Günter Emons, Grigor Gorchev, Philipp Harter, Pauline Wimberger, Anne Stähle, Lars Hanker, Felix Hilpert, Matthias Wilhelm Beckmann, Peter Dall, Carsten Gründker, Herbert Sindermann, Jalid Sehouli
- 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.
MetadatenVerfasserangaben: | Günter Emons, Grigor Gorchev, Philipp HarterORCiDGND, Pauline Wimberger, Anne Stähle, Lars HankerORCiDGND, Felix Hilpert, Matthias Wilhelm BeckmannORCiDGND, Peter Dall, Carsten Gründker, Herbert Sindermann, Jalid Sehouli |
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URN: | urn:nbn:de:hebis:30:3-352568 |
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DOI: | https://doi.org/10.1097/IGC.0000000000000044 |
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ISSN: | 1048-891X |
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ISSN: | 1525-1438 |
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Pubmed-Id: | https://pubmed.ncbi.nlm.nih.gov/24418927 |
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Titel des übergeordneten Werkes (Englisch): | International journal of gynecological cancer |
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Verlag: | Wiley-Blackwell |
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Verlagsort: | Oxford [u.a.] |
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Dokumentart: | Wissenschaftlicher Artikel |
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Sprache: | Englisch |
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Jahr der Fertigstellung: | 2014 |
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Datum der Erstveröffentlichung: | 24.02.2014 |
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Veröffentlichende Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Datum der Freischaltung: | 15.10.2014 |
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Freies Schlagwort / Tag: | Clinical trial; Endometrial cancer; LHRH receptor; Phase 2; Targeted therapy |
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Jahrgang: | 24 |
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Ausgabe / Heft: | 2 |
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Seitenzahl: | 6 |
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Erste Seite: | 260 |
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Letzte Seite: | 265 |
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Bemerkung: | 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. |
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HeBIS-PPN: | 366284029 |
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Institute: | Medizin / Medizin |
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DDC-Klassifikation: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Lizenz (Deutsch): | Creative Commons - Namensnennung-Nicht kommerziell-Keine Bearbeitung 3.0 |
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