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首页> 外文期刊>Cancer and Clinical Oncology >Primary CNS Tumors and Leptomeningeal, Disseminated and/or Multicentric Disease in Children Treated in Phase II Studies with Antineoplastons A10 and AS2-1
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Primary CNS Tumors and Leptomeningeal, Disseminated and/or Multicentric Disease in Children Treated in Phase II Studies with Antineoplastons A10 and AS2-1

机译：在II期研究中使用抗neoplaston A10和AS2-1治疗的儿童的原发性中枢神经系统肿瘤和软脑膜，弥散性和/或多中心疾病

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It is estimated that as many as 30% of patients with primary CNS tumors have leptomeningeal, disseminated, and/or multicentric disease (LDM). These patients respond poorly to conventional therapy. Fifty-seven children with LDM (median age of 7.1 years) were treated in multiple prospective phase II clinical studies of high- and low-grade primary CNS tumors with Antineoplastons A10 and AS2-1 (ANP). Their inclusion in this analysis was based on MRI imaging. Patients with glioblastoma were excluded. The patients received ANP therapy 6 times daily; A10: 8.77 g/kg/d; AS2-1: 0.35 g/kg/d. The response to ANP was monitored by MRIs every 8 weeks. Patients evaluable for efficacy (N = 40) received 12 or more weeks of ANP or developed progressive disease (PD) before 12 weeks. 10 patients (17.5%) achieved an objective response (OR) with 4 (7%) achieving a complete response (CR) and 6 (10.5%) had a partial response (PR). Stable disease (SD) was maintained in 7 patients (12.3%) and PD developed in 23 patients (40.4%). Survival analysis of the 57 children showed 2- and 5-year overall survival (OS) were both 28% while 10- and 15-year OS were both 26%. One of the patients achieving an OR had atypical teratoid/rhabdoid tumor (AT/RT) while nine had low-grade gliomas (LGGs). Grade 3 and 4 toxicities included hypokalemia (14.0%); fatigue, anemia, hypernatremia and leukopenia (3.5% each); diarrhea, hypertension, joint pain, thrombocytopenia, and somnolence (1.8% each). These findings suggest the need for a single-arm, phase II study of ANP in children with LDM.
机译：据估计，多达30％的中枢神经系统原发性肿瘤患者患有软脑膜，弥散性和/或多中心疾病（LDM）。这些患者对常规治疗反应差。对57名LDM儿童（中位年龄为7.1岁）接受了针对Antineoplastons A10和AS2-1（ANP）的高，低度原发性中枢神经系统肿瘤的多期前瞻性II期临床研究。它们包括在此分析中是基于MRI成像。胶质母细胞瘤患者被排除在外。每天接受6次ANP治疗; A10：8.77 g / kg / d; AS2-1：0.35g / kg / d。每8周通过MRI监测对ANP的反应。可评估疗效的患者（N = 40）在12周之前接受了12周或更多周的ANP或发展为进行性疾病（PD）。 10例患者（17.5％）达到了客观缓解（OR），4例（7％）达到了完全缓解（CR），6例（10.5％）达到了部分缓解（PR）。 7例患者（12.3％）保持稳定的疾病（SD），23例患者（40.4％）发生PD。对57名儿童的生存分析表明，2年和5年总生存率（OS）均为28％，而10年和15年OS均为26％。达到OR的患者中，一名患有非典型的类畸形/类人瘤（AT / RT），而九名患有低度胶质瘤（LGGs）。 3级和4级毒性包括低钾血症（14.0％）;疲劳，贫血，高钠血症和白细胞减少症（各占3.5％）;腹泻，高血压，关节痛，血小板减少和嗜睡（各占1.8％）。这些发现表明需要对LDM儿童进行ANP单臂II期研究。

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