LUTEINIZING-HORMONE-RELEASING HORMONE AGONIST TRIPTORELIN IN COMBINATION WITH CYTOTOXIC CHEMOTHERAPY IN PATIENTS WITH ADVANCED OVARIAN-CARCINOMA - A PROSPECTIVE DOUBLE-BLIND RANDOMIZED TRIAL

BACKGROUND. Several lines of evidence suggest that the proliferation o f ovarian carcinoma might be stimulated by gonadotrophins. A number of Phase I/Phase II clinical trials have reported that the suppression o f endogenous luteinizing hormone and follicle-stimulating hormone secr etion by luteinizing hormone-releasing hormone (LHRH) analogs induced objective remissions and/or disease stabilization in 10-30% of patient s with advanced refractory ovarian carcinoma. The current study was pe rformed to evaluate whether the addition of LHRH agonist treatment to standard platinum-based chemotherapy could prolong survival of patient s with surgically treated Stage III or IV epithelial ovarian carcinoma . METHODS. One hundred and thirty-five patients with Stage III or IV e pithelial ovarian carcinoma participated in this prospective randomize d double blind trial. After cytoreductive surgery, 69 patients receive d monthly injections of a depot preparation of the LHRH agonist [D-Trp (6)] LHRH (triptorelin, 3.75 mg) and 66 patients received placebo unti l their deaths or termination of the trial, respectively. All patients were treated with a standard platinum-based chemotherapy, and, if nec essary, with second- or third-line cytotoxic regimens. RESULTS. Endoge nous gonadotrophins were reliably suppressed in patients treated with triptorelin. However, their progression free and overall survival were not significantly different from that of patients receiving placebo i njections (statistical power > 80% for a difference between both group s of greater than or equal to 20%). CONCLUSIONS. The results of this t rial suggest that the suppression of endogenous gonadotrophins by conv entional doses of an LHRH agonist produces no relevant beneficial effe cts in patients with advanced ovarian carcinoma who receive standard s urgical cytoreduction and cytotoxic chemotherapy. (C) 1996 American Ca ncer Society.