Abstract
Purpose
The three CDK4/6 inhibitors (CDK4/6i) approved for use in HR-positive/HER2-negative metastatic breast cancer (MBC), palbociclib, ribociclib, and abemaciclib, are generally well tolerated; however, neutropenia is a common toxicity. Within the general population, neutropenia has been shown to be more common in individuals of African descent. The landmark CDK4/6i trials in MBC lacked racial diversity in their patient populations. We aimed to assess the toxicity profiles of CDK4/6is in a racially diverse population.
Methods
We conducted a retrospective study at Montefiore Medical Center in patients with HR-positive/HER2-negative MBC prescribed CDK4/6i as first or subsequent line therapy between January 2015 and April 2020. Baseline characteristics and laboratory data at various treatment timepoints were collected.
Results
The final analysis included 182 patients, of whom 46% were Black. Baseline absolute neutrophil count (ANC) was lower in the Black vs. Non-Black cohort (p = 0.001) but the change in ANC from baseline (delta-ANC) was smaller in the Black cohort, and the ANC at different treatment timepoints was similar between groups. There was no difference in the rate of infection or number of dose delays/reductions between racial groups. We did not find any difference in PFS between Black and Non-Black groups, regardless of the presence of CDK4/6i-induced neutropenia.
Conclusion
We analyzed toxicity profiles of 182 patients with HR-positive/HER2-negative MBC treated with CDK4/6i. Despite the lower baseline ANC seen in our Black cohort, treatment toxicities were similar between racial groups. Long-term outcomes with CDK4/6i therapy, measured by PFS, were similar between Black vs. Non-Black patients.
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Data availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Acknowledgements
The manuscript development is supported by The Einstein Paul Calabresi Career Development Program (NIH 5K12CA132783-08) and NIH/National Center for Advancing Translational Science (NCATS) Einstein-Montefiore CTSA (Grant Number UL1TR001073).
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The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.
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All authors contributed to the study conception and design as well as material preparation, data collection and analysis. The first draft of the manuscript was written by AW and JA and all authors commented on previous versions of the manuscript. All authors have read and approve the final manuscript.
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This retrospective chart review study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Human Investigation Committee (IRB) of Montefiore Medical Center/Einstein College of Medicine approved this study.
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Schreier, A., Munoz-Arcos, L., Alvarez, A. et al. Racial disparities in neutrophil counts among patients with metastatic breast cancer during treatment with CDK4/6 inhibitors. Breast Cancer Res Treat 194, 337–351 (2022). https://doi.org/10.1007/s10549-022-06574-8
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DOI: https://doi.org/10.1007/s10549-022-06574-8