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      Impact of COVID-19 pandemic on clinical and surgical breast cancer management

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      a , b , * , a , b
      EClinicalMedicine
      The Authors. Published by Elsevier Ltd.

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          Abstract

          The COVID-19 viral pandemic responsible for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease has dramatically impacted our work worldwide in the management of patients in terms of diagnosis and surgical treatment of cancer - including breast cancer. It has led to a rapid and unprecedented re-organization of surgical units to ensure that those patients with respiratory distress disease received optimal care. From this global situation, we can observe two important consequences that affect clinical practice. In the short term, researchers and related resources have been reassigned to managing the test procedures of COVID-19 patients, and routine research activities have been suspended. Moreover, studies and clinical trials for COVID-19 have become a priority. In addition, travel restrictions have meant that several international conferences, audits, and student training have been cancelled [1]. In the medium to longer term, recruitment delays resulting from the pandemic will negatively affect the early diagnosis of cancer and surgical procedures, with implications that are damaging not only financially, but also in terms of potential diagnosis of more advanced cancers, reducing possibilities of survival and optimal care delivery. A retrospective multicentric study by Li J. et al. [2], recently published in EClinicalMedicine, clearly demonstrated that the management of breast cancer patients suffered from a lack of care in terms of diagnosis and surgical procedures. They collected data on 8397 breast cancer patients from 97 Chinese cancer centers. In detail, Hubei province recorded the lowest incidence of early breast cancer (5.3%) in comparison to the other provinces (15.3%). Surgical procedures decreased dramatically from 16.4% (December 2019) to 2.6% (February 2020), and there was also a delay in timelines from surgery to adjuvant therapy. Lombardy is the region in Italy most affected by the COVID-19 infection, and the COVID-19 cumulative incidence growth rate peaked on 22March 2020 [3]. During the outset of the disease in February 2020 and throughout March, it became necessary to repurpose the surgical operating areas into intensive care units, and we observed progressive saturation levels of hospital bed occupancy. In the majority of cases, patients with breast cancer were classified as non-urgent [4]. At that time, our breast service at the European Institute of Oncology in Milan, was recognized by the Lombardy Regional Authorities as a “hub” center for breast cancer treatment during the re-organization of the pandemic emergency health system, and as such, provided continuity of care for patients whose treatment could not be delayed. In our cancer center, similarly to the Hubei province, we recorded a reduction of 87% in breast surgery outpatient clinical activity, with only 274 accesses compared to 2020 accesses in 2019 (an 84% reduction of extra-regional patients and a 42% reduction of patients from Lombardy). However, an increased number of patients (about 20%) from Lombardy was observed in comparison to the same period of 2019, because patients already scheduled for surgery in other breast services were transferred to our cancer center [5]. An international group of clinical experts described recently specific recommendations for early breast cancer management during this pandemic [6]. We cannot forget also the psychological impact of delayed cancer diagnosis due to the COVID-19 pandemic. When physical, psychological, social, and spiritual health of patients are dealt with in a constructive manner, cancer survivorship is seen as a continuum that begins with a state of illness and goes to a state of health. Consequently, the disease begins a meaningful aspect of health [7,8]. This aspect could be different after this pandemic, and cancer survivorship may be delayed in reaching this state of health (or never reach it). At the time of writing, the spread of the COVID-19 pandemic is decreasing, and this decrease appears to be well under way in Italy, as well as in its Lombardy region. However, we are still observing a low number of new early diagnoses of breast cancer. These data are worrying; we could expect an increased number of new breast cancer cases after the end of the pandemic and a greater number of more advanced breast cancer cases, probably also inoperable. COVID-19 has had an immense and negative effect on cancer treatment and research. In the very near future, we should expect a new health emergency for the management of these cancer patients. Declaration of Interests The authors have nothing to declare.

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          Covid-19 epidemic in Italy: evolution, projections and impact of government measures

          We report on the Covid-19 epidemic in Italy in relation to the extraordinary measures implemented by the Italian Government between the 24th of February and the 12th of March. We analysed the Covid-19 cumulative incidence (CI) using data from the 1st to the 31st of March. We estimated that in Lombardy, the worst hit region in Italy, the observed Covid-19 CI diverged towards values lower than the ones expected in the absence of government measures approximately 7–10 days after the measures implementation. The Covid-19 CI growth rate peaked in Lombardy the 22nd of March and in other regions between the 24th and the 27th of March. The CI growth rate peaked in 87 out of 107 Italian provinces on average 13.6 days after the measures implementation. We projected that the CI growth rate in Lombardy should substantially slow by mid-May 2020. Other regions should follow a similar pattern. Our projections assume that the government measures will remain in place during this period. The evolution of the epidemic in different Italian regions suggests that the earlier the measures were taken in relation to the stage of the epidemic, the lower the total cumulative incidence achieved during this epidemic wave. Our analyses suggest that the government measures slowed and eventually reduced the Covid-19 CI growth where the epidemic had already reached high levels by mid-March (Lombardy, Emilia-Romagna and Veneto) and prevented the rise of the epidemic in regions of central and southern Italy where the epidemic was at an earlier stage in mid-March to reach the high levels already present in northern regions. As several governments indicate that their aim is to “push down” the epidemic curve, the evolution of the epidemic in Italy supports the WHO recommendation that strict containment measures should be introduced as early as possible in the epidemic curve.
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            Recommendations for triage, prioritization and treatment of breast cancer patients during the COVID-19 pandemic.

