medwireNews: Electronic patient-reported outcomes (PROs) to monitor immune-related adverse events (irAEs) during immunotherapy for cancer is associated with a reduction in the incidence of serious AEs, emergency department visits, and treatment discontinuations, and a better quality of life (QoL), research suggests.
The 141 patients assigned to the electronic monitoring group completed a weekly online questionnaire to report their symptoms. This also involved an image recognition function to evaluate grades of typical irAEs. If the patient reported a grade 1 or 2 irAE, they were automatically sent standardized advice, but for higher grade irAEs, the app alerted the healthcare team who followed up via telephone and determined whether the patient should receive treatment or further evaluation.
A further 137 patients were randomly assigned to the traditional follow-up group consisting of clinic visits every 21 days and a telephone follow-up every 3 months.
As reported in JAMA Network Open, the study was carried out across 28 hospitals in China and included 278 patients who were receiving immunotherapy, most commonly for gastric, esophageal, or lung cancer. The majority (65.8%) were using immune checkpoint inhibitor monotherapy, while 16.2% were taking combination targeted agents, and 15.1% were taking combination chemotherapy. They were followed up for 6 months or until treatment completion.
irAEs overall occurred in a comparable number of the ePRO and control arms (78.7 vs 85.4%), most commonly dermatologic irAEs (27.7%), pneumonitis (18.0%), and musculoskeletal irAEs (12.2%). However, ePRO monitoring was associated with a significant reduction in severe irAEs, with respective rates of 20.6% and 33.6% (hazard ratio [HR]=0.51).
In addition, the proportion of patients visiting the emergency department was lower with electronic monitoring, at 16.3% versus 29.9% with in-person monitoring (HR=0.46), as was the rate of treatment discontinuation related to irAEs (3.6 vs 11.0%; HR=0.30).
The EORTC QLQ-C30 QoL total score was higher at 6 months in the ePRO than control group, with mean values of 74.2 versus 64.7 points on a scale of 0 to 100 points, with higher scores indicating better QoL. The between-group differences were especially evident for the physical and emotional function measures. In addition, less time was spent on following up patients (mean 8.2 vs 36.1 minutes), with all differences significantly favoring the intervention.
Xiaotia Zhang (Peking University School of Oncology, Beijing, China) and colleagues say: “These findings suggest that the ePRO follow-up model is efficient and may provide reliable information and management recommendations in patients receiving immunotherapy for cancer.”
In an accompanying commentary, Samuel Takvorian (University of Pennsylvania, Philadelphia, USA) and Tara Kaufmann (University of Texas at Austin, USA) say that “[g]iven the potential for rare but serious irAEs for which early recognition is critical, there is strong rationale for remote PRO monitoring among patients receiving immunotherapy.”
Noting that the total time per follow-up visit was shorter with ePRO than standard monitoring, the commentators suggest that “[a]n important future direction in the field is to study how PRO monitoring can improve efficiency and burden for clinicians while facilitating high-quality care […] especially as we face an epidemic of clinician burnout in health care.”
They therefore conclude that “we should be working to understand how interventions impact patient time spent on health care and incorporating such patient-centered outcomes into clinical trials.”
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JAMA Netw Open 2022; 5: e224427
JAMA Netw Open 2022; 5: e224437