Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment

• Published in: European journal of cancer (1990) Vol. 159; pp. 105 - 112
• Main Authors: Buttiron Webber, Tania, Provinciali, Nicoletta, Musso, Marco, Ugolini, Martina, Boitano, Monica, Clavarezza, Matteo, D'Amico, Mauro, Defferrari, Carlotta, Gozza, Alberto, Briata, Irene Maria, Magnani, Monica, Paciolla, Fortuna, Menghini, Nadia, Marcenaro, Emanuela, De Palma, Raffaele, Sacchi, Nicoletta, Innocenti, Leonello, Siri, Giacomo, D'Ecclesiis, Oriana, Cevasco, Isabella, Gandini, Sara, DeCensi, Andrea
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.2021; Elsevier Science Ltd; Published by Elsevier Ltd
• Subjects: Active control; Aged; Antibodies, Viral - blood; Antibody responses to the BNT162b2 vaccine; Biomarkers - blood; BNT162 Vaccine - administration & dosage; BNT162 Vaccine - adverse effects; BNT162 Vaccine - immunology; Cancer; Cancer biological treatment; Cancer chemotherapy; Cancer hormone therapy; Cancer immunotherapy; Cancer target therapy; Cancer therapies; Cancer vaccines; Case-Control Studies; Cell number; Chemotherapy; COVID-19 - immunology; COVID-19 - prevention & control; COVID-19 - virology; COVID-19 vaccine in cancer patients; Endocrine therapy; Female; Humans; Immunization; Immunogenicity; Immunogenicity, Vaccine; Immunoglobulin G; Immunosuppressive agents; Lymphocytes; Male; Middle Aged; mRNA; Neoplasms - diagnosis; Neoplasms - immunology; Neoplasms - therapy; Original Research; Patients; Prospective Studies; Risk Factors; Risk management; SARS-CoV-2 - immunology; SARS-CoV-2 - pathogenicity; SARS-CoV-2 vaccine; SARS-CoV-2 vaccine adverse effects; Seroconversion; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Surveillance; Time Factors; Treatment Outcome; Vaccination; Vaccination - adverse effects; Vaccine Efficacy; Vaccines; COVID-19 vaccine in cancer patients; SARS-CoV-2 vaccine adverse effects; Cancer chemotherapy; Immunogenicity; Cancer hormone therapy; SARS-CoV-2 vaccine; Antibody responses to the BNT162b2 vaccine; Cancer immunotherapy; Cancer target therapy; Cancer biological treatment
• ISSN: 0959-8049; 1879-0852; 1879-0852
• DOI: 10.1016/j.ejca.2021.09.030

Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment. Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose. Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4–8.7) on active surveillance, 13.9% (8.2–21.6) on chemotherapy, 11.4% (5.1–21.3) on hormone therapy, 21.7% (7.5–43.7) on targeted therapy and 4.8% (0.12–23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 109/L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009). Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 109/L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. NCT04932863. •SARS-CoV-2 infection leads to increased morbidity and mortality in cancer patients.•Up to 20% of patients on treatment had poor seroconversion after two BNT162b2 doses.•Lymphocyte count, age and chemo, targeted and hormone-therapy predict poor response.•Adverse events following vaccine were more frequent in women, young and non-smokers.•A booster dose and long-term surveillance is needed in 20% of patients on treatment.