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/m2 x 9 weeks for a maximum dose of </=30 units x 9) was changed, without subsequent mortality. The final dose schedule was 20 units/m2 bleomycin iv push day 1 every 3 weeks x 4, 75 mg/m2 etoposide days 1-5 every 3 weeks x 4 and 20 mg/m2 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. Copyright 1999 Academic Press.
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/m2 x 9 weeks for a maximum dose of </=30 units x 9) was changed, without subsequent mortality. The final dose schedule was 20 units/m2 bleomycin iv push day 1 every 3 weeks x 4, 75 mg/m2 etoposide days 1-5 every 3 weeks x 4 and 20 mg/m2 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. Copyright 1999 Academic Press.
Authors: Elizabeth R Burton; Mark Brady; Howard D Homesley; Peter G Rose; Toshiaki Nakamura; Joshua P Kesterson; Jacob Rotmensch; J Tate Thigpen; Linda Van Le Journal: Gynecol Oncol Date: 2015-11-23 Impact factor: 5.482