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The good, the bad, and the manageable: real-world outcomes with CDK4/6 inhibitors

Alexandra Paulet1, Silvia Mancini1, Martina Catalano2

  • 1School of Medicine and Surgery.

Anti-Cancer Drugs
|January 28, 2026
PubMed

Insights

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) are effective for metastatic breast cancer, but real-world data shows frequent toxicities. Managing side effects and adjusting doses are key to maintaining treatment benefits and improving outcomes.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Medicine

Background:

  • Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy are standard for hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (mBC).
  • Limited real-world data exists on the safety, dose modifications, and outcomes of CDK4/6i in clinical practice.

Purpose of the Study:

  • To evaluate the real-world safety, efficacy, and outcomes of CDK4/6i (palbociclib, ribociclib, abemaciclib) in patients with HR+/HER2- mBC.
  • To analyze the impact of adverse events and dose adjustments on treatment outcomes.

Main Methods:

  • Prospective observational study of patients with HR+/HER2- mBC treated with CDK4/6i between 2019 and 2024.
  • Data collection on adverse events, dose modifications, progression-free survival (PFS), and overall survival (OS).

Main Results:

  • Adverse events occurred in 77.5% of patients; neutropenia (palbociclib, ribociclib), diarrhea, and hepatic toxicity (abemaciclib) were common. Pulmonary toxicity affected 19.1% of abemaciclib patients.
  • Median PFS was 26.4 months and median OS was 31.1 months.
  • Dose reductions, needed in over 60% of patients, were associated with longer PFS and OS, while treatment discontinuation predicted worse outcomes. Grade 3-4 adverse events correlated with improved OS.

Conclusions:

  • Real-world toxicities of CDK4/6i in mBC are frequent but manageable with proactive management and dose adjustments.
  • Individualized dosing strategies, including dose reductions, are crucial for sustaining treatment benefits and potentially improving patient outcomes.
  • Effective management of CDK4/6i-related toxicities is essential for optimizing long-term survival in metastatic breast cancer patients.

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