COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials

被引:110
作者
Desai, Aakash [1 ]
Gainor, Justin F. [2 ]
Hegde, Aparna [3 ]
Schram, Alison M. [4 ]
Curigiliano, Guiseppe [5 ,6 ]
Pal, Sumanta [7 ]
Liu, Stephen V. [8 ]
Halmos, Balazs [9 ]
Groisberg, Roman [10 ]
Grande, Enrique [11 ]
Dragovich, Tomislav [12 ]
Matrana, Marc [13 ]
Agarwal, Neeraj [14 ]
Chawla, Sant [15 ]
Kato, Shumei [16 ]
Morgan, Gilberto [17 ]
Kasi, Pashtoon M. [18 ]
Solomon, Benjamin [19 ]
Loong, Herbert H. [20 ]
Park, Haeseong [21 ]
Choueiri, Toni K. [22 ]
Subbiah, Ishwaria M. [23 ]
Pemmaraju, Naveen [24 ]
Subbiah, Vivek [25 ,26 ,27 ]
机构
[1] Mayo Clin, Div Med Oncol, Coll Med, Rochester, MN USA
[2] Massachusetts Gen Hosp, Dept Med, Boston, MA 02114 USA
[3] Univ Alabama Birmingham, Dept Hematol & Oncol, ONeal Comprehens Canc Ctr, Birmingham, AL USA
[4] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
[5] Univ Milan, Dept Oncol & Hematooncol, Milan, Italy
[6] IRCCS, European Inst Oncol, Milan, Italy
[7] City Hope Comprehens Canc Ctr, Dept Med Oncol, Duarte, CA USA
[8] Georgetown Univ, Dept Dev Therapeut, Lombardi Comprehens Canc Ctr, Washington, DC USA
[9] Montefiore Med Ctr, Albert Einstein Coll Med, Dept Oncol, The Bronx, NY USA
[10] Rutgers Canc Inst New Jersey, Dept Melanoma Sarcoma Med Oncol, New Brunswick, NJ USA
[11] MD Anderson Canc Ctr, Dept Med Oncol, Madrid, Spain
[12] MD Anderson Banner Canc Ctr, Dept Hematol Oncol, Gilbert, AZ USA
[13] Ochsner, Expt Therapeut, Precis Canc Therapies Phase I Res Program, New Orleans, LA USA
[14] Univ Utah, Dept Med, Div Oncogen, Huntsman Canc Inst, Salt Lake City, UT 84112 USA
[15] Sarcoma Oncol Ctr, Santa Monia, CA USA
[16] Univ Calif San Diego, Ctr Personalized Canc Therapy, Moores Canc Ctr, La Jolla, CA 92093 USA
[17] Skane Univ Hosp, Dept Oncol, Lund, Sweden
[18] Univ Iowa, Dept Med, Div Hematol Oncol & Blood & Marrow Transplant, Iowa City, IA 52242 USA
[19] Peter MacCallum Canc Ctr, Dept Med Oncol, Melbourne, Vic, Australia
[20] Chinese Univ Hong Kong, Dept Clin Oncol, State Key Lab Translat Oncol, Hong Kong, Peoples R China
[21] Washington Univ, Dept Med, Div Oncol, St Louis, MO USA
[22] Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA
[23] Univ Texas MD Anderson Canc Ctr, Dept Palliat Rehabil & Integrat Med, Div Canc Med, Houston, TX 77030 USA
[24] Univ Texas MD Anderson Canc Ctr, Dept Leukemia, Div Canc Med, Houston, TX 77030 USA
[25] Univ Texas MD Anderson Canc Ctr, Dept Invest Canc Therapeut, Phase I Clin Trials Program, Div Canc Med, Houston, TX 77030 USA
[26] Univ Texas MD Anderson Canc Ctr, Div Pediat, Houston, TX 77030 USA
[27] Univ Texas MD Anderson Canc Ctr, MD Anderson Canc Network, Houston, TX 77030 USA
基金
美国国家卫生研究院;
关键词
D O I
10.1038/s41571-021-00487-z
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Patients with cancer have a high risk of morbidity and mortality from COVID-19. The rapid development of COVID-19 vaccines has provided new hope of mitigating the disease. Herein, the COVID19 and Cancer Clinical Trials Working Group calls for prioritization of patients with cancer, importantly including those participating in oncology clinical trials, for COVID-19 vaccination. The authors also provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. 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.
引用
收藏
页码:313 / 319
页数:7
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