Faecal microbiota transplantation for the treatment of diarrhoea induced by tyrosine-kinase inhibitors in patients with metastatic renal cell carcinoma
Faecal microbiota transplantation for the treatment of diarrhoea induced by tyrosine-kinase inhibitors in patients with metastatic renal cell carcinoma
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DOI：
10.1038/s41467-020-18127-y
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发表时间：
2020-08-28
影响因子：
16.6
通讯作者：
Cammarota, Giovanni
中科院分区：
文献类型：
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作者：
Ianiro, Gianluca;Rossi, Ernesto;Cammarota, Giovanni
腹泻是化疗药物中最棘手和最常见的不良事件之一，迄今尚无标准化治疗。越来越多的证据表明，肠道微生物组可以影响化疗引起的腹泻的发展。在这里，我们报告了粪便微生物群移植（FMT）治疗转移性肾细胞癌患者酪氨酸激酶抑制剂（TKI）诱导的腹泻的随机临床试验结果（ClinicalTrials.gov编号：NCT 04040712）。主要结局是治疗结束后四周腹泻的消退。将20名患者随机接受来自健康供体的FMT或安慰剂FMT（仅媒介物）。在治疗TKI诱导的腹泻方面，供体FMT比安慰剂FMT更有效，并且在接受供体粪便的受试者中观察到成功的植入。两个治疗组均未观察到严重不良事件。试验符合预先规定的终点。我们的研究结果表明，肠道微生物群的治疗操作可能成为管理TKI依赖性腹泻的有希望的治疗选择。
Diarrhoea is one of the most burdensome and common adverse events of chemotherapeutics, and has no standardised therapy to date. Increasing evidence suggests that the gut microbiome can influence the development of chemotherapy-induced diarrhoea. Here we report findings from a randomised clinical trial of faecal microbiota transplantation (FMT) to treat diarrhoea induced by tyrosine kinase inhibitors (TKI) in patients with metastatic renal cell carcinoma (ClinicalTrials.gov number: NCT04040712). The primary outcome is the resolution of diarrhoea four weeks after the end of treatments. Twenty patients are randomised to receive FMT from healthy donors or placebo FMT (vehicle only). Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces. No serious adverse events are observed in both treatment arms. The trial meets pre-specified endpoints. Our findings suggest that the therapeutic manipulation of gut microbiota may become a promising treatment option to manage TKI-dependent diarrhoea.