Results of phase IV clinical trial of combining endostar with chemotherapy for treatment of advanced non-small cell lung cancer (NSCLC).

Abstract

7598 Background: In order to further explore the efficacy of Endostar in combination with other standard chemotherapy in the management of advanced NSCLC as well as prognostic factors in advanced NSCLC, we conducted a multicentre phase IV clinical trial with combination of Endostar and chemotherapy. Methods: This trial was an open, multi-center clinical trial. All patients were diagnosed clinically and pathologically with advanced NSCLC. After enrollment, patients would be administered with standard chemotherapy and Endostar as treatment. Specific chemotherapy depends on the investigator's decision, but chemotherapy regimens remain standard chemotherapy as recommended by NCCN guideline for advanced NSCLC. Efficacy was evaluated after every 2 cycles of treatment. If there is any objective evidence of disease progression during the trial, the trial for this patient should be terminated immediately. The primary endpoint of this trial is overall survival (OS). In the first 6 months, follow-up was conducted every 2 months, subsequently every 4 months until death. Patients who did not have exact date of death were considered to be censored on the date of last follow-up confirming patients alive. Results: A total of 2,725 subjects were enrolled in this trial, and 1,219 subjects had died up to Oct. 15, 2009. The survival analysis showed that MST was 17.57 months, 1-year survival rate was 63.68%, 2-year survival rate was 39.79%, and median TTP was 7.37 months. Objective response rate (ORR) was 23.93%, and disease control rate (DCR) was 76.07%. There is no significant difference in the survival prognosis among combined regimens of Endostar and different standard chemotherapies. The primary clinical survival prognosis factors of advanced NSCLC are initial and retreatment, with or without distant metastasis, performance status, pathology and gender. Conclusions: Combined Endostar and standard chemotherapy regimens could improve the median survival time and overall survival rate of patients with advanced NSCLC, and there is no significant increase of the adverse effects of chemotherapy. The results of phase III and IV clinical trials were comparable. No significant financial relationships to disclose.