A Neoadjuvant Chemotherapy Trial for Early Breast Cancer is Impacted by COVID-19: Addressing Vaccination and Cancer Trials Through Education, Equity, and Outcomes.

While COVID-19 vaccine distribution has addressed vulnerabilities related to age and comorbidities, there is a need to ensure vaccination of patients with cancer receiving experimental and routine treatment, where interruption of treatment by infection is likely to result in inferior outcomes. Among patients with cancer, those undergoing neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy (Adj chemo) for early breast cancer (EBC) are at particularly high risk for inferior outcomes, in part, because optimal timing of chemotherapy is essential for promoting distant disease-free survival. COVID-19 data from the ongoing multicenter I-SPY 2 trial of NAC for EBC provides a window into the magnitude of the problem of treatment interruption, not only for the trial itself but also for routine Adj chemo. In the I-SPY 2 trial, 4.5% of patients had disruption of therapy by COVID-19, prior to wide vaccine availability, suggesting that nationally up to 5,700 patients with EBC were at risk for adverse outcomes from COVID-19 infection in 2020. To address this problem, vaccine education and public engagement are essential to overcome hesitancy, while equity of distribution is needed to address access. To accomplish these goals, healthcare organizations (HCO) need to not only call out disinformation but also engage the public with vaccine education and find common ground for vaccine acceptance, while partnering with state/local governments to improve efficiency of vaccine distribution. These approaches are important to improve trial access and to reduce susceptibility to COVID-19, as the pandemic could continue to impact access to clinical trials and routine cancer treatment.