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 ifosfamide and doxorubicin in patients with advanced or metastatic leiomyosarcomas of the uterus who had not received other chemotherapy. Thirty-five women were entered into this study; 1 patient was ineligible (primary not documented), leaving 34 patients treated with ifosfamide, 5.0 g/m2/24 hr, and mesna, 6.0 g/m2/36 hr, by continuous IV infusion preceded by doxorubicin, 50 mg/m2 iv over 15 min. Each course of therapy was repeated every 3 weeks if counts allowed. One patient was inevaluable for response, leaving 34 evaluable for toxicity and 33 evaluable for response of chemotherapy. GOG grade 3 or 4 granulocytopenia occurred in 17 patients (48.6%), 2 patients developed granulocytopenic fever (5.7%), and 1 died of sepsis. Two patients developed grade 3 thrombocytopenia, and 1 died of cardiotoxicity. There were nine partial and one complete responses for an overall response rate of 30.3%; the response duration averaged 4 months. The combination of ifosfamide and doxorubicin is toxic but has moderate activity in patients with advanced or metastatic leiomyosarcoma of the uterus.