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Ensuring a healthy lifestyle for the increasing number of Vietnamese migrants living in Japan is a key public health issue, including infectious disease responses such as tuberculosis (TB). To develop risk communication in relation to the TB response, this study aimed to explore the health issues and health-related behaviors of Vietnamese migrants living in Japan using a mixed method. A survey was conducted on Vietnam-born migrants, aged 18 years and over, in Tokyo. The survey consisted of questions on the following components: (1) demographics; (2) health-related issues and behavior; and (3) health-seeking behavior, information, and communication. A total 165 participants participated in the survey. The majority of the participants were young adults. 13% of the participants responded that they were concerned about their health. Moreover, 22% and 7% of the participants reported weight loss and respiratory symptoms, respectively. 44% of the participants answered they had no one to consult about their health in Japan when they needed it, and 58% answered they had no awareness of any Vietnamese-language health consultation services. Logistic regression analysis revealed that people who contact family members living in Vietnam or overseas using social networking services (SNSs) when they needed to consult someone about their health (adjusted odds ratio (AOR) = 6.09, 95% confidence interval (CI) 1.52–24.43) were more likely to present with one or more of the typical TB symptoms, compared to those who did not consult someone in this manner. Current smokers (OR = 3.08, 95% CI 1.15–8.23) were more likely to have health problems compared to non-smokers. The key informant interviews revealed that individual factors, the health system, and socio-environmental factors may hinder Vietnamese migrants’ health-seeking and health-information-seeking behaviors in Japan. TB risk communication approaches for migrants need to be developed considering their health-related behaviors while addressing their health needs.

Additional file 8: Table S8. Tumor cellularity in samples used for the first and second tumor–normal panel assays.

Additional file 2: Table S2. List of all short variants identified by the two panels with all pertinent information.

Additional file 5: Table S5. Number of reported short variants in the two panels according to the sample type.

Additional file 6: Table S6. Analysis of discordant variants that were detected only in one panel.

Additional file 4: Table S4. List of the 92 genes covered by the two panels.

Additional file 11: Figure S2. DNA quality and concordance rate between the two panels. (A) Distribution of reported variants in terms of concordance rate between the two panels (vertical axis) and DNA library concentration (horizontal axis). (B) Distribution of reported variants in terms of concordance rate between the two panels (vertical axis) and Q-value (horizontal axis).

Additional file 3: Table S3. List of all fusions identified by the two panels.

Additional file 9: Table S9. Number of point mutations in the concordant and discordant variants reported in the two different tumor–normal panel assays.

Additional file 7: Table S7. Number of point mutations in the variants reported in the tumor-only and tumor–normal panels.

832 Background: From June, 2019, two comprehensive genomic profiling (CGP) assays, "FoundationOne CDx" and “OncoGuide NCC Oncopanel”, were reimbursed by the national insurance system in Japan for patients who were refractory to standard chemotherapy. However, their clinical utility for chemotherapy-naïve cancer patients is unknown. Methods: We conducted a single institutional prospective observational study to evaluate the clinical utility of FoundationOne CDx assay (Cambridge, MA, USA) for the patients with chemotherapy-naïve advanced gastrointestinal malignancies. Patients with adequate H.E. sample were registered in this study. Primary outcome was the detection rate of at least one actionable/druggable cancer genomic alterations. The evidence levels were classified according to clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (Edition 1.0) (Sunami K. Cancer Sci. 2018). Results: From October 2018 to June 2019, a total of 238 patients were screened and the following 158 patients were registered: colorectal cancer (n = 60), gastric cancer (n = 19), esophageal cancer (n = 23), pancreatic cancer (n = 30), biliary tract cancer (n = 11), rare gastrointestinal malignancies (n = 15). The CGP data were obtained for 113 patients . Median turn-around time was 14 days (range 10-247 days). Actionable/druggable cancer genomic alterations were observed in 113 patients (100%)/ 65 patients (57.5%), respectively. Clinically relevant biomarkers and genomic alterations were identified in 22 patients (19.5%); BRCA2 (n = 4), ERBB2 (n = 4) , BRAF (n = 3) , EGFR (n = 3), FGFR2 (n = 2), MET (n = 2), NTRK (n = 2) , MSI-H (n = 2 ), TMB-high (n = 2), ALK (n = 1) , KIT (n = 1) and ROS1 (n = 1). Of note, novel biomarkers such as ROS1- GOPC fusion and PALB2 rearrangement were obtained in the patients with esophageal squamous cell carcinoma. Conclusions: This is the first study to evaluate the clinical utility of CGP in patient with chemotherapy-naïve advanced gastrointestinal malignancies. Our result indicated that CGP might provide a chance of potentially effective drugs as a novel approach in precision cancer medicine. Clinical trial information: UMIN000034830.

