title: Endostar combined with chemotherapy for treatment of metastatic colorectal and gastric cancer: a pilot study.
abstract: BACKGROUND
  Antiangiogenesis is a promising field of cancer therapy. Endostar, a novel recombinant human endostatin, is one of the few approved drugs acting as angiogenesis inhibitors of cancer in China. However, there are few clinical studies about Endostar in gastrointestinal cancer. This pilot study aimed to evaluate the efficacy and safety of the combination of Endostar and chemotherapy in patients with metastatic colorectal and gastric cancers.
  
  
  METHODS
  From March 2007 to October 2009, 23 patients were enrolled. Patients received Endostar intravenously at a dose of 15 mg daily from day 1 to 14 and day 1 to 7 when combined with 3- and 2-week chemotherapy regimens, respectively, which were determined according to patients' previous chemotherapy history. Treatment was repeated until disease progression, unacceptable toxicity or patients' refusal.
  
  
  RESULTS
  Seven, six and ten patients received Endostar as first-, second- and third-line therapy, respectively. A total of 75 cycles were administered. Twenty-one patients were assessable for responses. The overall response rate and disease control rate were 19.0% and 47.6%, respectively. All the four partial responses were among patients receiving Endostar as first-line therapy, whose response rate was 57.1%. The median time to progression and overall survival were 2.6 months (95%CI, 2.0 - 3.2 months) and 10.3 months (95%CI, 3.9 - 16.7 months), respectively. Toxicity was tolerable, with grade 3-4 toxicities observed for leucopenia (30.4%), neutropenia (34.8%), thrombocytopenia (17.4%) and anemia (13.0%). Three patients (13.0%) encountered transient sinus bradycardia with spontaneous remission.
  
  
  CONCLUSIONS
  Endostar combined with chemotherapy is well-tolerated in patients with metastatic colorectal and gastric cancers, and it is relatively effective as a first-line therapy.
authors.affiliation: Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
authors.forename: Jian-Feng
authors.initials: JF
authors.lastname: Zhou
authors.forename: Chun-Mei
authors.initials: CM
authors.lastname: Bai
authors.forename: Yu-Zhou
authors.initials: YZ
authors.lastname: Wang
authors.forename: Xiao-Yuan
authors.initials: XY
authors.lastname: Li
authors.forename: Yue-Juan
authors.initials: YJ
authors.lastname: Cheng
authors.forename: Shu-Chang
authors.initials: SC
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D043169:Endostatins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043169:Endostatins