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. 2023 May 9;24(10):8488.
doi: 10.3390/ijms24108488.

Abemaciclib, Palbociclib, and Ribociclib in Real-World Data: A Direct Comparison of First-Line Treatment for Endocrine-Receptor-Positive Metastatic Breast Cancer

Mónica Cejuela  1 , Ana Gil-Torralvo  1   2   3 , M Ángeles Castilla  2   3 , M Ángeles Domínguez-Cejudo  2   3 , Alejandro Falcón  1 , Marta Benavent  1   2   3 , Sonia Molina-Pinelo  2   3 , Manuel Ruiz-Borrego  1 , Javier Salvador Bofill  1   2   3
Affiliations

Abemaciclib, Palbociclib, and Ribociclib in Real-World Data: A Direct Comparison of First-Line Treatment for Endocrine-Receptor-Positive Metastatic Breast Cancer

Mónica Cejuela et al. Int J Mol Sci. .

Abstract

By the end of 2020, there were more than 8 million women alive who had received a breast cancer diagnosis in the previous 5 years, making it the most prevalent neoplasia in the world. About 70% of breast-cancer cases present positivity for estrogen and/or progesterone receptors and a lack of HER-2 overexpression. Endocrine therapy has traditionally been the standard of care for ER-positive and HER-2-negative metastatic breast cancer. In the last 8 years, the advent of CDK4/6 inhibitors has shown that adding them to endocrine therapy doubles PFS. As a result, this combination has become the gold standard in this setting. Three CDK4/6 inhibitors have been approved by the EMA and the FDA: abemaciclib, palbociclib, and ribociclib. They all have the same indications, and it is at each physician's discretion to choose one or the other. The aim of our study was to perform a comparative efficacy analysis of the three CDK4/6i using real-world data. We selected patients diagnosed with endocrine-receptor-positive and HER2-negative breast cancer who were treated with all three CDK4/6i as first-line therapy at a reference center. After 42 months of retrospective follow up, abemaciclib was associated with a significant benefit in terms of progression-free survival in endocrine-resistant patients and in the population without visceral involvement. In our real-world cohort, we found no other statistically significant differences among the three CDK4/6 inhibitors.

Keywords: CDK4/6 inhibitors; abemaciclib; breast cancer; breast carcinoma; cyclin inhibitors; endocrine therapy; metastatic; palbociclib; real world; ribociclib.

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Conflict of interest statement

M.C. reports advisory fees from Pfizer outside the submitted work. A.F. reports advisore fees from Pfizer, Roche, Seagen and Novartis as well as speakers grants from Roche, Pfizer, Novartis, Lilly, Seagen and Grunenthal. M.R.B reports advisory fees from Pfizer, Gilead, and Astrazeneca, as well as speaker grants from Daiichi Sankyo, AstraZeneca, and Pierre-Fabre. J.S.B. has received research grants from AstraZeneca, Lilly, Pfizer and Roche; consulting fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Pfizer, Roche and Seagen; and honoraria from Lilly, Novartis and Pfizer. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
(a) Progression-free survival according to CDK4/6i. Kaplan−Meier analysis of PFS comparing the different CDK4/6i in the study population. Abemaciclib−palbociclib, p = 0.241, by Breslow test; abemaciclib−ribociclib, p = 0.270, by Breslow test; palbociclib−ribociclib, p = 0.984, by Breslow test. (b) Overall survival according to CDK4/6i. Kaplan−Meier analysis of OS. Abemaciclib−Palbociclib, p = 0.791, by Breslow test; abemaciclib−ribociclib, p = 0.659, by Breslow test; palbociclib−ribociclib, p = 0.904, Breslow test.
Figure 1
Figure 1
(a) Progression-free survival according to CDK4/6i. Kaplan−Meier analysis of PFS comparing the different CDK4/6i in the study population. Abemaciclib−palbociclib, p = 0.241, by Breslow test; abemaciclib−ribociclib, p = 0.270, by Breslow test; palbociclib−ribociclib, p = 0.984, by Breslow test. (b) Overall survival according to CDK4/6i. Kaplan−Meier analysis of OS. Abemaciclib−Palbociclib, p = 0.791, by Breslow test; abemaciclib−ribociclib, p = 0.659, by Breslow test; palbociclib−ribociclib, p = 0.904, Breslow test.
Figure 2
Figure 2
Progression-free survival according to endocrine resistance. (a) Kaplan-Meier analysis of PFS comparing endocrine-sensitive patients to endocrine-resistant patients, p < 0.001 by log rank test. (b) Kaplan-Meier analysis of PFS comparing the different CDK4/6i in patients with endocrine resistance. Abemaciclib−palbociclib, p = 0.027, by log rank test; abemaciclib−ribociclib, p = 0.070 by log rank test; palbociclib−ribociclib, p = 0.972, by Breslow test. (c) Kaplan−Meier analysis of PFS comparing the different CDK4/6i in endocrine-sensitive patients. Abemaciclib−palbociclib: p = 0.726 by Breslow test; abemaciclib-ribociclib: p = 0.936 by Breslow test; palbociclib−ribociclib: p = 0.629 by Breslow test.
Figure 2
Figure 2
Progression-free survival according to endocrine resistance. (a) Kaplan-Meier analysis of PFS comparing endocrine-sensitive patients to endocrine-resistant patients, p < 0.001 by log rank test. (b) Kaplan-Meier analysis of PFS comparing the different CDK4/6i in patients with endocrine resistance. Abemaciclib−palbociclib, p = 0.027, by log rank test; abemaciclib−ribociclib, p = 0.070 by log rank test; palbociclib−ribociclib, p = 0.972, by Breslow test. (c) Kaplan−Meier analysis of PFS comparing the different CDK4/6i in endocrine-sensitive patients. Abemaciclib−palbociclib: p = 0.726 by Breslow test; abemaciclib-ribociclib: p = 0.936 by Breslow test; palbociclib−ribociclib: p = 0.629 by Breslow test.
Figure 3
Figure 3
Kaplan-Meier analysis of progression-free survival benefit of the three CDK4/6i in visceral and non-visceral disease. (a) Kaplan−Meier analysis of PFS comparing the non-visceral vs. visceral population, p = 0.469, by Breslow test. (b) Kaplan−Meier analysis of PFS comparing the three CDK4/6i in the population without visceral involvement. Abemaciclib−palbociclib, p = 0.038, by log rank test; abemaciclib−ribociclib, p = 0.581, by Breslow test; palbociclib−ribociclib, p = 0.163, by log rank test. (c) Kaplan−Meier analysis of PFS comparing the three CDK4/6i in the population with visceral disease. Abemaciclib−palbociclib, p = 0.937, by Breslow test; abemaciclib−ribociclib, p = 0.307, by Breslow test; palbociclib−ribociclib, p = 0.255, by Breslow test.
Figure 4
Figure 4
Flowchart of patient selection. The data source for this study was hospital pharmacy records. Patients were selected according to the inclusion criteria of this study: metastatic breast cancer patients receiving CDK4/6 inhibitors as first-line therapy.
See this image and copyright information in PMC

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