COMBINATION CHEMOTHERAPY WITH HYDROXYUREA, DACARBAZINE (DTIC), AND ETOPOSIDE IN THE TREATMENT OF UTERINE LEIOMYOSARCOMA - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

Advanced or recurrent uterine leiomyosarcomas have traditionally been resistant to most chemotherapeutic regimens. Preliminary reports sugge sted the combination of hydroxyurea, dacarbazine (DTIC), and etoposide (VP-16) was sufficiently effective to warrant larger trials. In a Pha se II trial undertaken by the Gynecologic Oncology Group, 39 patients with advanced or recurrent leiomyosarcoma were treated with 2 g of hyd roxyurea, 700 mg/m(2) of DTIC, and 300 mg/m(2) of VP-16 in divided dos es every 4 weeks. Thirty-eight patients were evaluable for response. T wo patients experienced complete responses and five had partial respon ses for a total objective response rate of 18.4% (95% confidence inter val: 7.7-34.3%). In general, therapy was well tolerated with moderate toxicity. Six of the seven responders had disease outside the pelvis. The combination of hydroxyurea, DTIC, and VP-16 exhibits moderate acti vity against uterine leiomyosarcoma. (C) 1996 Academic Press, Inc.