Cavanna Luigi, Proietto Manuela, Citterio Chiara, Anselmi Elisa, Zaffignani Elena, Stroppa Elisa Maria, Borsotti Maria Teresa, Contini Andrea, Di Girolamo Gabriella, Quitadamo Vincenzo Matteo, Bacchetta Nicoletta, Muroni Monica, Brescia Maria Grazia, Delledonne Marco
Oncology and Hematology Department, Piacenza General Hospital, Via Taverna 49, 29121 Piacenza, Italy.
Nurse Directory Unit, Piacenza General Hospital, Via Taverna 49, 29121 Piacenza, Italy.
Vaccines (Basel). 2022 Jan 21;10(2):164. doi: 10.3390/vaccines10020164.
Patients with cancer have a high risk of intubation, intensive care unit admission, or death from the coronavirus disease (COVID-19); age and comorbidities are additional risk factors. Vaccination is effective against COVID-19; however, patients with cancer have been excluded from pivotal clinical trials for COVID-19 vaccines. Data on COVID-19 vaccination in cancer patients who are older are lacking. This observational study was conducted to evaluate the seropositivity rate and safety of a two-dose regimen of the BNT162b2 or mRNA1273 vaccine in older patients (age ≥ 70 years) with solid tumors or with hematological malignances who are undergoing active anticancer treatment or whose treatment has been terminated within 6 months of vaccination. The control group was composed of healthy volunteers that were age-matched with the patient group. The primary endpoint was the seropositivity rate, and the secondary endpoints were safety, the factors influencing seroconversion, the IgG titers of patients versus healthy volunteers, and post-vaccine COVID-19 infection between 20 March 2021 and 14 July 2021. At our Institution (Oncology and Hematology Department, Hospital of Piacenza, North Italy), 443 patients with cancer underwent a program for COVID-19 vaccination; 115 (25.95%) were older than 70 (range 71-86 years) and form the basis of this study. All 115 patients accepted the vaccination. There were 64 female patients (55.65%), 94 patients (81.74%) with solid tumors, and 21 patients (18.26%) with hematological malignances. The primary endpoint of seropositivity was observed in 75 patients (65.22%)-70.21% in patients with solid tumors and 42.86% in patients with hematological malignances-versus in 100% of patients in the control group. Of the secondary endpoints, no grade 3-4 side effects and no COVID-19 infections were reported. The factor influencing seroconversion was the type of cancer. The patients' median IgG titers were significantly lower than in the control groups. The COVID-19 vaccines BNT162b2 and mRNA1273 were effective and safe among older patients with cancer when administered in real-world conditions.
癌症患者插管、入住重症监护病房或死于冠状病毒病（COVID-19）的风险很高；年龄和合并症是额外的风险因素。疫苗接种对COVID-19有效；然而，癌症患者被排除在COVID-19疫苗的关键临床试验之外。缺乏老年癌症患者COVID-19疫苗接种的数据。本观察性研究旨在评估BNT162b2或mRNA1273疫苗两剂方案在年龄≥70岁、正在接受积极抗癌治疗或在接种疫苗后6个月内治疗已终止的实体瘤或血液系统恶性肿瘤老年患者中的血清阳性率和安全性。对照组由与患者组年龄匹配的健康志愿者组成。主要终点是血清阳性率，次要终点是安全性、影响血清转化的因素、患者与健康志愿者的IgG滴度，以及2021年3月20日至2021年7月14日期间接种疫苗后的COVID-19感染情况。在我们机构（意大利北部皮亚琴察医院肿瘤与血液科），443例癌症患者接受了COVID-19疫苗接种计划；115例（25.95%）年龄超过70岁（范围71-86岁），构成了本研究的基础。所有115例患者均接受了疫苗接种。有64例女性患者（55.65%），94例（81.74%）实体瘤患者，21例（18.26%）血液系统恶性肿瘤患者。75例患者（65.22%）观察到血清阳性这一主要终点——实体瘤患者中为70.21%，血液系统恶性肿瘤患者中为42.86%，而对照组患者中为100%。在次要终点中，未报告3-4级副作用，也未报告COVID-19感染。影响血清转化的因素是癌症类型。患者的IgG滴度中位数显著低于对照组。在实际情况下，COVID-19疫苗BNT162b2和mRNA1273在老年癌症患者中有效且安全。