Background Immune checkpoint inhibitors (ICIs) are novel therapeutic agents that may lead to impressive and durable clinical benefits in various tumor types. However, more reliable biomarkers are needed to predict which patients are likely to respond to treatments. Tumor mutational burden (TMB) measured via next-generation sequencing (NGS)-based gene panel testing is a promising biomarker for response to ICIs in solid tumors. However, little is known about the preanalytical factors that can affect the TMB score. Methods The associations between the TMB score and sample characteristics, including sample DNA quality, sample type, sampling site, and storage period, were analyzed, using data of 199 patients with solid tumors who underwent OncoPrime, a hybrid capture-based NGS gene panel assay in our hospital. Results TMB score was significantly higher in samples that yielded a library concentration of 50 mutations/Mb) samples compared to the others. Conclusion Our results suggest that the TMB score estimated via NGS-based gene panel testing can be affected by the DNA library concentration and sample type (FFPE). Samples with poor quality may have elevated TMB due to false-positive variant calls.

Background Solid tumors are characterized by a highly acidic microenvironment that might hamper anti-cancer immunity. Several studies have shown that proton pump inhibitors (PPIs) can neutralize the pH of the tumor microenvironment and indirectly affect the function of cytotoxic T lymphocytes, suggesting a possible impact on clinical outcomes of immunotherapies. The aim of this analysis to explore the relationship between the use of PPIs and the efficacy of nivolumab monotherapy in 4 different types of cancer: malignant melanoma (MM), renal cell carcinoma (RCC), gastric cancer (GC), and head and neck cancer (HN). Methods A retrospective chart review was performed on 95 consecutive patients treated with nivolumab monotherapy between October 2014 and December 2018 at our hospital. Co-medication of PPIs was defined if the patient was prescribed any types of PPIs for more than 2 weeks during the administration of nivolumab. Response rates (RR), progression-free survival (PFS) and overall survival (OS) were compared between PPI users and non-users. Results The majority of patients were males (65.3%). The median age was 68 years. MM was the most common diagnosis (47.4%) followed by HN (24.2%) and GC (17.8%). PPIs were prescribed in 42% of the cases. There was no statistically significant difference in RR, OS or PFS between PPI users and non-users in GC and HN. However, co-medication of PPIs was associated with lower RR in MM, but higher RR in RCC. Although these results did not translate into significant changes in the PFS or OS, differences were observed in the Kaplan-Meyer curves of these two types of cancer. Conclusion Our analysis shows that PPIs could have different impact on the benefit of nivolumab monotherapy. These results suggest that unnecessary prescription of PPIs should be avoided in patients who are receiving PD1-based immunotherapy for the treatment of MM, and the effect of PPIs should be considered in interpreting the results from clinical trials.

148 Background: Tumor mutational burden (TMB) measured via next-generation sequencing (NGS)-based gene panel testing is a promising biomarker for response to immune checkpoint inhibitors (ICIs) in solid tumors. However, little is known about the characteristics of tissue sample that can affect the TMB score. Methods: Data of 199 patients with solid tumors who underwent NGS-based gene panel assay were reviewed. Associations between the TMB score and sample characteristics, including sample DNA quality, sample type, sampling site, and storage period, were analyzed. Clinical outcomes of patients with a high TMB score (≥10 mutations/megabase) who received anti-PD-1 antibodies (n = 22) were also analyzed. Results: TMB score was significantly higher in samples that yielded a DNA library concentration of < 5 nM and in samples obtained from formalin-fixed paraffin-embedded tissue (FFPE) compared to fresh frozen tissue. The sample storage period was also positively correlated with TMB score. Of the 22 patients with a high TMB score, partial response and stable disease were observed in two (9.1%) and five (22.7%) cases, respectively. Among 15 non-responders, 11 (73.3%) had a low DNA library concentration, thereby indicating that a high TMB score might be attributable to false positive mutation calls. Conclusions: Our results suggest that the TMB score estimated via NGS-based gene panel assay could be affected by the DNA library concentration, sample type and storage period.