Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin.

Abstract

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: Oliver A Cornely, Mark A Miller, Bruno Fantin, Kathleen Mullane, Yin Kean, Sherwood Gorbach
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 31 Issue 19 Pg. 2493-9 (Jul 01 2013) ISSN: 1527-7755 [Electronic] United States
• PMID: 23715579 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aminoglycosides
• Anti-Bacterial Agents
• Vancomycin
• Fidaxomicin

Topics

• Adult
• Aged
• Aminoglycosides (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Clostridioides difficile (drug effects)
• Diarrhea (drug therapy, microbiology)
• Double-Blind Method
• Enterocolitis, Pseudomembranous (chemically induced, complications, drug therapy)
• Female
• Fidaxomicin
• Humans
• Kaplan-Meier Estimate
• Logistic Models
• Male
• Middle Aged
• Multivariate Analysis
• Secondary Prevention
• Treatment Outcome
• Vancomycin (therapeutic use)