Jaffe N, Knapp J, Chuang V P, Wallace S, Ayala A, Murray J, Cangir A, Wang A, Benjamin R S
Cancer. 1983 Feb 1;51(3):402-7. doi: 10.1002/1097-0142(19830201)51:3<402::aid-cncr2820510308>3.0.co;2-p.
Intra-arterial CDP was utilized to treat the primary tumor in 11 pediatric patients with osteosarcoma and in one with malignant fibrous histiocytoma. The investigation commenced with a phase I-II pilot study in four osteosarcoma patients. A dose of 150 mg/m2 was found to be safe and effective in producing a clinical response. This was followed by a definitive study in the remaining seven osteosarcoma patients and in the one malignant fibrous histiocytoma patient. The results were assessed by specific clinical, pharmacologic, radiographic and pathologic criteria. The overall response in the definitive study was 50% with two patients exhibiting total tumor destruction. The success of intra-arterial CDP was attributed to its ability to achieve high local drug concentration and tumor penetration. This was demonstrated by pharmacologic studies.
对11例骨肉瘤患儿及1例恶性纤维组织细胞瘤患者采用动脉内注射顺铂治疗原发性肿瘤。研究始于对4例骨肉瘤患者进行的I-II期初步研究。发现150mg/m²的剂量在产生临床反应方面安全有效。随后对其余7例骨肉瘤患者和1例恶性纤维组织细胞瘤患者进行了确定性研究。通过特定的临床、药理学、影像学和病理学标准对结果进行评估。确定性研究中的总体缓解率为50%,2例患者肿瘤完全消失。动脉内注射顺铂的成功归因于其能够实现高局部药物浓度和肿瘤渗透。药理学研究证实了这一点。