重组人血管内皮抑素联合化疗治疗肺外中晚期恶性肿瘤的临床研究

Clinical study of endostar combined with chemotherapy for the multiple kind of advanced malignancies except lung cancer

目的评价重组人血管内皮抑素(恩度Endostar,-16)联合化疗治疗肺外中晚期恶性肿瘤的疗效及安全性。方法经病理或细胞学证实的肺外中晚期恶性肿瘤82例,其中研究组41例,接受恩度联合常规方案化疗(恩度15 mg/d,静滴4h,1～14d,间歇7 d重复,21d为1个周期);对照组41例,单纯接受常规方案化疗。2组至少用2个周期后进行近期疗效、临床受益率、疾病进展时间、生存率和生活质量,毒副反应的比较和评价。结果研究组41例中有40例可以评价客观疗效,对照组41例均可评价。研究组和对照组有效率分别为30.00%(12/40)和9.76%(4/41,P=0.02),临床受益率分别为72.50(29/40)和36.60%(15/41,P=0.04),疾病进展时间分别为7.63月和4.76个月(P=0.00),1年生存率分别为80.00%(32/40)和68.29%(28/41,P=0.23),2年生存率分别为25.00%(10/40)和9.76%(4/41,P=0.07),生活质量(QOL)改善稳定率分别为80.00%(32/40)和51.22%(21/41,P=0.006)。2组毒副反应相似,主要为骨髓抑制和恶心、呕吐,多为Ⅰ～Ⅱ度。结论重组人血管内皮抑素联合化疗,具有良好的临床疗效,与化疗药物有协同作用,可改善肺外中晚期恶性肿瘤患者的生活质量,提高局部控制率,延长疾病进展时间,且毒性低、安全性好,具有较好的临床应用前景。

Objective To evaluation the efficacy and toxicity endostar combination chemotherapy for advanced malignancies except lung. Methods 82 patients of advanced malignancies except lung identified by pathological or cytology. 41 cases accepted endostar combination chemotherapy; and the half cases accept normal scheme chemotherapy. After 2 cycles compared the short - term effects, time of disease progress, one year survival and quality of life, side effects were evaluated between two groups. Results Clinical curative effect, and side effects as neutropenia, nausea and vomiting were evaluated in 40 patients of trial group and all patients of control group. The trial group efficacy rate （RR）were 30.00% while the control group were 9.76% （P = 0.02 ） ; The clinical benefit rate were 72.50% in the trial group and 36.60% in the control group （P = 0.04） ; The time of disease progression（TIP） were 7.63 months and 4.76 months in trial group and in the control group, respectively （P = 0.00 ）. 1 year survival rates were 80, 00% and 68.29% （P = 0.23 ） and 2 year survival rates were 25.00% and 9.76% （ P = 0.07 ） in two groups. The quality of life （QOL） improve rate were 80% and 51.22% in two groups （ P = 0. 006）. The main side - effect was bone marrow suppression and nausea, vomiting, were both inI - lldegrees. Conclusion Endostar combination chemotherapy can improve the quality of life for advanced malignancies except lung.