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• W3187029348 abstract "The Coronavirus Disease 2019 (COVID-19) messenger RNA (mRNA) vaccines, BNT162b2 and mRNA-1273, manufactured by Pfizer-BioNTech and Moderna, respectively, received the United States Food and Drug Administration (FDA) emergency use authorisation in December 2020 and have since been widely administered. Recognising the increased mortality risk from COVID-19 in cancer patients [[1]Kuderer N.M. Choueiri T.K. Shah D.P. et al.Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study.Lancet (London, England). 2020; 395: 1907-1918Abstract Full Text Full Text PDF PubMed Scopus (1157) Google Scholar], the major cancer scientific societies such as the American Society of Clinical Oncology (ASCO) [[2]American Society of Clinical OncologyCOVID-19 vaccines & patients with cancer. ASCO, 2021https://www.asco.org/asco-coronavirus-information/covid-19-vaccines-patients-cancerDate accessed: July 12, 2021Google Scholar], European Society for Medical Oncology (ESMO) [[3]European Society for Medical OncologyCOVID-19 vaccination in cancer patients: ESMO statements. ESMO, 2021https://www.esmo.org/covid-19-and-cancer/covid-19-vaccinationDate accessed: July 12, 2021Google Scholar], and National Comprehensive Cancer Network (NCCN) [[4]The National Comprehensive Cancer NetworkCancer and COVID-19 vaccination. NCCN, 2021https://www.nccn.org/docs/default-source/covid-19/2021_covid-19_vaccination_guidance_v3-0.pdf?sfvrsn=b483da2b_60Date accessed: July 12, 2021Google Scholar] generally recommend COVID-19 vaccination in cancer patients if there are no contraindications. However, patients with active cancer were excluded from the landmark vaccine trials [[5]Corti C. Curigliano G. Commentary: SARS-CoV-2 vaccines and cancer patients.Ann Oncol. 2021; 32: 569-571Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar]. In addition, immune checkpoint inhibitors (ICIs) now constitute the contemporary standard-of-care systemic regimens across various cancer types. Therefore, there is a concern regarding the risk of immune-related adverse events (irAEs) after administration of COVID-19 mRNA vaccines in patients with cancer treated with an ICI, albeit there is a paucity of data. To further investigate this essential topic in cancer care, we conducted a retrospective chart review using the electronic medical record at Vanderbilt University Medical Centre (VUMC). The study cohort included cancer patients who received ICIs within one month of receiving a COVID-19 mRNA vaccine. All patients received two doses of COVID-19 mRNA vaccine as recommended by the manufacturers and had at least 30 days of follow-up after the second dose of vaccine. The primary outcome was the rate of irAEs. Additionally, the United States Centres of Disease Control (CDC) and FDA's Vaccine Adverse Event Reporting System (VAERS) database was reviewed for reported possible irAEs after COVID-19 vaccine administration. This study was approved by the institutional review board at VUMC. There were 81 patients at VUMC who met the criteria for analysis (Table 1). The median age was 70, and 60% were male. The most common cancer subtype was lung (27%), followed by melanoma (23%), kidney cancer (14%), and gastrointestinal/hepatic cancer (11%). Most patients received pembrolizumab (56%) or nivolumab (27%). The median duration of ICI treatment prior to vaccination was 6.6 months [interquartile range (IQR): 2.1–11.2]. The median duration between the most recent ICI infusion and the second dose of the COVID-19 vaccine was 13 days (IQR: 8–20). 9 patients (11%) had irAEs prior to COVID-19 vaccination (all ≤ grade 2). Patients received either the Pfizer-BioNTech (83%) or Moderna (17%) COVID-19 vaccine. After a minimum of 30 days of follow-up from the second dose of vaccine, zero of the 84 (95% CI, 0.0%–4.5%) patients had exacerbation of previous irAEs or diagnosis of new irAEs. One patient died during the 30-day follow-up due to cancer progression.Table 1Patient characteristics.All Patients (N = 81)Age (median, IQRaIQR: interquartile range.)70 (59–76)Sex (%) Male49 (60) Female32 (40)Cancer Type (%) Lung cancer22 (27) Melanoma19 (23) Kidney cancer11 (14) GI/Hepatic cancer9 (11) Head and Neck7 (9) Other13 (16)Immune checkpoint inhibitor (%) Pembrolizumab45 (56) Nivolumab22 (27) Durvalumab6 (7) Cemiplimab5 (6) Atezolizumab3 (4)Prior irAE (%)9 (11) Hypothyroidism3 (3.7) Hepatitis2 (2.5) Adrenal Insufficiency1 (1.2) Diabetes1 (1.2) Arthritis1 (1.2) Immune-mediated thrombocytopenia1 (1.2)Months on ICIbICI: immune checkpoint inhibitor. (median months, IQRaIQR: interquartile range.)6.6 (2.1–11.2)Days between most recent ICI prior to second dose of vaccine (median days, IQRaIQR: interquartile range.)13 (8–20)Covid-19 vaccine BNT 162b2 (Pfizer-BioNTech)67 (83)mRNA-1273 (Moderna)14 (17)a IQR: interquartile range.b ICI: immune checkpoint inhibitor. Open table in a new tab As of the cut-off date of 14th May 2021, there were 152,748 adverse events following the administration of COVID-19 mRNA vaccines reported to the VAERS. There were 24 events reported in patients concurrently receiving ICIs, and six of them had clinical presentations suspicious for irAEs (Table 2), including two with possible flares of pre-existing irAEs and four de novo irAEs.Table 2Cases suspicious for irAEs following