Evidence map›Paper›PMID 40920370›Full record

ArticleThe oncologist2025

The safety profile of belzutifan in renal tumors: real-world data from a tertiary academic center.

Aaron Jacob Winer, Paulo Siqueira do Amaral, Elizabeth G Ryan, Morgan A Lambrecht, Chiu-Lan Chen, Brian I Rini, Kathryn E Beckermann

Abstract read
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Aaron Jacob WinerDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, United States.ORCID 0000-0003-0635-7898
Paulo Siqueira do AmaralVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States.ORCID 0009-0003-3205-3799
Elizabeth G RyanVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States.
Morgan A LambrechtVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States.
Chiu-Lan ChenDepartment of Biostatics, Vanderbilt University Medical Center, Nashville, TN 37232, United States.
Brian I RiniVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States.ORCID 0000-0002-2212-080X
Kathryn E BeckermannVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States.ORCID 0000-0002-4616-6140

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBelzutifan is a HIF-2ɑ inhibitor approved for the treatment of tumors in von Hippel-Lindau (VHL) syndrome and sporadic metastatic clear cell renal cell carcinoma (spRCC) in the refractory setting. The efficacy and side effects of belzutifan are well-documented from clinical trials; however, real-world data examining the incidence and management of adverse events (AEs) are lacking. Our study aims to describe the AE profiles of belzutifan in spRCC and VHL populations.

methodsA retrospective analysis was conducted at Vanderbilt University Medical Center assessing patients who received belzutifan monotherapy. Primary endpoints were the incidence of anemia and hypoxia. Secondary endpoints included time to onset of anemia and hypoxia, as well as management strategies.

resultsForty-four patients were identified with either spRCC (n = 22) or VHL syndrome (n = 22). Patients with spRCC were older than VHL patients (median 67 vs 41 years) and had higher rates of chronic kidney disease (36.4% vs 4.5%) and prior nephrectomy (77.3% vs 40.9%). The spRCC patients had a median follow-up time of 3.8 months vs 26.8 months in VHL patients. Any-grade anemia occurred in the majority of spRCC and VHL patients (81% and 95.5%, respectively) with a median time of 25 days in spRCC patients and 77 days in VHL patients. While no patient with VHL experienced grade 3 anemia, 41% of spRCC patients developed grade ≥3 anemia. In spRCC, grade ≥3 hypoxia developed in 54.5% and for VHL patients, grade 3 hypoxia occurred in 9%. Median time to grade ≥3 hypoxia was 29 days (range 12-123) in spRCC patients and 225 days (range 105-345) in VHL patients. Supplemental oxygen was required in 52.5% of spRCC patients and 9.5% in VHL patients. Treatment discontinuation due to AEs occurred in 50% of spRCC patients and 13.6% of VHL patients.

conclusionsThe time to onset and severity of belzutifan AEs may differ between patients with VHL syndrome and spRCC. These findings suggest the need for a patient-centered approach to monitor and manage toxicity based on disease setting.

Indexed as

Carcinoma, Renal CellKidney Neoplasmsvon Hippel-Lindau DiseaseAdultAgedAnemiaFemaleHumansIndenesMaleMiddle AgedRetrospective StudiesTertiary Care CentersbelzutifanIndenesanemiabelzutifanhypoxiasafetyspRCCVHL

Identifiers

PMID40920370
PMCPMC12483163

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.