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
ZHOU Qi-chao*,BAO Yong, YU Zhong-hua, LI Jian-cheng, CHENG Zhi-bin, CHEN Long, HU Xiao, WANG Yan, WANG Jin, PENG Fang, XU Zu-min, MA Hong-lian, LU Ru-biao, CHEN Ming, DENG Xiao-wu
*Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China,Guangzhou 510060, China
Corresponding author:CHEN Ming, Department of Radiation Oncology,Zhejiang Tumor Hospital,Hongzhou 310022,China; Email:chenming@sysucc.org.cn;DENG Xiao-wu, Email:dengxw@sysucc.org.cn
Objective To evaluate the efficacy and safety 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 three-dimensional 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 not 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.
ZHOU Qi-chao*,BAO Yong,YU Zhong-hua et al. 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[J]. Chinese Journal of Radiation Oncology, 2012, 21(6): 500-503.
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