BACKGROUND:Overall survival (OS) is the gold standard endpoint in oncology trials but requires long follow-up and may be confounded by post-protocol treatments. Radiographic progression-free survival (rPFS) is used as an earlier endpoint in metastatic castration-resistant prostate cancer (mCRPC). This study evaluated the validity of rPFS as a surrogate for OS in first-line, asymptomatic/mildly symptomatic, androgen receptor pathway inhibitor (ARPi) naïve, mCRPC using methods recommended by Germany's Institute for Quality and Efficiency in Health Care (IQWiG). MATERIALS AND METHODS:A systematic search in Ovid® identified randomized controlled trials reporting both rPFS and OS. Trial-level rPFS-OS correlations of hazard ratios (HRs) were calculated using bivariate random-effects meta-analysis (BRMA) and weighted linear regression (WLR). Correlation strength was interpreted per IQWiG criteria. The surrogate threshold effect (STE) was estimated to assess surrogacy. Leave-one-out cross-validation (LOOCV) assessed model robustness. The primary analysis included trials meeting the proportional hazards (PH) assumption. Sensitivity analyses included trials violating PH and further excluded outliers outside the 95% confidence intervals (CIs) in the correlation plot. RESULTS:Eleven RCTs were identified. The primary analysis (n = 10 trials) yielded medium correlations (BRMA R2: 0.78 [95% CI: 0.53-0.90]; WLR R2: 0.65 [0.40-0.90]; STE: 0.83). Sensitivity analyses yielded medium (n = 11 trials) and strong (n = 8 trials) correlations. LOOCV showed good predictive accuracy (75%-82%). CONCLUSION:Results suggest rPFS is a valid surrogate for OS in first-line ARPi naïve mCRPC per IQWiG criteria. A statistically significant OS effect can be inferred for a trial demonstrating an upper confidence limit of HR < 0.83 in rPFS.
Background and study aims:Data on survival for elderly Western patients undergoing endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) are scarce. Patients and methods:A multicenter, prospective, cohort study (2016-2022) was conducted in 26 Spanish hospitals that included patients aged > 70 years treated with ESD for EGC. The primary endpoint was overall survival in octogenarians compared with the previous decade; secondary outcomes included safety and technical success. Results:A total of 217 patients were included, 135 in their 70s (Group A) and 82 in their 80s (Group B). Group B had higher comorbidity (73.2% vs 46.7%; P < 0.001) and greater anticoagulant use (39.5% vs 17.3%; P < 0.001). Technical success and intraprocedural adverse events were similar, but delayed bleeding was higher in Group B (22.8% vs 8.2%; P = 0.003). No intraprocedural deaths occurred, but three patients in Group B (3.6%) died within 30 days (2 post-ESD, 1 post-surgery). Of 169 patients followed (77.9%), 28 died (16%), including two cancer-related deaths in Group B. Five-year overall survival (OS) was 78% in Group A and 57% in Group B ( P = 0.03); median survival in Group B was 58.5 months. Multivariate analysis identified American Society of Anesthesiologists performance status (ASA-PS) ≥ III as the only independent risk factor for lower OS (hazard ratio 3.9; 95% confidence interval 1.3-11.3; P = 0.014). Conclusions:Octogenarians with EGC benefit from ESD in a Western setting in terms of disease-free survival, but have lower long-term survival due to comorbidities, underscoring the importance of pre-procedure risk assessment. ESD is a proven safe technique, but in the subgroup of patients aged ≥ 80 years with severe comorbidities (ASA-PS ≥ IV), periprocedural mortality is increased and the indication should be carefully evaluated.
Introducción La infección por el virus del dengue presenta un amplio espectro clínico y el manejo de líquidos es fundamental para prevenir la progresión a choque; sin embargo, la sobrecarga hídrica puede generar desenlaces adversos. El objetivo de este estudio fue analizar la asociación entre el balance hídrico acumulado en las primeras 48 horas y los desenlaces clínicos en pacientes pediátricos hospitalizados con dengue. Métodos Se realizó un estudio observacional de cohorte prospectiva en dos instituciones de tercer nivel del sur de Colombia entre abril y diciembre de 2023. Se incluyeron pacientes entre un mes y 18 años con diagnóstico confirmado de dengue. El balance hídrico se clasificó en tres categorías (<5%, 5–7% y >7%). Se evaluaron desenlaces clínicos como estancia hospitalaria, estancia en UCI y presencia de choque. Resultados Se incluyeron 104 pacientes. Se observó una mayor estancia hospitalaria en el grupo con balance hídrico entre 5–7% (mediana 6 días, RIC 5–8) en comparación con <5% (4 días, RIC 3–5) (p=0,004). La presencia de choque fue más frecuente en pacientes con balance hídrico >5% (100% vs 76%, p=0,013). No se encontraron diferencias en la estancia en UCI ni en otras complicaciones. Conclusiones Un balance hídrico acumulado superior al 5% se asocia con mayor estancia hospitalaria y mayor frecuencia de choque en pacientes pediátricos con dengue, lo que resalta la importancia de un manejo cuidadoso de líquidos en esta población.
