Home /Efficacy and safety of AEZS-108 (INN: zoptarelin doxorubicin acetate) an LHRH agonist linked to doxorubicin in women with platinum refractory or resistant ovarian cancer expressing LHRH receptors: a multicenter phase II trial of the AGO-study group (AGO G

Efficacy and safety of AEZS-108 (INN: zoptarelin doxorubicin acetate) an LHRH agonist linked to doxorubicin in women with platinum refractory or resistant ovarian cancer expressing LHRH receptors: a multicenter phase II trial of the AGO-study group (AGO G

Submitted by ctuttle on Thu, 12/17/2015 - 10:33
TitleEfficacy and safety of AEZS-108 (INN: zoptarelin doxorubicin acetate) an LHRH agonist linked to doxorubicin in women with platinum refractory or resistant ovarian cancer expressing LHRH receptors: a multicenter phase II trial of the AGO-study group (AGO G
Publication TypeJournal Article
Year of Publication2014
AuthorsEmons, G, Gorchev, G, Sehouli, J, Wimberger, P, Stähle, A, Hanker, L, Hilpert, F, Sindermann, H, Grundker, C, Harter, P
JournalGynecol Oncol
Volume133
Pagination427-32
KeywordsAdenocarcinoma, Clear Cell/*drug therapy/metabolism Adult Aged Antineoplastic Agents, Hormonal/*therapeutic use CA-125 Antigen/metabolism Cystadenocarcinoma, LHRH/metabolism Taxoids/therapeutic use Treatment Outcome, Neoplasm Fallopian Tube Neoplasms/*drug therapy/metabolism Female Gonadotropin-Releasing Hormone/*analogs & derivatives/therapeutic use Humans Immunohistochemistry Middle Aged Ovarian Neoplasms/*drug therapy/metabolism Peritoneal Neoplasms/*drug therapy/, Serous/*drug therapy/metabolism Disease-Free Survival Doxorubicin/*analogs & derivatives/therapeutic use Drug Resistance
Abstract

OBJECTIVES: To evaluate the activity and toxicity of AEZS-108 (Zoptarelin Doxorubicin Acetate) an LHRH agonist linked to doxorubicin in women with platinum refractory or resistant ovarian cancer expressing LHRH receptors. METHODS: Women with epithelial ovarian, fallopian tube or primary peritoneal cancer, expressing LHRH receptors were eligible for this trial, when they had progression during treatment with a platinum based regimen or within 6months after receiving a platinum based regimen and a previous taxane treatment. At least one measurable target lesion (RECIST) or CA-125 levels higher than twice the upper limit of normal range (GCIG-criteria) were required. Patients received AEZS-108 (267mg/m(2) equimolar to 76.8mg/m(2) of free doxorubicin) every 3weeks as a two hour i.v. infusion. RESULTS: Fifty-five of 59 (93%) of ovarian cancer samples screened expressed LHRH receptors. 42 patients were enrolled in this study and received at least 1 infusion of AEZS-108 (ITT population). Of these 42 patients 6 (14.3%) had a partial response, 16 (38%) stable disease, 16 (38%) progressive disease and 4 patients were not evaluable. Median time to progression was 12weeks (95% CI: 8-20weeks), and median overall survival was 53weeks (95% CI: 39-73weeks). Toxicity profile was favorable. CONCLUSION: AEZS-108 has a clinical activity in platinum refractory/resistant ovarian cancer which seems to be comparable to that of pegylated liposomal doxorubicin or to topotecan. Toxicity was comparably low. These data support the concept of a targeted chemotherapy for tumors expressing LHRH receptors.