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首页> 外文期刊>Cancer and Clinical Oncology >Antineoplastons A10 and AS2-1 in the Treatment of Children with Optic Pathway Glioma: Final Report for Protocol BT-23
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Antineoplastons A10 and AS2-1 in the Treatment of Children with Optic Pathway Glioma: Final Report for Protocol BT-23

机译：Antineoplastons A10和AS2-1在视神经胶质瘤患儿中的治疗：BT-23协议的最终报告

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Protocol BT-23, a Phase II study, was performed to determine the efficacy and safety of combination Antineoplaston A10 and Antineoplaston AS2-1 (ANP) in children with an optic pathway glioma (OPG). Sixteen patients (12 males, 4 females) ages 1 to 16 years (median age 4.5 years) were treated. The patients received ANP, by intravenous infusion, six times daily (i.e., every four hours). The length of treatment extended from a minimum of 4.1 weeks to a maximum of 210.0 weeks. The median dosage of A10 was 8.07 g/kg/d while for AS2-1 itwas 0.39 g/kg/d.Patients’ best response to ANP was determined: 12.5% of this patient population achieved a complete response, 18.8% achieved a partial response, and 31.3% maintained stable disease. The median overall survival was 78.5 months (95% CI: 37.6-92.3) while median progression-free survival was 45.4 months (95% CI: 7.1-71.4). ANPwas associated with a12% incidence of Grade 3 and a12% incidence of Grade 4 adverse drug experiences (ADEs). There were no Grade 5 ADEs. Grade 3 ADEs included somnolence and elevated SGOT; Grade 4 ADEsincluded hypernatremia and hypokalemia. Long-term quality of life was excellent with no chronic toxicity identified. Children with an OPG respond very well to ANP with good efficacy and toxicity profiles.
机译：进行了BT-23协议（一项II期研究），以确定抗视神经胶质瘤A10和抗neoplaston AS2-1（ANP）组合在视神经胶质瘤（OPG）儿童中的疗效和安全性。治疗年龄为1至16岁（中位年龄为4.5岁）的16例患者（男12例，女4例）。患者每天六次（即每四小时一次）通过静脉输注接受ANP。治疗时间从最小4.1周延长到最大210.0周。 A10的中位剂量为8.07 g / kg / d，而AS2-1的中位剂量为0.39 g / kg / d。确定了患者对ANP的最佳反应：该患者群体的12.5％达到完全缓解，18.8％达到部分缓解有31.3％的人保持稳定的疾病。中位总体生存期为78.5个月（95％CI：37.6-92.3），而中位无进展生存期为45.4个月（95％CI：7.1-71.4）。 ANP与3级发生率的12％和4级不良药物经历（ADEs）的发生率相关。没有5级ADE。 3级ADE包括嗜睡和SGOT升高; 4级不良事件包括高钠血症和低钾血症。长期生活质量极好，未发现慢性毒性。患有OPG的儿童对ANP有很好的疗效和毒性反应。

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