给免疫治疗“减毒增效”的辅助药物（七）--益生菌
1、 《益生菌联合PD-1抑制剂在治疗不可切除肝癌中的有效性及安全性分析》“纳入65例中晚期不可切除肝癌患者,其中实验组30例,对照组35例。”
““实验组”与“对照组”两组患者的治疗效果,ORR为40.0%vs 28.6%(p=0.332),DCR为70.0%vs 62.9%(p=0.544),两组差异无统计学意义。”
实验组OS均值为21.42个月(95%CI,18.198-24.643),对照组OS均值为17.30个月(95%CI,14.438-20.163),两组差异有统计学意义(p=0.035)。
"结论:1.与未使用益生菌组相比,使用益生菌能延长PD-1抑制剂治疗不可切除肝癌患者的总生存期;在客观缓解率、疾病控制率、手术转化率及无进展生存期方面两组差异虽无统计学意义,但益生菌治疗组呈现出较好的趋势。2.与未使用益生菌组相比,使用益生菌能降低患者腹泻与食欲减退的发生率,在其他不良反应发生率方面两组差异虽无统计学意义,但益生菌治疗组呈现出较低的趋势。
“实验组”患者均为初次使用 PD-1 抑制剂治疗前后 3 周内使用益生菌，使用情况如下： 益 适 优 即 食 型 益 生 菌 固 体 饮 料 ( 含 有 鼠 李 糖 乳 酪 杆 菌 Probio-M9 (Lacticaseibacillus rhamnosus Probio-M9)；2g/袋；1000 亿 CFU/g)1 袋口服(PO)，每天 1 次(QD)，服用 3 周及以上。
2、 《Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial》
“Previous studies have suggested that the gut microbiome influences the response to checkpoint inhibitors (CPIs) in patients with cancer. CBM588 is a bifidogenic live bacterial product that we postulated could augment CPI response through modulation of the gut microbiome. In this open-label, single-center study (NCT03829111), 30 treatment-naive patients with metastatic renal cell carcinoma with clear cell and/or sarcomatoid histology and intermediate- or poor-risk disease were randomized 2:1 to receive nivolumab and ipilimumab with or without daily oral CBM588, respectively. Stool metagenomic sequencing was performed at multiple timepoints. The primary endpoint to compare the relative abundance of Bifidobacterium spp. at baseline and at 12 weeks was not met, and no significant differences in Bifidobacterium spp. or Shannon index associated with the addition of CBM588 to nivolumab-ipilimumab were detected. Secondary endpoints included response rate, progression-free survival (PFS) and toxicity. PFS was significantly longer in patients receiving nivolumab-ipilimumab with CBM588 than without (12.7 months versus 2.5 months, hazard ratio 0.15, 95% confidence interval 0.05-0.47, P = 0.001). Although not statistically significant, the response rate was also higher in patients receiving CBM588 (58% versus 20%, P = 0.06). No significant difference in toxicity was observed between the study arms. The data suggest that CBM588 appears to enhance the clinical outcome in patients with metastatic renal cell carcinoma treated with nivolumab-ipilimumab. Larger studies are warranted to confirm this clinical observation and elucidate the mechanism of action and the effects on microbiome and immune compartments.”
页:
[1]