Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors
The incidence of severe immune-related adverse events (irAEs) in cancer subjects receiving immune checkpoint inhibitors (ICIs) following COVID-19 vaccination and the relationship between the incidence of severe irAE and the interval between COVID-19 vaccination and ICI dose have not been established...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-01-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2023.2207438 |
| _version_ | 1797673084827729920 |
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| author | Danielle Gilbert Junxiao Hu Theresa Medina Elizabeth R. Kessler Elaine T. Lam |
| author_facet | Danielle Gilbert Junxiao Hu Theresa Medina Elizabeth R. Kessler Elaine T. Lam |
| author_sort | Danielle Gilbert |
| collection | DOAJ |
| description | The incidence of severe immune-related adverse events (irAEs) in cancer subjects receiving immune checkpoint inhibitors (ICIs) following COVID-19 vaccination and the relationship between the incidence of severe irAE and the interval between COVID-19 vaccination and ICI dose have not been established. We performed a retrospective study evaluating the incidence of irAEs in solid tumor subjects receiving ICI therapy who received any COVID-19 vaccinations since FDA authorization. irAEs were defined as severe with one or more grade 3 or above events (CTCAE v5.0), multiple organ involvement, or requiring hospitalization for management. Two hundred and eighty-four subjects who received COVID vaccinations from December 2020 and February 2022 were included in this analysis [median age at vaccination 67 years (IQR 59.0–75.0); 67.3% male]. Twenty-nine subjects (10.2%) developed severe irAEs, of which 12 subjects (41.4%) received ICI monotherapy, 10 subjects (34.5%) received combination ICI therapy with nivolumab and ipilimumab, and 7 subjects (24.1%) received ICI plus VEGFR-TKI therapy. Hospitalization occurred in 62% of subjects with severe irAEs, with a median duration of 3 days (IQR: 3.0–7.5 days). Immunosuppressive therapy was required in 79.3%, with a median duration of 103 days (IQR: 42.0–179.0). ICI therapy was discontinued in 51.7% of subjects with severe irAE; dosing was held or interrupted in 34.5%. Among severe irAEs, the median interval between vaccination and ICI treatment closest to the occurrence of severe irAE was 15.5 days (IQR: 10.0–23.0). In solid tumor cancer subjects receiving ICIs, COVID-19 vaccination is not associated with an increased incidence of severe irAEs compared to historical data and may be safely administered during ICI cancer therapy in subjects who lack contraindications. |
| first_indexed | 2024-03-11T21:39:28Z |
| format | Article |
| id | doaj.art-162bdedf4f734f7e91ca7dcf11febc3d |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:39:28Z |
| publishDate | 2023-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-162bdedf4f734f7e91ca7dcf11febc3d2023-09-26T13:25:49ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2023-01-0119110.1080/21645515.2023.22074382207438Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitorsDanielle Gilbert0Junxiao Hu1Theresa Medina2Elizabeth R. Kessler3Elaine T. Lam4University of Colorado Cancer Center, University of Anschutz Medical CampusUniversity of Colorado Cancer Center Biostatistics Core, University of Colorado Anschutz Medical CampusUniversity of Colorado Cancer Center, University of Anschutz Medical CampusUniversity of Colorado Cancer Center, University of Anschutz Medical CampusUniversity of Colorado Cancer Center, University of Anschutz Medical CampusThe incidence of severe immune-related adverse events (irAEs) in cancer subjects receiving immune checkpoint inhibitors (ICIs) following COVID-19 vaccination and the relationship between the incidence of severe irAE and the interval between COVID-19 vaccination and ICI dose have not been established. We performed a retrospective study evaluating the incidence of irAEs in solid tumor subjects receiving ICI therapy who received any COVID-19 vaccinations since FDA authorization. irAEs were defined as severe with one or more grade 3 or above events (CTCAE v5.0), multiple organ involvement, or requiring hospitalization for management. Two hundred and eighty-four subjects who received COVID vaccinations from December 2020 and February 2022 were included in this analysis [median age at vaccination 67 years (IQR 59.0–75.0); 67.3% male]. Twenty-nine subjects (10.2%) developed severe irAEs, of which 12 subjects (41.4%) received ICI monotherapy, 10 subjects (34.5%) received combination ICI therapy with nivolumab and ipilimumab, and 7 subjects (24.1%) received ICI plus VEGFR-TKI therapy. Hospitalization occurred in 62% of subjects with severe irAEs, with a median duration of 3 days (IQR: 3.0–7.5 days). Immunosuppressive therapy was required in 79.3%, with a median duration of 103 days (IQR: 42.0–179.0). ICI therapy was discontinued in 51.7% of subjects with severe irAE; dosing was held or interrupted in 34.5%. Among severe irAEs, the median interval between vaccination and ICI treatment closest to the occurrence of severe irAE was 15.5 days (IQR: 10.0–23.0). In solid tumor cancer subjects receiving ICIs, COVID-19 vaccination is not associated with an increased incidence of severe irAEs compared to historical data and may be safely administered during ICI cancer therapy in subjects who lack contraindications.http://dx.doi.org/10.1080/21645515.2023.2207438covid-19vaccinesimmunotherapycheckpoint inhibitorscancer |
| spellingShingle | Danielle Gilbert Junxiao Hu Theresa Medina Elizabeth R. Kessler Elaine T. Lam Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors Human Vaccines & Immunotherapeutics covid-19 vaccines immunotherapy checkpoint inhibitors cancer |
| title | Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors |
| title_full | Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors |
| title_fullStr | Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors |
| title_full_unstemmed | Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors |
| title_short | Safety of COVID-19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors |
| title_sort | safety of covid 19 vaccines in subjects with solid tumor cancers receiving immune checkpoint inhibitors |
| topic | covid-19 vaccines immunotherapy checkpoint inhibitors cancer |
| url | http://dx.doi.org/10.1080/21645515.2023.2207438 |
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