Real-world data (RWD) with avelumab in patients (pts) with locally advanced or metastatic urothelial cancer (la-mUC): The AVEBLADDER study.
Artículo Materias > Biomedicina Universidad Europea del Atlántico > Investigación > Artículos y libros Abierto Inglés Background: Current standard of care for la-mUC pts who show no progression after platinum-based chemotherapy is maintenance with avelumab based on survival improvement (JAVELIN 100; Powles et al. NEJM 2020). However, the available RWD evidence on the use of avelumab in the E.U. is limited and there are concerns about the low uptake of this strategy based on figures from American series (Mamtani R et al; JAMA Netw Open 2023). We present here data on the use of avelumab in a large cohort of pts from different centres in Spain within the academic group GO NORTE. Methods: AVEBLADDER is a retrospective observational analysis in which clinical information was retrieved from pts treated across 14 centres in 13 provinces in Northern Spain. The study population included adult pts diagnosed with la/mUC (January 1, 2021-June 30, 2023) followed from date of diagnosis until death, loss to follow-up or end of study. Median overall survival (OS) was determined using the Kaplan-Meier method. Results: 419 pts were included. Median age was 71 [range 42-88]; 80% were males; 81% had primary bladder tumours and 94% predominant urothelial histology. Seventy three percent of pts had visceral/bony metastases and 59% were unfit for cisplatin. Most common 1st line treatment (tx) [88%] was platinum-based chemotherapy [median number of cycles 4]. Out of 369 pts who received platinum-based chemotherapy, non-progression (CR, PR or SD) was reported in 230 pts [62%], of whom only 85 pts [37%] received maintenance avelumab. Fifty-eight pts treated with avelumab were evaluable for response: 7 (10 %) achieved a CR, 12 (14%) PR, 22 (26%) SD and 17 (20%) PD. The most common reason for non-receiving avelumab in our series was lack of access/reimbursement according to country/region policy. Overall, 168 pts [40%] started 2nd line tx and atezolizumab was the most used agent, only 41 pts [24%] received third line tx. With a median follow-up of 11 months, 194 pts [46%] are still alive and median overall survival (OS) is estimated to be 28 months (95% CI 23-not reached) with maintenance avelumab vs 11 months (95% CI 9-13) for those who did not receive this drug. Conclusions: Despite the demonstrated improvement in OS for maintenance avelumab, its uptake in our series was low with roughly 40% of the pts. New policies and better access to the drug will most likely improve these figures and hopefully also the proportion of patients who progress to receive a third line where novel therapies are currently being implemented. AVEBLADDER is a study sponsored by GO NORTE a non-for-profit GU cooperative group. metadata Sotelo, Marta; Peláez, Mireia; Basterretxea, Laura; Varga, Estrella; Sánchez-Escribano, Ricardo; Pujol, Eduardo; Santander, Carmen; Martinez-Kareaga, Mireia; Arruti Ibarbia, Mikel; Rodríguez Ledesma, Inma; Álvarez-Fernández, Carlos; Piedra, Pablo; Calderero, Veronica; Lainez, Nuria; Verdun Aguilar, Juan Antonio; Gil-Arnaiz, Irene; Fernandez, Ricardo; Mazas Pérez-Oleaga, Cristina y Duran, Ignacio mail SIN ESPECIFICAR, mireia.pelaez@uneatlantico.es, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, cristina.mazas@uneatlantico.es, SIN ESPECIFICAR (2024) Real-world data (RWD) with avelumab in patients (pts) with locally advanced or metastatic urothelial cancer (la-mUC): The AVEBLADDER study. Journal of Clinical Oncology, 42 (16_sup). e16559-e16559. ISSN 0732-183X
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Background: Current standard of care for la-mUC pts who show no progression after platinum-based chemotherapy is maintenance with avelumab based on survival improvement (JAVELIN 100; Powles et al. NEJM 2020). However, the available RWD evidence on the use of avelumab in the E.U. is limited and there are concerns about the low uptake of this strategy based on figures from American series (Mamtani R et al; JAMA Netw Open 2023). We present here data on the use of avelumab in a large cohort of pts from different centres in Spain within the academic group GO NORTE. Methods: AVEBLADDER is a retrospective observational analysis in which clinical information was retrieved from pts treated across 14 centres in 13 provinces in Northern Spain. The study population included adult pts diagnosed with la/mUC (January 1, 2021-June 30, 2023) followed from date of diagnosis until death, loss to follow-up or end of study. Median overall survival (OS) was determined using the Kaplan-Meier method. Results: 419 pts were included. Median age was 71 [range 42-88]; 80% were males; 81% had primary bladder tumours and 94% predominant urothelial histology. Seventy three percent of pts had visceral/bony metastases and 59% were unfit for cisplatin. Most common 1st line treatment (tx) [88%] was platinum-based chemotherapy [median number of cycles 4]. Out of 369 pts who received platinum-based chemotherapy, non-progression (CR, PR or SD) was reported in 230 pts [62%], of whom only 85 pts [37%] received maintenance avelumab. Fifty-eight pts treated with avelumab were evaluable for response: 7 (10 %) achieved a CR, 12 (14%) PR, 22 (26%) SD and 17 (20%) PD. The most common reason for non-receiving avelumab in our series was lack of access/reimbursement according to country/region policy. Overall, 168 pts [40%] started 2nd line tx and atezolizumab was the most used agent, only 41 pts [24%] received third line tx. With a median follow-up of 11 months, 194 pts [46%] are still alive and median overall survival (OS) is estimated to be 28 months (95% CI 23-not reached) with maintenance avelumab vs 11 months (95% CI 9-13) for those who did not receive this drug. Conclusions: Despite the demonstrated improvement in OS for maintenance avelumab, its uptake in our series was low with roughly 40% of the pts. New policies and better access to the drug will most likely improve these figures and hopefully also the proportion of patients who progress to receive a third line where novel therapies are currently being implemented. AVEBLADDER is a study sponsored by GO NORTE a non-for-profit GU cooperative group.
