IN VITRO DRUG TESTING FOR LIMITED SCLC AND PHASE I DRUG DEVELOPMENT

一天两次放射治疗加VP 16和 顺铂治疗局限性小细胞肺癌仍在继续。 已有18名患者进入研究，14名患者中有13名 完成治疗的患者达到了完全的 减刑。18名患者中有14人还活着，没有癌症或 接受诱导治疗，中位随访时间10个月。 目前还没有患者因联合治疗而住院 肺炎。 一项使用二羟苯丙酮的I期试验，一种被确认为 人肿瘤集落形成对人肺癌的抗肿瘤活性 检测(HTCFA)已经启动。已经有23名患者被 在6个剂量水平下进行研究。主要的副作用是 所有患者均有嗜睡和低血压。已经有两名患者 因为嗜睡而停止治疗，而不是因为 低血压。初步药动学测定显示峰值 在3小时内吸收，该水平在以下时间内变化小于50% 给药间隔12小时。 从这些研究中我们得出结论，HTCFA已经确定了一个 具有新的副作用和最大耐受量的化合物 未联系到。

A protocol combining twice a day radiotherapy-plus VP 16 and cisplatin for limited stage small cell lung cancer continues. Eighteen patients have been entered onto study and 13 of 14 patients who have completed therapy have achieved a complete remission. 14 of 18 patients are alive and free of cancer or undergoing induction therapy with a median follow up of 10 months. No patients have been hospitalized for combined modality pneumonitis. A phase I trial using dihdrolenperone, an agent identified as being active against human lung cancer by the human tumor colony forming assay (HTCFA) has been initiated. Twenty-three patients have been studied at 6 dosage levels. The principle side effects have been somnolence and hypotension in all patients. Two patients have had to stop therapy because of somnolence and none because of hypotension. Preliminary pharmacokinetic determinations show peak absorption at 3 hours and that level vary less than 50% over the 12 hours dosing interval. From these studies we conclude that the HTCFA has identified a compound with novel side effects and the maximum tolerated dose has not been reached.