Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study

Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and...

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Veröffentlicht in:European journal of cancer (1990) 2021-11, Vol.157, p.124-131
Hauptverfasser: Shmueli, Einat S., Itay, Amit, Margalit, Ofer, Berger, Raanan, Halperin, Sharon, Jurkowicz, Menucha, Levin, Einav G., Levy, Itzchak, Olmer, Liraz, Regev-Yochay, Gili, Lustig, Yaniv, Rahav, Galia
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container_end_page 131
container_issue
container_start_page 124
container_title European journal of cancer (1990)
container_volume 157
creator Shmueli, Einat S.
Itay, Amit
Margalit, Ofer
Berger, Raanan
Halperin, Sharon
Jurkowicz, Menucha
Levin, Einav G.
Levy, Itzchak
Olmer, Liraz
Regev-Yochay, Gili
Lustig, Yaniv
Rahav, Galia
description Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2–4 weeks after each vaccine dose. The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p 
doi_str_mv 10.1016/j.ejca.2021.08.007
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We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2–4 weeks after each vaccine dose. The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p &lt; 0.0001) after the first dose and 84.1% versus 98.9% (p &lt; 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p &lt; 0.0001). Patients who were seronegative after the second dose had significantly more comorbidities than that with patients with seropositivity (77.8% vs 41.1%, respectively, p = 0.0042). Adequate antibody response after BNT162b2 vaccination was achieved after two doses but not after one dose, in patients with cancer vaccinated during anticancer therapy. •Majority of oncology patients were seropositive after the second dose of vaccination.•Humoural response rate and magnitude were lower in patients with cancer.•Comorbidities were more common among patients who were seronegative.•The vaccine was well-tolerated with no major adverse events.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2021.08.007</identifier><identifier>PMID: 34508994</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adverse events ; Antibodies, Viral - immunology ; Antibody response ; Antineoplastic Agents - therapeutic use ; BNT162 Vaccine ; Cancer ; Cancer therapies ; Chemotherapy ; Clinical Trial ; Co-morbidities ; Coronaviruses ; COVID-19 - immunology ; COVID-19 Vaccines - immunology ; COVID19 ; Evaluation ; Female ; Health Personnel ; Health risks ; Health services ; Humans ; IgG ; IgG antibody ; Immune response ; Immune system ; Immunogenicity, Vaccine - immunology ; Immunoglobulin ; Immunoglobulin G ; Immunotherapy ; Male ; Metastases ; Middle Aged ; Neoplasms - diet therapy ; Neoplasms - immunology ; Neoplasms - virology ; Oncology ; Patients ; Prospective Studies ; Radiation therapy ; Safety ; SARS-CoV-2 ; SARS-CoV-2 - immunology ; Seronegativity ; Seropositivity ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Solid tumors ; Tumors ; Vaccination - methods ; Vaccine ; Vaccines ; Viral diseases</subject><ispartof>European journal of cancer (1990), 2021-11, Vol.157, p.124-131</ispartof><rights>2021 Elsevier Ltd</rights><rights>Copyright © 2021 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Nov 2021</rights><rights>2021 Elsevier Ltd. All rights reserved. 2021 Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-262b489f3b8045bfbb1d1d5d1ef6aea9f17e0e6f96fdc5675bb773c57055223e3</citedby><cites>FETCH-LOGICAL-c483t-262b489f3b8045bfbb1d1d5d1ef6aea9f17e0e6f96fdc5675bb773c57055223e3</cites><orcidid>0000-0002-9779-1704</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0959804921005232$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34508994$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shmueli, Einat S.</creatorcontrib><creatorcontrib>Itay, Amit</creatorcontrib><creatorcontrib>Margalit, Ofer</creatorcontrib><creatorcontrib>Berger, Raanan</creatorcontrib><creatorcontrib>Halperin, Sharon</creatorcontrib><creatorcontrib>Jurkowicz, Menucha</creatorcontrib><creatorcontrib>Levin, Einav G.