title: A phase II trial of gemcitabine plus capecitabine for patients with advanced pancreatic adenocarcinoma.
abstract: OBJECTIVE
  While gemcitabine (GEM) is widely accepted for the treatment of advanced pancreatic cancer, capecitabine (CAP) has shown single agent activity and promising efficacy in combination with GEM. This phase II study was conducted to evaluate the efficacy and toxicity of GEM combined with dose escalated 14-day CAP as first-line chemotherapy for advanced pancreatic cancer. In addition, we also analyzed the correlation between CA19-9 response and clinical outcomes.
  
  
  METHODS
  Patients had advanced pancreatic adenocarcinoma, no prior systemic chemotherapy other than that given concurrently with radiation therapy, at lease one measurable disease, and adequate organ functions. The patients were treated with GEM 1,000 mg/m2 IV on days 1, 8 and CAP 1,000 mg/m2 twice a day PO on days 1-14, in 21-day cycles.
  
  
  RESULTS
  The objective RR among 45 patients was 40.0% (95% CI; 25.1-54.9), including 1CR (2.2%). The median TTP and OS were 5.4 months (95% CI; 1.8-9.0) and 10.4 months (95% CI; 6.2-14.5), respectively. Patients with >or=25% decline of serum CA19-9 had significantly better outcomes in terms of TTP and OS than those who did not (P < 0.03). The most frequent, grade 3-4, non-hematologic toxicity was hand-foot syndrome (6.7%).
  
  
  CONCLUSIONS
  The combination of GEM with dose escalated 14-day CAP is well tolerated and offers encouraging activity in the treatment of advanced pancreatic cancer. In addition, CA19-9 response correlates well with clinical outcomes in this population.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Kangnam-Gu, Seoul 135-710, South Korea.
authors.forename: Byeong-Bae
authors.initials: BB
authors.lastname: Park
authors.forename: Joon Oh
authors.initials: JO
authors.lastname: Park
authors.forename: Hyo Rak
authors.initials: HR
authors.lastname: Lee
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Dong Wook
authors.initials: DW
authors.lastname: Choi
authors.forename: Seong-Ho
authors.initials: SH
authors.lastname: Choi
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Heo
authors.forename: Jong Kyun
authors.initials: JK
authors.lastname: Lee
authors.forename: Kyu Taek
authors.initials: KT
authors.lastname: Lee
authors.forename: Do Hoon
authors.initials: DH
authors.lastname: Lim
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Ho-Yeong
authors.initials: HY
authors.lastname: Lim
authors.forename: Won Ki
authors.initials: WK
authors.lastname: Kang
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D014408:Biomarkers, Tumor / Q000032:analysis; D018395:CA-19-9 Antigen / Q000032:analysis; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D011379:Prognosis; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine