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Background This prospective observational study evaluated the real-world effectiveness of nivolumab monotherapy in previously treated advanced gastric cancer (GC). A preplanned 2-year final analysis was performed to confirm survival and tumor behavior with nivolumab monotherapy. Patients and Methods The primary endpoint was overall survival (OS). The data regarding tumor size were prospectively collected and evaluated using the RECIST criteria. Exploratory analyses were performed for survival according to the tumor response and depth of response (DpR) in patients with measurable lesions who were receiving nivolumab monotherapy as third- or later-line therapy. Results In 487 patients, the median OS and progression-free survival (PFS) were 5.8 (95% CI 5.3-6.9) months and 1.8 (95% CI 1.7-2.0) months, respectively. The response rate (RR) was 14.5% in 282 patients with measurable lesions. In 234 patients treated with third- or later-line, the DpR was found to be associated with PFS and OS in the Spearman analysis (r  = 0.55 and 0.44, respectively) as well as using a discrete variable. When the DpR was divided into 5 groups (−20%≥DpR; −20%

Aim: Nivolumab has survival benefit in patients with previously treated advanced gastric cancer; however, about 60% of the patients did not respond to nivolumab, raising the necessity of its predictive biomarkers. Gut microbiome has been shown to be associated with efficacy of anti-PD-1 antibody in various types of cancers, but little is known about gastric cancer. Design: This is an observational/translational study to evaluate clinical outcomes of nivolumab and to discover novel immune-related biomarkers (gut microbiome, genetic polymorphism, gene expression and metabolome in plasma) in gastric cancer, using fecal and blood samples at two points before and after treatment. Candidate factors will be explored in first 200 patients and then validated in last 300 patients. Trial registration: UMIN000030850. [ABSTRACT FROM AUTHOR]

Objective: To find out if it is feasible to extend the indication for local resection of submucosal gastric cancer without increasing the risk of lymph node metastases. Design: Retrospective study. Setting: University hospital, Japan. Subjects: 104 patients with gastric cancer confined to the submucosal layer who underwent conventional gastrectomy with lymphadenectomy. Interventions: The risk of nodal metastases was analysed retrospectively depending on the depth of submucosal invasion, size of the tumour, and other clinicopathological findings. Main outcome measures: The degree of submucosal invasion, size of the tumour, and incidence of lymph node metastasis. Results: 15/104 patients (14%) had lymph node metastases. No patient in whom submucosal invasion was less than 500 μm or tumour was less than 15mm in diameter developed lymph node metastases. Fewer patients had lymphatic permeation (37/89) and venous involvement (21/89) in the group without lymph node metastases. Conclusion: These data seem to support the hypothesis that early, minimally invasive, gastric cancer measuring <15 mm in diameter could be treated by endoscopic mucosal or local resection, and gastrectomy with lymphadenectomy might be unnecessary. [ABSTRACT FROM AUTHOR]