title: Phase II study of cisplatin/etoposide and endostar for extensive-stage small-cell lung cancer.
abstract: OBJECTIVE
  To investigate the efficacy and safety of endostar, a novel recombinant human endostatin, plus cisplatin, and etoposide in patients with extensive-stage small-cell lung cancer (ED-SCLC).
  
  
  METHODS
  Chemotherapy-naïve patients with histologically confirmed, measurable ED-SCLC were enrolled. Treatment consisted of cisplatin (25 mg/m(2)) administered intravenously (IV) on days 1-3; etoposide (120 mg/m(2)) administered intravenously (IV) on days 1-3; endostar (15 mg) administered intravenously (IV) on days 1-14 every 21 days for up to four cycles. The primary objective was to assess the progression-free survival (FPS). Secondary objectives were to assess the objective response rate, median overall survival (OS), and treatment-related toxicity.
  
  
  RESULTS
  Thirty-three patients were enrolled, the median age of the patients was 53 years (range, 29-74), twenty-three patients (69.7%) were men and 10 patients were women. Eastern Cooperative Oncology Group performance status scores were 0, 1,and 2 in 30.3, 60.6, and 9.1% of the patients, respectively. The overall response rate was 69.7%, one patient (3%) had a complete response, and 22 patients (66.7%) had partial responses. Five patients (15.1%) had stable disease; the median PFS was 5.0 months (95% CI, 4.2-5.6 months), and the 6-month PFS was 33.3%. The median OS was 11.5 months (95% CI, 9.6-13.4 months), and the 1-year OS was 38.1% (95% CI, 26-50.1%). Sixteen patients (48.5%) had at least one grade 3/4 adverse events; the most common grade 3/4 hematologic toxicity included neutropenia in 57.6%, thrombocytopenia in 12.1% of patients. The most common grade 3/4 non-hematologic toxicities included fatigue in 15.2%, nausea/vomiting in 9.1%, diarrhea in 6.1%, anorexia in 6.1%, mucositis in 6.1% of patients.
  
  
  CONCLUSIONS
  The addition of rh-endostain to cisplatin and etoposide in patients with ED-SCLC results in slightly improved PFS and OS relative to historical controls who received this chemotherapy regimen alone. This regimen appears to be well tolerated; the promising results suggest the further randomized phase III trial to define endostar's impact on SCLC treatment.
authors.affiliation: Department of Medical and Radiation Oncology, Zhongnan Hospital of Wuhan University, 430071, Wuhan, China.
authors.forename: Zheng-tao
authors.initials: ZT
authors.lastname: Zhou
authors.forename: Fu-xiang
authors.initials: FX
authors.lastname: Zhou
authors.forename: Qing
authors.initials: Q
authors.lastname: Wei
authors.forename: Li-yong
authors.initials: LY
authors.lastname: Zou
authors.forename: Bin-fang
authors.initials: BF
authors.lastname: Qin
authors.forename: Xu-shen
authors.initials: XS
authors.lastname: Peng
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D043169:Endostatins / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011994:Recombinant Proteins; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D043169:Endostatins; D011994:Recombinant Proteins; D005047:Etoposide; C522911:endostar protein; D002945:Cisplatin