Hospital Son Llatzer

Abstract Background: Ribociclib (RIB), a CDK4/6 inhibitor, in combination with endocrine therapy (ET), has demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC), as evidenced by the MONALEESA phase III trials. Despite these robust clinical trial outcomes, to our knowledge, real-world data on safety and tolerability of RIB + ET, in the Spanish healthcare setting, remain scarce. This study aims to address this gap by evaluating the safety profile of RIB in combination with a non-steroidal aromatase inhibitor (NSAI) as first-line (1L) therapy in both younger and older patients with HR+/HER2− ABC, based on routine clinical practice in Spain. In this report, we show a preliminary result from the first 147 patients. The final analysis will include at least 500 patients. Methods: This is a non-interventional, retrospective cohort study involving patients diagnosed with HR+/HER2− ABC who initiated 1L treatment with RIB + NSAI between January 2021 and August 2023. Data was collected exclusively from medical records across participating centers. Following the final patient inclusion date, a subsequent 12-month follow-up period (until August 2024) is established to ensure adequate exposure to RIB across all participants and to monitor the potential emergence of adverse events (AEs). If discontinuation occurs for any reason, the duration of exposure to RIB was measured. Results: The median follow-up was 23.8 months (range: 3.1 - 43.4), and the median time on treatment was 18.39 months (range: 0.5 - 43.4). Stratified by age, the PFS rate at 24 months was 63.3% (95% CI: 52.6 - 72.3) in patients aged ≤ 65 years and 65.5% (95% CI: 47.0 - 78.9) in those aged > 65 years. In general, the safety profile was consistent with previously reported data, with no new safety signals. From 141 patients reporting at least one AEs, 16 discontinued RIB due to AEs (10.9% of the whole population). The two most common AEs for both, safety and tolerability are summarized in Table 1. Conclusions: Preliminary real-world data suggest that RIB + NSAI is well tolerated in both younger and older patients with HR+/HER2− ABC in the Spanish healthcare setting. PFS outcomes appear consistent across age groups. Final results from the full set of at least 500 patients will provide more definitive insights into the safety profile and treatment outcomes. Citation Format: T. Díaz-Redondo, R. Sánchez-Bayona, P. Zamora Auñon, I. Garcia-Fructuoso, A. Bujosa, J. Sánchez, J. Ponce Lorenzo, A. Jiménez Ortega, E. Marin Olivo, A. Corbera, A. López. Ribo-age: age-stratified descriptive analysis of adverse drug reactions in patients with advanced breast cancer treated with ribociclib plus nonsteroidal aromatase inhibitors: preliminary results [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-12-06.

In November 2021, the Surviving Sepsis Campaign (SSC) published an update to its 2016 guidelines and recommendations. Subsequently, during the CIMU 2022 (33rd World Congress on Emergency Medicine, held in March 2022 in Guadalajara, Mexico), the 2021 SSC Guidelines were reviewed and analyzed from the perspective of emergency physicians (EPs). The experts involved in this task also reached consensus and published several key points of greatest interest and concern to EPs regarding the management of patients with severe infection or sepsis in hospital emergency departments (EDs). These points included several improvement proposals developed by GTLATINFURG (Latin American Working Group for Improving Infection Care in Emergency Departments) and formally presented in what became known as the "Guadalajara Declaration." That document outlined complementary or alternative considerations to the 2021 SSC Guidelines. The first proposal was to "develop guidelines aimed at detecting, preventing progression, and managing patients with severe infection and sepsis in EDs." Since then-and owing to numerous original research studies and review articles published by the GT-LATINFURG and INFURG-SEMES groups (Infection Study Group of the Spanish Society of Emergency Medicine)-we can now claim that there is scientific evidence generated in EDs themselves, or at least that existing evidence has been reviewed while considering the specific role of EPs. The main aim of this consensus document, as the initial presentation of the first proposal of the Guadalajara Declaration, is to analyze-based on routine clinical practice, experience, available evidence, and the perspective of ED physicians-several key issues and controversies in order to establish recommendations through expert consensus grounded in current scientific evidence.

ABSTRACTBackgroundLimited data are available on the management and outcomes of postoperative Crohn's disease (CD) in older patients. We aimed to describe the management of CD in the postoperative setting and assess surgical postoperative recurrence (POR) in this population.MethodsThis was a case‐control study including all adult patients with CD from the ENEIDA registry who had undergone a first intestinal resection with ileo‐colonic anastomosis. Patients were grouped according to their age at the time of the first surgery in older (over 60 years) subjects and controls (between 18 and 60 years of age).ResultsA total of 3982 (535 older subjects and 3454 controls) underwent a first intestinal resection for CD with an ileo‐colonic anastomosis. Time from CD diagnosis to surgery was significantly longer in older patients (114 ± 128 vs. 93 ± 97 months; p < 0.001). Older patients also had a lower proportion of penetrating CD (25% vs. 39%; p < 0.0001) and perianal disease (14% vs. 25%; p < 0.0001). A significantly lower proportion of older patients started preventive therapies for POR (32% vs. 51%; p < 0.0001). The cumulative risk of surgical POR was 3.2%, 5.3% and 10.1% in the older group and 3.6%, 6.6% and 14.2% in the control group at three, five and 10 years, respectively (p = 0.093). In the multivariate logistic regression analysis, only prevention with thiopurines was associated with a lower risk of surgical POR.ConclusionsAlthough postoperative preventive therapy with immunomodulators or biologicals is prescribed less often in older patients after a first intestinal resection, they develop surgical POR as often as younger adult patients.