title: A phase II study of Endostatin in combination with paclitaxel, carboplatin, and radiotherapy in patients with unresectable locally advanced non-small cell lung cancer.
abstract: BACKGROUND
  Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in different human cancers. This study assessed the efficacy of endostatin combined with concurrent chemoradiotherapy of non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Nineteen patients with unresectable stage III NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-l, and adequate organ function were treated with 60-66 Gy thoracic radiation therapy over 30-33 fractions concurrent with weekly 7.5 mg/m(2) endostatin for 14 days, 50 mg/m(2) paclitaxel, and 2 mg/mL/min carboplatin over 30 min. Patients were then treated with 7.5 mg/m(2) endostatin for 14 days, 150 mg/m(2) paclitaxel, and 5 mg/mL/min carboplatin every 3 weeks for 2 cycles as the consolidation treatment. The objective response rate was recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and the toxicity was evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria.
  
  
  RESULTS
  Six patients were unable to complete the consolidation treatment (4 pulmonary toxicity, 1 tracheoesophageal fistulae, and 1 progressive disease). Seventeen patients were included for data analysis. Specifically, one (5.9%) patient had a complete response and 12 (70.6%) had a partial response, whereas two patients had stable disease and the other two had disease progression. The overall response rate was 76% (95% confidence interval [CI], 51%-97%). The median progression-free survival was 10 months (95% CI, 7.6-12.3 months), and the median overall survival was 14 months (95% CI, 10.7-17.2 months). Early 10 patients who completed the treatment regimen showed that four patients experienced grade III pulmonary toxicity a few months after chemoradiotherapy, leading to the early closure of the trial according to the study design.
  
  
  CONCLUSIONS
  The result of concurrent endostatin treatment with chemoradiotherapy in locally advanced unresectable NSCLC did not meet the goal per study design with unacceptable toxicity. The real impact of endostatin as the first-line treatment combined with chemoradiotherapy on the survival of NSCLC patients remains to be determined. (NCT 01158144).
authors.affiliation: Departments of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guangji Road, Hangzhou, 310022, China.
authors.forename: Xiao-Jiang
authors.initials: XJ
authors.lastname: Sun
authors.affiliation: Departments of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, 310002, China.
authors.forename: Qing-Hua
authors.initials: QH
authors.lastname: Deng
authors.affiliation: Departments of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
authors.forename: Xin-Min
authors.initials: XM
authors.lastname: Yu
authors.affiliation: Departments of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guangji Road, Hangzhou, 310022, China.
authors.forename: Yong-Lin
authors.initials: YL
authors.lastname: Ji
authors.affiliation: Departments of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guangji Road, Hangzhou, 310022, China.
authors.forename: Yuan-Da
authors.initials: YD
authors.lastname: Zheng
authors.affiliation: Departments of Medical Oncology, Zhejiang Hospital, Hangzhou, 310013, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Departments of Radiation Oncology, Zhejiang Cancer Hospital, 38 Guangji Road, Hangzhou, 310022, China. xuyaping1207@163.com.
authors.forename: Ya-Ping
authors.initials: YP
authors.lastname: Xu
authors.affiliation: Departments of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, 310002, China. mashenglin@gmail.com.
authors.forename: Sheng-Lin
authors.initials: SL
authors.lastname: Ma
mesh_terms: D000328:Adult; D000368:Aged; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D043169:Endostatins / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D012074:Remission Induction
chemical_list: D043169:Endostatins; D016190:Carboplatin; D017239:Paclitaxel
keywords: Clinical trial; Concurrent chemoradiotherapy; Endostatin; NSCLC