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
10.3760/cma.j.issn.1004-4221.2012.06.005
- VernacularTitle:不可手术切除Ⅲ期非小细胞肺癌恩度联合同期放化疗多中心Ⅰ+Ⅱ期临床试验
- Author:
Qichao ZHOU
;
Yong BAO
;
Zhonghua YU
;
Jiancheng LI
;
Zhibin CHENG
;
Long CHEN
;
Xiao HU
;
Yan WANG
;
Jin WANG
;
Fang PENG
;
Zumin XU
;
Honglian MA
;
Rubiao LU
;
Ming CHEN
;
Xiaowu DENG
- Publication Type:Journal Article
- Keywords:
Carcinoma,non-small cell lung/radio-chemotherapy;
Endostar;
Prognosis
- From:
Chinese Journal of Radiation Oncology
2012;(6):500-503
- CountryChina
- Language:Chinese
-
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.
