A prospective phase Ⅰ / Ⅱ study of recombinant endostatin (Endostar) combined with concurrent radio-chemotherapy in patients with unresectable stage Ⅲ non-small cell lung cancer / 中华放射肿瘤学杂志

ABSTRACT

Objective To evaluatc the efficacy and safcty of recombinant endostatin (Endostar)combined with concurrent radio-chemotherapy (CRCT) in patients with unresectable stage Ⅲ non-small cell lung cancer (NSCLC).Methods From March 2009 to November 2011,47 patients received threedimensional conformal radiotherapy of 60-66 Gy in 30-33 fractions over 6-7 weeks And concurrent chemotherapy of docetaxel 65 mg/m2 and cisplatin 65 mg/m2.Endostar was administered once a week before and on week 2,4,6 during CRCT at a dose level of 7.5 mg/m2/d.Tumor response was evaluated with thoracic CT scans performed 4 weeks after completion of treatment in accordance with RECIST 1.1 criteria.Acute toxicities were evaluated in accordance with CTCAE 3.0.Results Forty-four patients completed treatment and toxicity evaluation,42 patients completed evaluation of efficacy.Five patients achieved complete response,29 partial response,3 stable disease,and 5 progressive disease,2 were net assessed.Overall response rate was 77％.One-year overall survival rate was 81％,and one-year progression-free survival rate was 51％.Twelve patients died,2 died of treatment related toxicities,8 of cancer,and 2 of unknown causes.Nineteen patients developed grade 3/4 neutrocytopenia,grade 3 acute esophagitis and pneumonitis were observed in 4 and 4 patients,respectively,and 1 patient died of pneumonitis.No patient developed cardiovascular toxicities and hemorrhage.Conclusions Endostar combined with CRCT for unresectable stage Ⅲ NSCLC was safe and the short term outcomes were promising.Further investigations are warranted.