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)

Journal article


Publication Details

Author(s): Emons G, Kurzeder C, Schmalfeldt B, Neuser P, De Gregorio N, Pfisterer J, Park-Simon TW, Mahner S, Schroeder W, Lueck HJ, Heubner ML, Hanker L, Thiel F, Hilpert F
Journal: Gynecologic Oncology
Publication year: 2016
Volume: 140
Journal issue: 3
Pages range: 450-6
ISSN: 0090-8258


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.


FAU Authors / FAU Editors

Thiel, Falk PD Dr.
Medizinische Fakultät


Additional Organisation
Frauenklinik


External institutions
Georg-August-Universität Göttingen
Gynaekologicum Bremen
Hannover Medical School / Medizinische Hochschule Hannover (MHH)
Kliniken Essen-Mitte
Philipps-Universität Marburg
Städtisches Klinikum Solingen
Technische Universität München (TUM)
Universitätsklinikum Essen
Universitätsklinikum Frankfurt
Universitätsklinikum Hamburg-Eppendorf (UKE)
Universitätsklinikum Schleswig-Holstein (UKSH)
Universitätsklinikum Ulm


How to cite

APA:
Emons, G., Kurzeder, C., Schmalfeldt, B., Neuser, P., De Gregorio, N., Pfisterer, J.,... Hilpert, F. (2016). 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). Gynecologic Oncology, 140(3), 450-6. https://dx.doi.org/10.1016/j.ygyno.2015.12.025

MLA:
Emons, Guenter, et al. "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)." Gynecologic Oncology 140.3 (2016): 450-6.

BibTeX: 

Last updated on 2018-07-11 at 08:53