TY  - JOUR
A1  - Emons, Günter
A1  - Gorchev, Grigor
A1  - Harter, Philipp
A1  - Wimberger, Pauline
A1  - Stähle, Anne
A1  - Hanker, Lars
A1  - Hilpert, Felix
A1  - Beckmann, Matthias Wilhelm
A1  - Dall, Peter
A1  - Gründker, Carsten
A1  - Sindermann, Herbert
A1  - Sehouli, Jalid
T1  - Efficacy and safety of AEZS-108 (LHRH agonist linked to doxorubicin) in women with advanced or recurrent endometrial cancer expressing LHRH receptors : a multicenter phase 2 trial (AGO-GYN5)
T2  - International journal of gynecological cancer
N2  - Objective: Advanced or recurrent endometrial cancer (EC) no longer amenable to surgery or radiotherapy is a life-threatening disease with limited therapeutic options left. Eighty percent of ECs express receptors for luteinizing hormone-releasing hormone (LHRH), which can be targeted by AEZS-108 (zoptarelin doxorubicin acetate). This phase 2 trial was performed to assess the efficacy and safety of AEZS-108 in this group of patients.
Methods: Patients had FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) III or IV or recurrent EC, LHRH receptor-positive tumor status, and at least had 1 measurable lesion (Response Evaluation Criteria in Solid Tumors). Prior anthracycline therapy was not allowed. Patients received AEZS-108 as a 2-hour infusion on day 1 of a 21-day cycle. The treatment was continued for a maximum of 6 to 8 cycles. The primary end point was the response rate determined by the Response Evaluation Criteria in Solid Tumors.
Results: From April 2008 to November 2009, 44 patients were included in the study at 8 centers in Germany (AGO) and 3 centers in Bulgaria. Forty-three of these patients were eligible. Two (5%) patients had a complete remission, and 8 (18%) achieved a partial remission. Stable disease for at least 6 weeks was observed in 44%. The median time to progression was 7 months, and the median overall survival was 15 months. The most frequently reported grade 3 or 4 adverse effects were neutropenia (12%) and leucopenia (9%).
Conclusions: AEZS-108, an LHRH-agonist coupled to doxorubicin, has significant activity and low toxicity in women with advanced or recurrent LHRH receptor-positive EC, supporting the principle of receptor-mediated targeted chemotherapy.
KW  - Endometrial cancer
KW  - Targeted therapy
KW  - LHRH receptor
KW  - Clinical trial
KW  - Phase 2
Y1  - 2014
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/35256
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-352568
SN  - 1048-891X
SN  - 1525-1438
N1  - Copyright © 2014 by IGCS and ESGO. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivitives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
VL  - 24
IS  - 2
SP  - 260
EP  - 265
PB  - Wiley-Blackwell
CY  - Oxford [u.a.]
ER  -