PMID- 34597941 OWN - NLM STAT- MEDLINE DCOM- 20211028 LR - 20211204 IS - 2059-7029 (Electronic) IS - 2059-7029 (Linking) VI - 6 IP - 5 DP - 2021 Oct TI - Reduced humoral immune response after BNT162b2 coronavirus disease 2019 messenger RNA vaccination in cancer patients under antineoplastic treatment. PG - 100274 LID - S2059-7029(21)00236-2 [pii] LID - 10.1016/j.esmoop.2021.100274 [doi] LID - 100274 AB - BACKGROUND: Cancer patients are at a higher risk of developing severe coronavirus disease 2019 (COVID-19). However, the safety and efficacy of COVID-19 vaccination in cancer patients undergoing treatment remain unclear. PATIENTS AND METHODS: In this interventional prospective multicohort study, priming and booster doses of the BNT162b2 COVID-19 vaccine were administered 21 days apart to solid tumor patients receiving chemotherapy, immunotherapy, targeted or hormonal therapy, and patients with a hematologic malignancy receiving rituximab or after allogeneic hematopoietic stem cell transplantation. Vaccine safety and efficacy (until 3 months post-booster) were assessed. Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain (RBD) antibody levels were followed over time (until 28 days after the booster) and in vitro SARS-CoV-2 50% neutralization titers (NT50) toward the wild-type Wuhan strain were analyzed 28 days after the booster. RESULTS: Local and systemic adverse events (AEs) were mostly mild to moderate (only 1%-3% of patients experienced severe AEs). Local, but not systemic, AEs occurred more frequently after the booster dose. Twenty-eight days after the booster vaccination of 197 cancer patients, RBD-binding antibody titers and NT50 were lower in the chemotherapy group 234.05 IU/ml [95% confidence interval (CI) 122.10-448.66] and 24.54 (95% CI 14.50-41.52), respectively compared with healthy individuals [1844.93 IU/ml (95% CI 1383.57-2460.14) and 122.63 (95% CI 76.85-195.67), respectively], irrespective of timing of vaccination during chemotherapy cycles. Extremely low antibody responses were seen in hematology patients receiving rituximab; only two patients had RBD-binding antibody titers necessary for 50% protection against symptomatic SARS-CoV-2 infection (<200 IU/ml) and only one had NT50 above the limit of detection. During the study period, five cancer patients tested positive for SARS-CoV-2 infection, including a case of severe COVID-19 in a patient receiving rituximab, resulting in a 2-week hospital admission. CONCLUSION: The BNT162b2 vaccine is well-tolerated in cancer patients under active treatment. However, the antibody response of immunized cancer patients was delayed and diminished, mainly in patients receiving chemotherapy or rituximab, resulting in breakthrough infections. CI - Copyright (c) 2021. Published by Elsevier Ltd. FAU - Peeters, M AU - Peeters M AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium; Center for Oncological Research (CORE), Integrated Personalized and Precision Oncology Network (IPPON), University of Antwerp and Antwerp University Hospital, Edegem, Belgium. Electronic address: marc.peeters@uza.be. FAU - Verbruggen, L AU - Verbruggen L AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Teuwen, L AU - Teuwen L AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Vanhoutte, G AU - Vanhoutte G AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Vande Kerckhove, S AU - Vande Kerckhove S AD - SD Infectious Diseases in Humans, Service Immune response, Sciensano, Brussels, Belgium. FAU - Peeters, B AU - Peeters B AD - Department of Laboratory Medicine, Antwerp University Hospital, Edegem, Belgium. FAU - Raats, S AU - Raats S AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Van der Massen, I AU - Van der Massen I AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - De Keersmaecker, S AU - De Keersmaecker S AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Debie, Y AU - Debie Y AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Huizing, M AU - Huizing M AD - Biobank Antwerp, Edegem, Belgium. FAU - Pannus, P AU - Pannus P AD - SD Epidemiology and Public Health, Sciensano, Brussels, Belgium. FAU - Neven, K AU - Neven K AD - SD Epidemiology and Public Health, Sciensano, Brussels, Belgium. FAU - Arien, K K AU - Arien KK AD - Virology Unit, Institute of Tropical Medicine Antwerp, Antwerp, Belgium; Department of Biomedical Sciences, University of Antwerp, Edegem, Belgium. FAU - Martens, G A AU - Martens GA AD - Department of Laboratory Medicine, AZ Delta General Hospital, Roeselare, Belgium. FAU - Van Den Bulcke, M AU - Van Den Bulcke M AD - SD Epidemiology and Public Health, Sciensano, Brussels, Belgium. FAU - Roelant, E AU - Roelant E AD - Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, Belgium. FAU - Desombere, I AU - Desombere I AD - SD Infectious Diseases in Humans, Service Immune response, Sciensano, Brussels, Belgium. FAU - Anguille, S AU - Anguille S AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium. FAU - Goossens, M AU - Goossens M AD - SD Epidemiology and Public Health, Sciensano, Brussels, Belgium. FAU - Vandamme, T AU - Vandamme T AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium; Center for Oncological Research (CORE), Integrated Personalized and Precision Oncology Network (IPPON), University of Antwerp and Antwerp University Hospital, Edegem, Belgium. FAU - van Dam, P AU - van Dam P AD - Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium; Center for Oncological Research (CORE), Integrated Personalized and Precision Oncology Network (IPPON), University of Antwerp and Antwerp University Hospital, Edegem, Belgium. LA - eng PT - Case Reports PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210908 PL - England TA - ESMO Open JT - ESMO open JID - 101690685 RN - 0 (Antineoplastic Agents) RN - 0 (COVID-19 Vaccines) RN - 0 (RNA, Messenger) RN - N38TVC63NU (BNT162 Vaccine) SB - IM MH - *Antineoplastic Agents MH - BNT162 Vaccine MH - *COVID-19 MH - COVID-19 Vaccines MH - Humans MH - Immunity, Humoral MH - *Neoplasms MH - Prospective Studies MH - RNA, Messenger MH - SARS-CoV-2 MH - Vaccination PMC - PMC8423808 OTO - NOTNLM OT - BNT162b2 COVID-19 vaccination OT - anti-RBD IgG antibody response OT - antineoplastic treatment OT - cancer OT - safety COIS- Disclosure MP declares to have an advisory role within Remedus. All other authors have declared no conflicts of interest. EDAT- 2021/10/02 06:00 MHDA- 2021/10/29 06:00 PMCR- 2021/09/08 CRDT- 2021/10/01 20:25 PHST- 2021/07/16 00:00 [received] PHST- 2021/08/16 00:00 [revised] PHST- 2021/09/01 00:00 [accepted] PHST- 2021/10/02 06:00 [pubmed] PHST- 2021/10/29 06:00 [medline] PHST- 2021/10/01 20:25 [entrez] PHST- 2021/09/08 00:00 [pmc-release] AID - S2059-7029(21)00236-2 [pii] AID - 100274 [pii] AID - 10.1016/j.esmoop.2021.100274 [doi] PST - ppublish SO - ESMO Open. 2021 Oct;6(5):100274. doi: 10.1016/j.esmoop.2021.100274. Epub 2021 Sep 8.