Author:
Kaye S B,Paul J,Cassidy J,Lewis C R,Duncan I D,Gordon H K,Kitchener H C,Cruickshank D J,Atkinson R J,Soukop M,Rankin E M,Davis J A,Reed N S,Crawford S M,MacLean A,Parkin D,Sarkar T K,Kennedy J,Symonds R P
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.
Publisher
American Society of Clinical Oncology (ASCO)
Cited by
125 articles.
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