Background: Immune-checkpoint inhibitors (ICI), including nivolumab and pembrolizumab, are among the standard treatments for previously treated advanced gastric cancer (AGC). This study aimed to evaluate the frequency of immune-related adverse events (irAEs) and the correlation between irAEs and their efficacy in AGC cases. Patients and Methods: Patients were divided into two groups according to irAE occurrence. The frequency of irAEs and the treatment outcome (response rate [RR], progression-free survival [PFS], and overall survival [OS]) were evaluated. The survival rates were evaluated by landmark analysis considering lead-time bias. Results: Among 108 patients who received nivolumab or pembrolizumab, 17 (15.7%) had irAEs. In a 4-week landmark analysis, the RR, median PFS, and median OS were 28.5%, 3.9 months (95% CI=2.8-9.3), and 12.2 months (95% CI=3.8-NA) in patients with irAEs, while 3.0% (2/65), 1.8 months (95% CI=1.4-2.1), and 3.5 months (95% CI, 2.9-5.1) in patients without irAEs, respectively. In multivariate analysis, irAEs were associated with better PFS (HR=2.08, 95% CI=1. 34-3.21). Conclusion: The occurrence of irAEs was associated with a better clinical outcome of ICIs in patients with AGC.Through development of immune-checkpoint inhibitors (ICIs), the prognosis of various cancer types, including gastric and gastroesophageal junction cancers, has improved (1, 2). Nivolumab, which is a monoclonal antibody targeting programmed cell death-1 (PD-1), has been shown to have efficacy and safety in heavily pretreated patients with gastric cancer (2). In a phase III placebo-controlled ATTRACTION-2 study in Asia, nivolumab monotherapy obtained an overall response rate (ORR) of 11.2% and increased the 12-month OS to 27% versus 11% by placebo [hazard ratio (HR)=0.63; p<0.0001], independent of PD-L1 positivity (2). In nonrandomized phase II KEYNOTE-158 study for advanced noncolorectal cancer with deficiency in DNA mismatch repair (dMMR) or high microsatellite instability (MSI-H), pembrolizumab monotherapy showed an ORR of 34.3%, median progression-free survival (mPFS) of 4.1 months, and median overall survival (mOS) of 23.5 months (3). In addition, 24 patients with dMMR/MSI-H gastric cancer 475 This article is freely accessible online.

Introduction: Third-line chemotherapy has been suggested to improve survival in patients with gastric cancer. This study aimed to identify factors associated with the induction of third-line chemotherapy for advanced gastric cancer, focusing on patient eligibility for clinical trial. Methods: We retrospectively analyzed 335 patients treated for unresectable or recurrent gastric cancer between April 2009 and May 2020. The patients were grouped into those that met the key eligibility criteria for clinical trial (136 patients, 40.6%) and those that did not (199 patients, 59.4%) before receiving first-line chemotherapy. Results: The overall survival (OS) were 16.8 months (95%CI, 14.0–19.6) and 9.3 months (95%CI, 7.8–11.0) in the eligible and ineligible group, respectively. Multivariate analyses to identify the risk factors associated with the induction of third-line chemotherapy revealed ineligibility of clinical trial (OR 1.95; 95%CI 1.15–3.31), number of metastatic sites (OR 1.99; 95%CI 1.23–3.22), low albumin concentration (OR 2.24; 95%CI 1.14–4.38) and a lack of complete or partial response to first-line treatment (OR 1.85; 95%CI 1.05–3.26). Indeed, in responders to first-line treatment for ineligible patients, the median OS was 17.7 months (95%CI, 10.6–27.9), respectively. Conclusions: Treatment outcomes were different for those eligible for clinical trials and those who were not. However, this study suggested that patients who responded to first-line treatment have more favorable prognoses when treated with salvage chemotherapy, even if they were deemed ineligible for clinical trials.

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Purpose The aim of the current study was to assess the inter-rater reliability and agreement of the Pressure Injury Primary Risk Assessment Scale for Home Care (PPRA-Home), a risk assessment scale recently developed for Japan-specific social welfare professionals called care managers, to predict pressure injury risk in geriatric individuals who require long-term home care needs. Methods A multicenter cross-sectional study was conducted at 30 home-based geriatric support services facilities located at four local districts in Japan. Eligible participants were individuals who needed partial or full assistance for daily living under Japan’s long-term care insurance system (care levels 1–5). The degree of agreement and kappa coefficient were calculated for each item and the total score, after which inter-rater reliability was determined. The effect of the participant’s care level on reliability was also evaluated as secondary analysis. Results A total of 96 participants were assessed by 83 care managers (two assessors scored each participant). The degree of agreement and calculated kappa coefficient of the PPRA-Home total score were 59% and 0.72, respectively, with the inter-rater reliability for the total score determined to be “Substantial”. Our subgroup analysis showed that the inter-rater reliability differed according to the participant’s care level. Accordingly, the kappa coefficient for the total score was lower in subgroup “care level 1–3” than in subgroup “care level 4–5” (0.51 and 0.76, respectively). Conclusion Our result showed that the PPRA-Home has substantial inter-rater reliability for evaluation of risks of pressure injury development at home care. However, some research focusing on intra-later reliability and validity of the PPRA-Home with adequate sample sizes are required to provide categorical conclusions on whether it can be used for the risk assessment scale in actual clinical settings.

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