COVID-19 mRNA vaccine administration.Age/SexaM: male; F: female.CancerICIbICI: immune checkpoint inhibitor.Vaccine manufacturerSymptoms onset after vaccinationSymptoms or diagnosisComments79/FLung cancerPembrolizumabPfizer-BioNTech7 daysRespiratory distressHistory of pembrolizumab associated pneumonitis37/MThymus cancerPembrolizumabPfizer-BioNTech1 dayAcute hemolytic anemiaLabs consistent with haemolytic anaemia48/MKidney cancerIpilimumab/nivolumabModernaSame dayShock requiring pressor supportHome medication includes hydrocortisone 10 mg/5 mg; history of adrenal insufficiency70/MProstate cancerPembrolizumabPfizer-BioNTech1 dayMyositisLabs/Imaging work-up consistent with inflammatory myositis; last pembrolizumab was 2 months ago77/FLung cancerPembrolizumabPfizer-BioNTech4 daysCardiogenic shockCoronary angiography showed no significant narrowing or blockage; labs showed elevated troponins68/MSarcomaPembrolizumabModerna5 daysPancreatitis/rashNo prior history of pancreatitisa M: male; F: female.b ICI: immune checkpoint inhibitor. Open table in a new tab We observed no signal of increased risk of development or exacerbation of irAEs after mRNA COVID-19 vaccination (either the Pfizer-BioNTech or Moderna vaccine) among cancer patients who were on active treatment with ICIs. These results support prior work, [[6]Waissengrin B. Agbarya A. Safadi E. Padova H. Wolf I. Short-term safety of the BNT162b2 mRNA COVID-19 vaccine in patients with cancer treated with immune checkpoint inhibitors.Lancet Oncol. 2021; 22: 581-583Abstract Full Text Full Text PDF PubMed Scopus (139) Google Scholar], which suggested no new or exacerbation of irAEs after administration of the Pfizer-BioNTech vaccine among 134 ICI-treated cancer patients. Further, after investigating the 152,748 adverse events in the VAERS, there were only six adverse events, which were suspicious for irAEs following COVID-19 vaccine administration. Given the large number of patients receiving ICIs, this is likely consistent with the background rate of irAEs. However, the VAERS is limited by its passive reporting system and cannot be used to establish causal effects of a given vaccine and cannot establish frequency data. Our study helps supplement the limited data available regarding the safety and risk of irAE of vaccination among patients with cancer receiving ICIs [[7]Desage A.L. Bouleftour W. Rivoirard R. et al.Vaccination and immune checkpoint inhibitors: does vaccination increase the risk of immune-related adverse events? A systematic review of literature.Am J Clin Oncol. 2021; 44: 109-113Crossref PubMed Scopus (17) Google Scholar,[8]Spagnolo F. Boutros A. Croce E. et al.Influenza vaccination in cancer patients receiving immune checkpoint inhibitors: a systematic review.Eur J Clin Invest. 2021; 51: e13604Crossref PubMed Scopus (13) Google Scholar]. Considering the high mortality rate from COVID-19 among cancer patients [[1]Kuderer N.M. Choueiri T.K. Shah D.P. et al.Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study.Lancet (London, England). 2020; 395: 1907-1918Abstract Full Text Full Text PDF PubMed Scopus (1157) Google Scholar], the benefit of COVID-19 vaccination exceeds the hypothetical increased risk of irAEs for patients receiving ICIs, which appears minimal or non-existent in this and other series. Limitations of this study include the retrospective nature, duration of follow up, and limited sample size. In summary, the current findings support major society guidelines to offer COVID-19 vaccines to cancer patients receiving ICIs [2American Society of Clinical OncologyCOVID-19 vaccines & patients with cancer. ASCO, 2021https://www.asco.org/asco-coronavirus-information/covid-19-vaccines-patients-cancerDate accessed: July 12, 2021Google Scholar, 3European Society for Medical OncologyCOVID-19 vaccination in cancer patients: ESMO statements. ESMO, 2021https://www.esmo.org/covid-19-and-cancer/covid-19-vaccinationDate accessed: July 12, 2021Google Scholar, 4The National Comprehensive Cancer NetworkCancer and COVID-19 vaccination. NCCN, 2021https://www.nccn.org/docs/default-source/covid-19/2021_covid-19_vaccination_guidance_v3-0.pdf?sfvrsn=b483da2b_60Date accessed: July 12, 2021Google Scholar]. Yu-Wei Chen: None. Matthew Tucker: None. Kathryn Beckermann: Grant support: BMS-LCFA-IASLC. Advising: Exelexis, BMS, and Astella Consulting: Aravive. Wade Iams: Consulting: OncLive, Clinical Care Options, Chardan. Advising: Genentech, Jazz Pharma, G1 Therapeutics, Mirati. Brian Rini: Research Funding to Institution: Pfizer, Hoffman-LaRoche, Incyte, AstraZeneca, Taris, Seattle Genetics, Arrowhead Pharmaceuticals, Immunomedics, BMS, Mirati Therapeutics, Merck, Surface Oncology, Dragonfly Therapeutics, Aravive, Exelixis. Consulting: BMS, Pfizer, GNE/Roche, Aveo, Synthorx, Compugen, Merck, Corvus, Surface Oncology, 3DMedicines, Aravive, Alkermes, Arrowhead, GSK, Shionogi, Eisai, Nikang Therapeutics. Stock: PTC therapeutics. Douglas Johnson: Research funding: BMS and Incyte. Advising: BMS, Catalyst, Iovance, Jansen, Merck, Novartis, Oncosec, and Pfizer." @default.
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• W3187029348 title "COVID-19 mRNA vaccines and immune-related adverse events in cancer patients treated with immune checkpoint inhibitors" @default.
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