Abstract

BackgroundImmune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved toxicity profile and quality of life. Symptom data collected by electronic (e) patient-reported outcomes (PRO) could be used as an input for machine learning (ML) based prediction models for the early detection of irAEs.MethodsThe utilized dataset consisted of two data sources. The first dataset consisted of 820 completed symptom questionnaires from 34 ICI treated advanced cancer patients, including 18 monitored symptoms collected using the Kaiku Health digital platform. The second dataset included prospectively collected irAE data, Common Terminology Criteria for Adverse Events (CTCAE) class, and the severity of 26 irAEs. The ML models were built using extreme gradient boosting algorithms. The first model was trained to detect the presence and the second the onset of irAEs.ResultsThe model trained to predict the presence of irAEs had an excellent performance based on four metrics: accuracy score 0.97, Area Under the Curve (AUC) value 0.99, F1-score 0.94 and Matthew’s correlation coefficient (MCC) 0.92. The prediction of the irAE onset was more difficult with accuracy score 0.96, AUC value 0.93, F1-score 0.66 and MCC 0.64 but the model performance was still at a good level.ConclusionThe current study suggests that ML based prediction models, using ePRO data as an input, can predict the presence and onset of irAEs with a high accuracy, indicating that ePRO follow-up with ML algorithms could facilitate the detection of irAEs in ICI-treated cancer patients. The results should be validated with a larger dataset.Trial registration Clinical Trials Register (NCT3928938), registration date the 26th of April, 2019

Highlights

  • Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events, arising from various organ systems without strong timely dependency on therapy dosing

  • We have previously shown that the real-world symptom data collected with Kaiku Health Electronic patient reported outcome (ePRO) tool on cancer patients receiving ICI therapy aligns with the data from clinical trials, and that correlations between different symptoms occur, which might reflect therapeutic efficiency, side effects, or tumor progression [20, 21]

  • The results show that machine learning (ML) models based on the ePRO and structured electronic health care record (EHR) data could accurately predict the presence of immune-related adverse events (irAEs)

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Summary

Introduction

Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Detection of irAEs could result in improved toxicity profile and quality of life. ICIs are associated with unique immune related adverse events (irAEs). These toxicities can arise from various organ systems, and, at any time point without temporal connection to the Iivanainen et al BMC Med Inform Decis Mak (2021) 21:205 therapy which makes these more unpredictable than AEs with traditional cancer therapies. Early detection of irAEs could result in an improved safety of the treatment and better quality of life (QoL)

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