Shi Heling, Xu Liyan, Liu Zhe
Department of Medical Oncology, Beijing Tuberculosis and Thoracic Tumor Hospital, Beijing 101149, P.R.China.
Zhongguo Fei Ai Za Zhi. 2004 Aug 20;7(4):325-8. doi: 10.3779/j.issn.1009-3419.2004.04.13.
To evaluate the efficacy and safety of homemade human rh-endostatin (YH-16) combined with NP regimen (vinorelbine+cisplatin) for stage IIIB-IV non small cell lung cancer (NSCLC), and to compare with NP regimen alone.
Eighteen NSCLC patients were divided into two groups. Group A ( n =9) received YH-16 combined with NP plan. Group B ( n =9) received NP regimen. They were treated with 2 or 3 cycles of chemotherapy. The overall response, time to progression (TTP), quality of life (QOL) and safety were observed.
The overall response was 22.2% in group A, and 0% in group B ( P > 0.05). The clinical benefit rate was 100% in group A, and 44.4% in group B ( P < 0.05). There was no significant relationship between response and clinical pathological characteristics of patients ( P > 0.05). The TTP was 178.8±70.8 days in group A and 85.4±48.2 days in group B ( P < 0.05). The main toxicities of the two groups were hematological toxicities, nausea and vomiting. No significant difference in incidence of toxicity was observed between the two groups ( P > 0.05).
The rh-endostatin combined with NP regimen for NSCLC tends to show a better chemotherapeutic effect and less toxicity than NP regimen alone. It is worthy of extensive clinical trial.
评估国产重组人血管内皮抑素（YH-16）联合NP方案（长春瑞滨+顺铂）治疗ⅢB-Ⅳ期非小细胞肺癌（NSCLC）的疗效及安全性，并与单纯NP方案进行比较。
将18例NSCLC患者分为两组。A组（n = 9）接受YH-16联合NP方案治疗。B组（n = 9）接受NP方案治疗。两组均进行2或3个周期的化疗。观察两组的总缓解率、疾病进展时间（TTP）、生活质量（QOL）及安全性。
A组总缓解率为22.2%，B组为0%（P>0.05）。A组临床受益率为100%，B组为44.4%（P<0.05）。缓解率与患者临床病理特征之间无显著相关性（P>0.05）。A组TTP为178.8±70.8天，B组为85.4±48.2天（P<0.05）。两组主要毒性反应为血液学毒性、恶心和呕吐。两组毒性发生率无显著差异（P>0.05）。
重组人血管内皮抑素联合NP方案治疗NSCLC较单纯NP方案化疗效果更好且毒性更小，值得进行广泛的临床试验。
