A Phase II evaluation of esorubicin in ovarian cancer: A Southwest Oncology Group study

Patients with a pathologically confirmed diagnosis of metastatic or advanced epithelial-type ovarian carcinoma were entered into a Phase II trial of esorubicin. Eligibility criteria included measurable disease; performance status (SWOG) 0-2; no more than one prior chemotherapeutic regimen; and no prior doxorubicin therapy. The starting esorubicin dosing schedule was 30 mg/m² every 3 weeks for good risk patients and 25 mg/m² every 3 weeks for poor risk patients. Twenty-one patients were eligible for evaluation of response and toxicity to treatment. These patients received a median of 3 courses of esorubicin (range 1-13 courses). None of the 21 patients experienced a response to esorubicin. Median survival was 5.5 months. Leukopenia was the major toxicity. Eleven (79%) of the good risk patients and 2 (29%) of the poor risk patients experienced severe to life-threatening leukopenia. Mild to severe anemia was seen in 10 (71%) of the good risk patients and 7 (100%) of the poor risk patients. We conclude that esorubicin is ineffective in the treatment of ovarian cancer patients who have received primary chemotherapy.