白介素－2的Ⅱ期临床试验报告

A PHASE II STUDY OF RECOMBINANT INTERLEUKIN-2 IN CANCR PATIENTS

共１５９例各种类型的恶性肿瘤病人进入了Ⅱ期临床试验。２５例病人接受了白介素－２（ＩＬ－２）单独全身治疗（静脉或皮下注射）；６０例病人接受了ＩＬ－２＋ＬＡＫ细胞全身性治疗；４１例癌性胸水病人接受了ＩＬ－２胸腔内灌注；６例癌性腹水病人接受了ＩＬ－２腹腔灌注；２７例病人接受了ＩＬ－２瘤内注射。单用ＩＬ－２全身治疗的病人没有病例获得临床缓解，２３晚期肾癌接受了ＩＬ－２＋ＬＡＫ细胞治疗，５例获得部分缓解，有效率２２％：癌件胸水和腹水的有效率分别为６８％和６７％：ＩＬ－２瘤内注射的有效率为３０％。Ｔ４／Ｔ８比值、ＮＫ细胞活性和ＬＡＫ细胞活性在全身性ＩＬ－２治疗后均有显著升高，并有统计学意义。病人接受本试验所用的ＩＬ－剂量后的毒副反应主要为发热、畏寒或寒战、疲乏，全组病人均无发生严重低血压、液体潴留等毛细血管渗漏现象。

One hundred and fifty-nine patient with a variety of malignancieswere entered into this)phase II clinical trial. Twenty-five patients received systemicadministeration(intravenous or subcutaneous injection) of interleukin-2(IL-2) alone.Sixty patients received systemic administration of IL-2 and LAK cells. Forty-onepatients with malignant pleural effusions received intrapleural instillation of IL-2. Sixpatients with malignant ascites received intraperitoneal instillation of IL-2.T wenty--seven patients received IL-2 intratumoral injection. No response was observed in pa-tients with IL-2 systemic treatment alone.There were five partial responses among23 patiantets with metastatic renal cell cancer(22% response rate).The overallresponse rates for pleural effusions and peritoneal effusions were 68% and 67% respe- ctively. IL-2 intratumoral injection produced odjective tumor regression in 30% ofpatients. The percentage of OKT4 cells, OKT4/OKT8 ratio, NK activity,and LAKactivity increased significantly after systemic IL-2 therapy.Toxicities mainly included fever, chills and fatigue. No patients developed severe hypotension and fluid retention or capillary-leak syndrome.