A multicenter phase II study with triptorelin (sustained-release LHRH agonist) in advanced or recurrent endometrial carcinoma: A French Anticancer Federation study

The objective of this phase II multicenter study was to assess the efficacy and tolerance of triptorelin (a sustained-release LHRH agonist) in advance d or recurrent endometrial cancer. A total of 101 monthly intramuscular inj ections were administered to 24 eligible patients (median number/patient = 3; range 1-12). Mainly due to progression, only 16 patients received 3 or m ore injections. Among the 23 evaluable patients, 1 complete and 1 partial r esponse (response rate of 8.7%) and 5 disease stabilizations were observed, often of long duration, but never in an irradiated area or after progestog ens treatment failure. Median survival for eligible patients was 7.2 months (range: 1-36 months). Only grade 1 toxicities possibly related to the trea tment were observed in 4 patients. In conclusion, triptorelin was safe, wel l tolerated, and easily manageable, and the very low toxicity did not impai r the quality of life in these patients with a very poor prognosis. Althoug h the response rate was disappointing, several patients showed early eviden ce of efficacy which may be of long duration. Response rates range between 0 and 45% in different published studies. Additional studies with stricter inclusion criteria and a larger sample size are necessary to better evaluat e the role of LHRH agonists in endometrial adenocarcinomas. (C) 1999 Academ ic Press.