Real-World Predictors of Severe Neutropenia Associated with Palbociclib and Endocrine Therapy for Metastatic Breast Cancer in Japanese Patients

Shinya Takada; Hideki Maeda; Kengo Umehara; Sayuri Kuwahara; Mitsugu Yamamoto; Nobumoto Tomioka; Kenichi Watanabe; Kozo Mino

doi:10.1248/bpb.b23-00187

Regular Articles

Real-World Predictors of Severe Neutropenia Associated with Palbociclib and Endocrine Therapy for Metastatic Breast Cancer in Japanese Patients

Shinya Takada , Hideki Maeda, Kengo Umehara, Sayuri Kuwahara, Mitsugu Yamamoto, Nobumoto Tomioka, Kenichi Watanabe, Kozo Mino

Author information

Shinya Takada Corresponding author
Department of Pharmacy, National Hospital Organization Hokkaido Cancer Center
Hideki Maeda
Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center
Kengo Umehara
Department of Pharmacy, National Hospital Organization Hokkaido Cancer Center
Sayuri Kuwahara
Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center
Mitsugu Yamamoto
Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center
Nobumoto Tomioka
Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center
Kenichi Watanabe
Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center
Kozo Mino
Department of Pharmacy, National Hospital Organization Hokkaido Cancer Center

Keywords: cyclin-dependent kinase 4/6 inhibitor, palbociclib, breast cancer, severe neutropenia, age-adjusted Charlson comorbidity index

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Supplementary material

2023 Volume 46 Issue 8 Pages 1105-1111

DOI https://doi.org/10.1248/bpb.b23-00187

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Abstract

Therapy for patients of metastatic breast cancer based on palbociclib, a cyclin-dependent kinase 4/6 inhibitor, has been approved in Japan. However, the risk factors for palbociclib-induced severe neutropenia in Japanese patients are rarely reported. Hence, the present study is aimed to identify the risk factors for adverse events requiring palbociclib dose reduction or discontinuation, and to identify the factors necessary to identify a more stable strategy for treatment continuation. This retrospective cohort analysis included patients with advanced breast cancer treated with 125 mg/d palbociclib. We demonstrated that severe neutropenia required significant dose reduction or therapy cessation. Most (77%) of the patients had severe neutropenia within the three courses. Risk factors for grade 3 or higher included low neutrophil counts (< 3250 /µL) before treatment [odds ratio (OR) = 9.10, 95% confidence interval (CI) (2.80–29.41), p < 0.001] and high age-adjusted Charlson comorbidity index (> 9) [OR = 1.64, 95% CI (1.09–2.48), p = 0.018]. Thus, low baseline neutrophil counts and high values for Age-adjusted Charlson comorbidity index are prospective predictive markers for palbociclib-induced severe neutropenia.

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