Burzynski S R, Kubove E
Drugs Exp Clin Res. 1987;13 Suppl 1:17-29.
Antineoplaston A3 is an oxidated mixture of small peptides and amino acid derivatives isolated from human urine which have shown antineoplastic activity in tissue culture and low toxicity in mice. Twenty-four patients diagnosed with 25 cases of neoplastic diseases were involved in the studies. The patients' diagnoses included: adenocarcinoma of the prostate, stage IV (7 cases); adenocarcinoma of the breast, stage IV (3); adenocarcinoma of the colon and rectum, stage IV (3); adenocarcinoma of the colon, status post resection (1); adenocarcinoma of the lung, stage III (2); squamous cell carcinoma of the lung, stage III (2); adenocarcinoma of the pancreas, stages II and IV (2); and single cases of adenocarcinoma of the kidney, stage IV; malignant fibrohistiocytoma, stage IV; glioblastoma multiforme, stage IV; basal cell epithelioma; and transitional cell carcinoma of the bladder, grade II. Only patients who had over six weeks' anticipated survival and who continued the treatment for over six weeks were eligible. In 23 patients, Antineoplaston A3 was administered in divided doses daily i.v. through a subclavian vein catheter. In one patient, the injections were given i.m. The length of treatment was from 44 to 478 days and the highest dosage was 76 mg/kg/24 h. Side-effects associated with treatment included febrile reaction (4 patients), vertigo (2), headache (2), flushing of the face, nausea and tachycardia (1 each). Adverse reactions were mild and occurred only once during the entire course of treatment. Desirable side-effects included increase of platelet count, increase of white blood cell count and increase of reticulocyte count. At the end of the study, there were 5 cases of complete remission, 5 of partial remission, nine of stable disease and six of increasing disease. The patients who obtained complete remission were diagnosed with cancers of the bladder, prostate, colon, and basal cell epithelioma. In view of its very limited toxicity and the interesting responses obtained, Antineoplaston A3 was submitted for Phase II clinical trials to establish its usefulness in cancer treatment.
抗瘤氨酸A3是一种从小便中分离出来的小肽和氨基酸衍生物的氧化混合物，它在组织培养中显示出抗肿瘤活性，对小鼠的毒性较低。24例被诊断患有25种肿瘤疾病的患者参与了研究。患者的诊断包括：前列腺腺癌，IV期（7例）；乳腺癌，IV期（3例）；结肠直肠癌，IV期（3例）；结肠癌，术后状态（1例）；肺癌，III期（2例）；肺鳞状细胞癌，III期（2例）；胰腺癌，II期和IV期（2例）；以及肾腺癌、IV期（1例）；恶性纤维组织细胞瘤，IV期（1例）；多形性胶质母细胞瘤，IV期（1例）；基底细胞上皮瘤（1例）；膀胱移行细胞癌，II级（1例）。只有预期生存期超过六周且持续治疗超过六周的患者才符合条件。23例患者通过锁骨下静脉导管每天静脉内分剂量给予抗瘤氨酸A3。1例患者采用肌肉注射给药。治疗时间为44至478天，最高剂量为76毫克/千克/24小时。与治疗相关的副作用包括发热反应（4例患者）、眩晕（2例）、头痛（2例）、面部潮红、恶心和心动过速（各1例）。不良反应较轻，且在整个治疗过程中仅出现一次。有益的副作用包括血小板计数增加、白细胞计数增加和网织红细胞计数增加。研究结束时，有5例完全缓解、5例部分缓解、9例病情稳定和6例病情进展。获得完全缓解的患者被诊断患有膀胱癌、前列腺癌、结肠癌和基底细胞上皮瘤。鉴于其毒性非常有限且取得了令人感兴趣的反应，抗瘤氨酸A3已提交进行II期临床试验，以确定其在癌症治疗中的有效性。
