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J Clin Oncol ; 39(2): 155-169, 2021 01 10.
Article in English | MEDLINE | ID: covidwho-1013168


This report presents the American Society of Clinical Oncology's (ASCO's) evaluation of the adaptations in care delivery, research operations, and regulatory oversight made in response to the coronavirus pandemic and presents recommendations for moving forward as the pandemic recedes. ASCO organized its recommendations for clinical research around five goals to ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality. The specific goals are: (1) ensure that clinical research is accessible, affordable, and equitable; (2) design more pragmatic and efficient clinical trials; (3) minimize administrative and regulatory burdens on research sites; (4) recruit, retain, and support a well-trained clinical research workforce; and (5) promote appropriate oversight and review of clinical trial conduct and results. Similarly, ASCO also organized its recommendations regarding cancer care delivery around five goals: (1) promote and protect equitable access to high-quality cancer care; (2) support safe delivery of high-quality cancer care; (3) advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care; (4) recognize and address threats to clinician, provider, and patient well-being; and (5) improve patient access to high-quality cancer care via telemedicine. ASCO will work at all levels to advance the recommendations made in this report.

Biomedical Research , COVID-19/therapy , Medical Oncology , Neoplasms/therapy , SARS-CoV-2 , Clinical Trials as Topic , Delivery of Health Care , Humans , Research Design , Societies, Medical
J Am Coll Surg ; 231(4): 434-447.e2, 2020 10.
Article in English | MEDLINE | ID: covidwho-728647


BACKGROUND: During the COVID-19 pandemic, surgical delays have been common for patients with ductal carcinoma in situ (DCIS) and early-stage estrogen receptor-positive (ER+) breast cancer, often in favor of neoadjuvant endocrine therapy (NET). To understand possible ramifications of these delays, we examined the association between time to operation and pathologic staging and overall survival (OS). STUDY DESIGN: Patients with DCIS or ER+ cT1-2N0 breast cancer treated from 2010 through 2016 were identified in the National Cancer Database. Time to operation was recorded. Factors associated with pathologic upstaging were examined using logistic regression analyses. Cox proportional hazard models were used to analyze OS. Analyses were stratified by disease stage and initial treatment strategy. RESULTS: There were 378,839 patients identified. Among those undergoing primary surgical procedure, time to operation was within 120 days in > 98% in all groups. Among cT1-2N0 patients selected for NET, operations were performed within 120 days in 59.6% of cT1N0 and 30.9% of cT2N0 patients. Increased time to operation was associated with increased odds of pathologic upstaging in DCIS patients (ER+: 60 to 120 days: odds ratio 1.15; 95% CI, 1.08 to 1.22; more than 120 days: odds ratio 1.44; 95% CI, 1.24 to 1.68; ER-: 60 to 120 days: NS; more than 120 days: odds ratio 1.36; 95% CI, 1.01 to 1.82; 60 days or less: reference), but not in patients with invasive cancer, irrespective of initial treatment strategy. No difference in OS was seen by time to operation in DCIS or NET patients. CONCLUSIONS: Increased time to operation was associated with a small increase in pathologic upstaging in DCIS patients, but did not impact OS. In patients with cT1-2N0 disease, NET use did not impact stage or OS, supporting the safety of delay strategies in ER+ breast cancer patients during the pandemic.

Betacoronavirus , Breast Neoplasms/diagnosis , Carcinoma, Ductal, Breast/diagnosis , Coronavirus Infections/epidemiology , Mastectomy/methods , Neoplasm Staging , Pneumonia, Viral/epidemiology , Receptors, Estrogen/metabolism , Adolescent , Adult , Aged , Aged, 80 and over , Biomarkers, Tumor/metabolism , Breast Neoplasms/epidemiology , Breast Neoplasms/surgery , COVID-19 , Carcinoma, Ductal, Breast/epidemiology , Carcinoma, Ductal, Breast/surgery , Comorbidity , Female , Follow-Up Studies , Humans , Middle Aged , Pandemics , Prognosis , Retrospective Studies , Risk Factors , SARS-CoV-2 , Survival Rate/trends , Time Factors , Time-to-Treatment , United States/epidemiology , Young Adult
J Natl Cancer Inst ; 113(4): 355-359, 2021 04 06.
Article in English | MEDLINE | ID: covidwho-361366


Caring for older patients with breast cancer presents unique clinical considerations because of preexisting and competing comorbidity, the potential for treatment-related toxicity, and the consequent impact on functional status. In the context of the COVID-19 pandemic, treatment decision making for older patients is especially challenging and encourages us to refocus our treatment priorities. While we work to avoid treatment delays and maintain therapeutic benefit, we also need to minimize the risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposures, myelosuppression, general chemotherapy toxicity, and functional decline. Herein, we propose multidisciplinary care considerations for the aging patient with breast cancer, with the goal to promote a team-based, multidisciplinary treatment approach during the COVID-19 pandemic and beyond. These considerations remain relevant as we navigate the "new normal" for the approximately 30% of breast cancer patients aged 70 years and older who are diagnosed in the United States annually and for the thousands of older patients living with recurrent and/or metastatic disease.

Breast Neoplasms/therapy , COVID-19/prevention & control , Interdisciplinary Communication , Medical Oncology/methods , Aged , Aged, 80 and over , Breast Neoplasms/diagnosis , Breast Neoplasms/metabolism , COVID-19/epidemiology , COVID-19/virology , Female , Humans , Medical Oncology/statistics & numerical data , Neoplasm Metastasis/prevention & control , Neoplasm Recurrence, Local/prevention & control , Pandemics , Receptor, ErbB-2/metabolism , SARS-CoV-2/physiology , United States