Endostar, an Anti-angiogenesis Inhibitor, Combined with Chemoradiotherapy for Locally Advanced Cervical Cancer.

This phase II randomized clinical trial aimed to assess the efficacy and toxicity of Endostar, an anti-angiogenesis inhibitor, combined with concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC). Patients with LACC were randomly assigned to either CCRT plus Endostar(CCRT+E arm) or CCRT alone (CCRT arm). All patients received pelvic intensity-modulated radiation therapy (IMRT)and brachytherapy. Weekly cisplatin was administered concurrently with IMRT. Patients in the CCRT+E arm also received concurrent Endostar every 3 weeks for 2 cycles. The primary endpoint was progression-free survival (PFS) and acute toxicities. The exploratory endpoint was the impact of vascular endothelial growth factor receptor-2 (VEGFR2) expression on long-term survival. A total of 116patientswere enrolled. Patients in the CCRT+E arm and in the CCRT arm had similar acute and late toxicity profile. The 1-and 2-year PFS were 91.4% vs. 82.1% and 80.8% vs. 63.5%（p=0.091）, respectively. The1-and 2-year distance metastasis-free survival （DMFS）were92.7% vs. 81.1% and 86.0% vs. 65.1%（p=0.031）, respectively. Patients with positive VEGFR2 expression had significant longer PFS and overall survival (OS), compared with those with negative VEGFR2 expression. Patients in the CCRT+E arm had significantly longer PFS, OS, and DMFS than those in the CCRT arm whenVEGFR2 expression was positive. In conclusion, CCRT plus Endostar significantly improved DMFS but not PFS over CCRT alone. The addition of Endostar could significantly improve survival for patients with positive VEGFR2 expression.