Bone metastases in advanced urothelial carcinoma patients
receiving enfortumab vedotin: A Real-World study from the
ARON-2EV project

J 2026

Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2EV project

RIZZO, Alessandro; Zin W MYINT; Francesco CICCIMARRA; Anca ZGURA; Marc R MATRANA et al.

Základní údaje

Originální název

Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2EV project

Autoři

Vydání

Clinical and Experimental Medicine, Milan, Springer, 2026, 1591-8890

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Itálie

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.500 v roce 2024

Označené pro přenos do RIV

Ano

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

Urothelial carcinoma; Enfortumab vedotin; Antibody-drug conjugates; Bone metastases; Clinical outcomes

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 3. 3. 2026 10:55, Mgr. Tereza Miškechová

Anotace

V originále

Enfortumab vedotin (EV) has been approved for the treatment of metastatic urothelial carcinoma (mUC), either as mono-therapy or in combination with immune checkpoint inhibitors, following results of recent practice-changing clinical trials. However, limited data exist regarding patients with bone metastases, leaving a critical gap in knowledge regarding the efficacy of EV in this subgroup. The study aimed to evaluate the impact of bone metastases on survival outcomes in patients with mUC treated with EV using data the ARON global real-world retrospective database, thereby addressing an important unmet clinical need. A total of 201 mUC patients with bone metastases and 377 without bone metastases who were treated with EV were analyzed from the ARON-2EV dataset. The coprimary endpoints were overall survival (OS) and progression-free survival (PFS) in mUC patients with and without bone metastases. Secondary endpoints included OS and PFS among patients with bone metastases who received versus did not receive radiotherapy or bone-targeted agents. The median OS was 11.2 months (95% CI 8.34-15.04) and 12.4 months (95% CI 10.71-15.21) in mUC patients with and without bone metastases, respectively. The median PFS was 6.0 months (95% CI 5.72-6.9) and 7.6 months (95% CI 6.6-8.24), respectively. No statistically significant difference in OS was observed between two groups (HR 1.16; 95% CI 0.9-1.5; p = 0.251), while patients without bone metastases had significantly longer PFS (HR 1.26; 95% CI 1.01-1.57; p = 0.0442). No significant survival differences were observed among patients with bone metastases based on receipt of radiotherapy or bone-targeted agents. In multivariate analyses, concomitant mixed histology and lung metastases were associated with shorter OS, while lung metastases and current smoking were associated with shorter PFS. This real-world analysis identified clinical factors associated with poorer outcomes in mUC patients with bone metastases treated with EV, including histology subtype, lung metastases, and smoking status. Further multicentric translational studies are warranted to validate these findings and to better understand the biologic mechanisms underlying limited EV efficacy in bone-metastatic disease.

Citovat

RIZZO, Alessandro; Zin W MYINT; Francesco CICCIMARRA; Anca ZGURA; Marc R MATRANA; Thomas BUTTNER; Jindrich KOPECKY; Alejo Rodriguez VIDA; Mimma RIZZO; Kazutoshi FUJITA; Oronzo BRUNETTI; Daniele SANTINI; Se Hoon PARK; Luigi FORMISANO; Alexandr POPRACH; Jakub KUCHARZ; Maria Colomba COMES; Samantha BOVE; Annarita FANIZZI; Raffaella MASSAFRA; Gerardo CAZZATO; Fernando Sabino Marques MONTEIRO; Veronica MOLLICA; Francesco MASSARI; Javier Molina CERRILLO a Matteo SANTONI. Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2EV project. Clinical and Experimental Medicine. Milan: Springer, 2026, roč. 26, č. 1, s. 1-9. ISSN 1591-8890. Dostupné z: https://doi.org/10.1007/s10238-025-02020-3.

@article{2558025,
 author = {Rizzo, Alessandro and Myint, Zin W and Ciccimarra, Francesco and Zgura, Anca and Matrana, Marc R and Buttner, Thomas and Kopecky, Jindrich and Vida, Alejo Rodriguez and Rizzo, Mimma and Fujita, Kazutoshi and Brunetti, Oronzo and Santini, Daniele and Park, Se Hoon and Formisano, Luigi and Poprach, Alexandr and Kucharz, Jakub and Comes, Maria Colomba and Bove, Samantha and Fanizzi, Annarita and Massafra, Raffaella and Cazzato, Gerardo and Monteiro, Fernando Sabino Marques and Mollica, Veronica and Massari, Francesco and Cerrillo, Javier Molina and Santoni, Matteo},
 article_location = {Milan},
 article_number = {1},
 doi = {https://doi.org/10.1007/s10238-025-02020-3},
 keywords = {Urothelial carcinoma; Enfortumab vedotin; Antibody-drug conjugates; Bone metastases; Clinical outcomes},
 language = {eng},
 issn = {1591-8890},
 journal = {Clinical and Experimental Medicine},
 title = {Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2EV project},
 url = {https://link.springer.com/article/10.1007/s10238-025-02020-3},
 volume = {26},
 year = {2026}
}

