IFOSFAMIDE AND DOXORUBICIN IN THE TREATMENT OF ADVANCED LEIOMYOSARCOMAS OF THE UTERUS - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

This is a Phase II groupwide study of the Gynecologic Oncology Group ( GOG) to determine the toxicity and efficacy of a combination of ifosfa mide and doxorubicin in patients with advanced or metastatic leiomyosa rcomas of the uterus who had not received other chemotherapy, Thirty-f ive women were entered into this study; 1 patient was ineligible (prim ary not documented), leaving 34 patients treated with ifosfamide, 5.0 g/m(2)/24 hr, and mesna, 6.0 g/m(2)/36 hr, by continuous IV infusion p receded by doxorubicin, 50 mg/m(2) iv over 15 min. Each course of ther apy was repeated every 3 weeks if counts allowed, One patient was inev aluable for response, leaving 34 evaluable for toxicity and 33 evaluab le for response of chemotherapy. GOG grade 3 or 4 granulocytopenia occ urred in 17 patients (48.6%), 2 patients developed granulocytopenic fe ver (5.7%), and 1 died of sepsis. Two patients developed grade 3 throm bocytopenia, and 1 died of cardiotoxicity. There were nine partial and one complete responses for an overall response rate of 30.3%; the res ponse duration averaged 4 months. The combination of ifosfamide and do xorubicin is toxic but has moderate activity in patients with advanced or metastatic leiomyo-sarcoma of the uterus. (C) 1996 Academic Press, Inc.