EVERolimus effectiveness after proGREssion on ENdocrine therapy plus CDK4/6 inhibitor for ER-positive/HER2-negative

Diogo Martins-Branco1, Soraia Lobo-Martins1, Philippe Aftimos2

  • 1Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Institut Jules Bordet, Academic Trials Promoting Team (ATPT), Bruxelles, Belgium.

Abstract

Insights

Adding everolimus to endocrine therapy offered a modest benefit for advanced ER-positive/HER2-negative breast cancer patients progressing on CDK4/6 inhibitors. Careful patient selection is crucial due to limited gains and toxicity.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Limited evidence exists for everolimus plus endocrine therapy in ER-positive/HER2-negative advanced breast cancer post-CDK4/6 inhibitors.
  • Assessing everolimus effectiveness and safety in this specific patient population is critical.

Purpose of the Study:

  • To evaluate the real-world effectiveness and safety of adding everolimus to endocrine therapy.
  • To compare outcomes in patients receiving endocrine therapy plus everolimus versus endocrine therapy alone after CDK4/6 inhibitor progression.

Main Methods:

  • Retrospective, quasi-experimental study (EVERGREEN) involving 207 women with ER-positive/HER2-negative advanced breast cancer.
  • Comparison of outcomes between patients treated with endocrine therapy plus everolimus and those receiving endocrine therapy alone.
  • Primary endpoint: real-world progression-free survival (rwPFS); secondary endpoints: time to everolimus failure, time to chemotherapy, overall survival.

Main Results:

  • Median rwPFS was 5.0 months with everolimus vs. 4.3 months without (aHR 0.68).
  • Time to everolimus failure was 4.2 months.
  • No significant differences observed in time to chemotherapy or overall survival; safety profile consistent with prior reports.

Conclusions:

  • Everolimus addition to endocrine therapy provides a modest clinical benefit for advanced ER-positive/HER2-negative breast cancer after CDK4/6 inhibitors.
  • The limited benefit and toxicity necessitate careful patient selection for an optimal risk-benefit ratio.

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