WEEKLY CISPLATIN+/-GLUTATHIONE IN RELAPSED OVARIAN-CARCINOMA
WEEKLY CISPLATIN+/-GLUTATHIONE IN RELAPSED OVARIAN-CARCINOMA
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DOI：
10.1046/j.1525-1438.1995.05020081.x
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发表时间：
1995-03-01
影响因子：
4.8
通讯作者：
MANGIONI, C
中科院分区：
文献类型：
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作者：
COLOMBO, N;BINI, S;MANGIONI, C
实验数据显示谷胱甘肽（GSH）作为顺铂诱导的神经毒性的保护剂的疗效和高剂量顺铂+ GSH治疗患者的神经毒性发生率低的临床证据的基础上，我们在一项随机II期研究中评价了GSH的神经保护作用。33例复发性卵巢癌患者，在至少1年的无病间隔期后，既往顺铂累积剂量范围为450-650 mg m（-2），随机接受顺铂50 mg m（-2），每周+/- 2.5 g GSH，连续9周。在基线和研究结束时进行临床和仪器神经学和耳科评估。31例可评价患者的总缓解率为：A组9/15例，B组12/16例，其中4/15例完全缓解，7/16例完全缓解。GSH治疗患者的顺铂给药剂量强度较高（56% vs 27%接受100%剂量强度）。GSH治疗组在神经保护方面检测到趋势，并且在两组之间的其他毒性中没有观察到显著或差异。它的结论是，可能的好处，可以预期从GSH和顺铂的伴随管理在高风险的发展神经毒性的患者，而不降低抗肿瘤活性。
On the basis of experimental data showing the efficacy of glutathione (GSH) as a protective agent on cisplatin-induced neurotoxicity and the clinical evidence of the low incidence of neurotoxicity in high-dose cisplatin + GSH treated patients we evaluated the neuroprotective effect of GSH in a randomized phase II study. Thirty-three patients with relapsed ovarian cancer after a disease-free interval of at least 1 year and a cumulative dose of prior cisplatin ranging 450-650 mg m(-2) were randomized to receive cisplatin 50 mg m(-2) weekly +/- 2.5 g GSH for 9 consecutive weeks. Clinical and instrumental neurologic and otologic evaluations were made at the baseline and at the end of the study. Overall response rate in 31 evaluable patients was: 9/15 in group A and 12/16 in group B, including 4/15 vs 7/16 complete responses. The administered dose intensity of cisplatin was higher in the GSH treated patients (100% dose intensity was received by 56% vs 27%). A trend in terms of neuroprotection was detected in the GSH treated group, and no ma]or difference was observed in the other toxicities between the two groups. It is concluded that possible benefit can be expected from the concomitant administration of GSH and cisplatin in patients at high risk of developing neurotoxicity, without decreasing the anti-tumor activity.