</creatorcontrib><creatorcontrib>Levy, Itzchak</creatorcontrib><creatorcontrib>Olmer, Liraz</creatorcontrib><creatorcontrib>Regev-Yochay, Gili</creatorcontrib><creatorcontrib>Lustig, Yaniv</creatorcontrib><creatorcontrib>Rahav, Galia</creatorcontrib><title>Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2–4 weeks after each vaccine dose. The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p &lt; 0.0001) after the first dose and 84.1% versus 98.9% (p &lt; 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p &lt; 0.0001). Patients who were seronegative after the second dose had significantly more comorbidities than that with patients with seropositivity (77.8% vs 41.1%, respectively, p = 0.0042). Adequate antibody response after BNT162b2 vaccination was achieved after two doses but not after one dose, in patients with cancer vaccinated during anticancer therapy. •Majority of oncology patients were seropositive after the second dose of vaccination.•Humoural response rate and magnitude were lower in patients with cancer.•Comorbidities were more common among patients who were seronegative.•The vaccine was well-tolerated with no major adverse events.</description><subject>Adverse events</subject><subject>Antibodies, Viral - immunology</subject><subject>Antibody response</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>BNT162 Vaccine</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Clinical Trial</subject><subject>Co-morbidities</subject><subject>Coronaviruses</subject><subject>COVID-19 - immunology</subject><subject>COVID-19 Vaccines - immunology</subject><subject>COVID19</subject><subject>Evaluation</subject><subject>Female</subject><subject>Health Personnel</subject><subject>Health risks</subject><subject>Health services</subject><subject>Humans</subject><subject>IgG</subject><subject>IgG antibody</subject><subject>Immune response</subject><subject>Immune system</subject><subject>Immunogenicity, Vaccine - immunology</subject><subject>Immunoglobulin</subject><subject>Immunoglobulin G</subject><subject>Immunotherapy</subject><subject>Male</subject><subject>Metastases</subject><subject>Middle Aged</subject><subject>Neoplasms - diet therapy</subject><subject>Neoplasms - immunology</subject><subject>Neoplasms - virology</subject><subject>Oncology</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Radiation therapy</subject><subject>Safety</subject><subject>SARS-CoV-2</subject><subject>SARS-CoV-2 - immunology</subject><subject>Seronegativity</subject><subject>Seropositivity</subject><subject>Severe acute respiratory syndrome</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Solid tumors</subject><subject>Tumors</subject><subject>Vaccination - methods</subject><subject>Vaccine</subject><subject>Vaccines</subject><subject>Viral diseases</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUuO1DAQhiMEYnoGLsACWWLDJsF24kckhASj4SGNYDOsLccpTztKJ8F2grLjAqzmApyFo3AS3HQzAhasbLk-_6qqL8seEVwQTPizroDO6IJiSgosC4zFnWxDpKhzLBm9m21wzepc4qo-yU5D6HAiZIXvZydlxbCs62qTfb2w1hltVqSHFgVtIa5otOjV-yvCaUPRoo1xg45uHJAbvn-b0hWGGNBnF7cojL1rkdGDAY88GHCLG65TVnTHx7gFr6cV_fhygzQKqdoDMinBA5r8GCYw0S2AQpzb9UF2z-o-wMPjeZZ9fH1xdf42v_zw5t35y8vcVLKMOU2dVbK2ZZOGY41tGtKSlrUELNega0sEYOC25rY1jAvWNEKUhgnMGKUllGfZi0PuNDc7aH-1o3s1ebfTflWjdurvyuC26npclKxoRTBLAU-PAX78NEOIaueCgb7XA4xzUJQJUlNOcJXQJ_-g3Tj7IY2nKMdUYFFxnih6oEzaSfBgb5shWO1tq07tbau9bYWlSi7Tp8d_jnH75bfeBDw_AJCWuTjwKphkz0Drkqyo2tH9L_8nWC-_uw</recordid><startdate>20211101</startdate><enddate>20211101</enddate><creator>Shmueli, Einat S.</creator><creator>Itay, Amit</creator><creator>Margalit, Ofer</creator><creator>Berger, Raanan</creator><creator>Halperin, Sharon</creator><creator>Jurkowicz, Menucha</creator><creator>Levin, Einav G.