Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer

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/m(2) and either a high dose (HD) of 100 mg/m(2) cisplatin or a low dose (LD) of 50 mg/m(2) (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-vp 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/m(2), representing the optimal balance between efficacy and toxicity.