title: Temsirolimus in women with platinum-refractory/resistant ovarian cancer or advanced/recurrent endometrial carcinoma. A phase II study of the AGO-study group (AGO-GYN8).
abstract: OBJECTIVE
  To evaluate activity and toxicity of mTOR inhibitor temsirolimus in patients with platinum-refractory/resistant ovarian cancer (OC) or advanced/recurrent endometrial carcinoma (EC).
  
  
  METHODS
  Women with epithelial ovarian, fallopian tube or primary peritoneal cancer were eligible, when they had progression during treatment with a platinum based regimen or within 6 months after receiving a platinum based regimen and a previous taxane treatment. Women with advanced/recurrent EC, no longer amenable to curative surgery and/or radiotherapy were eligible when they had no previous or only adjuvant chemotherapy. Preceding endocrine therapy for metastatic/recurrent disease was allowed. Patients received weekly IV infusions of 25mg temsirolimus. Primary endpoint was progression free survival rate after 4 months (OC) or 6 months (EC). A two stage design was applied.
  
  
  RESULTS
  Forty-four patients (OC: n=22; EC: n=22) were enrolled and received temsirolimus treatment. Median age was 56 years (OC) or 63 years (EC). After eight weeks of treatment, 10 of 21 evaluable patients in the OC cohort and 8 of 20 evaluable patients in the EC cohort had progressive disease. Thus efficacy did not meet the predefined levels during the first stage of recruitment and the trial was stopped. Some patients in both cohorts had long lasting PFS (>7 months). Toxicity of temsirolimus was mild.
  
  
  CONCLUSIONS
  Temsirolimus treatment was well tolerated in our patients, but did not meet the predefined efficacy criteria. In our study as in other trials on rapalogs in OC or EC, a few patients had long lasting disease stabilisations.
authors.affiliation: Klinikum Göttingen, Georg-August-Universität, Universitäts-Frauenklinik, Robert-Koch-Str. 40, 37075 Göttingen, Germany. Electronic address: emons@med.uni-goettingen.de.
authors.forename: Günter
authors.initials: G
authors.lastname: Emons
authors.affiliation: Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie, Henricistraße 92, 45136 Essen, Germany. Electronic address: c.kurzeder@kliniken-essen-mitte.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Kurzeder
authors.affiliation: Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik, Ismaningerstr. 22, 81675 München, Germany. Electronic address: b.schmalfeldt@uke.de.
authors.forename: Barbara
authors.initials: B
authors.lastname: Schmalfeldt
authors.affiliation: Koordinierungszentrum für Klinische Studien (KKS), Philipps-Universität Marburg, Karl-von-Frisch-Str. 4, 35043 Marburg, Germany. Electronic address: Petra.Neuser@KKS.uni-marburg.de.
authors.forename: Petra
authors.initials: P
authors.lastname: Neuser
authors.affiliation: Universitätsklinikum Ulm, Universitätsfrauenklinik, Prittwitzstr. 43, 89075 Ulm, Germany. Electronic address: Nikolaus.deGregorio@uniklinik-ulm.de.
authors.forename: Nikolaus
authors.initials: N
authors.lastname: de Gregorio
authors.affiliation: Städtisches Klinikum Solingen, Klinik für Gynäkologie und Geburtshilfe, Gotenstraße 1, 42653 Solingen, Germany. Electronic address: jacobus.pfisterer@googlemail.com.
authors.forename: Jacobus
authors.initials: J
authors.lastname: Pfisterer
authors.affiliation: Medizinische Hochschule Hannover, Frauenklinik, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Electronic address: park-simon.tjoung-won@mh-hannover.de.
authors.forename: Tjoung-Won
authors.initials: TW
authors.lastname: Park-Simon
authors.affiliation: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie, Martinistraße 52, 20246, Hamburg, Germany. Electronic address: Sven.Mahner@med.uni-muenchen.de.
authors.forename: Sven
authors.initials: S
authors.lastname: Mahner
authors.affiliation: GYNAEKOLOGIKUM Bremen, Praxisklinik für Gynäkologische Onkologie und Operative Gynäkologie, Schwachhauser Heerstr. 367, 28211, Bremen, Germany. Electronic address: prof.schroeder@gynaekologicum-bremen.de.
authors.forename: Willibald
authors.initials: W
authors.lastname: Schröder
authors.affiliation: Gynäkologisch-onkologische Praxis, Pelikanplatz 23, 30177 Hannover, Germany. Electronic address: hlueck@goph.de.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Lück
authors.affiliation: Universitätsklinik für Frauenheilkunde und Geburtshilfe, Hufelandstr. 55, 45147 Essen, Germany. Electronic address: martin.heubner@uk-essen.de.
authors.forename: Martin Leonhard
authors.initials: ML
authors.lastname: Heubner
authors.affiliation: Klinikum der J. W. Goethe-Universität, Zentrum für Frauenheilkunde und Geburtshilfe, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany. Electronic address: Lars.Hanker@uksh.de.
authors.forename: Lars
authors.initials: L
authors.lastname: Hanker
authors.affiliation: Universität Erlangen-Nürnberg, Klinik für Frauenheilkunde, Universitätsstr. 21-23, 91054 Erlangen, Germany. Electronic address: Falk.Thiel@af-k.de.
authors.forename: Falk
authors.initials: F
authors.lastname: Thiel
authors.affiliation: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynäkologie und Geburtshilfe, Arnold-Heller-Str. 3, Haus 24, 24105 Kiel, Germany,. Electronic address: felix.hilpert@gmail.com.
authors.forename: Felix
authors.initials: F
authors.lastname: Hilpert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy*; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D057239:Early Termination of Clinical Trials; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use; D066066:Response Evaluation Criteria in Solid Tumors; D019233:Retreatment; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D017671:Platinum Compounds; C401859:temsirolimus; D020123:Sirolimus
keywords: Endometrial cancer; Ovarian cancer; Rapalog; Temsirolimus; mTOR inhibitor