Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer
Mature results of a randomized trial of two doses of cisplatin for the treatment of ovarian cancer
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DOI:
10.1200/jco.1996.14.7.2113
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发表时间:
1996-07-01
影响因子:
45.3
通讯作者:
Symonds, RP
中科院分区:
文献类型:
--
作者:
Kaye, SB;Paul, J;Symonds, RP
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.