Department of Oncology, Sheba Medical Center, Derech Sheba 2, Tel-Hashomer, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel-Aviv University, P.O.B 39040 Ramat Aviv Tel Aviv Israel.
Department of Oncology, Sheba Medical Center, Derech Sheba 2, Tel-Hashomer, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel-Aviv University, P.O.B 39040 Ramat Aviv Tel Aviv Israel.
Eur J Cancer. 2021 Nov;157:124-131. doi: 10.1016/j.ejca.2021.08.007. Epub 2021 Sep 8.
Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events.
The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2-4 weeks after each vaccine dose.
The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 0.0001). Patients who were seronegative after the second dose had significantly more comorbidities than that with patients with seropositivity (77.8% vs 41.1%, respectively, p = 0.0042).
Adequate antibody response after BNT162b2 vaccination was achieved after two doses but not after one dose, in patients with cancer vaccinated during anticancer therapy.
患有癌症的患者患 2019 年冠状病毒病（COVID-19）重症的风险增加，因此，有关严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）疫苗安全性和有效性的数据至关重要。我们对接受 BNT162b2 疫苗接种的癌症患者进行了这项前瞻性研究，并对抗体反应和安全性进行了监测。目的是评估血清阳性率并确定无反应性免疫反应的预测因素。此外，我们还评估了不良事件的频率和严重程度。
该研究包括正在接受癌症治疗的实体瘤患者和作为对照的免疫功能正常的医护人员。在每次疫苗接种后 2-4 周测量受体结合域（RBD）免疫球蛋白 G（IgG）和中和抗体的血清滴度。
该分析包括 129 例患者，其中 70.5%的患者发生转移。患者接受化疗（55%）、免疫治疗（34.1%）、生物制剂（24.8%）、激素治疗（8.5%）和放疗（4.6%），单独或联合使用。首次接种后，癌症患者和对照组的血清阳性率分别为 32.4%和 59.8%（p<0.0001），第二次接种后分别为 84.1%和 98.9%（p<0.0001）。与对照组相比，患者的 RBD-IgG 滴度中位数较低（p<0.0001）。第二次接种后血清阴性的患者与血清阳性的患者相比，合并症明显更多（分别为 77.8%和 41.1%，p=0.0042）。
在接受癌症治疗期间接种 BNT162b2 疫苗的癌症患者中，两次接种后可获得足够的抗体反应，但一次接种后则不能。
