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Anticancer Res. 2009 Dec;29(12):5235-40.
In a previous phase I clinical trial of dietary methionine (MET) restriction with cystemustine treatment for melanoma or glioma, we determined the optimal MET-free diet duration to be 1 day. On this basis, a phase II clinical trial was initiated to evaluate safety and efficacy of this combination.
Twenty-two patients (20 with metastatic melanoma and 2 with recurrent gloma) received a median of 4 cycles of the association of a 1-day MET-free diet with cystemustine (60 mg/m(2)) every two weeks.
This association was well tolerated (toxicity and nutritional status). Toxicity remained mainly hematological and consisted of WHO grade 3-4 thrombocytopenia, leucopenia and neutropenia in 36, 27 and 27% of patients respectively. The median disease-free survival was 1.8 months and the median survival was 4.6 months, with 2 long-duration stabilizations. The plasmatic MET depletion obtained was of 40 + or - 31%.
在一项关于饮食蛋氨酸(MET)限制联合胱硫醚治疗黑素瘤或神经胶质瘤的 I 期临床试验中,我们确定了最佳的无蛋氨酸饮食持续时间为 1 天。在此基础上,启动了一项 II 期临床试验,以评估该联合方案的安全性和疗效。
22 例患者(20 例转移性黑素瘤和 2 例复发性神经胶质瘤)接受了中位 4 个周期的 1 天无蛋氨酸饮食联合胱硫醚(60mg/m2)治疗,每两周 1 次。
该联合方案耐受性良好(毒性和营养状况)。毒性主要为血液学毒性,分别有 36%、27%和 27%的患者出现了 WHO 分级 3-4 级血小板减少、白细胞减少和中性粒细胞减少。无疾病进展生存时间的中位数为 1.8 个月,总生存时间的中位数为 4.6 个月,有 2 例患者的疾病稳定时间较长。获得的血浆 MET 耗竭率为 40+或-31%。