CRIS

Permanent URI for this communityhttps://scripta.up.edu.mx/handle/20.500.12552/1

Browse

Search Results

Now showing 1 - 5 of 5

Some of the metrics are blocked by your
consent settings
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
;
Galli, Luca
;
Grande, Enrique
;
Park, Se Hoon
;
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.
Some of the metrics are blocked by your
consent settings
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
;
Soares, Andrey
;
Gupta, Shilpa
;
Calabrò, Fabio
;
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.
Some of the metrics are blocked by your
consent settings
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
;
Massari, Francesco
;
Taha, Tarek
;
Grande, Enrique
;
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.
Some of the metrics are blocked by your
consent settings
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
;
Morelli, Franco
;
Ürün, Yüksel
;
Buti, Sebastiano
;
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.
Some of the metrics are blocked by your
consent settings
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
;
Massari, Francesco
;
Basso, Umberto
;
Giannatempo, Patrizia
;
Grande, Enrique
24

CRIS

Browse

Filters

Settings

Sort By

Results per page

Search Results