Background The prognosis and recurrence patterns of early-diagnosed pancreatic ductal adenocarcinoma (PDAC), particularly following surgical resection, remain unclear. Methods This multicenter retrospective study analyzed patients who underwent surgical resection for PDAC between 2005 and 2023. Patients were categorized according to pathological stages 0, I, and II. Recurrence patterns and survival outcomes were compared among the three groups. Multivariate analysis was performed to identify independent risk factors for remnant pancreatic recurrence, including early-stage disease, postoperative follow-up of more than 5 years, and receipt of adjuvant chemotherapy. Results A total of 349 patients were included: 51 with stage 0, 77 with stage I, and 221 with stage II PDAC. The 5-year overall survival rates were 87%, 71%, and 49% for patients with stage 0, I, and II PDAC, respectively. Remnant pancreatic recurrence was observed in 10% of patients with stage 0 PDAC and 18% of patients with stage I PDAC, compared with 5% of those with stage II PDAC. Recurrence was significantly more frequent in stage I (P < 0.001) and tended to be higher in stage 0 (P = 0.062) than in stage II. Multivariate analysis identified pathological stage 0-I and postoperative follow-up of > 5 years as independent risk factors for remnant pancreatic recurrence. Conclusions Patients with early-stage PDAC exhibit a higher risk of remnant pancreatic recurrence than those with stage II disease. These findings underscore the importance of long-term pancreas-focused surveillance in early-stage PDAC to enable timely detection of late recurrence and potentially improve patients outcomes.
Background Group 2 pulmonary hypertension (PH), defined as PH caused due to left heart disease, remains a challenging condition. However, its prognostic impact and implications for emerging therapies are unclear. We aimed to evaluate the real‐world relationship between pulmonary vascular resistance (PVR) and prognosis in Group 2 PH and assess the efficacy of emerging therapies. Methods Two prospective registries supported by Japanese PH societies were analyzed: a current (2018–2024; n=563) and a previous (2012–2016; n=425) registry. The composite end points were hospitalization for heart failure, all‐cause death, ventricular assist device implantation, or cardiac transplantation. Results Stratified analyses using propensity score–matched data demonstrated a significant association between PVR >3 Wood units and prognosis in patients with Group 2 PH (6‐year event‐free rates, PVR >3 Wood units versus PVR ≦3 Wood units, previous registry: 72.9% versus 61.4%; current registry: 75.2% versus 55.4%). Consistent patterns were observed in both heart failure with reduced ejection fraction and heart failure with preserved ejection fraction subgroups. The use of SGLT2 (sodium‐glucose cotransporter‐2) inhibitors in the current registry was associated with improved outcomes in patients with elevated PVR, showing event‐free rates of 73.8% versus 35.5% in those without treatment. Among multivariate analyses including major treatment options, SGLT2 inhibitor treatment exhibited significant associations with improvement of composite end points. Conclusions Elevated PVR (>3 Wood units) identified a high‐risk subset of patients with Group 2 PH. The association between the use of SGLT2 inhibitors and better outcomes suggests a potential therapeutic role that warrants further investigation through controlled studies.
8099 Background: Combination therapy with anti-PD-L1 monoclonal antibodies and chemotherapy (ICI-chemotherapy) is the current standard treatment for patients(pts) with extensive-stage small cell lung cancer (ES-SCLC). However, its safety and efficacy in older pts (≥ 71 years) remain limited. Given the pivotal role of geriatric assessment (GA) in the older care, prospective data remain scarce. This study aimed to clarify the efficacy and safety of ICI-chemotherapy in older pts and to evaluate the association between GA and survival. Methods: This multicenter prospective study enrolled pts ≥ 71 years with ES-SCLC who received atezolizumab plus carboplatin and etoposide as first-line therapy. The primary endpoint was 1-year survival rate (SR). Based on existing results, the expected value was 60%, the threshold was 40% (α-error = 0.1 [two-sided], power = 0.75). The calculated sample size was 32 pts. A pre-treatment G8 assessment was mandatory for all pts. Secondary endpoints included safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: Between August 2022 and March 2024, a total of 32 pts were enrolled: median age 77 years (range 71–83); male/female = 27/5; PS 0/1 = 8/24, G8 scores ≥12 /＜12 /not collected were 19/12/1. The 1-year SR was 62.5% (95% confidence interval [CI]: 43.5–76.7). Median OS was 14.6 months (95% CI: 8.2–23.3), median PFS was 5.0 months (95% CI; 4.2–5.9), and ORR was 84.4% (95% CI; 66.3–93.7). Median OS by G8 (score ≥12 vs < 12) was 15.4 vs 12.3 months. Cox regression analysis including clinically important factors for survival (age, PS, G8, bone and brain metastasis at diagnosis) identified brain (HR; 3.1, 95% CI: 1.06 to 8.87; p = 0.039) and bone metastases (HR 3.5, 95% CI: 1.20 to 10.1; p = 0.022) as an independent factor. grade ≥ 3 adverse events (AEs) occurred in 87.5% of pts, and dose reduction was required in 45.1%. The most frequent AE was neutropenia (93.8%); one treatment-related death (stroke) was reported. Conclusions: ICI-combined chemotherapy demonstrated efficacy comparable to that in existing studies, but greater caution was required regarding safety in older pts. While G8 status did not affect survival in SCLC pts, the presence of bone or brain metastasis at diagnosis was identified as an independent prognostic factor. Clinical trial information: jRCT1061200024.
BACKGROUND:Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN. METHODS:This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026. ETHICS AND DISSEMINATION:This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences. TRIAL REGISTRATION NUMBER:jRCTs062240066.
