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

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<sup>EV</sup> 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.

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Journal
Clinical & Experimental Metastasis
Published
2025-02-20
DOI
https://doi.org/10.1007/s10585-025-10335-4
Citations
1
Primary Topic
Bladder and Urothelial Cancer Treatments
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article
Field-Weighted Citation Impact
2.01

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article

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

Giovanni Benedetti, Maria Teresa Bourlon, Ondřej Fiala, Bohuslav Melichar et al.
1 citations
Clinical & Experimental Metastasis
Bladder and Urothelial Cancer Treatments
2.01
article

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

Giovanni Benedetti, Maria Teresa Bourlon, Ondřej Fiala, Bohuslav Melichar, Sebastiano Buti, Fabio Calabrò, Cinzia Ortega, Matteo Santoni, Michèle Milella, Jakub Kucharz, Wataru Fukuokaya, Andrey Soares, Nicola Battelli, Vincenza Conteduca, Javier Molina‐Cerrillo, Takafumi Yanagisawa, Emmanuel Seront, Jindřich Kopecký, Se Hoon Park, Francesco Massari, Alfonso Gómez de Liaño, Yüksel Ürün, Alexandr Poprach, Fernando Sabino Marques Monteiro, Deniz Güncel Tural, Hideki Takeshita, Martín Ángel, Tomáš Büchler, Shilpa Gupta, Patrizia Giannatempo, Kazutoshi Fujita, Alessia Mennitto, Takahiro Kimura
article en
1 citations

Abstract

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<sup>EV</sup> 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.

Clinical & Experimental MetastasisVol. 42(2)
University of Foggia (IT), Jikei University School of Medicine (JP), University of Verona (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Parma (IT), Cliniques Universitaires Saint-Luc (BE), Cleveland Clinic (US), Koç University (TR), Ankara University (TR), Charles University (CZ), Masaryk University (CZ), Hospital Universitario Insular de Gran Canaria (ES), Hospital Israelita Albert Einstein (BR), Samsung Medical Center (KR), L'organizzazione Ospedale di Civitanova M (IT), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (MX), University Hospital in Motol (CZ), Masaryk Memorial Cancer Institute (CZ), Azienda USL di Bologna (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), Instituto Alexander Fleming (AR), University Hospital Hradec Králové (CZ), Hospital Sírio-Libanês (BR), The Maria Sklodowska-Curie National Research Institute of Oncology (PL), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), Social Insurance Saitama Chuo Hospital (JP), Hospital Universitario Ramón y Cajal (ES), Ospedale San Pietro Fatebenefratelli (IT), Ospedale di Macerata, University of Macerata (IT), Palacký University Olomouc (CZ), Sungkyunkwan University (KR), Saitama Medical University (JP), Universidad Panamericana (MX), Kindai University (JP), University of Bologna (IT)
Univerzita Karlova v Praze
Good health and well-being
Openalex Percentile: Top 19%
Bladder and Urothelial Cancer Treatments
2.01
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