Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer. Scottish Gynecology Cancer Trials Group

TitleMature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer. Scottish Gynecology Cancer Trials Group
Publication TypeJournal Article
Year of Publication1996
AuthorsKaye, SB, Paul, J, Cassidy, J, Lewis, CR, Duncan, ID, Gordon, HK, Kitchener, HC, Cruickshank, DJ, Atkinson, RJ, Soukop, M, Rankin, EM, Davis, JA, Reed, NSimon, Crawford, SM, MacLean, A, Parkin, D, Sarkar, TK, Kennedy, J, Symonds, RP, Group, SGynaecolog
JournalJ Clin Oncol
Volume14
Pagination2113-9
KeywordsAntineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use Cisplatin/*administration & dosage/adverse effects Cyclophosphamide/administration & dosage/adverse effects Disease-Free Survival Female Humans Middle Aged Ovarian Neoplasms/*
Abstract

PURPOSE: In 1992, we reported the first results of a randomized study in ovarian cancer, comprising two doses of cisplatin and indicated a significant difference (P = .0008) in median survival. Four years later, we now describe the results of this trial. PATIENTS AND METHODS: After a median follow-up of 4 years and 9 months, 115 of 159 cases of advanced ovarian cancer, originally randomized to receive six cycles of cyclophosphamide 750 mg/m2 and either a high dose (HD) of 100 mg/m2 cisplatin or a low dose (LD) of 50 mg/m2 (LD) cisplatin, have now died. RESULTS: The overall survival for HD and LD patients is 32.4% and 26.6%, respectively, and the overall relative death rate is 0.68 (P = .043). This represents a reduction in overall benefit with longer follow-up compared with the first 2 years (relative death rate of 0.52). Toxicity, particularly neurotoxicity, is still evident in the fourth year (10/31 on HD compared with 1/24 on LD). CONCLUSION: Our recommended dose of cisplatin in combination schedule is therefore 75 mg/m2, representing the optimal balance between efficacy and toxicity.