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Simple Summary The current review assessed the effects of the gut microbiome on clinical outcomes of immunotherapy and related adverse events (AEs) in cancer patients. Studies (n = 10) consistently reported that the gut microbiome prior to administering immune checkpoint inhibitors (ICIs) was associated with enhanced efficacy of ICIs and reduced AEs. Recent fecal microbiome transplant (FMT) studies demonstrated the modulatory effects of FMT on the composition and diversity of the gut microbiome in patients with refractory cancers and the potential to improve the efficacy of ICIs. Abstract Background: Emerging evidence suggests that gut microbiota influences the clinical response to immunotherapy. This review of clinical studies examines the relationship between gut microbiota and immunotherapy outcomes. Method: A literature search was conducted in electronic databases Medline, PubMed and ScienceDirect, with searches for “cancer” and “immunotherapy/immune checkpoint inhibitor” and “microbiome/microbiota” and/or “fecal microbiome transplant FMT”. The relevant literature was selected for this article. Results: Ten studies examined patients diagnosed with advanced metastatic melanoma (n = 6), hepatocellular carcinoma (HCC) (n = 2), non-small cell lung carcinoma (NSCLC) (n = 1) and one study examined combination both NSCLC and renal cell carcinoma (RCC) (n = 1). These studies consistently reported that the gut microbiome profile prior to administering immune checkpoint inhibitors (ICIs) was related to clinical response as measured by progression-free survival (PFS) and overall survival (OS). Two studies reported that a low abundance of Bacteroidetes was associated with colitis. Two studies showed that patients with anti-PD-1 refractory metastatic melanoma experienced improved response rates and no added toxicity when receiving fecal microbiota transplant (FMT) from patients with anti-PD-1 responsive disease. Conclusions: Overall, significant differences in the diversity and composition of the gut microbiome were identified in ICIs responders and non-responders. Our findings provide new insights into the value of assessing the gut microbiome in immunotherapy. Further robust randomized controlled trials (RCTs) examining the modulatory effects of the gut microbiome and FMT on ICIs in patients not responding to immunotherapy are warranted.

Simple Summary A substantial proportion of cancer patients receive radiotherapy (RT) during their cancer trajectory. One of the most challenging pelvic RT-related toxicities are gastrointestinal (GI) toxicities (e.g., abdominal pain, rectal bleeding, faecal incontinence, and diarrhoea) which impair the quality of life (QoL) of patients. Mounting evidence suggests that gut microbiota plays a pivotal role in health and disease, including cancer. Our current clinical review aims to assess the impact of RT on gut microbiota and GI toxicities in cancer patients to provide useful information, in addition to standard care, for clinicians and patients. Abstract Background: Gastrointestinal (GI) toxicities are common adverse effects of pelvic radiotherapy (RT). Several recent studies revealed that toxicity of RT is associated with dysbiosis of the gut microbiome. Method: A literature search was conducted in electronic databases Medline, PubMed, and ScienceDirect, with search terms “microbiome and/or microbiota” and “radiotherapy (RT) and/or chemoradiation therapy (CRT)” and “cancer”, and the relevant literature were selected for use in this article. Results: Eight prospective cohort studies were selected for review with a total of 311 participants with a range of 15–134 participants within these studies. The selected studies were conducted in patients with gynaecological (n = 3), rectal (n = 2), or prostate cancers (n = 1), or patients with various types of malignancies (n = 2). Three studies reported that cancer patients had significantly lower alpha diversity compared with healthy controls. Seven studies found that lower alpha diversity and modulated gut microbiome were associated with GI toxicities during and after pelvic RT (n = 5) and CRT (n = 2), whereas one study found that beta diversity was related to a complete response following CRT. Two further studies reported that fatigue was associated with dysbiosis of the gut microbiome and low alpha diversity during and after RT, and with dysbiosis of the gut microbiome and diarrhoea, respectively. Conclusion: Gut microbiome profiles are associated with GI toxicities and have the potential to predict RT/CRT-induced toxicities and quality of life (QoL) in patients undergoing those treatments. Further robust randomized controlled trials (RCTs) are required to elucidate the effect of gut microbiome profiles on RT-related adverse effects and responses to RT.