Niraparib was approved in the EU in 2017 as maintenance treatment for platinum-sensitive, recurrent ovarian cancer, and in 2020 as first-line maintenance after response to platinum-based chemotherapy. Results from a prospective, noninterventional, single-arm, postauthorization safety study characterizing the risk of developing myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) and other second primary malignancies (SPMs) in patients treated with niraparib in routine clinical practice are reported. Adult patients with epithelial ovarian cancer from Germany, Italy, the Netherlands, and Spain who received niraparib maintenance were enrolled. Patients were followed from niraparib initiation (index date) to the earliest of study completion at 5 years’ follow-up, study discontinuation, death, or final database lock (July 11, 2024). Incidence of MDS/AML, and other SPMs were reported, and treatment-emergent adverse events were summarized. Analyses were stratified by niraparib maintenance treatment line. Overall, 745 patients (181 first-line maintenance; 564 recurrent) were enrolled and included in this analysis (median age, 65 years; stage III/IV at diagnosis, 89.5
BACKGROUND AND AIMS:Evidence regarding the influence of vedolizumab (VDZ) on extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) is limited. Our aim was to analyze the effectiveness of VDZ in preexisting EIMs and the occurrence of de novo EIMs during VDZ therapy for IBD. METHODS:This observational, multicenter, retrospective cohort study included patients from the Spanish ENEIDA registry. All EIMs were assessed at baseline, and clinical response and worsening of IBD and EIMs were evaluated at 3 and 12 months after VDZ initiation, according to the physician's assessment. RESULTS:We retrospectively identified 551 patients with IBD treated with VDZ. At baseline, 133 patients (24.1%) had preexisting EIMs, with 77 having active EIMs. At 3 months, 29.9% of these patients showed clinical improvement, 16.9% experienced worsening, and 53.2% remained unchanged. Clinical response of IBD at 3 months was the only factor associated with EIM improvement (OR 3.72; 95% CI 1.08-12.83). Among 56 patients with inactive EIMs at baseline, 13.5% experienced worsening after 12 months. During follow-up, 25 patients (4.5%) developed 27 de novo EIMs. The presence of 2 preexisting EIMs was the only factor associated with de novo EIM onset (OR 16.2; 95% CI 4.3-60.9). Worsening of preexisting EIMs or de novo EIMs led to VDZ discontinuation in 15 patients (5.8% of all patients who discontinued VDZ and 2.7% of the entire cohort). CONCLUSIONS:VDZ achieved clinical response of active EIMs in nearly one-third of patients after 3 months. Although infrequent, VDZ may exacerbate inactive EIMs and induce de novo EIMs during therapy, potentially leading to treatment discontinuation.
BACKGROUND:Understanding the epidemiology of trauma-related mortality is essential to guide quality improvement and optimize trauma system performance. However, the absence of comprehensive regional registries often limits accurate assessment. This study aimed to characterize trauma-related deaths in Biscay (Spain), a European region with an intermediately mature trauma care system, including both prehospital and in-hospital deaths. METHODS:A retrospective, population-based observational study included all trauma-related deaths in 2019 and 2022. Data were obtained from forensic autopsy reports and cross-referenced with clinical registries from the Basque Health Service. Variables analyzed were demographics, injury mechanisms, severity scores (AIS, ISS, NISS), ASA-PS classification, medico-legal intent, and physiopathological cause of death. Years of potential life lost before age 70 (YPLL70) were calculated. RESULTS:A total of 313 trauma-related deaths were recorded: 151 in 2019 and 162 in 2022. Median age was 72 years (P25-P75: 52-84), and 67% were men. Low-energy falls accounted for 41% of cases and high-energy falls for 30%. The medico-legal intent was mainly unintentional (69%), followed by suicide (29%). Traumatic brain injury (47%) and massive hemorrhage (29%) were the leading physiopathological causes. Two distinct profiles emerged: young adults sustaining high-energy trauma with severe injuries, and older adults dying after low-energy mechanisms. CONCLUSION:This study highlights a dual epidemiological pattern of trauma-related mortality in a region with an intermediately mature trauma system. Adapting trauma care pathways to address both high- and low-energy trauma, particularly in an aging population, may improve efficiency, equity, and clinical outcomes.
To study the influence of parental age on aneuploidy rates (AR) in PGT-A cycles and on the recurrence rate. A total of 16,029 PGT-A cycles were studied over a 9-year period. The median age was 40.0 [37.0; 41.0] in women and 40.0 [37.0; 43.0] in men. In 48.3
Preventing exacerbations in chronic obstructive pulmonary disease (COPD) is a priority, as exacerbations accelerate progression, increase mortality, and impair quality of life. The use of biologics that act on specific inflammatory pathways through monoclonal antibodies in COPD offers a precision medicine strategy for high-risk patients who continue to experience frequent exacerbations despite optimal inhaled treatment. However, the use of these biologic therapies in COPD presents significant challenges, stemming from the clinical heterogeneity of the disease and the limited evidence available. Their indication and management must be personalized and precise, raising questions about how to implement a biologic therapy strategy in COPD in clinical practice. This clinical protocol focused on the use of biologic therapy in COPD sets out the objectives ("Why"), describes the selection of candidates ("In which patients"), the monitoring of response ("What should be measured") and how to implement it in clinical practice ("How") based on the available evidence and expert consensus.
