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Duration of treatment analysis

STUDY OBJECTIVE

To understand treatment durations, discontinuation rates, subsequent treatments, and treatment switches in patients with HR+/HER2- mBC receiving 1L palbociclib, ribociclib or abemaciclib in combination with an AI in US routine clinical practice.1

STUDY DESIGN

  • Data were extracted from the US real‑world Flatiron Health database, consistent with the approach used in P‑VERIFY.
  • In this analysis, 11,557 patients were followed from treatment initiation to the data cut‑off of 31 January 2025, compared with 9,146 patients in P‑VERIFY followed through 31 May 2024.1,2
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*1L CDK4/6i treatment duration was defined as the time from the start of the specific CDK4/6i to discontinuation of treatment or death during the 1L. Patient data were derived from the Flatiron Health US real-world oncology database of de-identified, longitudinal electronic health record data from >800 sites of care, including >721,000 patients with breast cancer.1-3
†Subsequent treatment was defined as a change in systemic therapy triggering a line advancement, with the exception of changes in AI (i.e., a change from one AI to another did not trigger a line advancement). Subsequent treatments for mBC were examined in patients who started 1L treatment in 2017 onward, when the three CDK4/6is were all approved in the US.
‡CDK4/6i switching was defined as changing CDK4/6i with or without changing the AI partner. 

PATIENT CHARACTERISTICS

After sIPTW, baseline demographics and clinical characteristics were generally balanced between the palbociclib, ribociclib and abemaciclib groups*1,7

*The balance in these baseline characteristics was assessed using a standardised mean differences approach, with values ≥0.1 indicating a non-negligible imbalance.1 Standard difference data not shown. More patients were eligible for the palbociclib cohort, as palbociclib was the first CDK4/6i approved in the US (in 2015), followed by ribociclib (in 2017) and abemaciclib (in 2018).1, 4-6 
†Visceral disease is defined as metastatic disease in the lung and/or liver. Patients could have had other sites of metastases.7
‡Bone-only disease is defined as metastatic disease in the bone only.7 

RESULTS: Treatment duration and discontinuation rates 

  • After sIPTW, palbociclib in the first-line treatment setting had longer treatment duration and lower discontinuation rates than ribociclib and abemaciclib.1 
  • Compared with palbociclib, ribociclib and abemaciclib had higher discontinuation rates as early as 3 months, which remained consistent after 12 and 24 months.1
  • In patients who started treatment from 2017 and onward, palbociclib also had longer treatment duration compared with ribociclib and abemaciclib.7

*1L CDK4/6i treatment duration was defined as the time from the start of the specific CDK4/6i to discontinuation of treatment or death during the 1L. Treatment durations were estimated using the Kaplan-Meier method and Cox proportional hazards models were used to calculate HRs and corresponding 95% CIs. Patients were censored at the earlier of their last medical activity or data cut-off if they were alive and had not experienced treatment discontinuation. Patient cohort included those initiated on treatment from 2015–2024.
†Descriptive statistical analysis only

    1L, first-line; Al, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4/6; DOT, duration of treatment; HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor positive; mBC, metastatic breast cancer; KM, Kaplan-Meier; US, United StatesECOG PS, Eastern Cooperative Oncology Group performance status; IQR, interquartile range; SD, standard deviation; sIPTW, stabilised inversed probability of treatment weighting; HR, hazard ratio; PAL, palbociclib; RIB, ribociclib; ABE, abemaciclib.

    References

    Brufsky A, et al. Presented at ESMO, Berlin, Germany, 17‒21 October 2025. Poster 523PRugo HS, et al. ESMO Open 2025; 10(1):104103. Torres AZ, et al. Adv Ther. 2022;39(6):2831–2849.IBRANCE® tablets [package insert]KISQALI tablets [package insert] US Food and Drug Administration. FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-initial-therapy-hr-positive-her2-negative-metastatic-breast-cancer [Accessed April 2026].Brufsky A, et al. Supplementary material. Presented at ESMO, Berlin, Germany, 17‒21 October 2025. Poster 523P
    PP-IBR-GBR-7000. April 2026

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