Concomitant medications in patients with metastatic urothelial
carcinoma receiving enfortumab vedotin: real-world data from
the ARON-2EV study

J 2025

Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2EV study

FIALA, Ondrej; Sebastiano BUTI; Kazutoshi FUJITA; de Liano Alfonso GOMEZ; Wataru FUKUOKAYA et al.

Základní údaje

Originální název

Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2EV study

Autoři

Vydání

CLINICAL & EXPERIMENTAL METASTASIS, DORDRECHT, SPRINGER, 2025, 0262-0898

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.200 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/25:00143821

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

Urothelial cancer; Enfortumab vedotin; Concomitant medication; Antibiotics; Corticosteroids; Concomitant drug score; ARON-2(EV) study; NCT05290038

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 2. 3. 2026 10:41, Mgr. Tereza Miškechová

Anotace

V originále

Patients with metastatic urothelial carcinoma (mUC) are typically elderly and often have other comorbidities that require the use of concomitant medications. In our study we evaluated the association of concomitant use of antibiotics (ATBs), proton pump inhibitors (PPIs), corticosteroids, statins, metformin and insulin with patient outcomes and we validated the prognostic role of a concomitant drug score in mUC patients treated with enfortumab vedotin (EV) monotherapy. Data from 436 patients enrolled in the ARON-2(EV) retrospective study were analyzed according to the concomitant medications used at baseline. Finally, the patients were stratified into three risk groups according to the concomitant drug score based on ATBs, corticosteroids and PPIs. Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. Inferior survival outcomes were observed in ATB users compared to non-users (OS: 7.3 months, 95%CI 5.0 - 12.3 vs 13.7 months, 95%CI 12.2 - 47.3, p = 0.001; PFS: 5.1 months 95%CI 3.3 - 17.7 vs 8.3 months, 95%CI 7.1 - 47.3, p = 0.001) and also in corticosteroid users compared to non-users (OS: 8.4 months, 95%CI 6.6 - 10.0 vs 14.2 months, 95%CI 12.7 - 47.3, p < 0.001; PFS: 6.0 months 95%CI 4.6 - 7.9 vs 8.9 months, 95%CI 7.2 - 47.3, p = 0.004). In the Cox multivariate analysis, the concomitant drug score was a significant factor predicting both OS (HR = 1.32 [95% CI 1.03 - 1.68], p = 0.026) and PFS (HR = 1.23 [95% CI 1.01 - 1.51], p = 0.044). Our findings suggest detrimental impact of concomitant use of ATBs and corticosteroids on survival outcomes and the prognostic utility of the concomitant drug score in previously treated mUC patients receiving EV.

Citovat

FIALA, Ondrej; Sebastiano BUTI; Kazutoshi FUJITA; de Liano Alfonso GOMEZ; Wataru FUKUOKAYA; Takahiro KIMURA; Takafumi YANAGISAWA; Patrizia GIANNATEMPO; Angel MARTIN; Alessia MENNITTO; Javier MOLINA-CERRILLO; Maria T BOURLON; Andrey SOARES; Hideki TAKESHITA; Fabio CALABRO; Cinzia ORTEGA; Jakub KUCHARZ; Michele MILELLA; Emmanuel SERONT; Se Hoon PARK; Deniz TURAL; Giovanni BENEDETTI; Yuksel URUN; Nicola BATTELLI; Bohuslav MELICHAR; Alexandr POPRACH; Tomas BUCHLER; Jindrich KOPECKY; Vincenza CONTEDUCA; Fernando Sabino Marques MONTEIRO; Francesco MASSARI; Shilpa GUPTA a Matteo SANTONI. Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2EV study. CLINICAL & EXPERIMENTAL METASTASIS. DORDRECHT: SPRINGER, 2025, roč. 42, č. 2, s. 1-13. ISSN 0262-0898. Dostupné z: https://doi.org/10.1007/s10585-025-10335-4.

@article{2557763,
 author = {Fiala, Ondrej and Buti, Sebastiano and Fujita, Kazutoshi and Gomez, de Liano Alfonso and Fukuokaya, Wataru and Kimura, Takahiro and Yanagisawa, Takafumi and Giannatempo, Patrizia and Martin, Angel and Mennitto, Alessia and MolinaandCerrillo, Javier and Bourlon, Maria T and Soares, Andrey and Takeshita, Hideki and Calabro, Fabio and Ortega, Cinzia and Kucharz, Jakub and Milella, Michele and Seront, Emmanuel and Park, Se Hoon and Tural, Deniz and Benedetti, Giovanni and Urun, Yuksel and Battelli, Nicola and Melichar, Bohuslav and Poprach, Alexandr and Buchler, Tomas and Kopecky, Jindrich and Conteduca, Vincenza and Monteiro, Fernando Sabino Marques and Massari, Francesco and Gupta, Shilpa and Santoni, Matteo},
 article_location = {DORDRECHT},
 article_number = {2},
 doi = {https://doi.org/10.1007/s10585-025-10335-4},
 keywords = {Urothelial cancer; Enfortumab vedotin; Concomitant medication; Antibiotics; Corticosteroids; Concomitant drug score; ARON-2(EV) study; NCT05290038},
 language = {eng},
 issn = {0262-0898},
 journal = {CLINICAL & EXPERIMENTAL METASTASIS},
 title = {Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2EV study},
 url = {https://link.springer.com/article/10.1007/s10585-025-10335-4},
 volume = {42},
 year = {2025}
}

