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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="research-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Annals of the Russian academy of medical sciences</journal-id><journal-title-group><journal-title xml:lang="en">Annals of the Russian academy of medical sciences</journal-title><trans-title-group xml:lang="ru"><trans-title>Вестник Российской академии медицинских наук</trans-title></trans-title-group></journal-title-group><issn publication-format="print">0869-6047</issn><issn publication-format="electronic">2414-3545</issn><publisher><publisher-name xml:lang="en">"Paediatrician" Publishers LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1384</article-id><article-id pub-id-type="doi">10.15690/vramn1384</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>ONCOLOGY: CURRENT ISSUES</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>АКТУАЛЬНЫЕ ВОПРОСЫ ОНКОЛОГИИ</subject></subj-group><subj-group subj-group-type="article-type"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">Cancer treatment and research in the context of COVID-19 pandemic: the experience of foreign countries</article-title><trans-title-group xml:lang="ru"><trans-title>Особенности лечения пациентов с онкологическими заболеваниями и проведение клинических исследований в области онкологии в условиях пандемии COVID-19: опыт зарубежных стран</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3061-6108</contrib-id><contrib-id contrib-id-type="spin">1728-0329</contrib-id><name-alternatives><name xml:lang="en"><surname>Kit</surname><given-names>Oleg I.</given-names></name><name xml:lang="ru"><surname>Кит</surname><given-names>Олег Иванович</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>Professor, Corresponding Member of the RAS</p></bio><bio xml:lang="ru"><p>д.м.н., профессор, член-корреспондент РАН</p></bio><email>rnioi@list.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1957-7363</contrib-id><contrib-id contrib-id-type="spin">8643-2348</contrib-id><name-alternatives><name xml:lang="en"><surname>Gevorkyan</surname><given-names>Yurii A.</given-names></name><name xml:lang="ru"><surname>Геворкян</surname><given-names>Юрий Артушевич</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, Professor</p></bio><bio xml:lang="ru"><p>д.м.н., профессор</p></bio><email>gevorkyan.000@mail.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0118-4935</contrib-id><contrib-id contrib-id-type="spin">8392-6679</contrib-id><name-alternatives><name xml:lang="en"><surname>Soldatkina</surname><given-names>Natalya V.</given-names></name><name xml:lang="ru"><surname>Солдаткина</surname><given-names>Наталья Васильевна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, PhD, Leading Research Associate</p></bio><bio xml:lang="ru"><p>д.м.н., в.н.с.</p></bio><email>snv-rnioi@yandex.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1594-1746</contrib-id><contrib-id contrib-id-type="spin">9968-1260</contrib-id><name-alternatives><name xml:lang="en"><surname>Gevorkyan</surname><given-names>Elvina Y.</given-names></name><name xml:lang="ru"><surname>Геворкян</surname><given-names>Эльвина Юрьевна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>Student</p></bio><bio xml:lang="ru"><p>студентка</p></bio><email>elvina.gev@gmail.com</email><xref ref-type="aff" rid="aff2"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">National Medical Research Centre for Oncology</institution></aff><aff><institution xml:lang="ru">Национальный медицинский исследовательский центр онкологии</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">I.M. Sechenov First Moscow State Medical University (Sechenov University)</institution></aff><aff><institution xml:lang="ru">Первый Московский государственный медицинский университет имени И.М. Сеченова (Сеченовский Университет)</institution></aff></aff-alternatives><pub-date date-type="preprint" iso-8601-date="2020-09-21" publication-format="electronic"><day>21</day><month>09</month><year>2020</year></pub-date><pub-date date-type="pub" iso-8601-date="2020-10-14" publication-format="electronic"><day>14</day><month>10</month><year>2020</year></pub-date><volume>75</volume><issue>4</issue><issue-title xml:lang="en"/><issue-title xml:lang="ru"/><fpage>278</fpage><lpage>282</lpage><history><date date-type="received" iso-8601-date="2020-06-25"><day>25</day><month>06</month><year>2020</year></date><date date-type="accepted" iso-8601-date="2020-08-24"><day>24</day><month>08</month><year>2020</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2020, "Paediatrician" Publishers LLC</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2020, Издательство "Педиатръ"</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="en">"Paediatrician" Publishers