Recombinant human endostatin combined with navelbine and cisplatin in first line treatment of advanced non-small cell lung cancer / 肿瘤

ABSTRACT

Objective: To investigate the short-term efficacy and safety of recombinant human endostatin YH-16 combined with navelbine and cisplatin in the first line treatment of advanced non-small cell lung cancer (NSCLC) and its effect on the survival. Methods: Eighty patients with advanced NSCLC were recruited from May, 2007 and May, 2010, and they were randomly divided into study group (n=40, treated with YH-16 combined with navelbine and cisplatin) and conrol group (n=40, treated with navelbine plus cisplatin). The short-term efficacy and adverse effects were evaluated every six weeks (one chemotherapy cycle was given every 3 weeks). The survival was calculated. Results: Thirty-nine patients in the study group and 36 patients in the control group were evaluable. The stable disease rate in the study group was higher than that in the control group (53.8% vs 27.8%, χ2=5.25, P=0.022), and the clinical benefit rate was also higher (76.9% vs 55.6%, χ2=3.85, P=0.050). The progressive disease rate in the study group was lower than that in the control group (23.1% vs 44.4%, χ2=3.85, P=0.050). There were no significantly differences in time to progression and overall survival between the two groups (P>0.05). Most adverse effects were hematologic toxicities and digestive reactions, and the incidence rate was not significantly different between the two groups. The incidence rate of abnormal electrocardiogram in asymptomatic person was higher in the study group than that in the control group (χ2=16.27, P=0.001). Conclusion: YH-16 combined with navelbine and cisplatin as the first line treatment for advanced NSCLC can improve the stable disease rate, and the clinical benefit rate, decrease the progressive disease rate, and increase the rate, of cardiac electrophysiological abnormality, but the overall safety is acceptable.