# Real-world evaluation of ImmuCare-PRO patient-reported outcomes in melanoma patients treated with immune checkpoint inhibitors

## TL;DR

A patient-reported outcomes system helped detect immune-related adverse events in melanoma patients receiving immunotherapy, enabling earlier management and reducing emergency visits.

## Contribution

A real-world evaluation of a PRO-based monitoring system for immune-related adverse events in melanoma patients treated with immune checkpoint inhibitors.

## Key findings

- The PRO system detected 64.7% of moderate-to-severe immune-related adverse events with clinical impact.
- The system saved a mean of 4.1 days before the next scheduled visit and prevented unnecessary emergency room visits.
- False alerts were often due to non-specific symptoms like fatigue or general pain.

## Abstract

Toxicity profile of immune checkpoint inhibitors (ICI) poses challenges for early detection of immune-related adverse events (IrAEs). In oncology, patient-reported outcomes (PROs) are reported to have a beneficial effect; however, their efficacy for IrAE detection in melanoma patients remains unclear. A remote patient-monitoring system was created in our department; we investigated its real-world impact in detecting grade 2 or above IrAEs occurring during ICI treatment in melanoma patients.

Patients receiving ICI for a melanoma were followed using a weekly online questionnaire containing 11 symptoms suggestive of IrAE. Moderate/severe symptoms generated an alert score and an intervention by an oncology nurse or physician. The system’s performance in detecting grade 2 or above IrAEs, as well as reasons for missed detections, were retrospectively assessed.

A total of 5202 questionnaires completed by 136 patients led to 783 (15.0%) alert scores; 64 of them were associated with 69 grade 2 or above IrAEs, with 22 (34.4%) questionnaires correctly detecting 27 grade 2 or above IrAEs, saving a mean 4.1 days on the next scheduled visit and leading to only one emergency room visit. Forty-two grade 2 or above IrAEs (mainly blood disorders, n = 31) were not detected. False alerts often resulted from functional or non-specific symptoms (32.3%), such as fatigue or general pain.

The ImmuCare-PRO system correctly detected a third of moderate-to-severe IrAEs, and most of those had clinical impact such as skin toxicities, colitis, and rheumatological IrAEs. This enables earlier management and could avoid unnecessary emergency room visits.

•Evaluation of a PROs program for melanoma on immunotherapy was conducted.•The PRO detected 64.7% of moderate-to-severe adverse events with clinical impact.•The PRO saved a mean of 4.1 days on the next scheduled visit.•False alerts were often due to non-specific symptoms (fatigue, general pain).•High adherence and feasibility were reported in both adjuvant and metastatic settings.

Evaluation of a PROs program for melanoma on immunotherapy was conducted.

The PRO detected 64.7% of moderate-to-severe adverse events with clinical impact.

The PRO saved a mean of 4.1 days on the next scheduled visit.

False alerts were often due to non-specific symptoms (fatigue, general pain).

High adherence and feasibility were reported in both adjuvant and metastatic settings.