High-dose versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: A randomized study of the gruppo oncologico nord-ovest

Purpose: The aim of the study was to compare high-versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin as primary chemotherapy for suboptimal stage III and IV ovarian cancer. Patients and Methods: One hundred forty-five patients were randomized to receive six courses of cisplatin 50 or 100 mg/m(2) plus epidoxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2). The two treatment arms were well balanced; all patients had greater than 2 cm and 37.2% had greeter than 5 cm of residual disease; 29.6% had stage IV disease. Results: patients in the high-dose arm received a double dose-intensity and double total dose of cisplatin. The high-dose regimen induced significantly more episodes of leukopenia (47.8% v 32.8%, P=.05), thrombocytopenia (21.7% v 3.2%, P=.003), anemia (37.6% v 12.5%, P=.002), nephrotoxicity (six v one patient), and neurotoxicity (30.4% v 6.3%, P=.002). There were no significant differences in efficacy in terms of clinical response rate (high-dose 57.5% v low-dose 61.1%), pathologic complete response (CR) (9.6% v 18.1%), median survival times (29 v 24 months), and median progression-free survival (18 v 13 months). Conclusion: This study shows that doubling the dose-intensity and total dose of cisplatin in combination with epidoxorubicin and cyclophosphamide has significant toxic effects and does not improve clinical outcome in patients with suboptimal ovarian cancer. (C) 1996 by American Society of Clinical Oncology.