重组人血管内皮抑制素YH-16联合用药治疗晚期非小细胞肺癌的多中心Ⅱ期临床试验

Rh-endostatin(YH-16) in combination with vinorelbine and cisplatin for advanced non-small cell lung cancer:a multicenter phase Ⅱ trial

目的:通过多中心Ⅱ期临床试验观察重组人血管内皮抑制素(YH-16)联合长春瑞滨(NVB)、顺铂(DDP)(NP方案)治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性。方法:入组晚期NSCLC病例54例,给予YH-16 7.5mg·m^(-2)(d1～14),NVB 25mg·m^(-2)(d1,8)以及DDP 30mg·m^(-2)(d2,3,4)。21d为1周期,共2～3周期。并以同期33例有相同特征并行NP方案治疗的患者作对照。观察两组的有效率、肿瘤进展时间(TTP)、生存质量(QOL)和不良反应。结果:试验组与对照组有效率分别为37.0%和24.2%(P>0.05);试验组中位TTP较单用NP组更长(分别为151d和100d,P=0.000)。最常见的3或4度不良反应包括白细胞降低(分别为25.9%和33.3%,P>0.05),中性粒细胞降低(分别为29.7%和39.4%,P>0.05),贫血(分别为7.4%和9.1%,P>0.05),恶心/呕吐(分别为3.7%和12.1%,P>0.05)。结论:YH-16联合NP方案与单用NP方案比较,有增加疗效和减低不良反应的趋势,值得进一步研究。

Objective: To evaluate the response rate, time to tumor progression (TTP), quality of life and toxicity with the combination of rh-endostatin (YH-16) and vinorelbine (NVB) plus cisplatin (DDP)(YH-16+NP) in patients with advanced non-small cell lung cancer (NSCLC). Methods: 54 patients with advanced NSCLC were administrated with YH-16 7.5mg·m^(-2)(day 1-14), NVB 25mg·m^(-2)(day 1 and 8) and DDP 30mg·m^(-2)(day 2, 3 and 4) every 21 days for two to three cycles. Additional 33 patients with advanced NSCLC treated with NVB and DDP in the same therapeutic cycles were used as control. Results: The treatment group showed a response rate of 37.0% versus control group of 24.2% (P>0.05). Patients receiving the triple therapy had median TTP of 151 days compared to 100 days in patients receiving bi-therapy (control)(P=0.000). The most common grade Ⅲ/Ⅳ adverse reactions in the triple therapy vs. control therapy were leucopenia (25.9% vs 33.3%, P>0.05), neutropenia (29.7% vs 39.4%, P>0.05), anemia (7.4% vs 9.1%, P>0.05) and nausea/vomiting (3.7% vs 12.1%, P>0.05). Conclusion: Significant efficacy and safety against NSCLC were observed in YH-16 in combination with vinorelbine and cisplatin compared with bi-therapy of vinorelbine and cisplatin. However, further clinical studies are apparent to assess actions of the triple therapy.