicities/QoL associated with ICI treatment in adult cancer patients.

Methods

PubMed, EMBASE, MEDLINE, PsycInfo, CINAHL, Web of Knowledge and the Cochrane Library were searched for primary research studies (2008 – 2023) which included at least one PROM in the reporting of outcomes at all timepoints (early/late). Results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.

Results

4,088 articles were screened and 31 studies were included (28 published since 2020). The National Cancer Institute PRO-CTCAE was most frequently used to assess ICI toxicities (12 studies), with 11 different PROMs being used overall. 17 PROMs were used to assess patients’ QoL, of which the most frequently used were the EORTC QLQ-C30 and its cancer-specific versions (31 studies), the EQ-5D-5L/3L (12 studies) and the FACT (6 studies). There was marked heterogeneity in the timing of PROMs relative to start of treatment and whether they were used to assess early/acute issues or those developing at a later stage. Missing longitudinal data was a major issue in many studies, which was rarely accounted for in analysis or data interpretation.

Conclusions

There is increased interest in the use of PROMs to support the identification of ICI related IRAEs and QoL issues. Optimization of PROM content to best identify early/late effects and subsequent standardization of use across ICI treatment pathways will facilitate a common language and meta-analysis within and across disease types. Guidelines on how to handle missing data within trials and real-world analyses will strengthen the interpretation of PROM data to inform clinical care.

Clinical trial identification

CRD42023457063.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Funding: National Institute for Health Research Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research Grant B180.

Disclosure

All authors have declared no conflicts of interest.