de Vries E G, Mulder N H, Postmus P E, Vriesendorp R, Willemse P H, Sleijfer D T
Cancer Treat Rep. 1986 May;70(5):595-8.
To evaluate the dose-limiting toxicity of teniposide (VM-26), a phase I study was conducted. VM-26, a semisynthetic podophyllotoxin derivative, was administered on 3 consecutive days. The initial total dose per course was 0.3 g/m2, with dose escalation to 0.6 and 1 g/m2. The most prominent side effects observed were severe skin rash in all three patients in the highest dose group and a dose-dependent degree of leukocytopenia and thrombocytopenia. In the highest dose group the leukocyte count in all courses was less than 1 X 10(9) cells/L and in three of five courses the platelet count was less than 25 X 10(9) cells/L. Of the 13 evaluable patients, five had partial remission, one had minor response, and four had stable disease. Further study should be centered on phase II studies in selected tumor groups at a VM-26 dose of 0.6 g/m2.
为评估替尼泊苷（VM - 26）的剂量限制性毒性，开展了一项I期研究。VM - 26是一种半合成鬼臼毒素衍生物，连续3天给药。每个疗程的初始总剂量为0.3g/m²，剂量递增至0.6和1g/m²。观察到的最突出副作用是最高剂量组的所有3例患者出现严重皮疹，以及白细胞减少和血小板减少的剂量依赖性程度。在最高剂量组，所有疗程的白细胞计数均低于1×10⁹/L，5个疗程中有3个疗程的血小板计数低于25×10⁹/L。在13例可评估患者中，5例部分缓解，1例轻度缓解，4例病情稳定。进一步研究应以0.6g/m²的VM - 26剂量在选定肿瘤组中进行II期研究为中心。
