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. 2024 Aug 12;24(1):185.
doi: 10.1007/s10238-024-01458-1.

Real-world experience with CDK4/6 inhibitors in hormone receptor-positive metastatic and recurrent breast cancer: findings from an Asian population

Bo-Fang Chen  1   2   3 , Yi-Fang Tsai #  1   2   3 , Ta-Chung Chao #  2   4   5 , Pei-Ju Lien  2 , Yen-Shu Lin  1   2   3 , Chin-Jung Feng  2   3   6 , Yen-Jen Chen  1   2   3 , Han-Fang Cheng  1   2   3 , Chun-Yu Liu  2   4   7 , Jiun-I Lai  7   8   9 , Ling-Ming Tseng  10   11   12 , Chi-Cheng Huang  13   14   15
Affiliations

Real-world experience with CDK4/6 inhibitors in hormone receptor-positive metastatic and recurrent breast cancer: findings from an Asian population

Bo-Fang Chen et al. Clin Exp Med. .

Abstract

Purpose: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy have demonstrated significant clinical benefits in progression-free and overall survival. This study investigates the outcomes associated with two kinds of CDK4/6i in patients with hormone receptor (HR)-positive metastatic and relapsed breast cancer to inform real-world evidence of treatment strategies.

Methods: This retrospective study included 340 Taiwanese patients with HR-positive advanced breast cancer from the Taipei Veterans General Hospital, between 2018 and 2023. We analyzed patient characteristics, treatment strategies and outcomes associated with two CDK4/6i. The efficacy of patients who experienced economic burden and interrupted CDK4/6i treatment after 2 years of National Health Insurance (NHI) reimbursement was also investigated.

Results: Patients receiving ribociclib and palbociclib showed no significant differences in age, histology, body mass index(BMI), or pathologic status. The distribution of disease status and endocrine therapy partners was comparable between the two groups. Dose reduction was similar, while patients with palbociclib tended to discontinue CDK4/6i usage, and those with ribociclib tended to switch to the other CDK4/6i or endocrine partners. There was no significant difference in progression-free survival (PFS) between the two CDK4/6i in the first-line setting. Adverse prognostic factors were increasing HER2 IHC score, higher Ki-67 levels, visceral and liver metastasis, prior chemotherapy, and endocrine therapy resistance, while higher BMI, bone-only metastasis, and letrozole treatment were associated with a lower risk of progression. The limited follow-up time in our study was insufficient to assess the outcomes of patients treated with interrupted CDK4/6i for up to two years under the NHI reimbursement policy.

Conclusion: Treatment outcomes between the two types of CDK4/6i did not differ significantly, indicating the safety and efficacy of CDK4/6i for the Asian population. Ribociclib and palbociclib showed similar efficacy in PFS in the real-world setting.

Keywords: Breast cancer; CDK4/6 inhibitors; Real-world data; Taiwanese; Treatment outcomes.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Sankey plot of changing regimens between different types of CDK4/6 inhibitors
Fig. 2
Fig. 2
Kaplan–Meier survival curve analysis for progression-free survival (PFS) between patients treated with palbociclib and ribociclib. a Whole cohort patients and b patients treated in the first-line treatment setting
Fig. 3
Fig. 3
Kaplan–Meier survival curve analysis for progression-free survival (PFS) between patients treated with prior chemotherapy or not. a Patients treated with palbociclib. Median PFS (mPFS) in non-prior chemotherapy (CT) and prior CT was 30.42 months versus 12.09 months. Hazard ratio = 2.023, P < 0.05. b Patients treated with ribociclib. mPFS was 29.89 months in non-prior CT and 7.06 months in prior CT, hazard ratio: 4.276, P < 0.05
Fig. 4
Fig. 4
Kaplan–Meier survival curve analysis for PFS between patients treated with endocrine therapy resistance (ETR) or not. a Patients treated with palbociclib. mPFS in non-ETR and ETR was 30.91 months versus 21.85 months. Hazard ratio: 1.655, P < 0.05. b Patients treated with ribociclib. mPFS in non-ETR and ETR was 42.08 months and 19.78 months, hazard ratio: 1.842, P < 0.05. *mPFS: medium progression-free survival.
Fig. 5
Fig. 5
Kaplan–Meier survival curve analysis for PFS between patients with dose reduction (DR) of CDK4/6 inhibitor or not. a Patients treated with palbociclib. mPFS in non-dose reduction and dose reduction was 28.94 months versus 24.51 months. Hazard ratio: 1.114, P = 0.641. b Patients treated with ribociclib. mPFS in non-dose reduction and dose reduction was 28.84 months and 57.59 months, hazard ratio: 0.722, P = 0.295. *mPFS: medium progression-free survival.
Fig. 6
Fig. 6
Survival analysis for patients who persisted with treatment and who interrupted treatment after 2 years
See this image and copyright information in PMC

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