COVID-19 vaccines in adult cancer patients with solid tumours undergoing active treatment: Seropositivity and safety. A prospective observational study in Italy

Patients with cancer are presumed a frail group at high risk of contracting coronavirus disease (COVID-19), and vaccination represents a cornerstone in addressing the COVID-19 pandemic. However, data on COVID-19 vaccination in cancer patients are fragmentary and poor. An observational study was cond...

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Bibliographic Details
Published in:	European journal of cancer (1990) Vol. 157; pp. 441 - 449
Main Authors:	Cavanna, Luigi, Citterio, Chiara, Biasini, Claudia, Madaro, Serena, Bacchetta, Nicoletta, Lis, Anna, Cremona, Gabriele, Muroni, Monica, Bernuzzi, Patrizia, Lo Cascio, Giuliana, Schiavo, Roberta, Mutti, Martina, Tassi, Maristella, Mariano, Maria, Trubini, Serena, Bandieramonte, Giulia, Maestri, Raffaella, Mordenti, Patrizia, Marazzi, Elisabetta, Vallisa, Daniele
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 01-11-2021 Elsevier Science Ltd The Authors. Published by Elsevier Ltd
Subjects:	Adult Aged Aged, 80 and over Antibodies Antibodies, Viral - immunology Anticancer treatment BNT162 Vaccine Cancer Cancer patients Cancer vaccines Coronaviruses COVID-19 COVID-19 - immunology COVID-19 vaccines COVID-19 Vaccines - immunology Dosage Female Health risks Humans Immunization Immunogenicity Immunogenicity, Vaccine - immunology Immunoglobulin G Infections Italy Male Metastases Middle Aged mRNA Neoplasms - immunology Neoplasms - virology Observational studies Original Research Pandemics Pandemics - prevention & control Patients Prospective Studies Safety SARS-COV-2 SARS-CoV-2 - immunology Seroconversion Severe acute respiratory syndrome coronavirus 2 Solid tumors Tumors Vaccination - methods Vaccine Vaccines Viral diseases Italy COVID-19 Cancer patients SARS-COV-2 Anticancer treatment Antibodies Vaccine Seroconversion
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Summary:	Patients with cancer are presumed a frail group at high risk of contracting coronavirus disease (COVID-19), and vaccination represents a cornerstone in addressing the COVID-19 pandemic. However, data on COVID-19 vaccination in cancer patients are fragmentary and poor. An observational study was conducted to evaluate the seropositivity rate and safety of a two-dose regimen of the BNT162b2 or messenger RNA-1273 vaccine in adult patients with solid cancer undergoing active anticancer treatment or whose treatment had been terminated within 6 months of the start of the study. The control group was composed of healthy volunteers. Serum samples were evaluated for SARS-COV-2 antibodies before vaccinations and 2–6 weeks after the administration of the second vaccine dose. Primary end-point: seropositivity rate. Secondary end-points: safety, factors influencing seroconversion, IgG titers of patients versus healthy volunteers, COVID-19 infection. Between 20th March 2021 and 12th June 2021, 293 consecutive patients with cancer-solid tumours underwent a program of COVID-19 vaccinations; of these, 2 patients refused vaccination, 13 patients did not receive the second dose of the vaccine because of cancer progression, and 21 patients had COVID-19 antibodies at baseline and were excluded. The 257 evaluable patients had a median age of 65 years (range 28–86), 66.15% with metastatic disease. Primary end-point: seropositivity rate in patients was 75.88% versus 100% in the control group. Secondary end-points: no Grade 3–4 side-effects, no COVID-19 infections were reported. Patients median IgG titer was significantly lower than in the control group; male sex and active anticancer therapy influenced negative seroconversion. BNT162b2 or messenger RNA-1273 vaccines were immunogenic in cancer patients, showing good safety profile. •Patients with cancer are at great risk of serious complications and death from coronavirus disease (COVID-19).•257 patients with cancer vaccinated against COVID-19, 75.88% showed seroconversion.•219 of the 257 patients (85.21%) were on active anticancer treatment.•No Grade 3–4 side-effects were reported.•Male sex and active anticancer treatment negatively influence serologic response.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0959-8049 1879-0852
DOI:	10.1016/j.ejca.2021.08.035