Recombinant human endostatin combined with TP regimen as postoperative adjuvant treatment for non-small-cell lung cancer: Efficacy analysis / 解放军医学杂志

ABSTRACT

Objective To evaluate the mid-term and long-term efficacy of recombinant human endostatin (rh-endostatin, EndostarTM) in combination with docetaxel and carboplatin (TP) regimen as a postoperative adjuvant treatment for non-small-cell lung cancer (NSCLC). Methods A randomized controlled trial was conducted in 76 patients who were admitted from October 2006 to July 2008. These patients were diagnosed with NSCLC and experienced complete excision. They were randomly divided into two groups (n=38) Endostar™ plus TP regimen was adopted for the treatment group, while only the TP regimen was used for the control group. After 40 months of postoperative followup, the difference in disease-free survival (DFS) and overall survival (OS) between the two groups was evaluated, and the number of circulating endothelial cells (CECs) and tumor microvessel density (MVD) were measured. Results DFS was significantly longer in the treatment group than in the control group (39.4 months versus 27.6 months, P<0.05). The three-year OS rate of the treatment group was significantly higher than that of the control group (89.4% versus 57.9%, P<0.05). The CECs decreased in both groups after the treatment, while the decline in the treatment group was more significant compared with the control group after four cycles of chemotherapy (P<0.05). There was a significant difference in the MVD between stages I, II, and III (P<0.05). The MVD in the patients with positive lymph nodes was significantly higher than that in the patients with negative lymph nodes. The MVD in poor differentiation was higher than that in moderate/good differentiation (P<0.05). Conclusions By comparing with the simple chemotherapy treatment, EndostarTM plus TP regimen as an adjuvant treatment was able to prolong the DFS and improve the three-year OS rate of NSCLC patients. CEC is a good indicator for predicting the efficacy of chemotherapy plus anti-angiogenesis treatment.