Abstract
BackgroundThe incidence of Clostridioides difficile infection (CDI) is reportedly higher and the cure rate lower in individuals with cancer vs those without cancer. An exploratory post hoc analysis of the MODIFY I/II trials (NCT01241552/NCT01513239) investigated how bezlotoxumab affected the rate of CDI-related outcomes in participants with cancer.MethodsParticipants received a single infusion of bezlotoxumab (10 mg/kg) or placebo during anti-CDI antibacterial treatment. A post hoc analysis of CDI-related outcomes was conducted in subgroups of MODIFY I/II participants with and without cancer.ResultsOf 1554 participants in the modified intent-to-treat (mITT) population, 382 (24.6%) were diagnosed with cancer (bezlotoxumab 190, placebo 192). Of participants without cancer, 591 and 581 received bezlotoxumab and placebo, respectively. In the placebo group, initial clinical cure (ICC) was achieved by fewer cancer participants vs participants without cancer (71.9% vs 83.1%; absolute difference, –11.3%; 95% CI, –18.6% to –4.5%); however, CDI recurrence (rCDI) rates were similar in cancer (30.4%) and noncancer (34.0%) participants. In participants with cancer, bezlotoxumab treatment had no effect on ICC rate compared with placebo (76.8% vs 71.9%), but resulted in a statistically significant reduction in rCDI vs placebo (17.8% vs 30.4%; absolute difference, –12.6%; 95% CI, –22.5% to –2.7%).ConclusionsIn this post hoc analysis of participants with cancer enrolled in MODIFY I/II, the rate of rCDI in bezlotoxumab-treated participants was lower than in placebo-treated participants. Additional studies are needed to confirm these results.Clinical Trial RegistrationMODIFY I (NCT01241552), MODIFY II (NCT01513239).
Highlights
The incidence of Clostridioides difficile infection (CDI) is reportedly higher and the cure rate lower in individuals with cancer vs those without cancer
Initial clinical cure (ICC) was achieved by fewer cancer participants vs participants without cancer (71.9% vs 83.1%; absolute difference, –11.3%; 95% confidence intervals (CIs), –18.6% to –4.5%); CDI recurrence rates were similar in cancer (30.4%) and noncancer (34.0%) participants
Bezlotoxumab treatment had no effect on initial clinical cure (ICC) rate compared with placebo (76.8% vs 71.9%), but resulted in a statistically significant reduction in rCDI vs placebo (17.8% vs 30.4%; absolute difference, –12.6%; 95% CI, –22.5% to –2.7%)
Summary
Participants received a single infusion of bezlotoxumab (10 mg/kg) or placebo during anti-CDI antibacterial treatment. Eligible participants were randomly allocated in a 1:1:1:1 ratio to receive a single 60-minute infusion (received on study day 1) of bezlotoxumab alone (10 mg/kg), actoxumab and bezlotoxumab (10 mg/kg each), actoxumab alone (10 mg/kg, MODIFY I only), or placebo (0.9% saline) [23] while they continued to receive anti-CDI antibiotics. Participants recorded their unformed bowel movements until 80–90 days postinfusion and were instructed to collect a stool sample and return to the clinic if they experienced a return of diarrhea. Participants with active cancer were identified based on a review of conditions reported on the medical history case report form for malignant solid tumors and hematologic malignancies that were identified by the investigator as ongoing at the time of randomization
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