Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01)
- PMID: 39454227
- DOI: 10.1016/j.ygyno.2024.10.019
Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01)
Abstract
Background: Granulosa cell ovarian tumors (GCT) are orphan disease with limited treatments. Hormone therapy is a potential treatment, due to the overexpression of hormone receptors in most tumors. This study explores the activity of the antiandrogen, enzalutamide, in metastatic cases.
Methods: We designed a phase II clinical trial under the Spanish Collaborative Group for Transversal Oncology and Rare and Orphan Tumors (GETTHI). Eligible participants were adult women with advanced GCT. Primary endpoint was objective response rate. Secondary endpoints included clinical benefit rate, progression-free survival, overall survival, and safety profile. Patients received enzalutamide 160 mg once daily.
Results: From April 2018 to March 2020, eighteen patients were screened, and sixteen were included across nine institutions. Median age was 56.4 years (range 45-71), and most were Caucasian (14 cases), one Arabian and one Latin. ECOG performance status was zero in 13 cases (81 %) and one in three (19 %). Six patients (38 %) had previously received hormone therapy as adjuvant treatment or for advanced disease, and 15 (94 %) chemotherapy. Median time from metastasis to study entry was 96 months (range 4.5-198). No objective response was observed, but the clinical benefit rate reached 68.8 % (95 % CI [46 %-91.5 %]). Median progression-free survival was 3.8 months (95 % CI [1.36-6.14]). Median overall survival was not reached, with a median follow-up of 6 months (range 2.2-19). At the time of database closure, 14 patients had discontinued treatment, 13 due to disease progression and one by personal choice. Two deaths attributed to disease progression were recorded. Five grade 3 adverse events were reported, with only one (asthenia) deemed related to the therapy.
Conclusions: Although enzalutamide demonstrated modest activity in GCT, durable stabilization was observed in some cases.
Trial registration: ClinicalTrials.gov Identifier: NCT03464201.
Keywords: Clinical trial; Enzalutamide; Granulosa cell ovarian carcinoma; Greko.
Copyright © 2024 Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of competing interest Jesus Garcia-Donas, corresponding author, has received research funding from Gilead Inc., Pfizer Inc., Merck Inc., Bristol-Myers Squibb, AstraZeneca, Novartis, MSD Inc., Roche Inc., Astellas Inc., Novartis Inc., and Exelixis Inc. He has acted as a speaker for Gilead Inc., Pfizer Inc., Merck Inc., Bristol-Myers Squibb, AstraZeneca, Novartis, Glaxo Smithkline Inc. and MSD Inc. He has served as a scientific advisor for Pfizer Inc., Merck Inc., Bristol-Myers Squibb, AstraZeneca, Novartis, and MSD Inc. Enrique Grande has received honoraria for speaker engagements, advisory roles or funding of continuous medical education from Adacap, AMGEN, Angelini, Astellas, Astra Zeneca, Bayer, Blueprint, Bristol Myers Squibb, Caris Life Sciences, Celgene, Clovis-Oncology, Eisai, Eusa Pharma, Genetracer, Guardant Health, HRA-Pharma, IPSEN, ITM-Radiopharma, Janssen, Lexicon, Lilly, Merck KGaA, MSD, Nanostring Technologies, Natera, Novartis, ONCODNA (Biosequence), Palex, Pharmamar, Pierre Fabre, Pfizer, Roche, Sanofi-Genzyme, Servier, Taiho, and Thermo Fisher Scientific. EG has received research grants from Pfizer, Astra Zeneca, Astellas, and Lexicon Pharmaceuticals. AR has received honoraria for speaker engagements, advisory roles or funding of continuous medical education from Astellas, Bristol Myers Squibb, IPSEN, Pfizer, and MSD.
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