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Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV)
(Springer Science and Business Media LLC, 2026)
Mollica, Veronica
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Massari, Francesco
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Fujita, Kazutoshi
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Giannatempo, Patrizia
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Grande, Enrique
Introduction: Avelumab, pembrolizumab, and enfortumab vedotin (EV) demonstrated efficacy in mUC following platinum-based chemotherapy. However, real-world data in patients with urothelial carcinoma with squamous differentiation (UCSD) are limited. The aim of this study is to assess the real-world clinical outcomes of avelumab, pembrolizumab, or EV in mUCSD patients. Materials and methods: The ARON-2EV study is a retrospective, international, multicenter analysis in patients with mUC treated with avelumab, pembrolizumab, or EV across 79 centers in 21 countries. Patients were divided into three cohorts: 1 (avelumab), 2 (pembrolizumab), and 3 (EV). Primary endpoints were overall survival (OS) and time on treatment (ToT). Secondary objectives included evaluating clinical factors associated with outcomes and exploring the impact of UCSD histology on response to therapy. Statistical methods included Kaplan–Meier estimates, log-rank tests, Fisher’s exact and chi-square tests, and Pearson’s correlation coefficients. Results: A total of 1918 patients, 1696 with advanced pure UC (pUC) and 222 with mUCSD (36 in cohort 1, 111 in cohort 2, and 75 in cohort 3), were included. Median OS was shorter in patients with UCSD compared to patients with pUC histology in the three cohorts (1: 13.0 vs 26.8 months, HR 2.66, p = 0.003; 2: 10.2 vs 18.5 months, HR 1.52, p = 0.008; and 3: 7.6 vs 13.1 months, HR 1.68, p = 0.011). Median ToT was shorter in patients with UCSD compared to patients with pUC histology in cohort 1 (3.5 vs 5.6 months, HR 1.57, p = 0.044) and 3 (7.6 vs 13.6 months, HR 1.83, p = 0.005) but not in cohort 2 (3.7 vs 4.7 months, HR 1.19, p = 0.177). Response to therapy was negatively correlated with UCSD histology in cohorts 2 (correlation coefficient 0.094, p = 0.008) and 3 (correlation coefficient 0.107, p = 0.021), while response to avelumab was not correlated with UCSD (correlation coefficient 0.072, p = 0.263). Conclusions: UCSD is a histology with a poor prognosis and response to treatments compared to pUC. Treatments activity and effectiveness in divergent differentiations should be addressed in dedicated prospective studies. ©The authors ©Springer.
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Toxicity-related immunotherapy discontinuation and outcome in patients with advanced renal cell carcinoma treated with immune-based combinations (ARON-1 study)
(Wiley, 2025)
Molina‐Cerrillo, Javier
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Roviello, Giandomenico
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Bourlon de los Ríos, María Teresa
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Studentova, Hana
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Fiala, Ondrej
The advent of immunotherapy (IO) has revolutionized the therapeutic landscape of advanced renal cell carcinoma (RCC). The aim of this study is to analyze clinical outcomes in patients who discontinued IO in metastatic RCC first line in a real-world setting. We retrospectively collected data about 1077 patients aged ≥18 years with a histologically confirmed diagnosis of clear cell RCC and histologically or radiologically confirmed metastatic disease, treated in 52 centers from 20 countries, between January 1, 2016 and April 1, 2024, from all three International metastatic renal cell carcinoma (mRCC) Database Consortium risk groups (favorable, intermediate, and poor). Each patient was treated in front-line with IO + Tirosine Kinase Inhibitor or IO + IO combinations. In this study we analyzed survival outcomes comparing patients who interrupted IO versus patients who continuously received it and multivariable analysis. We analyzed the clinical behavior of 185 patients who interrupted IO treatment due to SAE, 127 patients with IO-tyrosine kinase inhibitor, 58 patients with IO–IO versus 892 patients who do not discontinue IO treatment. No significant differences in OS were found in patients who discontinue treatment versus no discontinuation. Moreover, time to discontinuation seemed to be an OS predictor, being inferior in patients who interrupted IO in the first to third month versus patients who discontinued treatment after this time data. The ARON-1 study offers a comprehensive examination of toxicity-related IO discontinuation in advanced RCC, contributing to a better understanding of balancing treatment efficacy with tolerability. ©The authors ©Wiley.
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ERK1/2 Phosphorylation Predicts Survival in Recurrent Glioblastoma Following Intracerebral and Adjuvant PD-1/CTLA-4 Immunotherapy: A REMARK-guided Analysis
(American Association for Cancer Research, 2023)
Arrieta, Víctor A.
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Duerinck, Johnny
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Burdett, Kirsten B.
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Habashy, Karl J.
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Geens, Wietse
Purpose: Evidence suggests that MAPK pathway activation, as measured by ERK1/2 phosphorylation (p-ERK), predicts overall survival (OS) in patients with recurrent glioblastoma receiving anti-PD-1 therapy. We aimed to validate these findings in independent cohorts. Experimental Design: In a 24-patient clinical trial on recurrent glioblastoma and high-grade gliomas, we examined the link between p-ERK levels and OS. Patients received intravenous nivolumab, followed by maximal safe resection and an intracerebral injection of either ipilimumab alone or combined with nivolumab. Biweekly adjuvant nivolumab was then administered up to five times (NCT03233152). Using REporting recommendations for tumor MARKER prognostic studies (REMARK) criteria, we conducted independent analyses for p-ERK quantification and statistical evaluations. Additional comparative analysis included prior cohorts, totaling 65 patients. Cox proportional hazards models and meta-analysis were employed to assess p-ERK as a predictive biomarker after immunotherapy. ©American Association for Cancer Research
Scopus© Citations 6 25

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