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

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

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/m2或15mg/m2两个剂量组,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/m2剂量组和15mg/m2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/m2作为临床常规使用剂量。

Objective To investigate the response rate （RR）, time to tumor progression （TIP）, 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, muhicenter trial, the patients were randomly divided into two groups to receive daily 3 hours intravenous infusion of either 7.5 mg·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 TIP （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·（ m^2 ） -1 . d^-1 is clinically recommended.