| Tipo de Documento: | Artículo |
|---|---|
| Clasificación temática: | Materias > Biomedicina |
| Divisiones: | Universidad Europea del Atlántico > Investigación > Artículos y libros |
| Depositado: | 18 Sep 2024 23:30 |
| Ultima Modificación: | 18 Sep 2024 23:30 |
| URI: | https://repositorio.uneatlantico.es/id/eprint/14246 |
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Background Post-kala-azar dermal leishmaniasis (PKDL) is a skin condition that can become a complication in about 15 % of patients who have had kala-azar. Despite its significance, treatment options for PKDL are still limited. This systematic review and meta-analysis aim to evaluate the efficacy of amphotericin B for this condition. Methods PubMed, Embase, Cochrane, and Web of Science databases were searched for randomized controlled trials (RCTs) that reported the efficacy of Liposomal Amphotericin B in the treatment of PKDL. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Events per 100 observations with 95 % confidence intervals were performed for outcomes. Results Nine studies with 639 patients were included, the treatment durations ranging from 7 to 60 days. The mean age ranged from 9.2 to 31.0 years, and 359 patients were male. The PKDL treatment with liposomal amphotericin B resulted in a cure rate of 91.36 % (95 % CI: 76.60-97.15). However, a relapse was observed in 11.42 % (95 % CI: 6.20-20.8) of patients. Adverse events were common, with hepatic enzyme elevation (ALT/AST) being the most frequent (61.75 %; 95 % CI: 21.81–90.33), followed by fever in 29.93 % of cases (95 % CI: 5.09–77.30). Among the more serious side effects, decreased serum potassium was observed in 19.27 % (95 % CI: 3.84–58.82), and increased serum creatinine, indicative of nephrotoxicity, occurred in 15.08 % (95 % CI: 3.97–43.27). Nausea or vomiting, although less severe, affected 12.36 % of patients (95 % CI: 4.81–28.25). Conclusions These findings highlight that while liposomal amphotericin B is a potent therapeutic option for PKDL, its administration requires careful management and clinical vigilance to optimize outcomes and minimize risks.
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Enzymatic treatment shapes in vitro digestion pattern of phenolic compounds in mulberry juice
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What works in financial education? Experimental evidence on program impact
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Single-cell omics for nutrition research: an emerging opportunity for human-centric investigations
Understanding how dietary compounds affect human health is challenged by their molecular complexity and cell-type–specific effects. Conventional multi-cell type (bulk) analyses obscure cellular heterogeneity, while animal and standard in vitro models often fail to replicate human physiology. Single-cell omics technologies—such as single-cell RNA sequencing, as well as single-cell–resolved proteomic and metabolomic approaches—enable high-resolution investigation of nutrient–cell interactions and reveal mechanisms at a single-cell resolution. When combined with advanced human-derived in vitro systems like organoids and organ-on-chip platforms, they support mechanistic studies in physiologically relevant contexts. This review outlines emerging applications of single-cell omics in nutrition research, emphasizing their potential to uncover cell-specific dietary responses, identify nutrient-sensitive pathways, and capture interindividual variability. It also discusses key challenges—including technical limitations, model selection, and institutional biases—and identifies strategic directions to facilitate broader adoption in the field. Collectively, single-cell omics offer a transformative framework to advance human-centric nutrition research.
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