Bleomycin, etoposide, and cisplatin combination therapy of ovarian granulosa cell tumors and other stromal malignancies: A Gynecologic Oncology Group study

Objectives. The objectives of this study were to assess efficacy and toxicity of the combination of bleomycin, etoposide, and cisplatin (BEP) in this Phase II trial as first-line therapy for ovarian stromal malignancies, Methods. Patients with incompletely resected Stages II-IV or recurrent cancer underwent surgical debulking, There were two bleomycin-related deaths early in the trial; thus, the initial schedule of bleomycin (20 units/m(2) x 9 weeks for a maximum dose of less than or equal to 30 units x 9) was changed, without subsequent mortality. The final dose schedule was 20 units/m(2) bleomycin iv push day 1 every 3 weeks x 4, 75 mg/m(2) etoposide days 1-5 every 3 weeks x 4 and 20 mg/m(2) cisplatin days 1-5 every 3 weeks x 4, The frequency of negative second-look surgery was the primary outcome measure. Results. Seventy-five women were entered; 18 were excluded. Grade 4 myelotoxicity occurred in 61% of the patients. The end point used for response was negative second-look laparotomy. Thirty-seven percent (14/38) of the patients undergoing second-look laparotomy had negative findings. The six complete responders were of long median duration (24.4 months), Patients with measurable disease were at the highest risk of progression and death, Conclusions. BEP appears to be an active combination regimen for first-line chemotherapy of malignant tumors of the ovarian stroma. Myelotoxicity was tolerable, (C) 1999 Academic Press.