Real‐world benefit of combination palbociclib and endocrine therapy for metastatic breast cancer and correlation with neutropenia

Sun, James; Zhong, Xiaojun; José, Ma; Sun, Weihong; Han, Hyo S.; Soliman, Hatem; Loftus, Loretta; Costa, Ricardo; Armaghani, Avan; Soyano‐Muller, Aixa E.; Czerniecki, Brian J.; Lee, M. Catherine; Kiluk, John V.; Khakpour, Nazanin; Hoover, Susan; Laronga, Christine; Khong, Hung T.

doi:10.1002/cam4.4295

Cited by 13 publications

(8 citation statements)

References 38 publications

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“…Different from our study, neutrophil levels were recorded at weeks 2, 4, 6, 8, 12, 16, 18, and 24. Lower neutrophil levels were found to be correlated with a lower risk of progression (13). On the contrary, according to the results obtained in our study, the development of neutropenia on days 10 and 28 did not affect the risk of progression in the palbociclib group.…”

Section: Discussionsupporting

confidence: 51%

Does Cyclin-dependent Kinase 4/6 Inhibitor Toxicity Predict Treatment Response in Metastatic Hormone Positive Breast Cancer?

Gülbağcı

Demirci

Hacıbekiroğlu

et al. 2023

Preprint

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In estrogen and/or progesterone receptor expression (hormone receptor [HR]-positive) without human epidermal growth factor receptor 2 (HER2) overexpression (HR+/HER2−) metastatic breast cancer (MBC), a significant progression-free survival (PFS) benefit has been obtained with cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and endocrine therapy (ET) combinations in the first-line treatment. We mainly aimed to investigate whether the toxicities of CDK 4/6 inhibitors predict treatment response. This study was designed retrospectively. A total of 191 patients diagnosed with MBC were treated with CDK 4/6 inhibitors plus ETs between 2019 and 2021, in four centers included. One hundred six patients received ribociclib, and 85 patients received palbociclib. The most common adverse event in both groups was neutropenia. We found that toxicities didn’t predict response rates (RRs). Additionally, the RRs in patients with albumin levels above 4.1g/dl was better than that in patients with albumin levels 4.1g/dl and below in multivariate analysis when all patients were considered (OR,4.76;95%CI,1.30–17.46;p = 0.018). When the multivariate analysis was performed separately for those who received ribociclib and those who received palbociclib, it was seen that this difference was due to ribociclib (OR,49.89;95%CI,2.49–999.16;p = 0.011). Toxicities of CDK4/6-inhibitors didn’t predict RRs. However, pretreatment albumin level may predict ribociclib response.

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Section: Discussionsupporting

confidence: 51%

Does Cyclin-dependent Kinase 4/6 Inhibitor Toxicity Predict Treatment Response in Metastatic Hormone Positive Breast Cancer?

Gülbağcı

Demirci

Hacıbekiroğlu

et al. 2023

Preprint

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show abstract

“…The interpretation of real-world studies may be limited by the lack of a comparator group, small sample size, short follow-up, and/or differences in outcome endpoint definitions 15 – 18 . Only a few comparative effectiveness analyses of CDK4/6 inhibitor outcomes in MBC have been published to date, including DeMichele et al (2021) and Brufsky et al (2021) using the Flatiron Health Analytic Database (Flatiron Health, New York, NY) and Ha et al (2022) from one academic institution (Breast Medical Oncology database; MD Anderson Cancer Center, Houston, TX) 19 – 21 .…”

Section: Introductionmentioning

confidence: 99%

Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2− metastatic breast cancer

et al. 2022

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Data on real-world effectiveness of cyclin-dependent kinase 4/6 inhibitor combination therapy versus endocrine therapy alone are limited. The Flatiron Health Analytic Database was used to assess overall survival (OS) in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) metastatic breast cancer (MBC) treated with first-line palbociclib plus an aromatase inhibitor (AI) versus an AI alone in routine US clinical practice. In total, 2888 patients initiated treatment during February 3, 2015–March 31, 2020, with a potential ≥6-month follow-up (cutoff date, September 30, 2020). After stabilized inverse probability treatment weighting, median OS (95% CI) is significantly longer among palbociclib versus AI recipients (49.1 [45.2–57.7] versus 43.2 [37.6–48.0] months; hazard ratio, 0.76 [95% CI, 0.65–0.87]; P < 0.0001). Progression-free survival (95% CI) is 19.3 (17.5–20.7) versus 13.9 (12.5–15.2) months, respectively (hazard ratio, 0.70 [95% CI, 0.62–0.78]; P < 0.0001). These data support first-line palbociclib plus an AI treatment for HR+/HER2− MBC.(Trial number NCT05361655).

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“…Neutrophils have been shown to promote tumor growth and play a pro-angiogenic role by releasing matrix metalloproteinases that promote angiogenesis and play an immunosuppressive role by inhibiting CD8 + T cells. 11 Sun et al 12 studied the relationship between baseline ANC, NLR, and PFS in 165 patients with HR + / HER2- ABC treated with Palbociclib plus ET as first-line therapy. Univariate analysis revealed that ANC was significantly correlated with PFS, implying that the decrease in ANC suggested prolonged PFS.…”

Section: Hematologic-related Prognostic Parametersmentioning

confidence: 99%

Prognostic Parameters of Palbociclib in HR+/HER2- Advanced Breast Cancer: A Narrative Review

Wang

Chen

et al. 2023

Technol Cancer Res Treat

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Recent studies have demonstrated that the combination of Cyclin-Dependent Kinase 4/6 Inhibitor (CDK4/6i) and endocrine therapy (ET) is more effective than ET alone and significantly improves progression-free survival (PFS) and overall survival (OS) in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) breast cancer (BC). Palbociclib is the first CDK4/6i approved for use, and its clinical advantages have been shown. However, 30% of patients will continue to develop secondary drug resistance. Therefore, exploring the parameters that can predict the efficacy of Palbociclib and developing a clinical prediction model is essential for evaluating the prognosis of patients.

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Real‐world benefit of combination palbociclib and endocrine therapy for metastatic breast cancer and correlation with neutropenia

Abstract: Institutional review board obtained prior to the start of this study (ID: MCC 19591).

Cited by 13 publications

References 38 publications

Does Cyclin-dependent Kinase 4/6 Inhibitor Toxicity Predict Treatment Response in Metastatic Hormone Positive Breast Cancer?

Does Cyclin-dependent Kinase 4/6 Inhibitor Toxicity Predict Treatment Response in Metastatic Hormone Positive Breast Cancer?

Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2− metastatic breast cancer

Prognostic Parameters of Palbociclib in HR+/HER2- Advanced Breast Cancer: A Narrative Review

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