title: The effect of fibrin clot inhibitors on the immunomodulatory efficacy of Bacillus Calmette-Guérin therapy for non-muscle-invasive bladder cancer.
abstract: OBJECTIVE
  To determine if there is a difference in clinical outcomes among non-muscle-invasive bladder cancer patients taking fibrin clot-inhibiting (FCI) medications (aspirin, clopidogrel, or warfarin) while receiving Bacillus Calmette-Guérin (BCG) therapy compared with their counterparts not taking anticoagulation.
  
  
  METHODS
  Our Investigational Review Board-approved database was queried for patients who received an induction course of BCG from 2001 to 2011. The analysis included 224 patients with a minimum of 3 months of follow-up. Recurrence-free survival (RFS), cystectomy-free survival, overall survival, and disease-specific survival were analyzed using the Kaplan-Meier method stratified by FCI status. Logistic regression was used to predict the initial response rate to BCG and progression by FCI status.
  
  
  RESULTS
  Of the 224 patients analyzed, 68, 19, and 23 patients were taking aspirin, clopidogrel and warfarin, respectively, at BCG induction. No specific FCI was associated with differences in cystectomy-free survival, overall survival, disease-specific survival, or the likelihood of progression at recurrence. Neither warfarin nor clopidogrel affected RFS. Patients taking aspirin trended toward increased RFS, although this was not statistically significant (P = .058). Multivariate analysis showed aspirin use was associated with an increased initial response to BCG (odds ratio, 2.41; P = .031)
  
  
  CONCLUSIONS
  Contrary to the postulated inhibitory molecular effect of FCI on BCG-binding activity, this study did not substantiate a significant impact on BCG efficacy of the concomitant use of these medications during BCG induction. The observation that aspirin use potentiates an increased initial response to BCG may warrant further analysis.
authors.affiliation: Department of Urology, Columbia University Medical Center, New York, NY 10032, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Lipsky
authors.forename: Gina M
authors.initials: GM
authors.lastname: Badalato
authors.forename: Piruz
authors.initials: P
authors.lastname: Motamedinia
authors.forename: Greg W
authors.initials: GW
authors.lastname: Hruby
authors.forename: James M
authors.initials: JM
authors.lastname: McKiernan
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000494:pharmacology*; D001241:Aspirin / Q000494:pharmacology; D001500:BCG Vaccine / Q000627:therapeutic use*; D000077144:Clopidogrel; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D056747:Immunomodulation / Q000187:drug effects*; D060828:Induction Chemotherapy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D016017:Odds Ratio; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000494:pharmacology; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D014859:Warfarin / Q000494:pharmacology
chemical_list: D000276:Adjuvants, Immunologic; D000925:Anticoagulants; D001500:BCG Vaccine; D014859:Warfarin; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin