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. 2025 Feb;55(2):188-196.
doi: 10.1007/s00595-024-02893-z. Epub 2024 Jul 4.

Identification of peripheral blood test parameters predicting the response to palbociclib and endocrine therapy for metastatic breast cancer: a retrospective study in a single institution

Misato Yamamoto  1 , Masahiro Shibata  2   3 , Aya Tanaka  1   4 , Nobuyuki Tsunoda  1   5 , Norikazu Masuda  1
Affiliations

Identification of peripheral blood test parameters predicting the response to palbociclib and endocrine therapy for metastatic breast cancer: a retrospective study in a single institution

Misato Yamamoto et al. Surg Today. 2025 Feb.

Abstract

Purpose: Cyclin-dependent kinase 4/6 inhibitors have been used in endocrine therapy for patients with estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Although randomized trials have shown that combined therapies prolong progression-free survival (PFS) in comparison to endocrine monotherapy, the predictors of efficacy are unknown. This study aimed to identify the blood test parameters to predict the effects of palbociclib and endocrine therapy.

Methods: Seventy-nine patients treated with palbociclib and endocrine therapy between December 2017 and June 2022 were reviewed. We assessed PFS in patients according to factors evaluated based on patient characteristics and peripheral blood tests.

Results: Patients in the C-reactive protein (CRP)-high, lactate dehydrogenase (LDH)-high, and albumin (Alb)-low groups had significantly shorter PFS than those in the normal group. A multivariate analysis revealed that high LDH and low Alb levels were independent factors that affected PFS. The Alb-low group had an inferior disease control rate. Patients in the CRP-high, LDH-high, and Alb-low groups who received these therapies as first- or second-line treatments showed poor PFS.

Conclusions: Several predictors of the efficacy of palbociclib and endocrine therapy were identified in the peripheral blood test parameters of patients with ER-positive and HER2-negative subtypes of metastatic breast cancer.

Keywords: Albumin; Breast cancer; C-reactive protein; Lactate dehydrogenase; Palbociclib.

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Conflict of interest statement

Declarations. Conflict of interest: Norikazu Masuda received honoraria from AstraZeneca, Chugai Pharma, Daiichi Sankyo, Eisai, Eli Lilly Japan, and Pfizer, and received research Funding from AstraZeneca, Chugai Pharma, Daiichi Sankyo, Eisai, Eli Lilly Japan, Gilead Sciences, Kyowa-Kirin, MSD, Novartis, Ono Pharma, Pfizer, and Sanofi on behalf of the institution; National Hospital Organization Osaka National Hospital until September 2021, and Nagoya University Hospital from October 2021. Ethics approval and consent to participate: This study was approved by the Institutional Review Board of Nagoya University Hospital (No. 2022-0259). All procedures involving human participants were performed in accordance with the ethical standards of the Institutional Committee and the Declaration of Helsinki. All patients provided consent for the use of their clinical data in the form of opt-outs on a website.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curves for progression-free-survival (PFS). No significant differences were observed in PFS stratified according to the treatment lines (a), presence of visceral metastasis (b), progesterone receptor (PgR) positivity (c), type of combined endocrine therapy (d), baseline neutrophil count (e), lymphocyte count (f), or neutrophil-to-lymphocyte ratio (NLR) (g). AI, aromatase inhibitor; FUL, fulvestrant; and PgR, progesterone receptor
Fig. 2
Fig. 2
Progression-free-survival (PFS) curves in patients stratified according to the factors evaluated by peripheral blood tests. PFS was significantly shorter in the C-reactive protein (CRP)-high (a), lactate dehydrogenase (LDH)-high (b), and albumin (Alb)-low (c) groups than in the normal group. The CRP-high and LDH-high groups tended to show an inferior disease control rate (DCR) relative to the CRP-normal and LDH-normal groups, respectively. The Alb-low group experienced inferior DCR in comparison to the Alb-normal group (d)
Fig. 3
Fig. 3
Progression-free-survival (PFS) curves in patients who received palbociclib and endocrine therapy as first- or second-line treatment. Patients were stratified according to the standard values of C-reactive protein (CRP) (a), lactate dehydrogenase (LDH) (b), or albumin (Alb) (c). Patients with high CRP, high LDH, or low Alb levels experienced shorter PFS than those with normal CRP, LDH, or Alb levels, respectively
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References

    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7–33. - PubMed
    1. Tremont A, Lu J, Cole JT. Endocrine therapy for early breast cancer: Updated review. Ochsner J. 2017;17:405–11. - PMC - PubMed
    1. Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, André F, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31:1623–49. - PMC - PubMed
    1. Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375:1925–36. - PubMed
    1. Verma S, Bartlett CH, Schnell P, DeMichele AM, Loi S, Ro J, et al. Palbociclib in combination with fulvestrant in women with hormone receptor-positive/HER2-negative advanced metastatic breast cancer: Detailed safety analysis from a multicenter, randomized, placebo-controlled, Phase III study (PALOMA-3). Oncologist. 2016;21:1165–75. - PMC - PubMed

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