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Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO

I Ray-Coquard1, L Favier, B Weber

  • 1Department of Medical Oncology, Centre Léon Bérard, 28 rue Laennec, Lyon Cedex 08, France. isabelle.ray-coquard@lyon.unicancer.fr

British Journal of Cancer
|April 25, 2013
PubMed
Abstract

Insights

Everolimus shows promise for advanced endometrial cancer patients who have not responded to chemotherapy. This study found it effective and tolerable, supporting further research into this treatment approach.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Recurrent/metastatic endometrial cancer progressing after chemotherapy has limited treatment options.
  • Preclinical data suggest everolimus, an oral mTOR inhibitor, may benefit these patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of everolimus in patients with advanced or metastatic endometrial cancer refractory to chemotherapy.

Main Methods:

  • A multicenter, open-label, phase 2 study.
  • 44 patients received everolimus 10 mg daily until progression or toxicity.
  • Primary endpoint: 3-month non-progressive disease rate; Secondary endpoints: response duration, progression-free survival (PFS), overall survival (OS), and safety.

Main Results:

  • 3-month non-progressive disease rate was 36% (95% CI 22-52%), with 5% partial response (PR).
  • Median PFS was 2.8 months, and median OS was 8.1 months.
  • Common adverse events included anemia (100%), fatigue (93%), hypercholesterolemia (81%), and lymphopenia (81%).

Conclusions:

  • Everolimus demonstrated efficacy and acceptable tolerability in chemotherapy-refractory advanced/metastatic endometrial cancer.
  • Results support further development of PI3K-targeted therapies for endometrial cancer.

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