</creator><creator>Levy, Itzchak</creator><creator>Olmer, Liraz</creator><creator>Regev-Yochay, Gili</creator><creator>Lustig, Yaniv</creator><creator>Rahav, Galia</creator><general>Elsevier Ltd</general><general>Elsevier Science Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9779-1704</orcidid></search><sort><creationdate>20211101</creationdate><title>Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study</title><author>Shmueli, Einat S. ; Itay, Amit ; Margalit, Ofer ; Berger, Raanan ; Halperin, Sharon ; Jurkowicz, Menucha ; Levin, Einav G. ; Levy, Itzchak ; Olmer, Liraz ; Regev-Yochay, Gili ; Lustig, Yaniv ; Rahav, Galia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-262b489f3b8045bfbb1d1d5d1ef6aea9f17e0e6f96fdc5675bb773c57055223e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Antibodies, Viral - immunology</topic><topic>Antibody response</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>BNT162 Vaccine</topic><topic>Cancer</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Clinical Trial</topic><topic>Co-morbidities</topic><topic>Coronaviruses</topic><topic>COVID-19 - immunology</topic><topic>COVID-19 Vaccines - immunology</topic><topic>COVID19</topic><topic>Evaluation</topic><topic>Female</topic><topic>Health Personnel</topic><topic>Health risks</topic><topic>Health services</topic><topic>Humans</topic><topic>IgG</topic><topic>IgG antibody</topic><topic>Immune response</topic><topic>Immune system</topic><topic>Immunogenicity, Vaccine - immunology</topic><topic>Immunoglobulin</topic><topic>Immunoglobulin G</topic><topic>Immunotherapy</topic><topic>Male</topic><topic>Metastases</topic><topic>Middle Aged</topic><topic>Neoplasms - diet therapy</topic><topic>Neoplasms - immunology</topic><topic>Neoplasms - virology</topic><topic>Oncology</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Radiation therapy</topic><topic>Safety</topic><topic>SARS-CoV-2</topic><topic>SARS-CoV-2 - immunology</topic><topic>Seronegativity</topic><topic>Seropositivity</topic><topic>Severe acute respiratory syndrome</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Solid tumors</topic><topic>Tumors</topic><topic>Vaccination - methods</topic><topic>Vaccine</topic><topic>Vaccines</topic><topic>Viral diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shmueli, Einat S.</creatorcontrib><creatorcontrib>Itay, Amit</creatorcontrib><creatorcontrib>Margalit, Ofer</creatorcontrib><creatorcontrib>Berger, Raanan</creatorcontrib><creatorcontrib>Halperin, Sharon</creatorcontrib><creatorcontrib>Jurkowicz, Menucha</creatorcontrib><creatorcontrib>Levin, Einav G.</creatorcontrib><creatorcontrib>Levy, Itzchak</creatorcontrib><creatorcontrib>Olmer, Liraz</creatorcontrib><creatorcontrib>Regev-Yochay, Gili</creatorcontrib><creatorcontrib>Lustig, Yaniv</creatorcontrib><creatorcontrib>Rahav, Galia</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; 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We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2–4 weeks after each vaccine dose. The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. 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subjects Adverse events
Antibodies, Viral - immunology
Antibody response
Antineoplastic Agents - therapeutic use
BNT162 Vaccine
Cancer
Cancer therapies
Chemotherapy
Clinical Trial
Co-morbidities
Coronaviruses
COVID-19 - immunology
COVID-19 Vaccines - immunology
COVID19
Evaluation
Female
Health Personnel
Health risks
Health services
Humans
IgG
IgG antibody
Immune response
Immune system
Immunogenicity, Vaccine - immunology
Immunoglobulin
Immunoglobulin G
Immunotherapy
Male
Metastases
Middle Aged
Neoplasms - diet therapy
Neoplasms - immunology
Neoplasms - virology
Oncology
Patients
Prospective Studies
Radiation therapy
Safety
SARS-CoV-2
SARS-CoV-2 - immunology
Seronegativity
Seropositivity
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Solid tumors
Tumors
Vaccination - methods
Vaccine
Vaccines
Viral diseases
title Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study
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