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. 2025 Feb 1;11(1):10.
doi: 10.1038/s41523-025-00726-x.

Prevalence, clinicopathologic features and long-term overall survival of early breast cancer patients eligible for adjuvant abemaciclib and/or ribociclib

Sylvain Ladoire #  1   2   3 , Ariane Mamguem Kamga #  4   5 , Loick Galland  6 , Manon Reda  6   7 , Isabelle Desmoulins  6 , Didier Mayeur  6 , Courèche Kaderbhai  6 , Silvia Ilie  6 , Audrey Hennequin  6 , Henri Talucier  6 , Clementine Jankowski  8 , Charles Coutant  9   8 , Laurent Arnould  10 , Sandrine Dabakuyo  4   5
Affiliations

Prevalence, clinicopathologic features and long-term overall survival of early breast cancer patients eligible for adjuvant abemaciclib and/or ribociclib

Sylvain Ladoire et al. NPJ Breast Cancer. .

Abstract

Adjuvant CDK4/6 inhibitors (abemaciclib and ribociclib) associated with endocrine therapy reduced the risk of relapse for HR+/HER2- early breast cancer (eBC) patients in the monarchE and NATALEE trials. In this population-based study, we assess the real-life proportion, and long-term prognosis of patients treated for HR+/HER2- eBC between 2005 and 2015, and eligible for adjuvant CDK4/6 inhibitors according to these trial inclusion criteria. Among 3,103 patients, N = 440 (14.2%) would have been eligible for adjuvant abemaciclib, and N = 1068 (34.4%) for ribociclib. Node-negative patients who would have been eligible for adjuvant ribociclib represent 10.9% of the eligible population. 21.7% of patients now eligible for adjuvant abemaciclib, and 32.1% for ribociclib did not receive (neo)adjuvant chemotherapy. After a median follow-up of 144.7 months, 10-year overall survival confirms the prognostic relevance of the inclusion criteria used in pivotal trials. This study provides real-life insights into the prevalence, clinicopathological characteristics and long-term prognosis of HR+/HER2- eBC patients now eligible for adjuvant CDK4/6 inhibitors.

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Conflict of interest statement

Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Flow charts of patients with eligibility criteria.
A Eligibility for adjuvant abemaciclib according to the monarchE risk-based inclusion criteria. B Eligibility for adjuvant ribociclib according to the NATALEE risk-based inclusion criteria.
Fig. 2
Fig. 2. Overall survival (OS) of patients eligible or not to adjuvant abemaciclib according to monarchE inclusion criteria.
A Kaplan-Meier estimates for overall survival (OS) according to eligibility (red curve) or non-eligibility (blue curve) for adjuvant abemaciclib (according to the monarchE risk-based inclusion criteria). B Kaplan-Meier estimates for overall survival (OS) according to eligibility or not for adjuvant abemaciclib (according to the monarchE risk-based inclusion criteria), and axillary lymph node status: patients eligible for adjuvant abemaciclib with ≥4N+ (red curve), patients eligible for adjuvant abemaciclib with 1-3N+ (blue curve), patients not eligible for adjuvant abemaciclib with 1-3N+ (brown curve), and patients not eligible for adjuvant abemaciclib without node involvement (green curve). Median OS, median follow-up, number of events (deaths), and OS at 2, 3, 5, and 10 years are shown in the table below each survival curve.
Fig. 3
Fig. 3. Overall survival (OS) of patients eligible or not to adjuvant ribociclib according to NATALEE inclusion criteria.
A Kaplan-Meier estimates for overall survival (OS) according to eligibility (red curve) or non-eligibility (blue curve) for adjuvant ribociclib (according to the NATALEE risk-based inclusion criteria). B Kaplan-Meier estimates for overall survival (OS) according to eligibility or not for adjuvant ribociclib (according to NATALEE risk-based inclusion criteria), and axillary lymph node status: patients eligible for adjuvant ribociclib with N+ status (blue curve), patients eligible for adjuvant ribociclib with N- status (red curve), and patients not eligible for adjuvant ribociclib (green curve). Median OS, median follow-up, number of events (deaths), and OS at 2, 3, 5, and 10 years are shown in the table below each survival curve.
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