A PHASE-II STUDY OF LEUPROLIDE IN ADVANCED RECURRENT ENDOMETRIAL CANCER/

In order to determine the efficacy and toxicity of the gonadotrophin-r eleasing hormone agonist Leuprolide in the management of patients with recurrent or metastatic endometrial cancer, we performed a phase II s tudy. Patients were included if there was clinical or radiological doc umentation of bidimensionally measurable recurrent or metastatic endom etrial cancer that was deemed incurable. Treatment was 7.5 mg im every 28 days, and was to continue for at least 2 courses until evidence of disease progression, patient requested withdrawal, or unacceptable to xicity. Twenty-five patients received Leuprolide for recurrent or meta static endometrial cancer. The median age at study entry was 62 years, and the median time from initial diagnosis to first course of Leuprol ide was 25 months. Six patients had received no systemic or radiothera py prior to study entry, and 2 of these had not previously undergone h ysterectomy. Fifteen patients received prior pelvic radiotherapy and 3 patients received prior whole abdominal radiotherapy. Nine of the 25 patients had received prior progestational agents, and 2 had received prior systemic chemotherapy. There were no responders, 8 patients had stable disease for a median 5 months (range 1-8), 14 patients progress ed on therapy, and 3 patients were not evaluable for response due to r eceiving only 1 treatment. One patient experienced a grade 3 toxicity that was possibly attributable to Leuprolide (deep venous thrombosis). The median survival from study entry was 6 months. Twelve patients re ceived progesterone after discontinuing this study, and none responded . Leuprolide does not appear to be a clinically active agent in the tr eatment of recurrent or metastatic endometrial cancer. (C) 1997 Academ ic Press