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 |
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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 |
format | Article |
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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 < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 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 < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 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 & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shmueli, Einat S.</au><au>Itay, Amit</au><au>Margalit, Ofer</au><au>Berger, Raanan</au><au>Halperin, Sharon</au><au>Jurkowicz, Menucha</au><au>Levin, Einav G.</au><au>Levy, Itzchak</au><au>Olmer, Liraz</au><au>Regev-Yochay, Gili</au><au>Lustig, Yaniv</au><au>Rahav, Galia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2021-11-01</date><risdate>2021</risdate><volume>157</volume><spage>124</spage><epage>131</epage><pages>124-131</pages><issn>0959-8049</issn><eissn>1879-0852</eissn><abstract>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 < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 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.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>34508994</pmid><doi>10.1016/j.ejca.2021.08.007</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-9779-1704</orcidid><oa>free_for_read</oa></addata></record> |
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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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