Enzalutamide demonstrates modest activity in granulosa cell ovarian tumours

The use of the antiandrogen enzalutamide in patients with granulosa cell ovarian tumour (GCT) falls short in terms of significant radiological response or clinical benefit, according to a phase II trial.

Researchers enrolled adult women with advanced GCT from the Spanish Collaborative Group for Transversal Oncology and Rare and Orphan Tumors (GETTHI). These patients received enzalutamide 160 mg once a day.

The primary endpoint was objective response rate. Secondary endpoints included clinical benefit rate, progression-free survival, overall survival, and safety profile.

Of the 18 patients screened, 16 were included in the study. The median age of the study sample was 56.4 years, with 14 being Caucasian, one Arabian, and one Latin. The patients had ECOG performance status of 0 in 13 patients (81 percent) and 1 in three (19 percent). Hormone therapy was previously given in six patients (38 percent) as adjuvant treatment or for advanced disease, while chemotherapy was previously used in 15 (94 percent). Median time from metastasis to study entry was 96 months.

Over a median follow-up of 6 months, none of the patients had objective response, although the clinical benefit rate was 68.8 percent (95 percent confidence interval [CI], 46–91.5). Median progression-free survival was 3.8 months (95 percent CI, 1.36–6.14), and the median overall survival was not reached.

At the time of database lock, treatment had been discontinued in 14 patients, due to disease progression in 13 and by personal choice in one. Two patients died as a result of disease progression.

Five grade 3 adverse events were documented, including a case of asthenia deemed related to the therapy.