TY - JOUR
ID - 2557763
AU - Fiala, Ondrej - Buti, Sebastiano - Fujita, Kazutoshi - Gomez, de Liano Alfonso - Fukuokaya, Wataru - Kimura, Takahiro - Yanagisawa, Takafumi - Giannatempo, Patrizia - Martin, Angel - Mennitto, Alessia - Molina-Cerrillo, Javier - Bourlon, Maria T - Soares, Andrey - Takeshita, Hideki - Calabro, Fabio - Ortega, Cinzia - Kucharz, Jakub - Milella, Michele - Seront, Emmanuel - Park, Se Hoon - Tural, Deniz - Benedetti, Giovanni - Urun, Yuksel - Battelli, Nicola - Melichar, Bohuslav - Poprach, Alexandr - Buchler, Tomas - Kopecky, Jindrich - Conteduca, Vincenza - Monteiro, Fernando Sabino Marques - Massari, Francesco - Gupta, Shilpa - Santoni, Matteo
PY - 2025
TI - Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2EV study
JF - CLINICAL & EXPERIMENTAL METASTASIS
VL - 42
IS - 2
SP - 1-13
EP - 1-13
PB - SPRINGER
SN - 02620898
KW - Urothelial cancer
KW - Enfortumab vedotin
KW - Concomitant medication
KW - Antibiotics
KW - Corticosteroids
KW - Concomitant drug score
KW - ARON-2(EV) study
KW - NCT05290038
UR - https://link.springer.com/article/10.1007/s10585-025-10335-4
N2 - Patients with metastatic urothelial carcinoma (mUC) are typically elderly and often have other comorbidities that require the use of concomitant medications. In our study we evaluated the association of concomitant use of antibiotics (ATBs), proton pump inhibitors (PPIs), corticosteroids, statins, metformin and insulin with patient outcomes and we validated the prognostic role of a concomitant drug score in mUC patients treated with enfortumab vedotin (EV) monotherapy. Data from 436 patients enrolled in the ARON-2(EV) retrospective study were analyzed according to the concomitant medications used at baseline. Finally, the patients were stratified into three risk groups according to the concomitant drug score based on ATBs, corticosteroids and PPIs. Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. Inferior survival outcomes were observed in ATB users compared to non-users (OS: 7.3 months, 95%CI 5.0 - 12.3 vs 13.7 months, 95%CI 12.2 - 47.3, p = 0.001; PFS: 5.1 months 95%CI 3.3 - 17.7 vs 8.3 months, 95%CI 7.1 - 47.3, p = 0.001) and also in corticosteroid users compared to non-users (OS: 8.4 months, 95%CI 6.6 - 10.0 vs 14.2 months, 95%CI 12.7 - 47.3, p < 0.001; PFS: 6.0 months 95%CI 4.6 - 7.9 vs 8.9 months, 95%CI 7.2 - 47.3, p = 0.004). In the Cox multivariate analysis, the concomitant drug score was a significant factor predicting both OS (HR = 1.32 [95% CI 1.03 - 1.68], p = 0.026) and PFS (HR = 1.23 [95% CI 1.01 - 1.51], p = 0.044). Our findings suggest detrimental impact of concomitant use of ATBs and corticosteroids on survival outcomes and the prognostic utility of the concomitant drug score in previously treated mUC patients receiving EV.
ER -

FIALA, Ondrej; Sebastiano BUTI; Kazutoshi FUJITA; de Liano Alfonso GOMEZ; Wataru FUKUOKAYA; Takahiro KIMURA; Takafumi YANAGISAWA; Patrizia GIANNATEMPO; Angel MARTIN; Alessia MENNITTO; Javier MOLINA-CERRILLO; Maria T BOURLON; Andrey SOARES; Hideki TAKESHITA; Fabio CALABRO; Cinzia ORTEGA; Jakub KUCHARZ; Michele MILELLA; Emmanuel SERONT; Se Hoon PARK; Deniz TURAL; Giovanni BENEDETTI; Yuksel URUN; Nicola BATTELLI; Bohuslav MELICHAR; Alexandr POPRACH; Tomas BUCHLER; Jindrich KOPECKY; Vincenza CONTEDUCA; Fernando Sabino Marques MONTEIRO; Francesco MASSARI; Shilpa GUPTA a Matteo SANTONI. Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2\&{}lt;sup\&{}gt;EV\&{}lt;/sup\&{}gt; study. \textit{CLINICAL \&{} EXPERIMENTAL METASTASIS}. DORDRECHT: SPRINGER, 2025, roč.~42, č.~2, s.~1-13. ISSN~0262-0898. Dostupné z: https://doi.org/10.1007/s10585-025-10335-4.

Přehled o publikaci

Concomitant medications in patients with metastatic urothelial carcinoma receiving enfortumab vedotin: real-world data from the ARON-2<sup>EV</sup> study