Leuprolide acetate for treating refractory or persistent ovarian granulosa cell tumor.

OBJECTIVE: To evaluate leuprolide acetate for treating refractory or persistent ovarian granulosa cell tumor (GCT). STUDY
DESIGN: We treated six patients who had recurrent or persistent ovarian GCT with monthly intramuscular injections of a depot formulation of leuprolide acetate, 7.5 mg. Four patients had received prior cisplatin-based chemotherapy. Initially these patients' tumors had responded to the cisplatin, but then the disease had progressed in all cases. One of these four patients also had received prior therapy with tamoxifen that had resulted in three months of stable disease. Two patients had received no prior chemotherapy.
RESULTS: Responses could be evaluated in five of the six patients; in the sixth patient, only survival was evaluable. Among the five evaluable patients, two achieved partial responses lasting 3 and 11 months, with disease progression-free intervals of 4 and 12 months. The other three patients (60%; 95% confidence interval [CI], 20-95%), including two whose disease had progressed on chemotherapy, had stable disease with disease progression-free intervals of 3+, 3+ and 13+ months. The objective response rate was 40% (two of five patients; 95% CI, 10-90%). Cessation of disease progression was noted in all five of the evaluable patients (100%; 95% CI, 40-100%). The sixth patient, whose disease could not be evaluated, was treated with leuprolide acetate for 24 months and at this writing had no clinical evidence of disease. The therapy was convenient to administer, and no major side effects were noted. Leuprolide acetate thus appears to have activity in patients with refractory GCT, and it may prolong the disease progression-free interval. Further trials of this relatively nontoxic and convenient therapy are warranted.