Division of Medical Oncology, Mayo Clinic College of Medicine, Rochester, MN, USA.
Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Nat Rev Clin Oncol. 2021 May;18(5):313-319. doi: 10.1038/s41571-021-00487-z. Epub 2021 Mar 15.
Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility.
一些国家已基于新出现的疗效数据，对新冠病毒疫苗授予或批准了紧急使用授权。大多数新冠病毒疫苗的临床试验排除了患有活动性恶性肿瘤的患者，因此目前关于癌症患者接种疫苗的安全性、耐受性和疗效的数据有限。鉴于新冠大流行带来的风险，对于正在参加试验性抗癌治疗研究的患者，需要迅速决定是否使用针对新冠病毒的疫苗。患者不应该在参加肿瘤临床试验和接种新冠病毒疫苗之间做出选择。对于目前正在参加临床试验或可能寻求参加临床试验的癌症患者，临床试验发起者、研究者和治疗医生需要获得关于接种新冠病毒疫苗的操作指导。考虑到癌症患者因新冠病毒感染而导致的高发病率和死亡率，接种疫苗的益处可能远远超过疫苗相关不良反应的风险。在此，我们为参加肿瘤临床试验的患者提供接种新冠病毒疫苗的操作指导。在我们看来，持续提供高质量的肿瘤学治疗服务要求包括参加临床试验的患者在内的癌症患者应优先接种新冠病毒疫苗，这不应影响临床试验的入组资格。
