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Nivolumab plus cabozantinib in metastatic renal cell carcinoma: real-world evidence from the international ARON-1 study
(Frontiers Media S.A., 2025)
Bourlon de los Ríos, María Teresa
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Galli, Luca
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Grande, Enrique
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Park, Se Hoon
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Melichar, Bohuslav
Introduction: Four approved immune-based combinations for untreated metastatic renal carcinoma have demonstrated survival benefits. The ARON-1 study (NCT05287464) analyzed real-world data of patients with metastatic renal cell carcinoma receiving first-line immuno-oncology combinations. This sub-analysis is focused on the nivolumab plus cabozantinib effectiveness. Methods: We conducted a retrospective study across 52 centers in 17 countries, including patients with metastatic renal carcinoma treated with first-line nivolumab plus cabozantinib, regardless of histologic characteristics, performance status, or risk by IMDC prognostic model. Patients with incomplete medical data were excluded. The primary objective of this sub-analysis of the ARON-1 study was to evaluate the real-world effectiveness and safety. Results: A total of 333 patients were treated with nivolumab plus cabozantinib, clinical characteristics included ECOG performance status ≥2 20%, non-clear cell histology 16%, sarcomatoid de-differentiation 12%, and poor-risk by IMDC 28%. At a median follow-up of 15.9 months (95%CI 11.2-44.0), the median overall survival was not reached (40.0–NR), the probability of survival at 2 years was 75%, while median progression free survival was 33.7 months (95%CI 21.1-38.9). In the entire cohort, an objective response was observed in 58%, with 6% complete responses, and a median duration of response of 38.9 months (95%CI 33.7–NR). At multivariate analysis, adverse prognostic factors for overall survival included ECOG performance status ≥2, sarcomatoid de-differentiation, brain and bone metastases, and poor IMDC group. In the safety analysis, the incidence of grade 3 or higher toxicity was 37%, with hypertension and hand-foot syndrome being the most frequent adverse events. Conclusion: The findings in the present real-world study reaffirm the clinical benefits and safety of the nivolumab plus cabozantinib combination across all subgroups, including populations that are generally excluded from clinical trials for whom data is often missing. Poor performance status, sarcomatoid de-differentiation, bone or central nervous system metastases and IMDC poor risk group were confirmed as negative prognostic factors. ©The authors © Frontiers in Oncology ©Frontiers Media S.A.
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Geographical Differences in the Management and Outcomes of Patients With Advanced Urothelial Carcinoma Treated With Pembrolizumab After Progression on Platinum-Based Chemotherapy: Results From ARON-2 Study
(Lippincott Williams and Wilkins, 2025-07-01)
Rizzo, Mimma
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Soares, Andrey
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Gupta, Shilpa
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Calabrò, Fabio
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Takeshita, Hideki
Purpose: Our investigation assessed the impact of geographical disparities in the treatment of patients with advanced urothelial cancer (aUC) included in the international, real-world ARON-2 trial. Patients and Methods: The study population comprised 1,137 patients with aUC treated with pembrolizumab for relapsed or progressive disease after platinum-based chemotherapy (PBC) at 63 institutions in 19 countries. Patients were divided into three geographical areas: Europe (area 1: 791 patients), the United States (area 2: 156 patients), and Asia (area 3: 190 patients). Clinicopathologic and treatment data were extracted from medical records. The primary end points were to identify differences in patient and treatment characteristics and to assess overall survival (OS) and progression-free survival (PFS) between the three areas. Results: There were differences in patient characteristics: more patients age 70 years and older in area 1; more patients with BMI ≥25 kg/m2, squamous histotype, and T1 neoplasia at diagnosis in area 2; and more pure urothelial carcinoma in area 3. There were differences in treatment characteristics: Bacillus Calmette-Guérin instillations and primary tumor surgery were more common in area 1; neoadjuvant and adjuvant PBC, third-line therapies, and specifically enfortumab vedotin (EV) were less common in area 1. Median OS (mOS) from pembrolizumab initiation was 13.0 months in area 1, 29.1 months in area 2 and 13.2 months in area 3 (P < .001), and median PFS was 4.8 months, 5.2 months, and 3.8 months, respectively (P = .002). In patients receiving EV after progression to PBC and pembrolizumab, mOS was 44.1 months in area 1, 31.7 months in area 2, and 23.8 months in area 3 (P = .267). Conclusion: Real-world data suggest that facilitating and extending access to targeted therapies for patients with aUC in different geographical areas worldwide may lead to a consistent and widespread survival increase. ©The authors ©JCO Global Oncology ©Lippincott Williams and Wilkins.
