title: Phase II trial of capecitabine combined with thalidomide in second-line treatment of advanced pancreatic cancer.
abstract: BACKGROUND
  To evaluate the efficacy and tolerability of capecitabine combined with thalidomide in patients with advanced pancreatic cancer (APC) who have previously received gemcitabine-based therapy.
  
  
  METHODS
  A total of 31 patients were recruited prospectively in Shandong Tumor Hospital from May 2007 to April 2009. Capecitabine was offered to patients twice a day at a dose of 1250 mg/m(2) for 14-day then followed by 7-day rest. Thalidomide was administered 100 mg/day without interruption until disease progression or occurrence of unacceptable toxicity.
  
  
  RESULTS
  Two patients presented partial response (PR), 11 patients showed stable disease (SD) and eighteen patients presented progressive disease (PD). The median progression-free survival (PFS) was 2.7 months (95% confidence interval (CI), 2.4-3.3) and the median overall survival (OS) was 6.1 months (95% CI, 5.3-6.9). In the subgroup analysis, PFS had a significant difference between the serum CA19-9 level decreasing >25% and decreasing <25%, with 3.0 months (95% CI, 2.5-3.6) and 2.5 months (95% CI, 1.8-3.2), (Log Rank = 0.02), respectively. Hematological toxicity included leukocytopenia, anemia and neutropenia. Non-hematological toxicities included diarrhea, skin rash, nausea/vomiting, hand-foot syndrome, fatigue, dizziness, drowsiness and constipation.
  
  
  CONCLUSIONS
  Capecitabine combined with thalidomide is a well-tolerated second-line regimen, in patients with APC refractory to gemcitabine.
authors.affiliation: Department of Internal MedicineⅤ, Shang Dong Tumor Hospital, Jinan 250117, PR China.
authors.forename: Sheng-bin
authors.initials: SB
authors.lastname: Shi
authors.forename: Meng
authors.initials: M
authors.lastname: Wang
authors.forename: Zuo-xing
authors.initials: ZX
authors.lastname: Niu
authors.forename: Xiao-yong
authors.initials: XY
authors.lastname: Tang
authors.forename: Quan-yun
authors.initials: QY
authors.lastname: Liu
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D013792:Thalidomide; D000069287:Capecitabine; D005472:Fluorouracil