Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors

BMC Cancer

Antoniu-Oreste Gostian¹  Heinrich Iro¹  Maximilian Traxdorf¹  Sarina K. Müller¹  Markus Eckstein²  Rainer Fietkau³  Marlen Haderlein³  Philipp Schubert³  Thomas Weissmann³  Markus Hecht³  Udo S. Gaipl³  Luisa Maria Griewing³  Claudia Schweizer³  Sabine Semrau³  Benjamin Frey³  Sandra Rutzner³  Jian-Guo Zhou⁴ 

[1] Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany;Department of Otolaryngology - Head & Neck Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany;Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany;Institute of Pathology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany;Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsstraße 27, 91054, Erlangen, Germany;Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany;Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsstraße 27, 91054, Erlangen, Germany;Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany;Department of Oncology, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, China;

关键词: Immune checkpoint inhibitors;    PD-1;    Immune-related adverse events;    Toxicity;    Questionnaire;    PD-L1;    Side effects;    Solid tumors;    Patient-reported irAE;   

DOI  :  10.1186/s12885-021-08006-0

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY