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.
Multidisciplinary Oncologic Centre Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium.
ESMO Open. 2021 Oct;6(5):100274. doi: 10.1016/j.esmoop.2021.100274. Epub 2021 Sep 8.
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.
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.
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.
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.
癌症患者患严重 2019 冠状病毒病（COVID-19）的风险较高。然而，正在接受治疗的癌症患者接种 COVID-19 疫苗的安全性和有效性仍不清楚。
在这项干预性前瞻性多队列研究中，给正在接受化疗、免疫疗法、靶向或激素治疗的实体瘤患者以及接受利妥昔单抗或异基因造血干细胞移植后的血液恶性肿瘤患者，间隔 21 天接种两剂 BNT162b2 COVID-19 疫苗。评估疫苗安全性和疗效（直至加强针接种后 3 个月）。随着时间的推移（直至加强针接种后 28 天），监测抗严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）受体结合域（RBD）抗体水平，并在加强针接种后 28 天分析针对野生型武汉株的 SARS-CoV-250%中和滴度（NT50）。
局部和全身不良事件（AE）大多为轻度至中度（仅有 1%-3%的患者出现严重 AE）。加强针后更常出现局部而非全身 AE。197 名癌症患者在加强针接种后 28 天，与健康个体相比，化疗组的 RBD 结合抗体滴度和 NT50 较低{234.05 IU/ml（95%置信区间 122.10-448.66）和 24.54（95%置信区间 14.50-41.52）}，分别}，而与化疗周期中接种疫苗的时间无关。接受利妥昔单抗治疗的血液学患者出现极低的抗体反应；只有两名患者具有针对有症状 SARS-CoV-2 感染的 50%保护所需的 RBD 结合抗体滴度（<200 IU/ml），且只有一名患者的 NT50 高于检测限。在研究期间，有 5 名癌症患者检测出 SARS-CoV-2 感染呈阳性，包括一名接受利妥昔单抗治疗的患者发生严重 COVID-19，导致住院 2 周。
BNT162b2 疫苗在积极治疗中的癌症患者中耐受良好。然而，免疫接种癌症患者的抗体反应延迟且减弱，主要发生在接受化疗或利妥昔单抗治疗的患者中，导致突破性感染。
