重组人血管内皮抑制素YH-16治疗晚期非小细胞肺癌的临床研究

目的评价重组人血管内皮抑制素YH-16治疗复治的晚期非小细胞肺癌的有效率、肿瘤进展时间（TTP）、对生活质量的影响及不良反应,并为临床确定合适的用药剂量。方法本研究为随机对照多中心试验。患者随机分为7．5mg／m^2或15mg／m^2两个剂量组,均采用静脉滴注YH-163h,每天1次,连续给药28d。结果共入组68例,可评价疗效的患者60例。7．5mg／m^2剂量组和15mg／m^2剂量组有效率均为3．0％（P〉0．05）;中位TTP在意向治疗（ITT）人群分别为60d和71d（P〉0．05）,对生活质量的影响以及不良事件发生率分别为48．6％和38．7％（P〉0．05）。无预期以外的不良事件发生。结论YH-16对多程化疗后复发的非小细胞肺癌显示出一定的抗肿瘤活性,安全性较好,临床受益率高;建议采用7．5mg／m^2作为临床常规使用剂量。

Randomized phase II trial on escalated doses of Rh-endostatin (YH-16) for advanced non-small cell lung cancer

OBJECTIVE: To investigate the response rate (RR), time to tumor progression (TTP), quality of life (QOL) and adverse reaction in the treatment of pretreated advanced non-small cell lung cancer (NSCLC) using escalated doses of rh-endostatin (YH-16), and to determine the optimal dose for clinical application. METHODS: In this phase II randomized, controlled, multicenter trial, the patients were randomly divided into two groups to receive daily 3 hours intravenous infusion of either 7.5 mg x m(-2) or 15 mg/m(2) YH-16 for 28 days. RESULTS: Totally, 68 patients were entered and 60 patients were evaluable. There were no differences in RR (3.0% in both groups, P > 0.05), median TTP (ITT: 60 days versus 71 days, P > 0.05), QOL and incidence rate of adverse reactions (48.6% versus 38.7%, P > 0.05). No significant unexpected adverse events were observed. CONCLUSION: Rh-endostatin may have anti-tumor activity with high clinical benefit rate and is well tolerated in pretreated advanced NSCLC patients. The dose of 7.5 mg x (m(2))(-1) x d(-1) is clinically recommended.