Background:Gastric cancer (GC) with peritoneal dissemination remains a challenge with poor prognosis and limited treatment options. We aimed to compare solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) vs. nanoparticle-albumin-bound paclitaxel (nab-PTX) + RAM as second-line therapy for unresectable or recurrent GC with peritoneal dissemination. Methods:This prospective, randomised, open-label, multicentre phase 2 trial was conducted at 58 centres within the West Japan Oncology Group (WJOG) in Japan. Eligible participants were patients with histologically-confirmed GC with peritoneal dissemination refractory or intolerant to first-line therapy. Patients were randomised 1:1 to receive sb-PTX + RAM or nab-PTX + RAM. Primary endpoint was overall survival (OS); key secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety, and protocol-specified biomarker analyses including the assessment of stromal caveolin-1 (Cav-1) expression by immunohistochemistry on archival tumour specimens. The data cutoff for the analysis presented herein was January 27, 2021. This trial was registered in the Japan Registry of Clinical Trials (jRCTs031180022). Findings:Between Oct 1, 2018, and Jan 27, 2020, 105 patients were assigned to sb-PTX + RAM (n = 53) or nab-PTX + RAM (n = 52). Median follow-up was 18.1 months. Median OS was 8.1 months with sb-PTX + RAM and 7.2 months with nab-PTX + RAM (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.960; 95% CI, 0.621-1.484; P = 0.631). Median PFS was 5.1 vs. 3.9 months (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.965; 95% CI, 0.642-1.450; P = 0.893). ORR was 20.7% vs. 20.0% (P = 0.993), and DCR was 77.4% vs. 63.5% (P = 0.150), with sb-PTX + RAM and nab-PTX + RAM. Grade≥3 neuropathy occurred in 7.5% with sb-PTX + RAM and 17.6% with nab-PTX + RAM, and febrile neutropenia in 11.3% vs. 5.9%. In biomarker analysis, OS and PFS improved stepwise with increasing Cav-1 expression in patients receiving nab-PTX + RAM (P = 0.007, P = 0.012); no such association was observed with sb-PTX + RAM. Among patients with high stromal Cav-1 expression (IHC score 3+), nab-PTX + RAM showed some evidence of improved OS compared with sb-PTX + RAM (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.371; 95% CI, 0.130-1.060; P = 0.055). The interaction between Cav-1 expression and treatment arm showed a non-significant trend (HR for interaction, 0.364; 95% CI, 0.115-1.152; P = 0.086), consistent with this finding. Interpretation:Treatment with nab-PTX + RAM did not meet the prespecified threshold (HR < 0.90) for promising efficacy in patients with GC and peritoneal dissemination. High stromal Cav-1 expression was associated with improved efficacy of nab-PTX + RAM. Future studies should prospectively validate the predictive value of stromal Cav-1 in patients receiving nab-PTX + RAM. Funding:Taiho Pharmaceutical Co. Ltd.
Treatment-free remission (TFR) is an emerging goal for patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI). However, long-term TFR durability in real-world settings remains understudied. The J-SKI study, a large observational study, was conducted to evaluate long-term TFR outcomes in Japanese patients with CML. This interim analysis included 795 eligible patients from the prospective (n = 283) and retrospective (n = 512) cohorts. With a median follow-up of 32 months (range 0.8–168) after TKI discontinuation, the 5-year TFR rate was 65.2
Server-based screening tools impose subscription costs, while open-source alternatives require coding skills, and full-text screening has remained outside the scope of no-code open-source tools. We developed TiAb Review Plugin, an open-source Chrome browser extension that provides no-code, serverless artificial intelligence (AI)-assisted study selection covering both title and abstract (T A) screening and full-text screening. It uses Google Sheets as a shared database and Google Drive as a PDF store, and users supply their own large language model (LLM) API key. For T A screening, it offers manual review, LLM batch screening, and machine learning (ML) active learning. For full-text screening, it retrieves open-access PDFs from PubMed Central, Europe PMC, Unpaywall, OpenAlex, and publisher pages, supports blinded dual review with structured exclusion reasons and adjudication, optionally obtains an LLM judgment with page-anchored evidence, and computes PRISMA 2020 flow counts. We re-implemented the default ASReview algorithm (TF-IDF with Naive Bayes) in TypeScript and compared it with the Python original using 10-fold cross-validation on six datasets. For LLM T A screening, we compared 16 parameter configurations on a benchmark dataset, validated the best (Gemini 3.0 Flash, low thinking budget, TopP 0.95) on five public datasets (1,038 to 5,628 records; 0.5
Chronic kidney disease (CKD) is a global health issue, yet most patients remain undiagnosed. It is unclear whether recommendations for physician visit based on estimated glomerular filtration rate (eGFR) promote appropriate clinical practices among individuals with undiagnosed CKD. We aimed to investigate the impact of eGFR-based physician-visit recommendations on CKD-related clinical practices among health insurance beneficiaries who participated in annual health screening. We used health screening and administrative data of Japanese adults aged 40–74 years who underwent screening between April 2022 and March 2023. Participants were mailed their results along with eGFR-based recommendations for physician visits when eGFR was below designated cutoffs. To evaluate the impact of these recommendations on the receipt of guideline-concordant CKD practices within 1 year, we used a regression discontinuity model, treating eGFR as the running variable with a cutoff of 60 mL/min/1.73 m2. Our primary outcomes were serum creatinine (sCr) measurement and CKD diagnosis, which substantiate an actual physician visit. Secondary outcomes included urinary protein assessment and nutritional guidance, both essential for appropriate CKD management. We included 206,222 participants (62.2
