PURPOSE:Patients with cancer are at increased risk for Clostridium difficile-associated diarrhea (CDAD). Little is known about treatment response. PATIENTS AND METHODS: Two double-blind trials randomly allocated 1,105 patients with CDAD tofidaxomicin or vancomycintreatment (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. CONCLUSION: For patients with cancer, fidaxomicin treatment was superior to vancomycin, resulting in higher cure and sustained response rates, shorter TTROD, and fewer recurrences.
RCT Entities:
PURPOSE:Patients with cancer are at increased risk for Clostridium difficile-associated diarrhea (CDAD). Little is known about treatment response. PATIENTS AND 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. CONCLUSION: For patients with cancer, fidaxomicin treatment was superior to vancomycin, resulting in higher cure and sustained response rates, shorter TTROD, and fewer recurrences.
Authors: Andrew I T Hebbard; Monica A Slavin; Caroline Reed; Jason A Trubiano; Benjamin W Teh; Gabrielle M Haeusler; Karin A Thursky; Leon J Worth Journal: Support Care Cancer Date: 2017-02-02 Impact factor: 3.603
Authors: S M Heimann; J J Vehreschild; O A Cornely; H Wisplinghoff; M Hallek; R Goldbrunner; B W Böttiger; T Goeser; A Hölscher; S Baldus; F Müller; N Jazmati; S Wingen; B Franke; M J G T Vehreschild Journal: Infection Date: 2015-06-30 Impact factor: 3.553
Authors: C Rubio-Terrés; J Cobo Reinoso; S Grau Cerrato; J Mensa Pueyo; M Salavert Lletí; A Toledo; P Anguita; D Rubio-Rodríguez; M Watt; R Gani Journal: Eur J Clin Microbiol Infect Dis Date: 2015-09-25 Impact factor: 3.267