Levitt R, Buckner J C, Cascino T L, Burch P A, Morton R F, Westberg M W, Goldberg R M, Gallagher J G, O'Fallon J R, Scheithauer B W
St. Luke's Hospitals CCOP, Fargo, ND 58123, USA.
J Neurooncol. 1995;23(1):87-93. doi: 10.1007/BF01058464.
Amonafide, a novel imide derivative with broad preclinical antitumor activity, achieves significant cerebrospinal fluid levels in animal models. In order to test its antitumor activity in patients with recurrent diffuse infiltrative glioma of the astrocytic and oligodendroglial type, we performed a phase II clinical trial. Of the 22 eligible and evaluable patients treated, 2 (9%) experienced tumor regression lasting more than one year. No other patients experienced tumor regression; one remained stable more than six months. Toxicities consisted primarily of myelosuppression, vomiting, and venous irritation at the infusion site. We conclude that amonafide has minimal activity in recurrent glioma patients. Further investigations are not warranted in this study population.
氨萘非特是一种具有广泛临床前抗肿瘤活性的新型酰亚胺衍生物，在动物模型中可达到显著的脑脊液浓度。为了测试其对复发性星形细胞型和少突胶质细胞型弥漫性浸润性胶质瘤患者的抗肿瘤活性，我们开展了一项II期临床试验。在接受治疗的22例符合条件且可评估的患者中，2例（9%）出现了持续超过一年的肿瘤消退。没有其他患者出现肿瘤消退；1例病情稳定超过6个月。毒性主要包括骨髓抑制、呕吐和输液部位的静脉刺激。我们得出结论，氨萘非特对复发性胶质瘤患者的活性极小。在该研究人群中无需进一步研究。
