title: Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO.
abstract: BACKGROUND
  Patients with recurrent/metastatic endometrial cancer that progresses after chemotherapy have limited treatment options and poor outcomes. Preclinical data suggest the oral mammalian target of rapamycin inhibitor everolimus may provide clinical benefit in these patients.
  
  
  METHODS
  In this multicenter, open-label, phase 2 study, patients with advanced or metastatic endometrial cancer refractory to one or two previous chemotherapy regimens received everolimus 10 mg per day until progression or unacceptable toxicity. Primary end point was the non-progressive disease rate at 3 months. Secondary end points included duration of response, progression-free, and overall survival (OS), and safety.
  
  
  RESULTS
  Forty-four patients were enrolled (median age, 65 years); 66% received one previous chemotherapy regimen. The 3-month non-progressive disease rate was 36% (95% confidence interval 22-52%), including two patients (5%) with partial response (PR). At 6 months, two additional patients experienced PR. Median duration of response was 3.1 months. Median progression-free and OS were 2.8 months and 8.1 months, respectively. The most common adverse events were anaemia (100%), fatigue (93%), hypercholesterolaemia (81%), and lymphopenia (81%).
  
  
  CONCLUSIONS
  Everolimus demonstrated efficacy and acceptable tolerability in patients with chemotherapy-refractory advanced or metastatic endometrial cancer. These results support the further development of phosphatidylinositol 3-kinase-targeted therapies in endometrial cancer.
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, 28 rue Laennec, Lyon Cedex 08, France. isabelle.ray-coquard@lyon.unicancer.fr
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.forename: L
authors.initials: L
authors.lastname: Favier
authors.forename: B
authors.initials: B
authors.lastname: Weber
authors.forename: C
authors.initials: C
authors.lastname: Roemer-Becuwe
authors.forename: P
authors.initials: P
authors.lastname: Bougnoux
authors.forename: M
authors.initials: M
authors.lastname: Fabbro
authors.forename: A
authors.initials: A
authors.lastname: Floquet
authors.forename: F
authors.initials: F
authors.lastname: Joly
authors.forename: A
authors.initials: A
authors.lastname: Plantade
authors.forename: D
authors.initials: D
authors.lastname: Paraiso
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D000068338:Everolimus; D005260:Female; D006801:Humans; D008875:Middle Aged; D000081082:Phosphoinositide-3 Kinase Inhibitors; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015996:Survival Rate; D058570:TOR Serine-Threonine Kinases / Q000037:antagonists & inhibitors*
chemical_list: D000970:Antineoplastic Agents; D000081082:Phosphoinositide-3 Kinase Inhibitors; D000068338:Everolimus; C546842:MTOR protein, human; D058570:TOR Serine-Threonine Kinases; D020123:Sirolimus