TY - JOUR
ID - 2558025
AU - Rizzo, Alessandro - Myint, Zin W - Ciccimarra, Francesco - Zgura, Anca - Matrana, Marc R - Buttner, Thomas - Kopecky, Jindrich - Vida, Alejo Rodriguez - Rizzo, Mimma - Fujita, Kazutoshi - Brunetti, Oronzo - Santini, Daniele - Park, Se Hoon - Formisano, Luigi - Poprach, Alexandr - Kucharz, Jakub - Comes, Maria Colomba - Bove, Samantha - Fanizzi, Annarita - Massafra, Raffaella - Cazzato, Gerardo - Monteiro, Fernando Sabino Marques - Mollica, Veronica - Massari, Francesco - Cerrillo, Javier Molina - Santoni, Matteo
PY - 2026
TI - Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2EV project
JF - Clinical and Experimental Medicine
VL - 26
IS - 1
SP - 1-9
EP - 1-9
PB - Springer
SN - 15918890
KW - Urothelial carcinoma
KW - Enfortumab vedotin
KW - Antibody-drug conjugates
KW - Bone metastases
KW - Clinical outcomes
UR - https://link.springer.com/article/10.1007/s10238-025-02020-3
N2 - Enfortumab vedotin (EV) has been approved for the treatment of metastatic urothelial carcinoma (mUC), either as mono-therapy or in combination with immune checkpoint inhibitors, following results of recent practice-changing clinical trials. However, limited data exist regarding patients with bone metastases, leaving a critical gap in knowledge regarding the efficacy of EV in this subgroup. The study aimed to evaluate the impact of bone metastases on survival outcomes in patients with mUC treated with EV using data the ARON global real-world retrospective database, thereby addressing an important unmet clinical need. A total of 201 mUC patients with bone metastases and 377 without bone metastases who were treated with EV were analyzed from the ARON-2EV dataset. The coprimary endpoints were overall survival (OS) and progression-free survival (PFS) in mUC patients with and without bone metastases. Secondary endpoints included OS and PFS among patients with bone metastases who received versus did not receive radiotherapy or bone-targeted agents. The median OS was 11.2 months (95% CI 8.34-15.04) and 12.4 months (95% CI 10.71-15.21) in mUC patients with and without bone metastases, respectively. The median PFS was 6.0 months (95% CI 5.72-6.9) and 7.6 months (95% CI 6.6-8.24), respectively. No statistically significant difference in OS was observed between two groups (HR 1.16; 95% CI 0.9-1.5; p = 0.251), while patients without bone metastases had significantly longer PFS (HR 1.26; 95% CI 1.01-1.57; p = 0.0442). No significant survival differences were observed among patients with bone metastases based on receipt of radiotherapy or bone-targeted agents. In multivariate analyses, concomitant mixed histology and lung metastases were associated with shorter OS, while lung metastases and current smoking were associated with shorter PFS. This real-world analysis identified clinical factors associated with poorer outcomes in mUC patients with bone metastases treated with EV, including histology subtype, lung metastases, and smoking status. Further multicentric translational studies are warranted to validate these findings and to better understand the biologic mechanisms underlying limited EV efficacy in bone-metastatic disease.
ER -

RIZZO, Alessandro; Zin W MYINT; Francesco CICCIMARRA; Anca ZGURA; Marc R MATRANA; Thomas BUTTNER; Jindrich KOPECKY; Alejo Rodriguez VIDA; Mimma RIZZO; Kazutoshi FUJITA; Oronzo BRUNETTI; Daniele SANTINI; Se Hoon PARK; Luigi FORMISANO; Alexandr POPRACH; Jakub KUCHARZ; Maria Colomba COMES; Samantha BOVE; Annarita FANIZZI; Raffaella MASSAFRA; Gerardo CAZZATO; Fernando Sabino Marques MONTEIRO; Veronica MOLLICA; Francesco MASSARI; Javier Molina CERRILLO a Matteo SANTONI. Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2\&{}lt;sup\&{}gt;EV\&{}lt;/sup\&{}gt; project. \textit{Clinical and Experimental Medicine}. Milan: Springer, 2026, roč.~26, č.~1, s.~1-9. ISSN~1591-8890. Dostupné z: https://doi.org/10.1007/s10238-025-02020-3.

Přehled o publikaci

Bone metastases in advanced urothelial carcinoma patients receiving enfortumab vedotin: A Real-World study from the ARON-2<sup>EV</sup> project