key: cord-0902958-odg2fw6o authors: Brenes Sánchez, J.M.; López Picado, A.; Olivares Crespo, M.E.; García Sáenz, J.A.; De La Plata Merlo, R.M.; Herrera De La Muela, María title: BREAST CANCER MANAGEMENT DURING COVID-19 PANDEMIC IN MADRID: SURGICAL STRATEGY date: 2020-10-24 journal: Clin Breast Cancer DOI: 10.1016/j.clbc.2020.10.006 sha: aeb2f10cdc06bc38d6a9b2bc76b835982d6726d6 doc_id: 902958 cord_uid: odg2fw6o PURPOSE: From the first case of SARS-CoV-2 infection in Wuhan (China), the infection spread all around the world causing a pandemic of coronavirus disease-2019 (COVID-19). Spain has been one of the most severely affected countries, and Madrid has reported a high number of cases and deaths. We discuss our strategies for optimal breast cancer management during COVID-19 pandemic. PATIENTS AND METHODS: Retrospective observational study at Clínico San Carlos Hospital to analyze breast cancer patient management during the pandemic outbreak and surgical strategy after the pandemic outbreak. We created a practical and dynamic tool based on a "traffic light" system for prioritizing surgical time. Every patient was contacted by telephone with a preoperative COVID-19 protocol. After surgical procedures, patient satisfaction was assessed using EORTC IN-PATSAT32. RESULTS: Breast cancer patients actively treated with surgical procedures were put on a waiting list and received systemic therapy. Telemedicine was used to evaluate any side effects and to avoid unnecessary hospital visits. Surgery was only considered after the pandemic outbreak and then only those procedures designed to minimize surgical complications and therefore reduce hospital stay. We also measured patients´ satisfaction with medical and nursing scales that resulted “very good” evaluation tending to “excellent”. CONCLUSION: It is necessary to adapt the management of oncology treatment and the surgical strategy to optimize resources during the COVID-19 pandemic. Patients´ perception of care quality and the degree of patient’s satisfaction with health services has potential relevance in the absence of outcome data. On December 2019, from the first case of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection in Wuhan (China), the infection spread westward all around the world causing a pandemic. The pandemic escalated into a global lockdown and a health care crisis. As the disease acquired the category of a pandemic, many countries struggled to adapt their health care systems to address this new emergency. Spain has been one of the country most severely affected by coronavirus disease 2019 , and Madrid has reported a high number of cases and deaths. The high number of COVID-19 (caused by SARS-CoV-2) in Madrid exceeded existing hospital capacity. This health care crisis seriously threatened the medical attention given to other diseases, including cancer 1 . Breast cancer remains one of the major public health problems due to its high incidence, prevalence, and mortality 2 . Our Breast Cancer Unit has been working from the outset of the pandemic to take care of our patients, using our own clinical experience and according to the current recommendations and protocols 3 . The results were different clinical points that aimed to balance the prevention of SARS-CoV-2 infection and provide oncological treatments, while maintaining the highest healthcare quality for the breast cancer patients. Our approach aims to present the treatment strategies adopted by a Breast Cancer Unit at Clínico San Carlos Hospital in Madrid throughout the course of the epidemic. Principal considerations and conceptual framework: The two principal considerations in approaching breast cancer management during the COVID-19 pandemic at our center are: 1. Breast cancer management during COVID-19 outbreak. 2. Surgical strategy after COVID-19 outbreak. The primary endpoints were to describe two different strategies throughout the course of the epidemic: -Systemic oncology therapy according to the breast cancer subtype during COVID-19 outbreak. -Surgical procedures (surgical procedures in breast and/or axilla) after COVID-19 outbreak. The secondary endpoints included the residual cancer burden (RCB) present after neoadjuvant treatment and every event related with the surgical procedure and/or adverse outcomes of COVID-19. Additionally, age, waiting time for treatment and the inpatient stay were also included. This study has been approved by the Clinical Research Ethics Committee of Hospital Clínico San Carlos. GROUP A: The group A study included all newly-diagnosed patients (stage I-III), patients undergoing neoadjuvant therapy and patients whose surgical treatments were postponed between March 15 th and April 21 st (N=29 patients). These postponed J o u r n a l P r e -p r o o f surgical procedures were considered priority B and C (Consortium Priorities) 3 during the pandemic outbreak. Every treatment was rescheduled based on immunohistochemical (IHC) analysis and HER2/neu gene amplification by FISH (Fluorescence in situ hybridization). Immunohistochemical breast cancer prognostic and therapeutic markers included: estrogen receptor (ER), human epidermal growth factor receptor-2 (HER2), Ki-67 and progesterone receptor (PR). Patients with ER-(negative estrogen receptor) and HER2-(negative human epidermal growth factor receptor-2) tumors received neoadjuvant chemotherapy and patients with HER2-tumors received neoadjuvant chemotherapy and targeted treatment. For ER+ (positive estrogen receptor) and HER2-invasive breast cancer, prior to surgical intervention we administered neoadjuvant endocrine therapy. Endocrine responsiveness 4-6 was evaluated with the 21-gene RS assay testing, in early breast cancer: cT1c-T3 cN0 G2-3 and cT1b cN0 G3 ER+/HER2-invasive breast cancer. Telemedicine was used to evaluate any side effects and to avoid unnecessary hospital visits thus minimizing exposure to the risk of SARS-CoV-2 infection. The B group study included patients with surgical procedures between April 22 nd and May 6 th (N=28 patients). Surgical procedures were partially restored in line with availability of resources, according to the epidemic trend. Prior to surgery, prognostic clinical points were evaluated weekly by a multidisciplinary breast group and factors related to risk of delaying surgery were