            The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) associated disease (COVID-19) outbreak seriously challenges globally all health care systems and professionals. Expert projections estimate that despite social distancing and lockdown being practiced, we have yet to feel the full impact of COVID-19. In this manuscript we provide guidance to prepare for the impact of COVID-19 pandemic on breast cancer patients and advise on how to triage, prioritize and organize diagnostic procedures, surgical, radiation and medical treatments.
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              Effect of the COVID-19 pandemic on cancer treatment and research

              The coronavirus disease 2019 (COVID-19) outbreak, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has rapidly escalated into a global pandemic. Patients with haematological and other cancers,1, 2 and recipients of haematopoietic stem cell transplantation (HSCT), could be at particular risk from COVID-19, since they tend to be older, have multiple comorbidities, and are often immunosuppressed by their disease or therapy. A retrospective analysis of 355 patients who died of COVID-19 in Italy showed that 20% had active cancer, 3 and a study from 2013–17 of 678 patients who had an HSCT found that 112 (17%) developed human coronavirus infection, of whom 34 had lower respiratory tract infection. 4 However, evidence regarding the effect of COVID-19 on patients with cancer is inadequate. The influx of a large number of patients with COVID-19 requiring intensive monitoring and mechanical ventilation has resulted in overloading of hospital systems in the affected regions and countries, disrupting routine treatment of haematology and cancer patients who constitute an especially fragile and vulnerable population, and whose outcomes are likely to be negatively affected if the usual standard of care is delayed. Travel restrictions, patient concerns, regulatory guidance, and sequestering of oncology staff have resulted in many cancer outpatient visits being replaced by telephone consultation, and deferral of some routine therapy, tests, and procedures. Estimating the risk versus benefit of administering potentially immunosuppressive treatment to patients with cancer with a scarcity of knowledge about this novel disease, and balancing individual versus societal benefits in the new reality of stretched resources, poses acute ethical dilemmas to oncologists. Investigators, government agencies, and professional societies have provided initial experiences and guidance on managing the continued care of patients with cancer during the current period of crisis. 5 Routine visits should be done via telephone or rescheduled, oral medications should be delivered to the patient's home to cover the peak period of the pandemic, and biological samples should be collected and processed at a local facility near the patient's residence. Cancer multidisciplinary team meetings should be done via a virtual platform, and changes should be made to individual treatment plans as needed for the duration of the pandemic. Patients with leukaemia, lymphoma, or myeloma; those receiving radical radiotherapy for lung cancer, cytotoxic chemotherapy, immunotherapy, antibodies, protein kinase inhibitors, or poly ADP ribose polymerase (PARP) inhibitors; and those with recent bone marrow or stem cell transplants could be especially vulnerable to COVID-19. 5 The European Society of Medical Oncology and National Health Service England have suggested a tiered approach for categorising patients into different priorities for receiving active cancer therapy during the pandemic. 5 Higher priority should be given if the patient's condition is immediately life threatening or clinically unstable, or the intervention is expected to result in substantial overall survival gain or improvement of quality of life. Oncologists should consider changing intravenous treatments to subcutaneous or oral routes, using longer intervals between immunotherapy regimens, deferring non-urgent supportive therapies, using granulocyte-colony stimulating factor as primary prophylaxis, and discussing treatment breaks for patients on long-term therapy. 5 Radiation treatment should be prioritised for patients with rapidly proliferating tumours and those whose planned radiotherapy has already begun, and hypofractionation should be considered to shorten the treatment duration. Patients with cancer who develop COVID-19 should be treated in the respiratory or intensive care units rather than in the oncology or radiotherapy units. 2 The COVID-19 pandemic has had a serious and disruptive effect on the conduct of haematology and oncology clinical trials, with both immediate and delayed consequences. In the short term, research staff and resources have been reassigned to manage the rush of patients with COVID-19 at many academic institutions and participating hospitals, and routine clinical research activities have been suspended. Trials testing treatments for COVID-19 have been prioritised. Research-related appointments to hospitals for site selection or qualification, source data verification, drug accountability, audit, and site staff training by contract research organisations (CROs) and sponsors have been cancelled because of travel restrictions. A sharp reduction in recruitment to ongoing trials and a delay in the planned launch of new haematology and oncology studies might be expected during the peak of the pandemic. A delay can also be anticipated in data entry into clinical trial databases owing to study coordinators working remotely with reduced access to the source data. As hospital radiology departments and laboratories are stretched during the pandemic, and to reduce the risk of SARS-CoV-2 infection to trial subjects, some protocol-mandated visits and study procedures, such as tumour assessments and biopsies, have been delayed or cancelled. A delay in imaging will impact progression-free endpoints of ongoing studies, while quality of life endpoints will be affected if patients miss study visits. Most regulatory authorities require that COVID-19 infection and related (serious) adverse events, such as dyspnoea and acute respiratory distress syndrome, be specifically captured and reported. 