Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting.

Published on May 13, 2019in Actas Urologicas Espanolas0.994
· DOI :10.1016/J.ACUROE.2019.03.010
J. Amores Bermúdez2
Estimated H-index: 2
,
I. Osman García3
Estimated H-index: 3
+ 7 AuthorsA. Juárez Soto3
Estimated H-index: 3
Sources
Abstract
Abstract Introduction and objectives Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune-related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. Material and methods Retrospective, multicenter study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. Results The mean age of the 26 patients included was 63.7 ± 11.5 years; 96% were ECOG 0–1 and 78% had favorable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1–14). All patients experienced an adverse event at different grades, with fatigue, fever and anemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). Conclusion In the real-life clinical setting, nivolumab shows favorable outcomes, similar to those reported by other studies.
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References19
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#2Giacomo CartenìH-Index: 39
Last. Giuseppe ProcopioH-Index: 36
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OBJECTIVE: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. PATIENTS AND METHODS: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminol...
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Last. Roberto SabbatiniH-Index: 24
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BACKGROUND: Results from phase III clinical trial CheckMate 025 have established nivolumab as the standard of care for treatment of metastatic renal-cell carcinoma (mRCC) after VEGF inhibitor failure; however, elderly patients are under-represented in the registration trial and little is known about the activity of nivolumab in this subgroup. The purpose of the Expanded Access Program was to provide nivolumab to patients with mRCC who had progressed despite treatment with other agents that were ...
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#1Kenar D. Jhaveri (Hofstra University)H-Index: 27
#2Mark A. Perazella (Yale University)H-Index: 72
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#1Shrujal S. Baxi (Cornell University)H-Index: 27
#2Annie Yang (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 5
Last. Deborah Korenstein (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 23
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Abstract Objective To evaluate rates of serious organ specific immune-related adverse events, general adverse events related to immune activation, and adverse events consistent with musculoskeletal problems for anti-programmed cell death 1 (PD-1) drugs overall and compared with control treatments. Design Systematic review and meta-analysis. Data sources Medline, Embase, Cochrane Library, Web of Science, and Scopus searched to 16 March 2017 and combined with data from ClinicalTrials.gov. Study se...
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Last. Toni K. Choueiri (Brigham and Women's Hospital)H-Index: 120
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615Background: The immuno-oncology (IO) checkpoint inhibitor nivolumab and the tyrosine kinase inhibitor (TKI) cabozantinib have both been shown in phase III clinical trials to be effective in metastatic renal cell carcinoma (mRCC) after progression on first-line therapy. We sought to explore the real-world efficacy of these therapies in second-line mRCC. Methods: Using the IMDC database, a retrospective analysis was performed on mRCC patients treated with second-line nivolumab or cabozantinib. ...
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#2Sylvie NegrierH-Index: 67
Last. Bernard Escudier (Institut Gustave Roussy)H-Index: 109
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577Background: Nivolumab (N) has been approved for the treatment of mRCC after failure of 1 or 2 tyrosine kinase inhibitors (TKI) based on the results of Checkmate 025 study. Right after approval, we initiated the NIVOREN GETUG-AFU 26 study (NCT03013335), a French multicenter prospective study to evaluate safety and efficacy of N in a “real world setting”. Methods: Patients (pts) with clear cell mRCC could be enrolled if they had received at least one TKI. Compared with the pivotal trial, inclus...
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#1Cesar E Ochoa (Mayo Clinic)H-Index: 3
#2Richard W. Joseph (Mayo Clinic)H-Index: 41
Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops, and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to t...
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#1Michael A. Postow (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 76
#2Robert Sidlow (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 10
Last. Matthew D. Hellmann (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 81
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The wide range of immune-related adverse effects associated with immune checkpoint blockade can complicate this effective therapy and limit its use in patients with cancer. This review surveys the adverse effects and their management.
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#1Kazuyuki Numakura (Akita University)H-Index: 19
#2Mizuki Kobayashi (Akita University)H-Index: 1
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PURPOSE: Despite nivolumab being increasingly used for treating metastatic renal cell carcinoma (mRCC), differing findings have been reported about its efficacy and safety in elderly patients. Thus, this study was aimed at evaluating nivolumab's efficacy and safety for treating mRCC in Japanese patients aged ≥ 75 years. METHODS: From March 2013 to August 2019, 118 mRCC patients (89 men and 29 women) were treated with nivolumab. The objective response rates (ORRs) were compared between patients a...
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