title: Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin.
abstract: OBJECTIVE
  Patients with cancer are at increased risk for Clostridium difficile-associated diarrhea (CDAD). Little is known about treatment response.
  
  
  METHODS
  Two double-blind trials randomly allocated 1,105 patients with CDAD to fidaxomicin or vancomycin treatment (modified intent-to-treat [mITT]), and 183 of these had cancer. Univariate and multivariate post hoc analyses compared effects of treatment and patient characteristics on cure, recurrence, and sustained response after 4 weeks. Time to resolution of diarrhea (TTROD) was also evaluated.
  
  
  RESULTS
  Patients with cancer had a lower cure rate and longer TTROD than patients without cancer. Recurrence rates were similar. Cure was more likely with fidaxomicin than vancomycin (odds ratio [OR] 2.0; P = .065), recurrence was less likely (OR = 0.37; P = .018), and sustained response more frequent (OR = 2.56; P = .003). Under vancomycin, median TTROD was longer in patients with cancer than in those without (123 v 58 hours; log-rank P < .001). With fidaxomicin, median TTROD was not significantly affected by presence of cancer (74 v 54 hours; log-rank P = .145). In the full mITT population, age, hypoalbuminemia, and cancer were inversely associated with clinical cure by multivariate analysis. Study treatment with vancomycin was a significant predictor of recurrence (P < .001). Within the cancer population, low albumin was negatively and fidaxomicin was positively associated with improved cure.
  
  
  CONCLUSIONS
  For patients with cancer, fidaxomicin treatment was superior to vancomycin, resulting in higher cure and sustained response rates, shorter TTROD, and fewer recurrences.
authors.affiliation: Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany. oliver.cornely@ctuc.de
authors.forename: Oliver A
authors.initials: OA
authors.lastname: Cornely
authors.forename: Mark A
authors.initials: MA
authors.lastname: Miller
authors.forename: Bruno
authors.initials: B
authors.lastname: Fantin
authors.forename: Kathleen
authors.initials: K
authors.lastname: Mullane
authors.forename: Yin
authors.initials: Y
authors.lastname: Kean
authors.forename: Sherwood
authors.initials: S
authors.lastname: Gorbach
mesh_terms: D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000187:drug effects*; D003967:Diarrhea / Q000188:drug therapy / Q000382:microbiology*; D004311:Double-Blind Method; D004761:Enterocolitis, Pseudomembranous / Q000139:chemically induced / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D000077732:Fidaxomicin; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D055502:Secondary Prevention; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use*
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D014640:Vancomycin; D000077732:Fidaxomicin