PHASE II WBH AND IFOSFAMIDE/CARBOPLATIN/ETOPOSIDE (ICE) THERAPY IN SARCOMA

早些时候的两项研究导致了一项41.8的II期试验的设计。 摄氏度(x 60分钟)体外全身热疗(WBH) ICE，即异环磷酰胺(5g/m2)，卡铂(300 mg/m2)，以及 足叶乙苷与湿润烧伤后一起服用，以及湿润烧伤后第2天和第3天(100 mg/m2) 适用于患有难治性肉瘤的成人患者。12名患者进入 这场审判；所有的都是可评估的。8名患者有既往病史 化疗与疾病进展有关。在WBH/ICE之后， 观察到7例部分缓解(58%)；3例患者 病情稳定；上述10名患者各 接受了四个周期的治疗。两名患者表现为进展性 疾病。观察到世卫组织分级(三次或四次)的毒性事件 包括：红细胞(2；2)、白细胞(5；7)、血小板(1；6)、 肾(1；6)。其他毒性(I级和2级)包括：Anasarca， 腹泻、室性心律失常、压疮和口周疱疹 单纯的。基于对毒性数据的分析，一种替代的WBH 为了减少发病率，采用了辐射加热技术。这 威斯康星大学开发的技术已经消除了 上述毒性(与体外WBH相关)。到目前为止 (1996年4月)，12名患者中有7名在一段时间内有反应 吕贝克大学的辐射热WBH试验。这场审判现在是 随着大学的加入，成为多院校的试点 威斯康星大学和埃森大学。这项试验的结果 应为多机构第三阶段提供坚实的基础 学习。

Two earlier studies resulted in the design of a phase II trial of 41.8- degree-celsius (x 60 min) extracorporeal whole body hyperthermia (WBH) with ICE, i.e., ifosfamide (5 g/m2), carboplatin (300 mg/m2), and etoposide given with WBH, as well as day 2 and 3 post WBH (100 mg/m2) for adult patients with refractory sarcoma. Twelve patients entered this trial; all were evaluable. Eight patients had a history of prior chemotherapy associated with disease progression. Following WBH/ICE, seven partial remissions were observed (58 percent); three patients experienced disease stabilization; the aforementioned ten patients each received four cycles of therapy. Two patients exhibited progressive disease. Episodes of WHO-graded (three; or four) toxicity observed included: red blood cell (2;2); white blood cell (5;7); platelet (1;6); renal (1;6). Other toxicities (grade I and 2) included: anasarca, diarrhea, ventricular arrhythmias, pressure sores, and perioral herpes simplex. Based on an analysis of the toxicity data, an alternative WBH technology, I.E, radiant heat, was adopted to reduce morbidity. This technology developed at the University of Wisconsin, has eliminated the aforementioned toxicities (associated with extracorporeal WBH). To date (April 1996), seven of twelve patients have had responses in an on going radiant heat WBH trial at the University of Lubeck. This trial is now becoming a multi-institutional trial with the addition of the University of Wisconsin and the University of Essen. The results of this trial should provide a solid foundation for a multi-institutional phase III study.