未经批准:针对严重急性呼吸道综合症冠状病毒2(SARS-CoV-2)的疫苗非常有效。然而,免疫功能低下的参与者被排除在随机对照临床试验之外.这项研究评估了辉瑞/BioNTechBNT162b2(BNT162b2)疫苗在接受积极抗癌治疗的乳腺癌和妇科癌症患者中的疗效和安全性,以及健康参与者的对照组。
UNASSIGNED:积极抗癌治疗的乳腺癌(n=44)或妇科恶性肿瘤(n=6)患者对BNT162b2疫苗的免疫反应(28次化疗,主要是蒽环类或紫杉烷,目标治疗和22),并在没有癌症的对照组(n=67)中,通过使用LIAISONXL工具(DiaSorinS.p.A.)评估的S1结合免疫球蛋白G(IgG)浓度测量的SARS-CoV-2中和抗体滴度进行了研究。在疫苗剂量之前和之后至少3周施用第二剂量的BNT162b2疫苗后评估反应。
未经评估:总的来说,癌症队列的43/50(86%)患者(乳腺癌组中74%,妇科恶性肿瘤组中100%)在第二剂BNT162b2疫苗后产生IgG抗体。在接受化疗的患者和接受靶向治疗的患者之间,应答率没有统计学上的显着差异。大多数接受化疗或不接受靶向治疗的患者,21/28(75%),疫苗后开发出可靠的抗体滴度。所有7名无应答患者都在接受基于蒽环类的方案。基于IgG水平(0-400AU/ml),患者被分类为阴性(“无反应者”),弱正,或强阳性(\'响应者\')。在BNT162b2疫苗施用后,没有记录癌症治疗方案的延迟或报告的副作用。所有健康参与者均为强烈阳性。两个研究队列之间的应答率存在显著差异(p<0.001)。
未经证实:大多数患者在第二次免疫后出现抗体滴度。然而,鉴于无反应者或弱反应者的持续存在,似乎需要额外的免疫促进剂,随着疫苗接种时间表的积极规划,随着时间的推移,疫苗给药与化疗有关。
UNASSIGNED: Vaccines 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.
UNASSIGNED: Immune 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.
UNASSIGNED: Overall, 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).
UNASSIGNED: Most 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.