Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Haematology (DIPO), University of Milan, Milan, Italy.
Department of Oncology and Haematology (DIPO), University of Milan, Milan, Italy; Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy.
Eur J Cancer. 2021 May;148:316-327. doi: 10.1016/j.ejca.2021.01.046. Epub 2021 Feb 25.
Coronavirus disease 2019 (COVID-19) has affected more than 96 million people worldwide, leading the World Health Organization (WHO) to declare a pandemic in March 2020. Although an optimal medical treatment of COVID-19 remains uncertain, an unprecedented global effort to develop an effective vaccine hopes to restore pre-pandemic conditions. Since cancer patients as a group have been shown to be at a higher risk of severe COVID-19, the development of safe and effective vaccines is crucial. However, cancer patients may be underrepresented in ongoing phase 3 randomised clinical trials investigating COVID-19 vaccines. Therefore, we encourage stakeholders to provide real-time data about the characteristics of recruited participants, including clearly identifiable subgroups, like cancer patients, with sample sizes large enough to determine safety and efficacy. Moreover, we envisage a prompt implementation of suitable registries for pharmacovigilance reporting, in order to monitor the effects of COVID-19 vaccines and immunisation rates in patients with cancer. That said, data extrapolation from other vaccine trials (e.g. anti-influenza virus) showed a favourable safety and efficacy profile for cancer patients. On the basis of the evidence discussed, we believe that the benefits of the vaccination outweigh the risks. Consequently, healthcare authorities should prioritise vaccinations for cancer patients, with the time-point of administration agreed on a case-by-case basis. In this regard, the American Society of Clinical Oncology and the European Society of Medical Oncology are advocating for cancer patients a high priority status, in the hope of attenuating the consequences of the pandemic in this particularly vulnerable population.
2019 年冠状病毒病（COVID-19）已在全球范围内影响了超过 9600 万人，世界卫生组织（WHO）于 2020 年 3 月宣布 COVID-19 大流行。尽管 COVID-19 的最佳医疗治疗方法仍不确定，但全球正在以前所未有的努力开发有效的疫苗，希望恢复大流行前的状况。由于癌症患者已被证明患严重 COVID-19 的风险较高，因此开发安全有效的疫苗至关重要。然而，癌症患者在正在进行的 COVID-19 疫苗的 3 期随机临床试验中可能代表性不足。因此，我们鼓励利益相关者提供有关招募参与者特征的实时数据，包括明确可识别的亚组，例如癌症患者，其样本量足以确定安全性和有效性。此外，我们设想迅速实施适合药物警戒报告的登记册，以监测 COVID-19 疫苗在癌症患者中的效果和免疫接种率。也就是说，从其他疫苗试验（例如抗流感病毒）推断的数据表明癌症患者的安全性和有效性良好。基于所讨论的证据，我们认为接种疫苗的益处大于风险。因此，医疗保健当局应优先为癌症患者接种疫苗，并根据具体情况商定接种时间。在这方面，美国临床肿瘤学会和欧洲肿瘤内科学会正在为癌症患者争取高度优先的地位，希望减轻这一特别脆弱人群在大流行中的后果。
