Günter Emons1, Christian Kurzeder2, Barbara Schmalfeldt3, Petra Neuser4, Nikolaus de Gregorio5, Jacobus Pfisterer6, Tjoung-Won Park-Simon7, Sven Mahner8, Willibald Schröder9, Hans-Joachim Lück10, Martin Leonhard Heubner11, Lars Hanker12, Falk Thiel13, Felix Hilpert14. 1. Klinikum Göttingen, Georg-August-Universität, Universitäts-Frauenklinik, Robert-Koch-Str. 40, 37075 Göttingen, Germany. Electronic address: emons@med.uni-goettingen.de. 2. Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie, Henricistraße 92, 45136 Essen, Germany. Electronic address: c.kurzeder@kliniken-essen-mitte.de. 3. Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik, Ismaningerstr. 22, 81675 München, Germany. Electronic address: b.schmalfeldt@uke.de. 4. Koordinierungszentrum für Klinische Studien (KKS), Philipps-Universität Marburg, Karl-von-Frisch-Str. 4, 35043 Marburg, Germany. Electronic address: Petra.Neuser@KKS.uni-marburg.de. 5. Universitätsklinikum Ulm, Universitätsfrauenklinik, Prittwitzstr. 43, 89075 Ulm, Germany. Electronic address: Nikolaus.deGregorio@uniklinik-ulm.de. 6. Städtisches Klinikum Solingen, Klinik für Gynäkologie und Geburtshilfe, Gotenstraße 1, 42653 Solingen, Germany. Electronic address: jacobus.pfisterer@googlemail.com. 7. Medizinische Hochschule Hannover, Frauenklinik, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Electronic address: park-simon.tjoung-won@mh-hannover.de. 8. Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie, Martinistraße 52, 20246, Hamburg, Germany. Electronic address: Sven.Mahner@med.uni-muenchen.de. 9. GYNAEKOLOGIKUM Bremen, Praxisklinik für Gynäkologische Onkologie und Operative Gynäkologie, Schwachhauser Heerstr. 367, 28211, Bremen, Germany. Electronic address: prof.schroeder@gynaekologicum-bremen.de. 10. Gynäkologisch-onkologische Praxis, Pelikanplatz 23, 30177 Hannover, Germany. Electronic address: hlueck@goph.de. 11. Universitätsklinik für Frauenheilkunde und Geburtshilfe, Hufelandstr. 55, 45147 Essen, Germany. Electronic address: martin.heubner@uk-essen.de. 12. Klinikum der J. W. Goethe-Universität, Zentrum für Frauenheilkunde und Geburtshilfe, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany. Electronic address: Lars.Hanker@uksh.de. 13. Universität Erlangen-Nürnberg, Klinik für Frauenheilkunde, Universitätsstr. 21-23, 91054 Erlangen, Germany. Electronic address: Falk.Thiel@af-k.de. 14. 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.
Abstract
OBJECTIVES: 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.
OBJECTIVES: 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.
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