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Pembrolizumab plus Lenvatinib in patients with metastatic Renal Cell Carcinoma: real-world evidences from the international ARON- 1 study
(Springer Science and Business Media LLC, 2025)
Porta, Camillo
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Massari, Francesco
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Taha, Tarek
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Grande, Enrique
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Bourlon de los Ríos, María Teresa
Background: Pembrolizumab plus lenvatinib is a treatment option for metastatic Renal Cell Carcinoma (mRCC). In the ARON-1 study we investigated we the real-world experiences gained from the use of this combination for mRCC. Methods: We retrospectively investigated real-world clinical outcomes of mRCC patients receiving pembrolizumab plus lenvatinib within the ARON-1 study. Overall survival (OS) was calculated from the start of pembrolizumab plus lenvatinib to death for any cause. Progression-Free Survival (PFS) was defined as the time from the start of pembrolizumab to progression or death from any cause. Duration of response (DoR) was defined as the time from the start of pembrolizumab to disease progression or death, whichever occurred first, in patients who achieved complete remission (CR) or partial response (PR). Overall Response Rate (ORR) was defined as the proportion of patients who achieve a CR or PR per RECIST criteria. Adverse events were retrospectively collected from electronic and paper charts and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Results: Overall, we included 202 mRCC patients treated with pembrolizumab plus lenvatinib. The median follow-up time was 15.1 months. The median OS was not reached (NR), with a median PFS of 25.6 months and an Overall Response Rate (ORR) of 59%. The median Duration of Response (DoR) was 26.2 months. G3-G4 adverse events (AEs) were observed in 92 patients (46%), with hypertension being the most common AE (13%). Conclusions: Pembrolizumab plus lenvatinib is an effective and tolerable treatment for mRCC also in the real-world setting. ©The authors ©Springer Science and Business.
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Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience
(Wiley, 2025)
Rizzo, Mimma
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Morelli, Franco
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Ürün, Yüksel
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Buti, Sebastiano
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Park, Se Hoon
Background: Recently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody–drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory to platinum and immune-checkpoint inhibitor (ICI) therapy. Our study provides a retrospective, international, real-world analysis comparing the effectiveness of EV to chemotherapy in this setting. Methods: The data were extracted from the medical records of patients treated with EV or chemotherapy following pembrolizumab for recurrent or progressive aUC after platinum-based chemotherapy. Patients were assessed for overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR). Results: Our analysis included 247 patients treated with EV (88, 36%) or chemotherapy (159, 64%). Median OS was 9.1 months (95%CI 7.2–10.7) in the overall study population, 13.6 months (95%CI 10.0–31.0) in patients receiving EV and 6.8 months (95%CI 6.0–8.9) in patients receiving chemotherapy (p < 0.001). The OS benefit of EV was not affected by primary tumour site and histology, metastatic sites, type of first platinum-based chemotherapy or response to pembrolizumab. In the EV cohort, the median PFS was significantly longer (8.8 months [95%CI 6.5–17.0] vs. 3.0 months [95%CI 2.6–3.7]) and the ORR was significantly higher (56% vs. 23%) than in the chemotherapy cohort. ©The authors ©Wiley ©Cancer Medicine.
