Geburtshilfe Frauenheilkd 2014; 74 - FV_03_04
DOI: 10.1055/s-0034-1388557

Temsirolimus in women with platinum-resistant ovarian cancer or advanced/recurrent endometrial cancer: a multicenter phase II trial of the AGO Study Group (AGO-GYN 8)

F Hilpert 1, C Kurzeder 2, B Schmalfeldt 3, P Neuser 4, N de Gregorio 5, J Pfisterer 6, TW Park-Simon 7, S Mahner 8, W Schröder 9, HJ Lück 10, M Heubner 11, L Hanker 12, F Thiel 13, G Emons 14
  • 1University of Schleswig-Holstein Campus Kiel, Gynecology and Obstetrics, Kiel, Germany
  • 2Kliniken-Essen-Mitte GmbH Huyssens-Stiftung/Knappschaft, Gynäkologische Onkologie, Essen, Germany
  • 3Klinikum rechts der Isar der Technischen Univ. München, Frauenklinik und Poliklinik, München, Germany
  • 4Philipps-Universität Marburg, Koordinierungszentrum für Klinische Studien, Marburg, Germany
  • 5Universitätsklinikum Ulm, Frauenklinik, Ulm, Germany
  • 6Zentrum f. Gynäkologische Onkologie, Kiel, Germany
  • 7Medizinische Hochschule Hannover Zentrum für Frauenheilkunde, Universitätsfrauenklinik, Hannover, Germany
  • 8Universitätsklinikum Hamburg-Eppendorf, Univ.-Frauenklinik und Poliklinik, Hamburg, Germany
  • 9Gynaekologicum Bremen, Praxisklinik für Gynäkologische Onkologie und Operative Gynäkologie, Bremen, Germany
  • 10Gynäkologisch-onkologische Praxis, Hannover, Germany
  • 11Universitätsklinikum Essen, Frauenklinik, Essen, Germany
  • 12Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, Germany
  • 13Universitätsklinikum Erlangen, Frauenklinik, Erlangen, Germany
  • 14Universitätsmedizin Göttingen Georg-August-Universität, Frauenklinik, Göttingen, Germany

Background: Inhibition of mTOR with temsirolimus (T) might be an efficacious treatment of patients with epithelial ovarian cancer (OC) or endometrial cancer (EC).

Methods: Patients (pts) with platinum and taxane resistant OC (n = 22) or with advanced/recurrent EC, who had not received previous chemotherapy (n = 22) were treated with weekly IV infusions of T (25 mg). Primary endpoint was progression free survival after 4 months (OC) or 6 months (EC). A two stage design was used with second stage of accrual if < 10 of the first 22 pts (OC) or < 7 of the first 22 pts (EC) had progressive disease after the first 8 weeks of T-treatment.

Results: 22 pts each were treated in the OC and the EC cohort respectively. Median age was 56 years (OC) or 63 years (EC). After 8 weeks of treatment with T, 10 pts in the OC cohort and 7 pts in the EC group had progressive disease. Toxicity of T was mild: grade 4: 1 ileus (OC), grade 3: anemia 1, abdominal pain 1, ALT elevation 1, ascites 3 (OC), diarrhea 1, vomiting 2.

Conclusions: T-treatment was well tolerated in our patients. It did, however, not meet the predefined efficacy criteria with 10 of 22 pts (OC) and 7 of 22 pts (EC) having progressive disease after 8 weeks of treatment.