A randomized trial of Bacteroides fragilis 839 on preventing chemotherapy-induced myelosuppression and gastrointestinal adverse effects in breast cancer patients.
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Abstract
Background and objectives: To evaluate the potential benefits of Bacteroides fragilis 839 (BF839), a next-generation probiotics, in reducing myelosuppression and gastrointestinal toxicity associated with chemotherapy in breast cancer patient.
Methods and study design: 40 women with early breast cancer were randomly assigned to the BF839 (n=20) or placebo (n=20) during the administration of adjuvant chemotherapy (4 cycles of epirubicin 100mg/m2 and cyclophosphamide 600mg/m2). Myelosuppression and gastrointestinal adverse effects were monitored in both groups.
Results: Throughout the four treatment cycles, the percentage of patients experiencing myelosuppression was 42.5% in the BF839 group, significantly lower than the 66.3% observed in the control group (p=0.003). Two patients in the BF839 group and three patients in the placebo group received recombinant human granulocyte colony-stimulating factor (rhG-CSF) due to leuko-penia/neutropenia. When considering an ITT analysis, which included all patients regardless of rhG-CSF treatment, the BF839 group exhibited less reduction from baseline in white blood cells (-0.31±1.19 vs -1.15±0.77, p=0.012) and neutrophils (0.06±1.00 vs -0.84±0.85, p=0.004) compared to the placebo group. The difference became even more significant when excluding the patients who received rhG-CSF injections. Throughout the four treatment cycles, compared to the placebo group, the BF839 group had significantly lower rates of 3-4 grade nausea (35.0% vs 71.3%, p=0.001), vomiting (20.0% vs 45.0%, p=0.001), and diarrhea (15.0% vs 30.0%, p=0.023).
Conclusions: These findings suggest that BF839 has the potential to effectively mitigate myelosuppression and gastrointestinal toxicity associated with chemotherapy in breast cancer patients.
背景与目的方法和研究设计:40名早期乳腺癌女性患者在接受辅助化疗(4个周期的表柔比星100毫克/平方米和环磷酰胺600毫克/平方米)期间,随机分配到BF839(20人)或安慰剂(20人)组。对两组患者的骨髓抑制和胃肠道不良反应进行了监测:在四个治疗周期中,BF839组出现骨髓抑制的患者比例为42.5%,明显低于对照组的66.3%(P=0.003)。由于白细胞减少症/中性粒细胞减少症,BF839 组的两名患者和安慰剂组的三名患者接受了重组人粒细胞集落刺激因子(rhG-CSF)治疗。ITT分析包括所有患者,无论是否接受rhG-CSF治疗,与安慰剂组相比,BF839组的白细胞(-0.31±1.19 vs -1.15±0.77, p=0.012)和中性粒细胞(0.06±1.00 vs -0.84±0.85, p=0.004)较基线下降较少。如果剔除注射 rhG-CSF 的患者,差异会更加显著。在四个治疗周期中,与安慰剂组相比,BF839组的3-4级恶心(35.0% vs 71.3%,p=0.001)、呕吐(20.0% vs 45.0%,p=0.001)和腹泻(15.0% vs 30.0%,p=0.023)发生率显著降低:这些研究结果表明,BF839 有可能有效减轻乳腺癌患者化疗引起的骨髓抑制和胃肠道毒性。
期刊介绍:
The aims of the Asia Pacific Journal of Clinical Nutrition
(APJCN) are to publish high quality clinical nutrition relevant research findings which can build the capacity of
clinical nutritionists in the region and enhance the practice of human nutrition and related disciplines for health
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