Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer
2015
Abstract 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 (7.5mg/m 2 /d) for 7days at weeks 1, 3, 5, and 7, while two cycles of docetaxel (65mg/m 2 ) and cisplatin (65mg/m 2 ) were administered on days 8 and 36, with concurrent thoracic radiation to a dose of 60–66Gy. 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 25.0months. Overall response rate was 77%. The estimated median progression-free survival (PFS) was 9.9months, and the estimated median overall survival (OS) was 24.0months. 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.
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