Stewart D J, Hugenholtz H, DaSilva V F, Benoit B G, Richard M T, Verma S, Earhart R, Robillard L
Ontario Cancer Treatment and Research Foundation, Ottawa Regional Cancer Centre, Canada.
J Neurooncol. 1992 Jun;13(2):183-8. doi: 10.1007/BF00172769.
Twenty patients with astrocytomas recurrent after surgery +/- radiation were treated on a phase II protocol of the new anthracycline derivative menogaril 115 mg/m2 administered intravenously once per week. Sixteen patients were evaluable for treatment efficacy. No patient achieved a major therapeutic response. Three patients (19%) had stable disease for greater than 8 weeks, including one who showed minor evidence of tumor regression, but less than 50%. Thirteen patients failed. Treatment was well tolerated. One patient developed granulocytopenia, while none developed thrombocytopenia. Four patients required an interruption in their treatment for one to two weeks because of development of granulocytopenia (one patient) or other reasons. Other toxic effects included arm vein phlebitis and skin irritation, skin discoloration of the infused arm, mild to moderate nausea and vomiting, diarrhea, stomatitis, and a fatal central venous catheter infection. Despite the fact that menogaril appeared to have therapeutic activity against recurrent astrocytomas in our phase I studies, we could not document any activity in this phase II study.
20例手术后复发伴或不伴放疗的星形细胞瘤患者接受了一项II期试验方案的治疗，给予新型蒽环类衍生物美诺立尔115mg/m²，每周静脉注射1次。16例患者可评估治疗效果。无患者取得主要治疗反应。3例患者（19%）疾病稳定超过8周，其中1例有轻微肿瘤缩小迹象，但缩小不到50%。13例患者治疗失败。治疗耐受性良好。1例患者出现粒细胞减少，无患者出现血小板减少。4例患者因出现粒细胞减少（1例患者）或其他原因需要中断治疗1至2周。其他毒性反应包括手臂静脉炎和皮肤刺激、输注侧手臂皮肤变色、轻至中度恶心和呕吐、腹泻、口腔炎以及1例致命的中心静脉导管感染。尽管在我们的I期研究中美诺立尔似乎对复发性星形细胞瘤有治疗活性，但在这项II期研究中我们未能证明其有任何活性。
