Host-related biomarkers including gut microbiome to predict toxicities of nivolumab in advanced gastric cancer: DELIVER trial (JACCRO GC-08)
Abstract
245 Background: Nivolumab monotherapy demonstrated survival benefit in previously treated gastric cancer (GC) patients (pts) (Kang YK, et al. Lancet 2017) and was involved into standard of care in advanced GC. Immune-related adverse events (irAEs) were observed in about 10% of pts treated with immune-check point inhibitor. Several studies revealed that the toxicities of anti-PD-1-based immunotherapy was associated with composition of gut microbiome, but little is known about GC. We therefore investigated whether host-related factors including genomic information in gut microbiome will serve as predictors for nivolumab-induced toxicities in advanced GC. Methods: The observational/translational study (DELIVER trial: UMIN000030850) has enrolled 501 pts with advanced GC treated with nivolumab alone from March 2018 to August 2019 to evaluate real-world data and discover host-related biomarkers using fecal and blood samples which were collected before treatment with nivolumab [Takahashi Y, et al. Gastric Cancer 2021]. In the biomarker part, the relationship between markers of microbiome/genetic polymorphisms and AEs was evaluated as previously planned for the secondary endpoint. Genomic data in fecal samples and single nucleotide polymorphisms (SNPs) in blood samples were measured by genome shotgun sequence and microarray, respectively, at central lab. Genera and pathway with a median difference of ≥0.01 of normalized value and P-value < 0.05 of t-test were picked up from the…
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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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