Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study
BackgroundVaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are highly effective. Nevertheless, immunocompromised participants were excluded from randomized controlled clinical trials. This study evaluates the efficacy and safety of the Pfizer/BioNTech BNT162b2 (BNT162b2)...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-08-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.951026/full |
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| author | Pietro De Placido Erica Pietroluongo Carmine De Angelis Carmine De Angelis Margherita Tafuro Chiara Barraco Rosa Giannatiempo Roberto Buonaiuto Francesco Schettini Francesco Schettini Francesco Schettini Anna Iervolino Emilia Anna Vozzella Mario Giuliano Mario Giuliano Roberto Bianco Grazia Arpino |
| author_facet | Pietro De Placido Erica Pietroluongo Carmine De Angelis Carmine De Angelis Margherita Tafuro Chiara Barraco Rosa Giannatiempo Roberto Buonaiuto Francesco Schettini Francesco Schettini Francesco Schettini Anna Iervolino Emilia Anna Vozzella Mario Giuliano Mario Giuliano Roberto Bianco Grazia Arpino |
| author_sort | Pietro De Placido |
| collection | DOAJ |
| description | BackgroundVaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are highly effective. Nevertheless, immunocompromised participants were excluded from randomized controlled clinical trials. This study evaluates the efficacy and safety of the Pfizer/BioNTech BNT162b2 (BNT162b2) vaccine in patients with breast and gynecological cancer treated with active anticancer therapy versus a control cohort of healthy participants.MethodsImmune responses to the BNT162b2 vaccine in patients with breast cancer (n = 44) or a gynecological malignancy (n = 6) on active anticancer therapy (28 on chemotherapy, mostly anthracycline- or taxane-based, and 22 on target therapy) and in a control cohort of participants without cancer (n = 67) were investigated by SARS-CoV-2 neutralizing antibody titers measured by S1-binding immunoglobulin G (IgG) concentrations assessed using the LIAISON XL tools (DiaSorin S.p.A.). Response was assessed after a second dose of the BNT162b2 vaccine administered before and at least 3 weeks after the vaccine dose.ResultsOverall, 43/50 (86%) patients of the cancer cohort (74% in the breast cancer group and 100% in the gynecological malignancy group) developed IgG antibodies after the second dose of the BNT162b2 vaccine. There were no statistically significant differences in responder rates between patients treated with chemotherapy and those on target therapy. The majority of patients who received chemotherapy with or without target therapy, 21/28 (75%), developed a reliable antibody titer after a vaccine. All seven non-responder patients were undergoing an anthracycline-based regimen. Based on IgG levels (0–400 AU/ml), patients were classified as negative (‘non-responders’), weakly positive, or strongly positive (‘responders’). No delay in cancer therapy schedule or reported side effects were recorded after BNT162b2 vaccine administration. All healthy participants were strongly positive. Responder rates differed significantly between the two study cohorts (p < 0.001).ConclusionsMost patients develop antibody titers after the second immunization. However, given the persistence of non-responders or weak responders, additional immunization booster seems to be required, along with proactive planning in the vaccination schedule, with vaccine administration spaced out over time with respect to chemotherapy. |
| first_indexed | 2024-04-13T18:30:22Z |
| format | Article |
| id | doaj.art-6a9f571bba7b42059f1138bf7c02ac54 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-13T18:30:22Z |
| publishDate | 2022-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-6a9f571bba7b42059f1138bf7c02ac542022-12-22T02:35:05ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-08-011210.3389/fonc.2022.951026951026Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational studyPietro De Placido0Erica Pietroluongo1Carmine De Angelis2Carmine De Angelis3Margherita Tafuro4Chiara Barraco5Rosa Giannatiempo6Roberto Buonaiuto7Francesco Schettini8Francesco Schettini9Francesco Schettini10Anna Iervolino11Emilia Anna Vozzella12Mario Giuliano13Mario Giuliano14Roberto Bianco15Grazia Arpino16Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyLester and Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, United StatesDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyOspedale Evangelico Betania, Department of Pathology, Naples, ItalyDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyMedical Oncology Department, Hospital Clinic of Barcelona, Barcelona, SpainFaculty of Medicine, University of Barcelona, Barcelona, SpainTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, SpainDirezione Generale, Azienda Ospedaliera Universitaria Federico II, Naples, ItalyDirezione Sanitaria, Azienda Ospedaliera Universitaria Federico II, Naples, ItalyDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyLester and Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, United StatesDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, ItalyBackgroundVaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are highly effective. Nevertheless, immunocompromised participants were excluded from randomized controlled clinical trials. This study evaluates the efficacy and safety of the Pfizer/BioNTech BNT162b2 (BNT162b2) vaccine in patients with breast and gynecological cancer treated with active anticancer therapy versus a control cohort of healthy participants.MethodsImmune responses to the BNT162b2 vaccine in patients with breast cancer (n = 44) or a gynecological malignancy (n = 6) on active anticancer therapy (28 on chemotherapy, mostly anthracycline- or taxane-based, and 22 on target therapy) and in a control cohort of participants without cancer (n = 67) were investigated by SARS-CoV-2 neutralizing antibody titers measured by S1-binding immunoglobulin G (IgG) concentrations assessed using the LIAISON XL tools (DiaSorin S.p.A.). Response was assessed after a second dose of the BNT162b2 vaccine administered before and at least 3 weeks after the vaccine dose.ResultsOverall, 43/50 (86%) patients of the cancer cohort (74% in the breast cancer group and 100% in the gynecological malignancy group) developed IgG antibodies after the second dose of the BNT162b2 vaccine. There were no statistically significant differences in responder rates between patients treated with chemotherapy and those on target therapy. The majority of patients who received chemotherapy with or without target therapy, 21/28 (75%), developed a reliable antibody titer after a vaccine. All seven non-responder patients were undergoing an anthracycline-based regimen. Based on IgG levels (0–400 AU/ml), patients were classified as negative (‘non-responders’), weakly positive, or strongly positive (‘responders’). No delay in cancer therapy schedule or reported side effects were recorded after BNT162b2 vaccine administration. All healthy participants were strongly positive. Responder rates differed significantly between the two study cohorts (p < 0.001).ConclusionsMost patients develop antibody titers after the second immunization. However, given the persistence of non-responders or weak responders, additional immunization booster seems to be required, along with proactive planning in the vaccination schedule, with vaccine administration spaced out over time with respect to chemotherapy.https://www.frontiersin.org/articles/10.3389/fonc.2022.951026/fullCOVID - 19BNT162b2COVID vaccinebreast cancerchemotherapytarget therapies |
| spellingShingle | Pietro De Placido Erica Pietroluongo Carmine De Angelis Carmine De Angelis Margherita Tafuro Chiara Barraco Rosa Giannatiempo Roberto Buonaiuto Francesco Schettini Francesco Schettini Francesco Schettini Anna Iervolino Emilia Anna Vozzella Mario Giuliano Mario Giuliano Roberto Bianco Grazia Arpino Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study Frontiers in Oncology COVID - 19 BNT162b2 COVID vaccine breast cancer chemotherapy target therapies |
| title | Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study |
| title_full | Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study |
| title_fullStr | Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study |
| title_full_unstemmed | Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study |
| title_short | Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study |
| title_sort | safety and immunogenicity of the covid 19 vaccine bnt162b2 for patients with breast and gynecological cancer on active anticancer therapy results of a prospective observational study |
| topic | COVID - 19 BNT162b2 COVID vaccine breast cancer chemotherapy target therapies |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.951026/full |
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