Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic inflammatory condition associated with functional impairment and a relevant socioeconomic burden. While direct healthcare costs have been partially described in Spain, indirect costs related to loss of work productivity remain insufficiently characterized. This study aimed to estimate the indirect costs associated with CRSwNP in Spain from a societal perspective, focusing on productivity losses due to absenteeism and presenteeism. A cost-of-illness analysis with a one-year time horizon and a societal perspective was conducted in working-age adults (18–64 years) with CRSwNP in Spain. Disease prevalence (0.8
Epidemiological data from Sapin are lacking, especially in a publication relating Spanish data and prevalence of programmed cell death ligand-1 (PD-L1) expression. This study aimed to evaluate the prevalence of PD-L1 expression by Combined Positive Score (CPS) ≥ 5 in patients with advanced esophagogastric adenocarcinoma (aEGAC) in Spain. This observational, retrospective, and multicenter study collected sociodemographic and clinical data from adult patients with locally advanced unresectable, recurrent, or metastatic EGAC across 21 centers in the AGAMENON-SEOM registry. CPS PD-L1 expression was centrally analyzed using the IHC 28–8 pharmDx. A total of 166 patients were included, with 144 valid and evaluable samples. The primary tumor locations were stomach (70.1
LBA109 Background: Although PD-1/PD-L1 inhibitors plus chemo have expanded treatment options for previously untreated PD-L1–positive advanced TNBC, there still remains a critical unmet need to improve outcomes. SG previously demonstrated significant clinical benefit in pretreated metastatic TNBC (mTNBC). We report results from the ASCENT-04/KEYNOTE-D19 study in patients with previously untreated, PD-L1–positive (CPS ≥ 10; 22C3 assay) locally advanced unresectable or mTNBC. Methods: Patients were randomized 1:1 to SG (10 mg/kg IV, day 1 & 8) + pembro (200 mg, day 1, max 35 cycles) in 21-day cycles or chemo (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + pembro until disease progression or unacceptable toxicity. Randomization was stratified by curative treatment-free interval, geography, and prior exposure to anti–PD-(L)1 therapy in the curative setting. Primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS); objective response rate (ORR) and duration of response (DOR) by BICR; and safety. Results: 443 patients were randomized at a 1:1 ratio: 221 to SG + pembro and 222 to chemo + pembro. The median follow-up was 14 mo. SG + pembro showed a significant improvement in PFS by BICR compared with chemo + pembro (hazard ratio [HR], 0.65; 95% CI, 0.51-0.84; P = .0009; Table). Median DOR was 16.5 mo for SG + pembro vs 9.2 mo for chemo + pembro (Table). Although OS data were immature, a positive early trend in OS improvement was also noted. The most frequent (≥ 10% of patients) grade ≥ 3 treatment-emergent adverse events (TEAEs) with SG + pembro were neutropenia (43%) and diarrhea (10%); and with chemo + pembro were neutropenia (45%), anemia (16%), and thrombocytopenia (14%). Conclusions: SG + pembro led to a statistically significant and clinically meaningful improvement in PFS vs chemo + pembro with durable responses, no new safety concerns for SG or pembro, and a lower rate of treatment discontinuation due to TEAEs in patients with previously untreated, PD-L1–positive advanced TNBC. These data support the use of SG + pembro as a potential new standard of care treatment in this patient population. Clinical trial information: NCT05382286 . Efficacy, BICR, intent-to-treat SG + pembro(n = 221) Chemo + pembro(n = 222) Median PFS (95% CI), mo 11.2 (9.3-16.7) 7.8 (7.3-9.3) HR (95% CI); P -value (adjusted for randomization stratification factors) 0.65 (0.51-0.84); P = .0009 ORR (95% CI), % 59.7 (52.9-66.3) 53.2 (46.4-59.9) Median DOR (95% CI), mo 16.5 (12.7-19.5) 9.2 (7.6-11.3) Safety (TEAEs), all treated, n (%) n = 221 n = 220 Any grade; grade ≥ 3 220 (> 99); 158 (71) 219 (> 99); 154 (70) Led to dose reduction 78 (35) 96 (44) Led to any treatment discontinuation 26 (12) 68 (31)