LLC</copyright-holder><copyright-holder xml:lang="ru">Издательство "Педиатръ"</copyright-holder><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/" start_date="2021-10-14"/><license><ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/">https://vestnikramn.spr-journal.ru/jour/about/submissions</ali:license_ref></license></permissions><self-uri xlink:href="https://vestnikramn.spr-journal.ru/jour/article/view/1384">https://vestnikramn.spr-journal.ru/jour/article/view/1384</self-uri><abstract xml:lang="en"><p>The coronavirus disease 2019 (COVID-19) has rapidly swept the world. Patients with cancer could be at particular risk of COVID-19, since they are often immunosuppressed by their therapy. Assessing the risk-benefit ratio of potentially immunosuppressive treatment for patients with cancer with insufficient knowledge of this new disease and balancing individual and community benefits poses acute ethical dilemmas for oncologists. Researchers provided the first guidelines for cancer patients treatment. Individual treatment plans should be adjusted to minimise routine visits, procedures and tests. Patients should be categorised into different priorities for receiving active cancer therapy during the pandemic. Oncologists should consider changing intravenous treatments to subcutaneous or oral routes, as well as suspending radiation therapy or using hypofractionation. In case of developing COVID-19 patients with cancer should be treated in the respiratory or intensive care units rather than in the oncology units. Preventive measures and emergency plans to help patients should also be developed. The COVID-19 pandemic has had a devastating impact on clinical research in haematology and oncology. A dramatic reduction in the number of participants in current research and delays in planned haematology and oncology research, as well as adverse financial consequences and potential delays in the delivery of promising drugs to patients should be expected. Regulatory agencies provided guidelines on managing clinical trials during the COVID-19 pandemic, emphasising the importance of pragmatism and flexibility in routine visits, procedures and tumour assessments and clearly documenting protocol deviations. Ensuring patients’ safety during the pandemic is of primary priority. Every trial participant should be contacted before the planned visit to ensure they don’t have any COVID-19 symptoms. Laboratory and radiological assessments should be done at the closest to patient medical facility, and some investigational products, such as oral medications, should be delivered directly to patient to avoid hospital visits. The COVID-19 pandemic has had a serious negative impact on both treatment of cancer patients and research in this area. The support of all stakeholders is the only thing that can help ensure the best possible care for patients at this difficult time.</p></abstract><trans-abstract xml:lang="ru"><p>Коронавирусная инфекция 2019 г. (COVID-19) быстро охватила весь мир. Онкологические пациенты составляют особую группу риска, так как и само заболевание, и терапия, которую они получают, часто оказывают иммуносупрессивное действие. Исследователи разных стран предоставили первые рекомендации по лечению онкологических больных в период пандемии. Индивидуальные планы лечения должны корректироваться с целью минимизации рутинных посещений, процедур и исследований. Врачам-онкологам необходимо рассмотреть перевод пациентов на пероральное и подкожное введение препаратов вместо инфузионного, а также приостановление лучевой терапии или использование гипофракционирования. Также рекомендуется разработать профилактические меры и план действий в чрезвычайных ситуациях для оказания помощи пациентам. Пандемия новой коронавирусной инфекции оказала разрушительное воздействие на проведение клинических исследований в области гематологии и онкологии, так как многие научные сотрудники и ресурсы были направлены в институты и больницы для оказания помощи возросшему потоку пациентов с COVID-19. Следует ожидать резкое сокращение числа участников текущих исследований, задержки планируемых запусков новых гематологических и онкологических исследований, а также пагубные финансовые последствия и возможные задержки поставок перспективных лекарств пациентам. При проведении любых исследований в настоящее время обеспечение безопасности пациентов имеет первостепенное значение. Пандемия COVID-19 оказала серьезное негативное воздействие и на лечение больных с онкологическими заболеваниями, и на исследования в этой области. И лишь поддержка всех заинтересованных сторон поможет обеспечить помощь пациентам в это непростое время.