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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).
- Source :
-
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society [Int J Gynecol Cancer] 2014 Feb; Vol. 24 (2), pp. 260-5. - Publication Year :
- 2014
-
Abstract
- 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.<br />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.<br />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%).<br />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.
- Subjects :
- Adult
Aged
Aged, 80 and over
Doxorubicin pharmacology
Doxorubicin therapeutic use
Endometrial Neoplasms metabolism
Female
Gonadotropin-Releasing Hormone pharmacology
Gonadotropin-Releasing Hormone therapeutic use
Humans
Middle Aged
Neoplasm Recurrence, Local metabolism
Receptors, LHRH biosynthesis
Doxorubicin analogs & derivatives
Endometrial Neoplasms drug therapy
Gonadotropin-Releasing Hormone analogs & derivatives
Neoplasm Recurrence, Local drug therapy
Receptors, LHRH antagonists & inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 1525-1438
- Volume :
- 24
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
- Publication Type :
- Academic Journal
- Accession number :
- 24418927
- Full Text :
- https://doi.org/10.1097/IGC.0000000000000044