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首页> 外文期刊>Journal of Cancer Therapy >A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Primary Brain Tumors—Final Report (Protocol BT-09)
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A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Primary Brain Tumors—Final Report (Protocol BT-09)

机译：成年原发性脑肿瘤患者抗neoplaston A10和AS2-1的II期研究—最终报告（协议BT-09）

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Antineoplastons A10 and AS2-1 (ANP) are synthetic derivatives of glutamine, isoglutamine, and phenylacetic acid. In 1993, a phase II clinical trial program began according to protocols based on the initial protocol, BT-06, which was transferred from the National Institutes of Health (NIH). Protocol BT-09 was designed for different types of primary brain tumors in adults that were not curable by standard treatment. The study was designed as a single arm, two-stage, phase II trial of ANP as a monotherapy in a high-risk, poor-prognosis population. The total number of registered subjects was 40. The majority of patients were diagnosed with high-grade tumors (N = 33). In this group, 12 patients carried diagnosis of anaplastic astrocytoma (AA) and 11 patients of glioblastoma. In the group of low-grade tumors (N = 7), there were 6 cases of low-grade glioma, and 1 neurocytoma grade 2. A group of 12 patients did not receive any prior treatment, 12 patients had surgical resection only, 5 patients received radiation therapy (RT) only, and 11 patients received both RT and chemotherapy. The median duration of ANP was 16.6 weeks. The median dosage of A10 was 7.16 g/kg/d and AS2-1 was 0.27 g/kg/d. Responses were accessed by gadolinium-enhanced magnetic resonance imaging (MRI). Objective responses (OR) in all patients were 22.5% and in the AA group were 41.7% of patients. The median progression-free survival (PFS) in the AA group was 5.4 months. The median overall survival (OS) was 12.7 months and OS at 1 and 2 years was 54.5% and 45.5% correspondingly. The treatment was well-tolerated with reversible grade 3 and 4 toxicities in 35% of all patients (N = 40). In conclusion, the study reached efficacy endpoint and ANP was well-tolerated and compared favorably to the current treatment of AA.
机译：抗赘生物A10和AS2-1（ANP）是谷氨酰胺，异谷氨酰胺和苯乙酸的合成衍生物。 1993年，根据最初协议BT-06的协议开始了II期临床试验计划，该协议是从国立卫生研究院（NIH）转移而来的。协议BT-09设计用于成人的不同类型的原发性脑肿瘤，这些肿瘤无法通过标准治疗治愈。该研究被设计为ANP的单臂，两阶段，II期试验，作为高风险，预后不良人群的单药治疗。已注册的受试者总数为40名。大多数患者被诊断出患有高级别肿瘤（N = 33）。在该组中，有12例诊断为间变性星形细胞瘤（AA），而11例为胶质母细胞瘤。在低度肿瘤（N = 7）组中，有6例低度神经胶质瘤和1个2级神经细胞瘤。一组12例患者未接受过任何治疗，12例仅接受了手术切除，5例患者仅接受放射治疗（RT），而11名患者接受了放射治疗和化学疗法。 ANP的中位持续时间为16.6周。 A10的中位剂量为7.16 g / kg / d，AS2-1的中位剂量为0.27 g / kg / d。通过g增强磁共振成像（MRI）获得反应。所有患者的客观反应（OR）为22.5％，AA组为41.7％。 AA组的中位无进展生存期（PFS）为5.4个月。中位总生存期（OS）为12.7个月，而1年和2年的OS分别为54.5％和45.5％。在所有患者中，有35％（N = 40）的患者具有可逆的3级和4级毒性耐受性。总之，该研究达到了疗效终点，并且ANP耐受性良好，并且与目前的AA治疗相比具有优势。

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