title: CA 19-9 as a biomarker in advanced pancreatic cancer patients randomised to gemcitabine plus axitinib or gemcitabine alone.
abstract: BACKGROUND
  Response assessment in advanced pancreatic cancer (APC) is difficult and predictive markers are needed. There are insufficient data on the value of carbohydrate antigen 19-9 (CA 19-9) and cytostatic-targeted therapies. Axitinib, a selective vascular endothelial growth factor (VEGF) receptors 1, 2, 3 inhibitor, may increase overall survival (OS) in APC.
  
  
  METHODS
  We assessed serum CA 19-9, clinical outcomes and diastolic blood pressure (dBP) in APC patients receiving gemcitabine plus axitinib (Gem+A) or gemcitabine alone.
  
  
  RESULTS
  In the total population (N=95), median OS was significantly longer in patients with baseline CA 19-9 values at or below the median than in those with values above it (12.2 months [95% confidence interval (CI), 8.6-16.6%] vs 5.0 months [95% CI, 3.9-5.7%]; P<0.0001). This also reached significance in the Gem+A arm (median OS, 12.5 months [95% CI, 8.6-16.6%] vs 4.9 months [95% CI, 3.6-5.6%]; P<0.0001). Patients with any dBP>90 mmHg had significantly longer OS than those who did not. However, there was no predictive significance of CA 19-9.
  
  
  CONCLUSIONS
  Baseline CA 19-9 levels had prognostic value for OS, but caution is advised in interpreting CA 19-9 as a predictive biomarker for novel cytostatic agents such as VEGF-targeted therapies in phase II studies.
authors.affiliation: Department of Cancer Medicine, Hammersmith Hospital, Du Cane Road, London W12 0HS, UK.
authors.forename: H S
authors.initials: HS
authors.lastname: Wasan
authors.forename: G M
authors.initials: GM
authors.lastname: Springett
authors.forename: C
authors.initials: C
authors.lastname: Chodkiewicz
authors.forename: R
authors.initials: R
authors.lastname: Wong
authors.forename: J
authors.initials: J
authors.lastname: Maurel
authors.forename: C
authors.initials: C
authors.lastname: Barone
authors.forename: B
authors.initials: B
authors.lastname: Rosbrook
authors.forename: A D
authors.initials: AD
authors.lastname: Ricart
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.forename: J-P
authors.initials: JP
authors.lastname: Spano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077784:Axitinib; D014408:Biomarkers, Tumor / Q000097:blood*; D018395:CA-19-9 Antigen / Q000097:blood*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003971:Diastole; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D007191:Indazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D007093:Imidazoles; D007191:Indazoles; D003841:Deoxycytidine; D000077784:Axitinib; D000093542:Gemcitabine