A Phase Ⅱ Study of Endostatin in Combination with Paclitaxel, Carboplatin, and Radiotherapy in Patie

来源 :2014华东胸部肿瘤论坛暨第七届浙江省胸部肿瘤论坛 | 被引量 : 0次 | 上传用户:conansmh
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  [Purpose] The aim of this phase Ⅱ study was to determine the efficacy and feasibility of incorporating Endostatin into concurrent chemoradiation (CRT) for unresectable locally advanced non-small cell lung cancer (NSCLC).[Patients and Methods] Patients with unresectable stage Ⅲ1 NSCLC,performance status 0~1, and adequate organ function were accrued in this study.Patients received thoracic radiation therapy 60~66 Gy over 30~33 fractions and concurrent with Endostatin 7.5mg/m2 over 3 hours d1-14,Paclitaxel 50mg/m2 weekly over 1 hour,Carboplatin AUC=2 mg/mL/min over 30 min weekly.Followed by Endostatin 7.5mg/m2 d1-14, Paclitaxel 175mg/m2 d1 and Carboplatin AUC=5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.Objective response rate according to the RECIST criteria was recorded and toxicity was evaluated using the NCI Common Toxicity Criteria.[Results] Nineteen eligible patients (including 16 squamous,3 adenosquamous) enrolled in the study received concurrent Endostar,paclitaxel/carboplatin and definitive thoracic radiation therapy (CRT).Six patients were unable to complete the followed consolidation treatment (Four because of pulmonary toxicity,one because of tracheoesophageal fistulae, and one because of progressive disease).Seventeen patients were included in the analysis of response.One patient (5.9%) had a complete response, 13 patients (70.6%) had a partial response,while 2 patients disease remained stable and 2 patient had progression of the disease.The overall response rate (76% ,95%confidence interval (CI):51%~97%) didnt exceed the goal per study design (85.0%),and the toxicity analysis after 10 patients had completed treatment indicated four patients had at least grade 111 pulmonary toxicity.Therefore, the study was closed according to the protocol definition.The median progression-free survival (PFS) was 10.0 months (95%CI: 7.6~12.3 months) , and the median overall survival (OS) was 14.0 months (95%CI:10.7~17.2 months).[Conclusion] Endostatin could not be successfully integrated into CRT for unresectable locally advanced NSCLC.Endostatin likely enhances radiation pneumonitis.The impact of Endostatin on survival as a first-line treatment in combination with radiochemotherapy remains to be determined.(NCT01158144)
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