BACKGROUND:Triple-negative breast cancer is an aggressive breast cancer subtype, and there remains an unmet need to improve outcomes in patients with previously untreated, programmed death ligand 1 (PD-L1)-positive, locally advanced unresectable or metastatic triple-negative breast cancer. METHODS:In this phase 3, open-label, international trial, we randomly assigned patients in a 1:1 ratio to receive sacituzumab govitecan plus pembrolizumab or chemotherapy plus pembrolizumab. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included overall survival, objective response (complete or partial response) and duration of response as assessed by blinded independent central review, and safety. RESULTS:A total of 443 patients were randomly assigned to receive sacituzumab govitecan plus pembrolizumab (221 patients) or chemotherapy plus pembrolizumab (222 patients). The median progression-free survival was 11.2 months (95% confidence interval [CI], 9.3 to 16.7) with sacituzumab govitecan plus pembrolizumab and 7.8 months (95% CI, 7.3 to 9.3) with chemotherapy plus pembrolizumab (hazard ratio for disease progression or death, 0.65; 95% CI, 0.51 to 0.84; two-sided P<0.001). Data for overall survival were immature. The percentage of patients with an objective response was 60% (95% CI, 53 to 66) with sacituzumab govitecan plus pembrolizumab and 53% (95% CI, 46 to 60) with chemotherapy plus pembrolizumab; among patients with a response, the median duration of response was 16.5 months (95% CI, 12.7 to 19.5) and 9.2 months (95% CI, 7.6 to 11.3), respectively. Adverse events of grade 3 or higher occurred in 71% of the patients receiving sacituzumab govitecan plus pembrolizumab and in 70% of those receiving chemotherapy plus pembrolizumab; the incidence of treatment discontinuation due to adverse events was 12% and 31%, respectively. Adverse events leading to death occurred in 3% of the patients in each group. CONCLUSIONS:Sacituzumab govitecan plus pembrolizumab led to significantly longer progression-free survival than chemotherapy plus pembrolizumab among patients with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. (Funded by Gilead Sciences; ASCENT-04/KEYNOTE-D19 ClinicalTrials.gov number, NCT05382286.).
The European Renal Association (ERA) Registry collects data on patients with kidney failure receiving kidney replacement therapy (KRT). This paper presents a summary of the ERA Registry Annual Report 2023, and focuses specifically on comparisons by age. The complete ERA Registry Annual Report 2023 is available in the Supplementary information. For 2023, data were collected from 34 countries in Europe and countries bordering the Mediterranean Sea. Using these data, incidence and prevalence of KRT, kidney transplantation rates, survival probabilities, and expected remaining lifetimes were calculated. In 2023, the ERA Registry covered 519 million people in the participating countries. The incidence of KRT was 151 per million population (pmp). Among incident patients, 29% were aged ≥75 years, 64% were male, and the most common primary renal disease (PRD) was diabetes mellitus (22%). Most patients (83%) started KRT with haemodialysis (HD), 11% started with peritoneal dialysis (PD), and 6% underwent pre-emptive kidney transplantation. On 31 December 2023, the prevalence of KRT was 1101 pmp. Among prevalent patients, 24% were aged ≥75 years, 62% were male, and the most common PRD was of miscellaneous origin (18%). Moreover, 56% of prevalent patients received HD, 5% received PD, and 39% were living with a functioning graft. In 2023, the kidney transplantation rate was 43 pmp, with 69% of kidneys coming from deceased donors. For patients starting KRT between 2014 and 2018, 5-year survival probability was 51%. The proportions of incident and prevalent patients aged ≥75 varied considerably across European countries. In addition, incident patients aged ≥75 were more often male, and had more often hypertension as PRD compared with younger patients. Only 1% of incident patients aged ≥75 received a pre-emptive kidney transplant, while among prevalent patients of the same age, 22% was living with a functioning graft.
