The incidence of Clostridioides difficile infection (CDI) is reportedly higher and the cure rate lower in individuals with cancer versus 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.
Participants 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.
Of 1,554 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 versus participants without cancer (71.9% versus 83.1%; absolute difference [95% CI]: -11.3% [-18.6, -4.5]), however, CDI recurrence (rCDI) rates were similar in cancer (30.4%) and non-cancer (34.0%) participants. In participants with cancer, bezlotoxumab treatment had no effect on ICC rate compared with placebo (76.8% versus 71.9%), but resulted in a statistically significant reduction in rCDI versus placebo (17.8% versus 30.4%; absolute difference [95% CI]: 12.6% [-22.5, -2.7]).
In 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.
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