Abstract
BackgroundImmune checkpoint inhibitors (ICI) have become standard treatment in different tumor entities. However, safe treatment with ICI targeting the PD-1/PD-L1 axis requires early detection of immune-related adverse events (irAE). There exist different questionnaires of drug manufacturers for the detection of irAE that have not been validated so far.MethodsThe prospective non-interventional ST-ICI trial studied treatment with PD-1/PD-L1 ICI alone or combined with radiotherapy. In the current analysis, the detection rate of self-reported irAE with a patient questionnaire containing 41 different questions was compared to clinician-reported irAE.ResultsBetween April 2017 and August 2019, a total of 104 patients were prospectively enrolled. NSCLC (44%) and HNSCC (42%) were the most frequent tumor entities. A total of 784 questionnaires were collected. A total of 29 irAE were reported by clinicians. The most frequent irAE was hypothyroidism (9%), followed by skin reactions (5%), hepatitis (4%), diarrhea (3%), and pneumonitis (3%). Questions that became significantly more often positive at time points of clinician-reported irAE were “weight change”, “difficulty to grip things”, “bloody or mucous stool” and “insomnia”. Self-reported organ-specific questions detected at least 50% of clinician-reported irAE of gastrointestinal, lung, endocrine, and skin irAE. It was not possible to detect hepatic irAE with the questionnaire.ConclusionQuestionnaires can help to detect gastrointestinal, lung, endocrine, or skin irAE, but not hepatic irAE. Questions on “weight change” and “insomnia” may help to increase the detection rate of irAE, besides organ-specific questions. These results are a valuable contribution to the future development of a specific and practicable questionnaire for early self-reported detection of irAE during ICI therapy in cancer patients.Trial registrationClinicalTrials.gov, NCT03453892. Registered on 05 March 2018.
Highlights
Immune checkpoint inhibitors (ICI) have become standard treatment in different tumor entities
Patient selfreports on immune-related adverse events (irAE) may help to ensure an early detection of irAE despite these long dose intervals
Patients Patients with non-melanoma solid tumors and the indication for ICI treatment with either a Programmed cell death 1 protein (PD-1) or Programmed cell death ligand 1 (PD-L1) inhibitor were eligible for the trial
Summary
Immune checkpoint inhibitors (ICI) have become standard treatment in different tumor entities. Safe treatment with ICI targeting the PD-1/PD-L1 axis requires early detection of immune-related adverse events (irAE). Treatment with immune checkpoint inhibitors (ICI) against programmed cell death protein 1 (PD-1) and one of its ligands PD-L1 have become one of the most promising approaches in the field of cancer therapy. Their application in oncologic treatment is continuously increasing [1, 2]. The occurrence and frequency of reported adverse events (AE) differ between patient self-reports and diagnoses of the managing clinicians. Patient selfreports on irAE may help to ensure an early detection of irAE despite these long dose intervals
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