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欧洲癌症研究与治疗组织(EORTC)关于丙酮醛双缩氨基脲治疗晚期肾细胞癌的II期研究。

An EORTC phase II study of methyl-glyoxal bis-guanylhydrazone in advanced renal cell cancer.

作者信息

Child J A, Bono A V, Fossa S D, Ten Bokkel Huinink W W, De Pauw M, Stoter G

出版信息

Eur J Cancer Clin Oncol. 1982 Jan;18(1):85-7. doi: 10.1016/0277-5379(82)90030-x.

DOI:10.1016/0277-5379(82)90030-x
PMID:7200896
Abstract

In a phase II study of methyl-glyoxal bis-guanylhydrazone (methyl-GAG) in patients with bi-dimensionally measurable metastases of renal cell cancer, 30 patients were given 500 mg/m2 weekly for at least 4 treatment cycles and were evaluable for response. Three patients (10%) achieved partial remission (PR) with a duration of 8-12 weeks; in 11 patients the disease was assessed as stable; and in 16 there was progression. A total of 40 patients were evaluable for toxicity. Nausea and vomiting occurred in 17 (43%), neuropathy, myopathy or myalgia in 8 (21%) and mucositis in 6 (14%). In addition to 3 patients taken off treatment before 4 treatment cycles, toxicity precluded further treatment in 3 others after 5, 6 and 7 cycles respectively. Methyl-GAG has minimal activity in renal cell cancer and, in this dose schedule, causes appreciable toxicity.

摘要

在一项关于甲基乙二醛双胍腙(methyl-GAG)治疗肾细胞癌二维可测量转移患者的II期研究中,30例患者每周接受500mg/m²治疗,至少进行4个治疗周期,并可评估疗效。3例患者(10%)达到部分缓解(PR),持续时间为8 - 12周;11例患者疾病被评估为稳定;16例出现进展。共有40例患者可评估毒性。17例(43%)出现恶心和呕吐,8例(21%)出现神经病变、肌病或肌痛,6例(14%)出现黏膜炎。除了3例在4个治疗周期前停止治疗的患者外,毒性分别在5、6和7个周期后导致另外3例患者无法继续治疗。甲基乙二醛双胍腙在肾细胞癌中的活性极小,在此剂量方案下会引起明显毒性。

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