Resolution of Clostridium difficile-associated diarrhea in patients with cancer
treated with fidaxomicin or vancomycin.
Author(s): Cornely OA(1), Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S.
Affiliation(s): Author information:
(1)Department I of Internal Medicine, University Hospital of Cologne, Cologne,
Germany. oliver.cornely@ctuc.de
Publication date & source: 2013, J Clin Oncol. , 31(19):2493-9
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.
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