title: A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer.
abstract: OBJECTIVE
  This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.
  
  
  METHODS
  We enrolled 63 patients who received capecitabine 830 mg/m(2) orally twice daily on days 1-21 plus gemcitabine 1000 mg/m(2) as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles.
  
  
  RESULTS
  A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent.
  
  
  CONCLUSIONS
  The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.
authors.affiliation: Division of Hematooncology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Dongsan-Dong, Chung-Gu, Daegu 200-712, South Korea. shs7436@dsmc.or.kr
authors.forename: Hong Suk
authors.initials: HS
authors.lastname: Song
authors.forename: Young Rok
authors.initials: YR
authors.lastname: Do
authors.forename: Heung Moon
authors.initials: HM
authors.lastname: Chang
authors.forename: Min Hee
authors.initials: MH
authors.lastname: Ryu
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Yeul Hong
authors.initials: YH
authors.lastname: Kim
authors.forename: Dae Sik
authors.initials: DS
authors.lastname: Hong
authors.forename: Jae Yong
authors.initials: JY
authors.lastname: Cho
authors.forename: Kyoung Eun
authors.initials: KE
authors.lastname: Lee
authors.forename: Si Young
authors.initials: SY
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010349:Patient Compliance; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine