TY - JOUR
T1 - COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials
AU - the COVID19 and Cancer Clinical Trials Working Group
AU - Desai, Aakash
AU - Gainor, Justin F.
AU - Hegde, Aparna
AU - Schram, Alison M.
AU - Curigliano, Giuseppe
AU - Pal, Sumanta
AU - Liu, Stephen V.
AU - Halmos, Balazs
AU - Groisberg, Roman
AU - Grande, Enrique
AU - Dragovich, Tomislav
AU - Matrana, Marc
AU - Agarwal, Neeraj
AU - Chawla, Sant
AU - Kato, Shumei
AU - Morgan, Gilberto
AU - Kasi, Pashtoon M.
AU - Solomon, Benjamin
AU - Loong, Herbert H.
AU - Park, Haeseong
AU - Choueiri, Toni K.
AU - Subbiah, Ishwaria M.
AU - Pemmaraju, Naveen
AU - Subbiah, Vivek
N1 - Publisher Copyright:
© 2021, Springer Nature Limited.
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
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U2 - 10.1038/s41571-021-00487-z
DO - 10.1038/s41571-021-00487-z
M3 - Review article
C2 - 33723371
AN - SCOPUS:85105761483
SN - 1759-4774
VL - 18
SP - 313
EP - 319
JO - Nature Reviews Clinical Oncology
JF - Nature Reviews Clinical Oncology
IS - 5
ER -