Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors
Abstract Background Immune 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 manufacture...
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BMC
2021-03-01
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Series: | BMC Cancer |
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Online Access: | https://doi.org/10.1186/s12885-021-08006-0 |
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doaj-588a19908b4c4c22ab7e82c0c6069723 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Luisa Maria Griewing Claudia Schweizer Philipp Schubert Sandra Rutzner Markus Eckstein Benjamin Frey Marlen Haderlein Thomas Weissmann Sabine Semrau Antoniu-Oreste Gostian Sarina K. Müller Maximilian Traxdorf Heinrich Iro Jian-Guo Zhou Udo S. Gaipl Rainer Fietkau Markus Hecht |
spellingShingle |
Luisa Maria Griewing Claudia Schweizer Philipp Schubert Sandra Rutzner Markus Eckstein Benjamin Frey Marlen Haderlein Thomas Weissmann Sabine Semrau Antoniu-Oreste Gostian Sarina K. Müller Maximilian Traxdorf Heinrich Iro Jian-Guo Zhou Udo S. Gaipl Rainer Fietkau Markus Hecht Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors BMC Cancer Immune checkpoint inhibitors PD-1 Immune-related adverse events Toxicity Questionnaire PD-L1 |
author_facet |
Luisa Maria Griewing Claudia Schweizer Philipp Schubert Sandra Rutzner Markus Eckstein Benjamin Frey Marlen Haderlein Thomas Weissmann Sabine Semrau Antoniu-Oreste Gostian Sarina K. Müller Maximilian Traxdorf Heinrich Iro Jian-Guo Zhou Udo S. Gaipl Rainer Fietkau Markus Hecht |
author_sort |
Luisa Maria Griewing |
title |
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors |
title_short |
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors |
title_full |
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors |
title_fullStr |
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors |
title_full_unstemmed |
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors |
title_sort |
questionnaire-based detection of immune-related adverse events in cancer patients treated with pd-1/pd-l1 immune checkpoint inhibitors |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2021-03-01 |
description |
Abstract Background Immune 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. Methods The 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. Results Between 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. Conclusion Questionnaires 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 registration ClinicalTrials.gov, NCT03453892 . Registered on 05 March 2018. |
topic |
Immune checkpoint inhibitors PD-1 Immune-related adverse events Toxicity Questionnaire PD-L1 |
url |
https://doi.org/10.1186/s12885-021-08006-0 |
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doaj-588a19908b4c4c22ab7e82c0c60697232021-03-28T11:44:17ZengBMCBMC Cancer1471-24072021-03-0121111010.1186/s12885-021-08006-0Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitorsLuisa Maria Griewing0Claudia Schweizer1Philipp Schubert2Sandra Rutzner3Markus Eckstein4Benjamin Frey5Marlen Haderlein6Thomas Weissmann7Sabine Semrau8Antoniu-Oreste Gostian9Sarina K. Müller10Maximilian Traxdorf11Heinrich Iro12Jian-Guo Zhou13Udo S. Gaipl14Rainer Fietkau15Markus Hecht16Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergComprehensive Cancer Center Erlangen-EMNDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergComprehensive Cancer Center Erlangen-EMNComprehensive Cancer Center Erlangen-EMNComprehensive Cancer Center Erlangen-EMNComprehensive Cancer Center Erlangen-EMNDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergAbstract Background Immune 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. Methods The 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. Results Between 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. Conclusion Questionnaires 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 registration ClinicalTrials.gov, NCT03453892 . Registered on 05 March 2018.https://doi.org/10.1186/s12885-021-08006-0Immune checkpoint inhibitorsPD-1Immune-related adverse eventsToxicityQuestionnairePD-L1 |