Endostar in combination with postoperative adjuvant chemotherapy prolongs the disease free survival of stage IIIA NSCLC patients with high VEGF expression

Abstract

Purpose: The aim of this study is to compare the therapeutic effect between endostar plus adjuvant chemotherapy and adjuvant chemotherapy alone in the patients with completely resected non-small cell lung cancer (NSCLC) at stage IB to IIIA. Experimental Design: This is an open, multicenter, randomized (1:1) study with 250 NSCLC patients. Completely resected NSCLC patients at stages IB to IIIA were randomized to receive adjuvant NP plus endostar (Vinorelbine 25 mg/m2 on day 1 and day 8 plus Cisplatin 75 mg/m2 on day 1, and plus endostar 7.5 mg/m2 per day iv for consecutive 14 days) or NP regimen alone. Every 21 days were set as one cycle for 4 cycles. The primary endpoint was disease-free survival (DFS). Secondary endpoints included tumor response rate, overall survival and safety. Results: The two groups had no significant difference in the incidence of toxicity reaction. Endostar plus NP prolonged the DFS of patients with completely resected NSCLC at stage IIIA (19.33±3.73 vs 17.10±9.68 months) but with no statistical difference compared to NP alone. In the endostar plus NP group, those cases with high expression of vascular endothelial growth factor (VEGF) showed a significantly better DFS than those with low VEGF expression (48.45±3.52 vs 40.18±4.54 months, P<0.05). Conclusions: Vascular targeted therapy with endostar plus NP prolongs the DFS of patients with complete resectable NSCLC in stage IIIA and significantly extends the DFS of NSCLC patients with high VEGF expression, but does not show benefits in OS for stage IB−IIIA.