In patients with renal cell carcinoma, a live bacterial product + immunotherapy combination elicits promising clinical benefit in association with enrichment of bacterial species in responders montypal NazliDizman cityofhope
To identify the functional potential of microbial communities, we ran MetaPhlAn 3.0 data through HUMAnN 3.0
. Generated metabolic pathways were compared using the Wilcoxon signed rank test between baseline and week 12 in the nivolumab–ipilimumab and nivolumab–ipilimumab plus CBM588 arms, separately. Metabolic pathways with avalue less than 0.05 were considered significant and were shown as a heatmap using the function heatmap.2 of the gplots package for R version 4.1.1.
Peripheral blood samples were collected in 10 ml cell preparation tubes at baseline and weeks 7, 12, 17 and 25. All samples were processed within a window of 4–6 h after collection. Processing involved centrifugation at 1,800 ×for 20 min followed by plasma extraction for circulating cytokine analysis.
spp. collected from baseline to 12 weeks. With a cumulative sample size of 30 patients , we would have 80% power to detect a 1 s.d. change in specific-test with a one-sided type I error of 0.05. Secondary measures included comparison of the Shannon diversity index at baseline and at 12 weeks and quantitative comparisons of changes in the abundance of other specific bacterial species. Details of this analysis can be found in the full protocol .
With respect to clinical endpoints, PFS was characterized as the time from randomization to disease progression or death , and overall survival was defined as the time from randomization to death. These were compared between the study arms using the Kaplan–Meier method and log-rank test. Objective response rate was compared between arms using the Fisher exact test.
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