Phase II trial of intra-arterial chemotherapy using a novel lipophilic platinum derivative (SM-11355) in patients with hepatocellular carcinoma
Phase II trial of intra-arterial chemotherapy using a novel lipophilic platinum derivative (SM-11355) in patients with hepatocellular carcinoma
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DOI：
10.1023/b:drug.0000011793.72775.d1
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发表时间：
2004-04-01
影响因子：
3.4
通讯作者：
Kubo, Y
中科院分区：
文献类型：
--
作者：
Okusaka, T;Okada, S;Kubo, Y
SM-11355是一种亲脂性铂衍生物，是一种新型的肝细胞癌（HCC）动脉化疗药物。进行了SM-11355的II期研究，以评估未经化疗的HCC患者的抗肿瘤活性和毒性。16例患者经导管动脉注射SM-11355-碘油乳剂（20-120 mg/体）。治疗后3个月通过计算机断层扫描评估反应。完全缓解（CR）定义为所有肿瘤消失或100%坏死，肿瘤中的阿曲碘油蓄积被认为是坏死的指示。9例患者达到CR（56%; 95%置信区间，29.9-80.2%）。3级毒性为中性粒细胞减少（19%）、总胆红素升高（19%）、AST升高（44%）和ALT升高（19%）。无患者显示4级毒性或肾功能不全发作。其他常见的不良反应是嗜酸性粒细胞增多（100%）和发热（94%）。SM-11355的动脉内化疗耐受性良好，在HCC患者中显示出有希望的抗肿瘤活性。
SM-11355, a lipophilic platinum derivative, is a novel intra-arterial chemotherapeutic agent for hepatocellular carcinoma (HCC). A phase II study of SM-11355 was conducted to evaluate the antitumor activities and the toxicity in chemotherapy-naive patients with HCC. Sixteen patients were treated with transcatheter arterial injection of SM-11355-lipiodol emulsion (20-120 mg/body). The responses were evaluated by computed tomography 3 months after treatment. Complete response (CR) was defined as disappearance or 100% necrosis of all tumors, and lipiodol accumulation in tumors was regarded as indicating necrosis. Nine patients achieved CR (56%; 95% confidence interval, 29.9-80.2%). The grade 3 toxicities were neutropenia (19%), total bilirubin elevation (19%), AST elevation (44%), and ALT elevation (19%). None of the patients showed grade 4 toxicities or episodes of renal dysfunction. Other common adverse effects were eosinophilia (100%) and pyrexia (94%). Intra-arterial chemotherapy with SM-11355, which was well tolerated, showed promising antitumor activity in patients with HCC.