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

• Published in: European journal of cancer (1990) 2021-11, Vol.157, p.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: Article
• Language: English
• 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
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2021.08.035

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.