重组人血管内皮抑素在非小细胞肺癌患者根治性手术后早期辅助治疗中的临床应用

Clinical Application of Rh-endostain in Early Postoperative Adjuvant Treatment of Non-small Cell Lung Cancer Patients

目的研究重组人血管内皮抑素(恩度)在非小细胞肺癌术后早期辅助治疗中的临床价值。方法 2007年10月至2009年3月在我科接受肺癌根治性手术后早期(术后8~9 d)恩度治疗的非小细胞肺癌(NSCLC)患者共38例,并与同期手术后3周开始单纯行辅助化疗的对照组37例患者相比较,观察两组患者5年的无疾病进展时间(PFS)、总的生存率(OS)等,以及不良反应。结果与对照组比较,恩度治疗组平均PFS延长了9.8个月(P<0.05),中位PFS延长了8.8个月(P<0.05)。在5年生存时间方面,恩度治疗组总生存率、平均生存时间、中位生存时间分别为47.4%、50.1个月、59.3个月,而对照组分别为29.7%、42.1个月、43.5个月,两组之间有显著性差异(P<0.05)。治疗组中仅有1例患者手术切口愈合不良,两组中其他患者均未发生支气管胸膜瘘、感染等不良事件。结论对于根治性手术切除的早、中期NSCLC患者,在术后早期辅助治疗中采用恩度和敏感含铂化疗药物联合治疗可显著提高患者的远期疗效。多靶点抗血管生成药物联合化疗药物用于NSCLC患者术后早期辅助治疗的处理策略,或将广泛应用于临床。

Objective To evaluate the clinical effect of rh-endostain （EndostarTM） in early adjuvant treatment of non-small cell lung cancer patients undergoing radical surgical treatment. Methods From October 2007 to March 2009, 38 patients with radical pneumonectomy and systemic lymph node resection received rh-endostain injection as early adjuvant treatment. As a control group, 37 patients simultaneously underwent radical resection, and only received adjuvant chemotherapy subsequently after operation 3 weeks. The clinical outcomes including progress-free survival （PFS）, overall survival（OS） as well as incidence of serious complications were compared between the two groups. Results Compared with control group, the average PFS and the median PFS in EndostarTM treatment group respectively prolonged for 9.8months and 8.8 months （P〈0.05）. There was significant difference in overall 5-year survival parameters between two groups, The 5-year overall survival rate,the average survival time and the median survival time in treatment group and control group were 47.4% VS 29.7%, 50.1months VS 42.1months and 59.3 months VS 43.5 months respectively（P〈0.05）. Only one patient in treatment group had poor healing of chest incision. The others in the two groups had no complications including bronchopleural fistula, infection and so on. Conclusions Compared with adjuvant chemotherapy after radical resection 3 weeks alone in early to moderate NSCLC patients, the addition of EndostarTM to adjuvant chemotherapy regimen results in significantly improvement in long-term effect. The therapeutic strategy of Multi-targeted antiangiogenic drug combined with adjuvant chemotherapy in NSCLC patients＇early adjuvant treatment after operation will be used widely in future：