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

Cejuela, Mónica; Gil-Torralvo, Ana; Castilla, María Ángeles; Dominguez-Cejudo, Maria A; Falcón, Alejandro; Benavent, Marta; Molina-Pinelo, Sonia; Ruíz-Borrego, Manuel; Bofill, Javier Salvador

doi:10.3390/ijms24108488

Cited by 25 publications

(11 citation statements)

References 41 publications

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“…In the MARIA study (RWD in Italian and German patients), 12-month progression-free rates (PFRs) were 80% in patients treated with first-line P+AI. A recently published study of 206 patients evaluated the clinical benefit of palbociclib (n = 96), ribociclib (n = 54) and abemaciclib (n = 56) after 42 months of follow-up [34]. Whilst abemaciclib was associated with a significant PFS benefit in endocrine-resistant patients and those without visceral involvement, there were no other statistically significant differences among the palbociclib, ribociclib or abemaciclib groups [34].…”

Section: Discussionmentioning

confidence: 99%

Clinical Impact of CDK4/6 Inhibitors in De Novo or PR− or Very Elderly Post-Menopausal ER+/HER2− Advanced Breast Cancers

Tang,

Yeo,

De Souza

et al. 2023

Cancers

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The CDK4/6 inhibitors significantly increase progression-free survival (PFS) in ER+/HER2− advanced breast cancer patients. In clinical trials, overall survival (OS) improvement has been demonstrated for ribociclib and abemaciclib but not for palbociclib. We undertook a real-world evaluation of PFS and OS in 227 post-menopausal patients who received first-line CDK4/6 inhibitors. There is no significant difference in median PFS (27.5 months vs. 25.7 months, p = 0.3) or median OS (49.5 months vs. 50.2 months, p = 0.67) in patients who received either palbociclib or ribociclib, respectively. De novo disease is significantly associated with prolonged median PFS and median OS compared with recurrence disease (47.1 months vs. 20.3 months (p = 0.0002) and 77.4 months vs. 37.3 months (p = 0.0003), respectively). PR– tumours have significantly reduced median PFS and OS compared with PR+ disease (19.2 months vs. 38 months (p = 0.003) and 34.3 months vs. 62.6 months (p = 0.02), respectively). In the very elderly (>80 years), median PFS and OS are significantly shorter compared with patients who are 65 years or below (14.5 months vs. 30.2 months (p = 0.01), and 77.4 months vs. 29.6 months (p = 0.009), respectively) in the palbociclib group. Our data suggest that the benefit in the very elderly is limited, and PR+/de novo disease obtains the maximum survival benefit.

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Section: Discussionmentioning

confidence: 99%

Clinical Impact of CDK4/6 Inhibitors in De Novo or PR− or Very Elderly Post-Menopausal ER+/HER2− Advanced Breast Cancers

Tang,

Yeo,

De Souza

et al. 2023

Cancers

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“…(Table 1). This treatment bias may be because a greater number of lesions is a poor prognostic factor, so incorporating CDK4/6i may increase disease control and bene t PFS and OS, as described in the palbociclib trials and studies (31,(33)(34)(35). Although the number of metastases seems to be an important factor in the therapeutic decision, the location was not, as no signi cant differences were found.…”

Section: Discussionmentioning

confidence: 99%

“…(Table 1). In any case, it has been described that treatment with CDK4/6i bene ts patients regardless of whether they have visceral metastases or not (16,31,33,34). In contrast, other factors such as KI-67 > 20%, tumour grade 3 and oestrogen negative receptor did not show signi cant differences between the arms (31).…”

Section: Discussionmentioning

confidence: 99%

Retrospective registry of patients with locally advanced/metastatic HR+/HER2− breast cancer treated in clinical practice in Andalusia.

