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)

Emons G, Gorchev G, Harter P, Wimberger P, Staehle A, Hanker L, Hilpert F, Beckmann M, Dall P, Gruendker C, Sindermann H, Sehouli J (2014)

Publication Type: Journal article

Publication year: 2014

Journal

International Journal of Gynecological Cancer Lippincott, Williams & Wilkins / Wiley-Blackwell: No OnlineOpen

Book Volume: 24

Pages Range: 260-5

Journal Issue: 2

DOI: 10.1097/IGC.0000000000000044

Abstract

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.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.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%).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.

Authors with CRIS profile

Matthias Beckmann Lehrstuhl für Geburtshilfe und Frauenheilkunde

Involved external institutions

Georg-August-Universität Göttingen DE Germany (DE) University Hospital "Dr. Georgi Stranski" BG Bulgaria (BG) Universitätsklinikum Essen DE Germany (DE) St. Vincentius-Kliniken / ViDia Kliniken DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Städtisches Klinikum Lüneburg DE Germany (DE) AEterna Zentaris GmbH DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) Kliniken Essen-Mitte DE Germany (DE)

How to cite

APA:

Emons, G., Gorchev, G., Harter, P., Wimberger, P., Staehle, A., Hanker, L.,... Sehouli, J. (2014). 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). International Journal of Gynecological Cancer, 24(2), 260-5. https://doi.org/10.1097/IGC.0000000000000044

MLA:

Emons, Guenter, et al. "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)." International Journal of Gynecological Cancer 24.2 (2014): 260-5.

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