Abstract：
BACKGROUND: Abemaciclib-induced diarrhea is a relevant concern in clinical practice. Postbiotics have emerged as a promising option for managing it.
METHODS: We conducted a retrospective-prospective, 2-group, observational study to assess the impact of the postbiotic PostbiotiX-Restore, derived by Lactobacillus paracasei CNCM I-5220, on abemaciclib-induced diarrhea in patients with hormone receptor-positive HER2-negative breast cancer. The prospective population (Postbio group) received postbiotic during the first cycle of abemaciclib, while the retrospective one received standard care (Standard group). Diarrhea grading was defined according to the National Cancer Institute\'s Common Terminology Criteria for Adverse Events.
RESULTS: During the first cycle, diarrhea occurred in 78.9% of patients in the Standard cohort and 97.1% in the Postbio one, with most cases being G1-G2. Severe (G3) diarrhea was significantly less frequent in the Postbio group (0%) compared to the Standard one (7.9%; P = .029). Over the entire study period, while the grading difference was not statistically significant, G3 events were less frequent in the Postbio population (5.9%) than the Standard one (15.4%). Moreover, Postbio patients required fewer dose reductions due to diarrhea compared to the Standard group (P = .002). Notably, in the Postbio population, G1 and G2 events had short median durations (3 and 1 days, respectively) and, for the 2 patients experiencing G3 events during the second abemaciclib cycle (off postbiotic), diarrhea lasted only 1 day.
CONCLUSIONS: Our study demonstrates the effect of PostbiotiX-Restore in mitigating abemaciclib-induced diarrhea, resulting in reduced severity, fewer dose reductions, and shorter duration. Further exploration and validation in larger cohorts are needed.
METHODS: We conducted a retrospective-prospective, 2-group, observational study to assess the impact of the postbiotic PostbiotiX-Restore, derived by Lactobacillus paracasei CNCM I-5220, on abemaciclib-induced diarrhea in patients with hormone receptor-positive HER2-negative breast cancer. The prospective population (Postbio group) received postbiotic during the first cycle of abemaciclib, while the retrospective one received standard care (Standard group). Diarrhea grading was defined according to the National Cancer Institute\'s Common Terminology Criteria for Adverse Events.
RESULTS: During the first cycle, diarrhea occurred in 78.9% of patients in the Standard cohort and 97.1% in the Postbio one, with most cases being G1-G2. Severe (G3) diarrhea was significantly less frequent in the Postbio group (0%) compared to the Standard one (7.9%; P = .029). Over the entire study period, while the grading difference was not statistically significant, G3 events were less frequent in the Postbio population (5.9%) than the Standard one (15.4%). Moreover, Postbio patients required fewer dose reductions due to diarrhea compared to the Standard group (P = .002). Notably, in the Postbio population, G1 and G2 events had short median durations (3 and 1 days, respectively) and, for the 2 patients experiencing G3 events during the second abemaciclib cycle (off postbiotic), diarrhea lasted only 1 day.
CONCLUSIONS: Our study demonstrates the effect of PostbiotiX-Restore in mitigating abemaciclib-induced diarrhea, resulting in reduced severity, fewer dose reductions, and shorter duration. Further exploration and validation in larger cohorts are needed.
摘要：
背景：Abemaciclib引起的腹泻是临床实践中的相关问题。益生菌已经成为管理它的一个有希望的选择。
方法：我们进行了回顾性前瞻性研究，2组,观察性研究，以评估后生物PostbiotiX-Restore的影响，由副干酪乳杆菌CNCMI-5220衍生，对激素受体阳性HER2阴性乳腺癌患者的abemaciclib引起的腹泻。在abemaciclib的第一个周期中，预期人群（Postbio组）接受了postbiotic，而回顾性研究者接受标准治疗（标准组）。根据美国国家癌症研究所的不良事件通用术语标准定义腹泻分级。
结果：在第一个周期中，标准队列中78.9%的患者发生腹泻，Postbio队列中97.1%的患者发生腹泻，大多数病例为G1-G2。与标准组（7.9％；P=0.029）相比，Postbio组（0％）的严重（G3）腹泻频率明显较低。在整个研究期间,虽然分级差异无统计学意义，Postbio人群中G3事件的频率（5.9％）低于标准人群（15.4％）。此外，与标准组相比，由于腹泻，Postbio患者需要更少的剂量减少（P=0.002）。值得注意的是,在Postbio人口中，G1和G2事件的中位持续时间较短（3天和1天，分别)和，对于在第二个abemaciclib周期期间经历G3事件的2名患者（脱离后生物），腹泻只持续了1天。
结论：我们的研究证明了PostbiotiX-Restore在减轻abemaciclib引起的腹泻中的作用，导致严重程度降低，减少剂量，和较短的持续时间。需要在更大的队列中进行进一步的探索和验证。
方法：我们进行了回顾性前瞻性研究，2组,观察性研究，以评估后生物PostbiotiX-Restore的影响，由副干酪乳杆菌CNCMI-5220衍生，对激素受体阳性HER2阴性乳腺癌患者的abemaciclib引起的腹泻。在abemaciclib的第一个周期中，预期人群（Postbio组）接受了postbiotic，而回顾性研究者接受标准治疗（标准组）。根据美国国家癌症研究所的不良事件通用术语标准定义腹泻分级。
结果：在第一个周期中，标准队列中78.9%的患者发生腹泻，Postbio队列中97.1%的患者发生腹泻，大多数病例为G1-G2。与标准组（7.9％；P=0.029）相比，Postbio组（0％）的严重（G3）腹泻频率明显较低。在整个研究期间,虽然分级差异无统计学意义，Postbio人群中G3事件的频率（5.9％）低于标准人群（15.4％）。此外，与标准组相比，由于腹泻，Postbio患者需要更少的剂量减少（P=0.002）。值得注意的是,在Postbio人口中，G1和G2事件的中位持续时间较短（3天和1天，分别)和，对于在第二个abemaciclib周期期间经历G3事件的2名患者（脱离后生物），腹泻只持续了1天。
结论：我们的研究证明了PostbiotiX-Restore在减轻abemaciclib引起的腹泻中的作用，导致严重程度降低，减少剂量，和较短的持续时间。需要在更大的队列中进行进一步的探索和验证。
