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Observational Study
. 2021 Nov:157:441-449.
doi: 10.1016/j.ejca.2021.08.035. Epub 2021 Sep 2.

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

Luigi Cavanna  1 , Chiara Citterio  2 , Claudia Biasini  2 , Serena Madaro  2 , Nicoletta Bacchetta  2 , Anna Lis  2 , Gabriele Cremona  2 , Monica Muroni  2 , Patrizia Bernuzzi  2 , Giuliana Lo Cascio  3 , Roberta Schiavo  3 , Martina Mutti  2 , Maristella Tassi  3 , Maria Mariano  3 , Serena Trubini  3 , Giulia Bandieramonte  3 , Raffaella Maestri  2 , Patrizia Mordenti  2 , Elisabetta Marazzi  2 , Daniele Vallisa  2
Affiliations
Observational Study

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

Luigi Cavanna et al. Eur J Cancer. 2021 Nov.

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Keywords: Antibodies; Anticancer treatment; COVID-19; Cancer patients; SARS-COV-2; Seroconversion; Vaccine.

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Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Luigi Cavanna: Consulting or Advisory Role for AstraZeneca; Travel, Accommodations, Expenses from Pfizer, Ipsen And Celgene. Other authors: No Relationships to Disclose.

Figures

Fig. 1
Fig. 1
Forest plot of the multivariable impact of covariates on serologic response.
Fig. 2
Fig. 2
Serologic response based on sex.
Fig. 3
Fig. 3
Serologic response based on treatment (Bio: biological therapy, Che: chemotherapy, Imm: immunotherapy).
Fig. 4
Fig. 4
IgG value after the second dose of vaccine in patients and volunteers.
See this image and copyright information in PMC

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