</p></trans-abstract><kwd-group xml:lang="en"><kwd>COVID-19</kwd><kwd>cancer</kwd><kwd>immunosuppression</kwd><kwd>clinical trials</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>COVID-19</kwd><kwd>прогрессирующая онкопатология</kwd><kwd>иммуносупрессия</kwd><kwd>клинические исследования</kwd></kwd-group><funding-group/></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Zhang L, Zhu F, Xie L, et al. Clinical characteristics of COVID-19-infected cancer patients: a retrospective case study in three hospitals within Wuhan, China. Ann Oncol 2020. Published online March 26. doi: https://doi.org/10.1016/j.annonc.2020.03.296.</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>You B, Ravaud A, Canivet A, et al. The official French guidelines to protect patients with cancer against SARS-CoV-2 infection. Lancet Oncol. 2020. Published online March 25. doi: https://doi.org/10.1016/S1470-2045(20)30204-7.</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>Onder G, Rezza G, Brusaferro S. Case-fatality rate and characteristics of patients dying in relation to COVID-19 in Italy. JAMA. 2020. Published online March 23. doi: https://doi.org/10.1001/jama.2020.4683.</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>Eichenberger EM, Soave R, Zappetti D, et al. Incidence, significance, and persistence of human coronavirus infection in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2019;54(7):1058–1066. doi: https://doi.org/10.1038/s41409-018-0386-z</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>Saini KS, de las Heras В, de Castro J, Venkitaraman R, Poelman М, Srinivasan G, Lamba Saini M, Verma S, Leone M, Aftimos Ph, Curigliano G. Effect of the COVID-19 pandemic on cancer treatment and research. doi: https://doi.org/10.1016/S2352-3026(20)30123-X.</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>National Health Service England. Clinical guide for the management of noncoronavirus patients requiring acute treatment: cancer. March 23, 2020. Available from: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/specialty-guide-acute-treatment-cancer-23- march-2020.pdf (accessed: 01.04.2020).</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>Каприн А.Д., Гамеева Е.В., Поляков А.А., Корниецкая А.Л., Рубцова Н.А., Феденко А.А. Влияние пандемии COVID-19 на онкологическую практику. Сибирский онкологический журнал. — 2020. — Т. 19. — № 3. — С. 5–22. [Kaprin AD, Gameeva EV, Polyakov AA, Kornietskaya AL, Rubtsova NA, Fedenko AA. Impact of the COVID-19 Pandemic on the oncological practice. Siberian Journal of Oncology. 2020;19(3):5–22. (In Russ.)]. doi: https://doi.org/10.21294/1814-4861-2020-19-3-5-22.</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>Sud A, Jones ME, Broggio J, Loveday C, Torr B, Garrett A, Nicol DL, Jhanji S, Boyce SA, Gronthoud F, Ward P, Handy JM, Yousaf N, Larkin J, Suh Y-E, Scott S, Pharoah PDP, Swanton C, Abbosh C, Williams M, Lyratzopoulos G, Houlston R, Turnbull C. Collateral damage: the impact on outcomes from cancer surgery of the COVID-19 pandemic. doi: https://doi.org/10.1016/j.annonc.2020.05.009.</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>Ginsburg KB, Curtis GL, Timar RE, George AK, Cher ML. Delayed Radical Prostatectomy is Not Associated with Adverse Oncologic Outcomes: Implications for Men Experiencing Surgical Delay Due to the COVID-19 Pandemic. doi: https://doi.org/10.1097/JU.0000000000001089.</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>ASCO Coronavirus Resources. Available from: www.asco.org/asco-coronavirus-information/care-individuals-cancer-during-covid-19.</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>National Cancer Institute. Guidance for collection of adverse events related to COVID-19 infection. March 25, 2020. Available from: https://ctep.cancer.gov/content/ docs/Adverse_Event_Guidance_COVID-19_Final_3-25-20.pdf (accessed: 06.04.2020).</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020;395:1033–1034. doi: https://doi.org/10.1016/s0140-6736(20)30628-0.</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>European Medicines Agency. Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic. March 20, 2020. Available from: https://www.ema.europa.eu/en/documents/press-release/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic_en.pdf (accessed: 01.04.2020).</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>US FDA. FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic. March 2020. Available from: https://www.fda.gov/ media/136238/download (accessed: 01.04.2020).</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>Medicines and Healthcare products Regulatory Agency. Managing clinical trials during Coronavirus (COVID-19). March 19, 2020. Available from: https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19 (accessed: 01.04.2020).</mixed-citation></ref></ref-list></back></article>
