Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer

Purpose: The objective of this study was to evaluate the efficacy and safety of Endostar combined with concurrent chemoradiotherapy (CCRT) in patients with stage III non-small-cell lung cancer (NSCLC). Methods: Patients with unresectable stage III NSCLC were treated with Endostar (7.5 mg/m²/d) for 7 days at weeks 1, 3, 5, and 7, while two cycles of docetaxel (65 mg/m²) and cisplatin (65 mg/m²) were administered on days 8 and 36, with concurrent thoracic radiation to a dose of 60–66 Gy. Primary end points were short-term efficacy and treatment-related toxicity. Results: Fifty patients were enrolled into the study, and 48 were assessable. Of the 48 patients, 83% had stage IIIB and 65% had N3 disease. Median follow-up was 25.0 months. Overall response rate was 77%. The estimated median progression-free survival (PFS) was 9.9 months, and the estimated median overall survival (OS) was 24.0 months. The 1-, 2-, and 3-year local control rates were 75%, 67%, and 51%, PFS rates were 48%, 27%, and 16%, and OS rates were 81%, 50%, and 30%, respectively. All toxicities were tolerable with proper treatment. Conclusions: The combination of Endostar with CCRT for locally advanced NSCLC patients was feasible and showed promising survival and local control rates