6 Site staff and monitors will need to be trained in this regard. In the medium to longer term, recruitment delays resulting from the pandemic will negatively affect drug development timelines, with damaging financial implications and potential delays in getting promising drugs to patients. An increase in protocol deviations over the duration of the pandemic can be expected, potentially affecting patient safety because of missing or late reporting of adverse events. COVID-19-related deaths could potentially affect survival endpoints in some studies. Cytokine release syndrome is a known toxicity of chimeric antigen receptor T-cell therapy and also occurs in a subgroup of patients with COVID-19, 7 but the effect on ongoing immunotherapy trials is presently unknown. Regulatory agencies such as the US Food and Drug Administration, European Medicines Agency, and the UK Medicines and Healthcare products Regulatory Agency have issued guidelines on managing clinical trials during the COVID-19 pandemic, stressing the importance of pragmatism and flexibility in tumour assessments and visits (via protocol amendments as necessary), protecting patient safety, clearly documenting protocol deviations, and disallowing prospective protocol waivers.8, 9, 10 Ensuring patient safety during the pandemic is of utmost priority. Training courses on COVID-19 symptoms, management, and use of personal protective equipment should be implemented. A phone contact with the trial participant should be made the day before the planned visit, to enquire if they have any COVID-19 symptoms. Hospital access should be restricted for vendors, visitors, trial monitors, and auditors. Virtual support services should be implemented for trial participants, and where feasible, remote access to relevant medical charts should be granted to trial monitors to review, verify, and raise queries. Such systems should have robust security and audit trails. Several CROs are responding to this new reality by adapting their usual processes and developing new methods of remote, secure trial monitoring, site staff training, drug accountability, and source data verification and review, while recognising and respecting the disparities in national legislation in different countries with regard to remote access to medical records by CROs and direct shipment of medication to patients. A discussion between investigators and sponsors should take place to consider withdrawal of optional trial procedures (eg, biopsies), and to allow laboratory and radiological assessments to be done at an accredited facility closest to the patient. For some investigational products, such as oral medications typically distributed for self-administration, alternative safe delivery methods should be implemented to avoid hospital visits by patients. The implementation of such alternative processes should be as consistent with the protocol as possible, and sponsors and clinical investigators should document the reasons for any contingency measures adopted. Sponsors and clinical investigators should clearly document how restrictions related to COVID-19 led to the changes in study conduct, the duration of those changes, and which trial participants were affected and how. Since radiology services are likely to be stretched during the pandemic, central imaging review should be instituted to ensure good quality of data for clinical trial patients. COVID-19 has had a huge and negative effect on cancer treatment and research. We hope that with the support of all stakeholders, patients with cancer and trial participants can receive the best possible care even in these exceptionally difficult times. © 2020 Sputnik/Science Photo Library 2020 Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
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                Author and article information

                Journal
                EClinicalMedicine
                EClinicalMedicine
                EClinicalMedicine
                The Authors. Published by Elsevier Ltd.
                2589-5370
                20 September 2020
                September 2020
                20 September 2020
                : 26
                : 100523
                Affiliations
                [a ]Division of Breast Surgery, European Institute of Oncology, IRCCS, Milan, Italy
                [b ]Department of Oncology and Hemato-Oncology, Faculty of Medicine, University of Milan, Milan, Italy
                Author notes
                [* ]Corresponding author at: Director Division of Breast Surgery, European Institute of Oncology, IRCCS, Via G. Ripamonti 435, Milan, Italy.
                Article
                S2589-5370(20)30267-4 100523
                10.1016/j.eclinm.2020.100523
                7502176
                679a79e5-0dc5-416e-8093-f1b196403ab5
                © 2020 The Authors

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 5 August 2020
                : 11 August 2020
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