Abstract
Purpose
Over 40% of newly diagnosed metastatic breast cancer patients are ≥ 70 years old; however, this population is less likely to be represented in clinical trials. The objective of this study was to analyze PFS, dose reductions, dose delays, and toxicity in a geriatric population receiving palbociclib in a non-trial setting.
Methods
Patients with metastatic breast cancer receiving palbociclib in any line of therapy were identified from a cohort of 845 patients at a large academic institution. Dose delays, dose reductions, and toxicities were retrospectively extracted from the medical record. Data were analyzed using Fischer’s exact test for categorized variables and T test/Wilcoxon rank-sum test for continuous variables. PFS and OS were analyzed using the Kaplan–Meier method.
Results
605 patients who met eligibility criteria were included. 160 patients were ≥ 65 years old and 92 patients were ≥ 70 years old. Patients ≥ 70 had a significantly increased number of dose reductions (p = 0.03) and dose delays (p = 0.02) compared to the younger patients. There was no significant increase in toxicities, including neutropenic fever, infections, or hospitalizations, in the ≥ 70 cohort (p = 0.3). The ≥ 70 cohort had a significantly improved PFS as compared to the younger cohort (p = 0.02); however, age was no longer a significant variable in the multivariate analysis.
Conclusions
Palbociclib was well tolerated in the geriatric population and there was no difference in PFS between older and younger patients. These results are reassuring as palbociclib becomes the frontline standard of care therapy for patients.
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Palbociclib (Ibrance) [package insert] (2017) Pfizer, New York
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Dr. Clifton receives research support from T32 CA009666-24.
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The following authors report conflicts of interest: Dr. Jennifer Litton—advisory boards and consulting for Pfizer (both uncompensated); research funding for clinical trials from Pfizer. Dr. Meghan Karuturi—consulting for Pfizer. Dr. Debu Tripathy—Novartis: clinical trial support (support paid to the institution), consultant, consulting for Pfizer. Dr. Clifton, Dr. Min, and Jaime Kimmel do not report any conflicts of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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The Institutional Review Board approved this study; informed consent requirement was waived given the retrospective study design.
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Clifton, K., Min, Y., Kimmel, J. et al. Progression-free survival (PFS) and toxicities of palbociclib in a geriatric population. Breast Cancer Res Treat 175, 667–674 (2019). https://doi.org/10.1007/s10549-019-05181-4
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DOI: https://doi.org/10.1007/s10549-019-05181-4