Lunardi P, Osman Farah J, Mastronardi L, Puzzilli F, Lo Bianco F M
Department of Neurological Sciences, University of Rome La Sapienza, Italy.
Acta Neurochir (Wien). 1996;138(2):215-20. doi: 10.1007/BF01411364.
The object of this study is to evaluate the efficacy of a high dose of carboplatin in 20 patients operated on for high grade glioma (Group A) compared with a matched control (Group B) treated with BCNU administered after radiotherapy. The toxicity profile has been evaluated during the therapy. The survival of patients entering this study was measured in terms of months: the mean survival time was 10.45 months and the median 11.0 months in the group treated with carboplatin (8 patients are still alive); the 18-month survival rate was 10%. The mean survival time of the control group was 9.85 months and the median 10.5 months; no patients are still alive and the 18-month survival rate was 0%. On the basis of our phase II clinical study, we could conclude that i.v. administration of high-doses of carboplatin in high grade gliomas is generally well tolerated and the results are better than those of a matched control treated with 1-2 courses of BCNU (low-dose). The adjuvant treatment and the role of carboplatin in the therapy of high grade gliomas is discussed.
本研究的目的是评估高剂量卡铂对20例接受高级别胶质瘤手术患者(A组)的疗效,并与放疗后接受卡氮芥治疗的匹配对照组(B组)进行比较。在治疗期间评估了毒性情况。以月为单位衡量进入本研究患者的生存期:接受卡铂治疗组的平均生存时间为10.45个月,中位数为11.0个月(8例患者仍存活);18个月生存率为10%。对照组的平均生存时间为9.85个月,中位数为10.5个月;无患者存活,18个月生存率为0%。基于我们的II期临床研究,我们可以得出结论,静脉注射高剂量卡铂治疗高级别胶质瘤通常耐受性良好,结果优于接受1 - 2疗程卡氮芥(低剂量)治疗的匹配对照组。文中还讨论了辅助治疗以及卡铂在高级别胶质瘤治疗中的作用。