identified: age, tumor biology, active anticancer therapy (cytotoxic chemotherapy, targeted drugs, endocrine therapy and/or immunotherapy), cancer status (responding to treatment versus progressing). -Medium priority (Yellow -surgical procedures in maximum four weeks): patients with endocrine therapy without genomic testing. We gave higher priority to younger women with neoadjuvant endocrine therapy. -Low priority (Green -surgical procedures more than four weeks): endocrine therapy in elderly patients, patients with anti-HER2 monotherapy, re-excision procedures and in situ ductal carcinoma (ER+/ER-). It was assumed that all benign, cosmetic and risk reducing surgery could be deferred. Furthermore, we completed the triage by taking into account other comorbidities requiring active treatment such as hypertension, diabetes and heart disease, also taking into account the patient´s preferences. The most common surgery option was minimal surgical procedures to avoid surgical complications and reduce hospital stay thus minimizing the risk of exposure to the virus. Every patient was telephoned and checked according to our hospital preoperative COVID-19 protocol. (Appendix 1). In-patient satisfaction with cancer care was measured in group B with the EORTC IN-PATSAT32 7 . Patients were contacted by telephone after their discharge from hospital, were informed of the objectives and procedures of the survey and were invited to take part. None of the patients refused to participate. The EORTC IN-PATSAT32 questionnaire is composed of 32 questions designed to assess cancer patients' perception of the quality of hospital-based care, relevant across country settings. This questionnaire was developed according to the guidelines and procedures recommended by the EORTC QL Group. The survey was carried out via phone call as a structured interview with closed questions. The patient can choose from 5 alternative responses on the Likert scale ("poor", "fair", "good", "very good", "excellent"). This type of response scale has been shown to have methodological advantages over other types of response scales. All scores are linearly transformed to a 0-100 scale. The selected timeframe was each individual hospital stay. This test can discriminate between patients with different care expectations and varying preexisting intentions as to recommending their hospital to other potential health care users. A higher score reflects a higher level of satisfaction. Table 1 . Six patients (20.7%) with invasive triple negative breast cancer underwent docetaxel plus carboplatin neoadjuvant chemotherapy. Two additional single carboplatin cycles were rescheduled in two patients (6.9%) from this group before surgical procedure during this phase. Finally, both patients achieved pathological complete response (pCR) at surgery. In addition, there is a direct relation between care satisfaction levels and adherence to medical recommendations, adherence of oncological treatment regime and health condition improvement 24 . In the present study we considered psychological impact after surgical procedures. We found that the COVID-19 pandemic required rapid changes in relation to outpatient consultations, information, and interventions. Our results show that all medical and nursing scales got a final "very good" evaluation tending to "excellent". The lowest score was hospital accessibility, which the test itself recognizes has lower internal consistency because it includes two related elements but totally different in concept (ease of access to the hospital itself-transport and parking lots-and ease of access to services inside the hospital). Breast Cancer Unit was perceived by patients as good, this has a potential relevance in the absence of outcome data. In this paper we also share an approach that provides physicians with a visual and dynamic tool for prioritizing surgical time. Further investigation and different points must be considered in breast cancer care and surgery over the following months and particularly should a second wave occur. World Health Organization Rationalizing breast cancer surgery during the COVID-19 pandemic Recommendations for Prioritization, Treatment and Triage of Breast Cancer Patients During the COVID-19 Pandemic. The COVID-19 Pandemic Breast Cancer Consortium: Representatives from the American Society of Breast Surgeons (ASBrS), the National Accreditation Program for Breast Centers (NAPBC), the National Comprehensive Care Network (NCCN), the Commission on Cancer (CoC), and American College of Radiology (ACR) Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32) Cancer Patients in SARS-CoV-2 Infection: A Nationwide Analysis in China ESMO Management and Treatment Adapted Recommendations in the COVID-19 Era: Breast Cancer Recommendations for triage, prioritization and treatment of breast cancer patients during the COVID-19 pandemic COVID-19: The European institute of oncology as a "hub" centre for breast cancer surgery during the pandemic in Milan (Lombardy region, northern Italy)-A screenshot of the first month Personalized riskbenefit ratio adaptation of Breast Cancer care at the epicentre of Covid-19 outbreak Taking a second look at neoadjuvant endocrine therapy for the treatment of early stage estrogen receptor positive breast cancer during the COVID-19 outbreak Recommendations for Prioritization, Treatment, and Triage of Breast Cancer Patients During the COVID-19 Pandemic. The COVID-19 Pandemic Breast Cancer Consortium Clinical characteristics of COVID-19-infected cancer patients: A retrospective case study in three hospitals within Wuhan COVID-19 mortality in patients with cancer on chemotherapy or other anticancer treatments: a prospective cohort study Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV Admitted to ICUs of the Lombardy Region COVID-19 in breast cancer patients: a cohort at the Institut Curie hospitals in the Paris area Cancer treatment during COVID-19 pandemic Rationalizing Breast Cancer Surgery During the COVID-19 Pandemic Impact of the COVID-19 pandemic on surgical breast cancer care in the Netherlands: a multicentre restrospective cohort study. Clin Breast Cancer Poor clinical outcomes for patients with cancer during the COVID-19 pandemic The impact of the COVID-19 pandemic on breast cancer patients awaiting surgery