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

David A. Potter, Alexandra Thomas, Hope S. Rugo

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)4486-4490
Number of pages5
JournalClinical Cancer Research
Volume27
Issue number16
Early online dateJun 9 2021
DOIs
StatePublished - Aug 15 2021

Bibliographical note

Funding Information:
The authors acknowledge the I-SPY 2 Clinical Trial Consortium, Quantum Leap Healthcare Collaborative (2013 to present), and the Foundation for the National Institutes of Health (2010 to 2012) and by a grant (28XS197) from the National Cancer Institute Center for Biomedical Informatics and Information Technology. The authors sincerely appreciate the ongoing support for the I-SPY2 Trial from the Safeway Foundation, the William K. Bowes Jr. Foundation, and Give Breast Cancer the Boot. The authors thank Dr. Laura Esserman, principal investigator of the I-SPY 2 trial (UCSF), the I-SPY 2 Consortium co-investigators, as well as Smita Asare, Laura Sit, and Xiaofan Xu for their support and guidance. The authors thank Drs. Monica Gandhi (UCSF, San Francisco, CA), Melanie Swift and John O’Horo (Mayo Clinic, Rochester, MN), Abraham Jacob (University of Minnesota, Minneapolis, MN), and John Pastor (M Health/Fairview) for helpful comments on COVID-19 vaccines and their distribution.

Funding Information:
D.A. Potter reports grants from Quantum Leap Healthcare Collaborative and Seagen during the conduct of the study, as well as grants from Department of Defense, ImmunoMet Therapeutics, Pfizer, Innocrin, Takeda, Nektar Therapeutics, Roche, AstraZeneca, Spectrum Pharmaceuticals, Huya Bioscience International, Immuno-medics, Gilead Sciences, and National Cancer Institute of Mexico outside the submitted work. A. Thomas reports grants from Sanofi, as well as other support from Gilead Sciences, Bristol Myers Squibb, Johnson and Johnson, Pfizer, Beyond-Spring Pharmaceuticals, Lilly, and Genentech outside the submitted work. H.S. Rugo reports grants from Pfizer, Lilly, Novartis, Immunomedics, Merck, Roche, Sermonix, Polyphor, Daiichi, AstraZeneca, OBI, Macrogenics, and Odonate, as well as personal fees from Puma, Mylan, and Samsung outside the submitted work.

Funding Information:
The authors acknowledge the I-SPY 2 Clinical Trial Consortium, Quantum Leap Healthcare Collaborative (2013 to present), and the Foundation for the National Institutes of Health (2010 to 2012) and by a grant (28XS197) from the National Cancer Institute Center for Biomedical Informatics and Information Technology. The authors sincerely appreciate the ongoing support for the I-SPY2 Trial from the Safeway Foundation, the William K. Bowes Jr. Foundation, and Give Breast Cancer the Boot. The authors thank Dr. Laura Esserman, principal investigator of the I-SPY 2 trial (UCSF), the I-SPY 2 Consortium co-investigators, as well as Smita Asare, Laura Sit, and Xiaofan Xu for their support and guidance. The authors thank Drs. Monica Gandhi (UCSF, San Francisco, CA), Melanie Swift and John O'Horo (Mayo Clinic, Rochester, MN), Abraham Jacob (University of Minnesota, Minneapolis, MN), and John Pastor (M Health/Fairview) for helpful comments on COVID-19 vaccines and their distribution.

Publisher Copyright:
© 2021 American Association for Cancer Research

Keywords

  • Breast Neoplasms/drug therapy
  • COVID-19 Vaccines/immunology
  • COVID-19/prevention & control
  • Clinical Trials as Topic
  • Female
  • Health Education
  • Healthcare Disparities
  • Humans
  • Neoadjuvant Therapy
  • SARS-CoV-2/immunology
  • Vaccination

PubMed: MeSH publication types

  • Journal Article

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