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Abstract Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.

BACKGROUND AND OBJECTIVE:The distribution of body fat is closely related to cardiovascular disease and outcomes, although its impact on patient prognosis after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) has not been evaluated. We investigated the impact of truncal fat distribution on long-term clinical outcomes after DES treatment. METHODS:In 441 DES-treated patients, dual energy X-ray absorptiometry was performed to assess total and regional body fat distribution after index PCI. The ratio of truncal fat to total body fat mass (%FMtrunk/FMtotal) was calculated as a representative parameter for truncal fat distribution. The primary endpoint was major adverse cardiac events (MACE), a composite of ischemia-driven target vessel revascularization (TVR), non-procedural myocardial infarction, cardiac death at 5 years. RESULTS:During the median follow-up duration of 1780 days, MACE occurred in 22.0% of patients, with the highest-quartile group of %FMtrunk/FMtotal having a higher rate than the lowest quartile group (27.8% vs. 15.3%; log rank p = 0.026). The difference was driven by a higher rate of ischemia-driven TVR (25.9% vs. 9.9%; log rank p = 0.008). In multivariable Cox regression analyses, %FMtrunk/FMtotal was independently associated with MACE (hazard ratio: 1.075; 95% CI: 1.022-1.131; p = 0.005), but body mass index (BMI) was not. CONCLUSIONS:In DES-treated patients, truncal fat distribution is associated with unfavorable clinical outcomes and is more clinically relevant than BMI.

Objectives: To develop and validate a new risk-of-bias tool for nonrandomized studies (NRSs). Study Design and Setting: We developed the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS). A validation process with 39 NRSs examined the reliability (interrater agreement), validity (the degree of correlation between the overall assessments of RoBANS and Methodological Index for Nonrandomized Studies [MINORS], obtained by plotting the overall risk of bias relative to effect size and funding source), face validity with eight experts, and completion time for the RoBANS approach. Results: RoBANS contains six domains: the selection of participants, confounding variables, the measurement of exposure, the blinding of the outcome assessments, incomplete outcome data, and selective outcome reporting. The interrater agreement of the RoBANS tool except the measurement of exposure and selective outcome reporting domains ranged from fair to substantial. There was a moderate correlation between the overall risks of bias determined using RoBANS and MINORS. The observed differences in effect sizes and funding sources among the assessed studies were not correlated with the overall risk of bias in these studies. The mean time required to complete RoBANS was approximately 10 min. The external experts who were interviewed evaluated RoBANS as a ''fair'' assessment tool. Conclusions: RoBANS shows moderate reliability, promising feasibility, and validity. The further refinement of this tool and larger validation studies are required. [ABSTRACT FROM AUTHOR]