Cornely Oliver A, Mullane Kathleen M, Birch Thomas, Hazan-Steinberg Sabine, Nathan Richard, Bouza Emilio, Calfee David P, Ellison Misoo Chung, Wong Michael T, Dorr Mary Beth
Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Department I of Internal Medicine, Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany.
Section of Infectious Diseases, Department of Medicine, University of Chicago, Chicago, Illinois, USA.
Open Forum Infect Dis. 2020 Jan 31;7(2):ofaa038. doi: 10.1093/ofid/ofaa038. eCollection 2020 Feb.
The incidence of 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.
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 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%).
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.
MODIFY I (NCT01241552), MODIFY II (NCT01513239).
据报道，与非癌症患者相比，癌症患者的艰难梭菌感染（CDI）发病率更高，治愈率更低。一项针对MODIFY I/II试验（NCT01241552/NCT01513239）的探索性事后分析研究了贝佐妥单抗如何影响癌症患者中与CDI相关的结局发生率。
参与者在抗CDI抗菌治疗期间接受单次输注贝佐妥单抗（10 mg/kg）或安慰剂。对MODIFY I/II试验中有癌症和无癌症的参与者亚组进行了与CDI相关结局的事后分析。
在改良意向性治疗（mITT）人群的1554名参与者中，382名（24.6%）被诊断患有癌症（贝佐妥单抗组190名，安慰剂组192名）。在无癌症的参与者中，分别有591名和581名接受了贝佐妥单抗和安慰剂治疗。在安慰剂组中，癌症参与者实现初始临床治愈（ICC）的比例低于无癌症参与者（71.9%对83.1%；绝对差异为-11.3%；95%CI为-18.6%至-4.5%）；然而，癌症参与者（30.4%）和非癌症参与者（34.0%）的CDI复发（rCDI）率相似。在癌症参与者中，与安慰剂相比，贝佐妥单抗治疗对ICC率没有影响（76.8%对71.9%），但与安慰剂相比，rCDI有统计学意义的降低（17.8%对30.4%；绝对差异为-12.6%；95%CI为-22.5%至-2.7%）。
在这项对纳入MODIFY I/II试验的癌症参与者的事后分析中，接受贝佐妥单抗治疗的参与者的rCDI率低于接受安慰剂治疗的参与者。需要进一步的研究来证实这些结果。
MODIFY I（NCT01241552），MODIFY II（NCT01513239）。