Piudo,

López-Barajas,

Flores

et al. 2024

Preprint

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Background Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2‒) metastatic breast cancer (MBC). Objective To assess whether clinical or demographic characteristics limit access to first line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017, and April 2020. In addition, effectiveness will be described in an exploratory analysis. Methods Physicians from 12 centers abstracted demographic and clinical characteristics, treatment and outcome data for women with HR+/HER2- MBC receiving and not receiving CDK4/6i in addition to hormonal treatment in the first-line setting a 3:1 proportion. Kaplan–Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). Results A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). CDK 4/6i treated patients were younger (p = 0.0011), and biopsies of the metastatic disease were done more frequently (p = 0.0454), with multiple metastases, and with differences in relation to the time of diagnosis of metastatic disease (p = 0.0304). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6–28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. Conclusions Younger patients, biopsies of metastatic disease and with multiple metastases were more frequently treated with CDK4/6i.

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“…Previous research has indicated that abemaciclib is associated with a lower preference weight in comparison to other CDK4/6i due to adverse events, including diarrhea, abdominal pain, grade 3/4 neutropenia, tromboembolitic disease (Maculaitis et al, 2020), or acute liver injury (Beachler et al, 2021). Additionally, findings from a singular study (Cejuela et al, 2023) underscored diarrhea as a significant adverse reaction experienced by all patients, highlighting its clinical importance (Arbuckle et al, 2000). A meta-analysis regarding the risk of other side effects, such as stomatitis, demonstrated that especially palbociclib, among all CDK4/6i, could increase this risk impacting on patient adherence to the treatment (Long et al, 2021).…”

Section: Introductionmentioning

confidence: 99%

Digging in real-word electronic database for assessing CDK 4/6 inhibitors adherence in breast cancer patients from Romania

Turcu-Stiolica,

Udristoiu,

Subtirelu

et al. 2024

Front. Pharmacol.

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Introduction: It is imperative for patients to respect the prescribed treatments to achieve the anticipated clinical outcomes, including the outpatients receiving oral anti-cancer drugs such as selective cyclin-dependent kinase 4/6 inhibitors (CDK 4/6i). With the introduction of three CDK 4/6i drugs in the Romanian pharmaceutical market in 2018, our study aimed to evaluate medication adherence and the influencing factors among patients undergoing treatment with palbociclib, ribociclib, or abemaciclib for advanced or metastatic breast cancer.Methods: Medication adherence was assessed using the Proportion of Days Covered (PDC) method, and Spearman correlation analysis was conducted to explore the relationships between adherence, age, gender, and follow-up duration.Results: The study enrolled 330 breast cancer patients, with an average follow-up period of 14.6 ± 12.5 months for palbociclib, 10.6 ± 7.1 months for ribociclib, and 8.6 ± 6.4 months for abemaciclib-treated patients. A small proportion of patients demonstrated non-adherence: 12.8% for palbociclib, 14.6% for ribociclib, and 14.7% for abemaciclib. Among patients receiving palbociclib, there was no significant correlation between adherence, age (rho = 0.07, p = 0.35), or gender (rho = −0.144, p = 0.054). However, a significant correlation was found with the duration of follow-up (rho = −0.304, p < 0.0001). Similar results were observed for patients receiving ribociclib or abemaciclib. Most patients received combination therapy with letrozole (46%) and exemestane (13%) for palbociclib, letrozole (48%) and fulvestrant (19%) for ribociclib, and fulvestrant (39%) and letrozole (27%) for abemaciclib,Discussion: High adherence rates were observed among patients treated with CDK 4/6i drugs, with no significant differences noted among the three drugs in this class. However, the collected patient data was limited, lacking information on adverse reactions that could potentially lead to treatment discontinuation, as determined by the oncologist’s decision not to prescribe. Consequently, a comprehensive understanding of all factors contributing to the low adherence levels is hindered.

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

Cited by 25 publications

References 41 publications

Clinical Impact of CDK4/6 Inhibitors in De Novo or PR− or Very Elderly Post-Menopausal ER+/HER2− Advanced Breast Cancers

Clinical Impact of CDK4/6 Inhibitors in De Novo or PR− or Very Elderly Post-Menopausal ER+/HER2− Advanced Breast Cancers

Retrospective registry of patients with locally advanced/metastatic HR+/HER2− breast cancer treated in clinical practice in Andalusia.

Digging in real-word electronic database for assessing CDK 4/6 inhibitors adherence in breast cancer patients from Romania

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