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Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2EV Study
(2024)
Fiala, Ondřej
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Massari, Francesco
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Basso, Umberto
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Giannatempo, Patrizia
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Grande, Enrique
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Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project
(2024)
Alessandro Rizzo
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Fernando Sabino Marques Monteiro
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Yüksel Ürün
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Francesco Massari
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Se Hoon Park
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Differences in the expression of the phosphatase PTP-1B in patients with localized prostate cancer with and without adverse pathological features
(2024)
Bourlon de los Ríos, María Teresa
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Shaddai Urbina-Ramirez
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Haydee C. Verduzco-Aguirre
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Mauricio Mora-Pineda
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Hugo E. Velazquez
<jats:sec><jats:title>Introduction</jats:title><jats:p>Patients with adverse pathological features (APF) at radical prostatectomy (RP) for prostate cancer (PC) are candidates for adjuvant treatment. Clinicians lack reliable markers to predict these APF preoperatively. Protein tyrosine phosphatase 1B (PTP-1B) is involved in migration and invasion of PC, and its expression could predict presence of APF. Our aim was to compare PTP-1B expression in patients with and without APF, and to explore PTP-1B expression as an independent prognostic factor.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Tissue microarrays (TMAs) were constructed using RP archival specimens for immunohistochemical staining of PTP-1B; expression was reported with a standardized score (0-9). We compared median PTP-1B score between cases with and without APF. We constructed two logistic regression models, one to identify the independence of PTP-1B score from biologically associated variables (metformin use and type 2 diabetes mellitus [T2DM]) and the second to seek independence of known risk factors (Gleason score and prostate specific antigen [PSA]).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 73 specimens were suitable for TMA construction. Forty-four (60%) patients had APF. The median PTP-1B score was higher in those with APF: 8 (5-9) vs 5 (3-8) (p=0.026). In the logistic regression model including T2DM and metformin use, the PTP-1B score maintained statistical significance (OR 1.21, 95% CI 1.01-1.45, p=0.037). In the model including PSA and Gleason score; the PTP-1B score showed no independence (OR 1.68, 95% CI 0.97-1.41, p=0.11). The area under the curve to predict APF for the PTP-1B score was 0.65 (95% CI 0.52-0.78, p=0.03), for PSA+Gleason 0.71 (95% CI 0.59-0.82, p=0.03), and for PSA+Gleason+PTP-1B score 0.73 (95% CI 0.61-0.84, p=0.001).</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>Patients with APF after RP have a higher expression of PTP-1B than those without APF, even after adjusting for T2DM and metformin exposure. PTP-1B has a good accuracy for predicting APF but does not add to known prognostic factors.</jats:p></jats:sec>
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Tomografía por emisión de positrones
(Colegio de Medicina Interna de México AC, 2007-07-01)
Coronel Ayala, Omar Francisco
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Serna Macías, José Antonio
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Bourlon Cuellar, René
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Bourlon de los Ríos, María Teresa
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Gómez Sámano, Miguel Ángel
Toda enfermedad tiene una historia natural y su evolución se debe a diferentes procesos biológicos. Uno de estos incluye el proceso dinámico, del cual no pueden obtenerse las imágenes que reflejan la actividad corporal, a menos que se realice alguna determinación metabólica y se compare con el resto de las funciones fisiológicas. En este contexto, la tomografía por emisión de positrones proporciona información de dichos procesos y ofrece un punto de vista diferente del resto de las modalidades de imagen. La finalidad de la tomografía por emisión de positrones es producir imágenes que ilustren la función fisiológica y específica de algún proceso molecular; por lo tanto, se utiliza para determinar el metabolismo de la glucosa, la perfusión y el flujo sanguíneo, la tasa de unión de los complejos receptor-ligando y el intercambio de oxígeno. Con estas imágenes se distinguen los estados funcionales, normales o alterados, de alguna estructura específica. En comparación con la medicina nuclear, la tomografía por emisión de positrones utiliza radiofármacos (radiotrazadores marcados), como: carbono, oxígeno, nitrógeno y flúor (elementos básicos de los sustratos biológicos). Estos isótopos se parecen a los sustratos naturales como azúcares, agua, proteínas y oxígeno. Dicha técnica modifica la tasa costo-beneficio en el área de la oncología, cardiología y neurología para el tratamiento del paciente, además de proporcionar las siguientes ventajas: a) diagnosticar enfermedades antes que se produzcan cambios estructurales; b) vigilar la respuesta al tratamiento; c) pronosticar procedimientos quirúrgicos innecesarios, y d) detectar metástasis distantes u ocultas. ©Medicina Interna de México.
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Overview and characterization of penile cancer content across social media platforms
(Frontiers Media, 2023)
Ortiz-Guerra, Ruben Alejandro
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Jaime-Casas, Salvador
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Martinez-Cannon, Bertha Alejandra
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Ariza-Avila, Jose C.
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González-Morales, Ana P.
Background: Social media platforms (SMP) are an emerging resource that allows physicians, patients, and families to converse on cancer prevention, diagnosis, and treatment. We aimed to characterize penile cancer (PC) content shared on SMP. Methods: We searched PC posts on Twitter, Facebook, and Instagram from July 1st, 2021, through June 30th, 2022. Two independent, blinded reviewers analyzed the hashtags: #PenileCancer, #PenileCancerAwareness, and #PenileNeoplasm. Descriptive statistics were used for posts characterization, Pearson´s correlation coefficient for associations, and Cohen’s weighted kappa coefficient for inter-rater agreement rate. ©Frontiers Media
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