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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<a class="ep_document_link" href="/10290/1/Influence%20of%20E-learning%20training%20on%20the%20acquisition%20of%20competences%20in%20basketball%20coaches%20in%20Cantabria.pdf"><img class="ep_doc_icon" alt="[img]" src="/10290/1.hassmallThumbnailVersion/Influence%20of%20E-learning%20training%20on%20the%20acquisition%20of%20competences%20in%20basketball%20coaches%20in%20Cantabria.pdf" border="0"/></a>
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Josep Alemany Iturriaga mail josep.alemany@uneatlantico.es, Álvaro Velarde-Sotres mail alvaro.velarde@uneatlantico.es, Javier Jorge mail , Kamil Giglio mail ,
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Technological firms invest in R&D looking for innovative solutions but assuming high costs and great (technological) uncertainty regarding final results and returns. Additionally, they face other problems related to R&D management. This empirical study tries to determine which of the factors favour or constrain the decision of these firms to engage in R&D. The analysis uses financial data of 14,619 ICT listed companies of 22 countries from 2003 to 2018. Additionally, macroeconomic data specific for the countries and the sector were used. For the analysis of dynamic panel data, a System-GMM method is used. Among the findings, we highlight that cash flow, contrary to the known theoretical models and empirical evidences, negatively impacts on R&D investment. Debt is neither the right source for R&D funding, as the effect is also negative. This suggests that ICT companies are forced to manage their R&D activities differently, relying more on other funding sources, taking advantage of growth opportunities and benefiting from a favourable macroeconomic environment in terms of growth and increased business sector spending on R&D. These results are similar in both sub-sectors and in all countries, both bank- and market based. The exception is firms with few growth opportunities and little debt.
Inna Alexeeva-Alexeev mail inna.alexeeva@uneatlantico.es, Cristina Mazas Pérez-Oleag mail cristina.mazas@uneatlantico.es,
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Assessment Of Lower Limb Asymmetries In Soccer Players According To The Stage Of The Season
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Álvaro Velarde-Sotres mail alvaro.velarde@uneatlantico.es, Jeffrey Mjaanes mail , Angel Olider Rojas Vistorte mail , Julio Calleja-González mail ,
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Exploring body composition and somatotype profiles among youth professional soccer players
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