Purpose of review
The COVID-19 pandemic has had a devastating impact on virtually all aspects of the healthcare system, including oncology clinical trials. The purpose of this review is to describe the impact of the pandemic on national breast cancer clinical trials.
Recent findings
Of the 61 breast cancer–specific cooperative group breast cancer clinical trials open to accrual during the pandemic, 32% of them received supplementary tailored guidance regarding current and foreseeable challenges for clinical sites and investigators due to COVID-19. Many clinical trial sites reported decreases in enrollment and accrual, drastic disruptions to protocol, and challenges related to research infrastructure, staff burden, and assuring social distancing.
Summary
The challenges early in pandemic led to many operational changes in clinical trials, including use of electronic consent for enrollment, telemedicine visits, and mail order pharmacy. The pandemic highlighted aspects of breast cancer clinical trial that could be modernized while maintaining research integrity.
African American (AA) women have higher breast cancer mortality rates than other groups, with Triple negative breast cancer (TNBC) being more common among AAs with a worse prognosis. Our study seeks to explore differences among Non-Hispanic Black (NHB) vs. White (NHW) women, with Stage IV TNBC, focusing on survival and treatment patterns.
MethodsData from a specialized SEER Program dataset were examined for TNBC patients diagnosed with metastatic disease from 2012-2016. Neighborhood socioeconomic status (nSES) was de ned using the Yost index based on census tract measures of income, education, housing, employment. Univariate and multivariate analyses were performed to evaluate receipt of surgery, radiation, and chemotherapy. Overall survival was evaluated using Kaplan-Meier curve and Cox proportional hazards model analysis.
Results25,761 TNBC cases were identi ed with 1,420 being metastatic (5.5%). Bone was the most common site for metastasis, with patients' age being 63.7 years for NHW vs. 59.5 years for NHB. NHB women had the highest percentage of low nSES (62.3% vs 29.3%; p-value = 0.001). On univariate analysis, fewer NHBs received radiation compared to NHWs (27.1 vs. 32.6%; p-value = 0.040). On multivariate analysis, all women were less likely to undergo treatment if unmarried (p-value < 0.01). NHB women had lower median survival compared to NHW women (13 vs. 15 months; p-value < 0.01). Receipt of surgery and chemotherapy reduced the risk of mortality (p-value < 0.01).
ConclusionNHB women had lower median survival with metastatic TNBC. Race was associated with different treatment utilization. With a mortality differential between NHW and NHB women with metastatic TNBC, more investigation is needed to inform strategies to reduce this disparity.
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