Evidence map›Paper›PMID 40391586›Full record

Observational studyFuture oncology (London, England)2025

Real-world efficacy and safety of nivolumab and ipilimumab in metastatic renal cell carcinoma: a Polish multicenter study.

Renata Pacholczak-Madej, Artur Drobniak, Łukasz Stokłosa, Aleksandra Grela-Wojewoda, Jacek Calik, Natalia Versuti Viegas, Daria Tusień-Małecka, Marek Szwiec, Jolanta Dobrzańska, Agnieszka Roman and 5 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Future oncology (London, England), 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. Article
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

15 authors.

Renata Pacholczak-MadejDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland.ORCID 0000-0002-6535-4841
Artur DrobniakDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland.
Łukasz StokłosaDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland.
Aleksandra Grela-WojewodaDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Poland.
Jacek CalikDepartment of Clinical Oncology, University Hospital in Wroclaw, Wrocław, Poland.
Natalia Versuti ViegasDepartment of Clinical Oncology, University Hospital in Wroclaw, Wrocław, Poland.
Daria Tusień-MałeckaClinical and Experimental Oncology Clinic, Institute of Oncology, Karol Marcinkowski Medical University, Poznań, Poland.
Marek SzwiecDepartment of Surgery and Oncology, University of Zielona Góra, Zielona Góra, Poland.
Jolanta DobrzańskaDepartment of Oncology, Jagiellonian University Medical College, Krakow, Poland.
Agnieszka RomanDepartment of Clinical Oncology, Ludwik Rydygier Hospital, Krakow, Poland.
Anna BidasDepartment of Clinical Oncology, Holy Cross Cancer Center, Kielce, Poland.
Angelika Gawlik-UrbanDepartment of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Poland.
Jerzy WalochaDepartment of Anatomy, Jagiellonian University, Medical College, Krakow, Poland.
Paweł BlecharzDepartment of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Poland.
Mirosława PuskulluogluDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab plus ipilimumab (NIVO+IPI) is a first-line treatment for metastatic renal cell carcinoma (mRCC) in intermediate- and poor-risk patients. Real-world evidence (RWE) studies are needed to validate its efficacy and safety in clinical practice.

methodsThis multicenter retrospective study included 145 mRCC patients treated with NIVO+IPI at nine oncology centers in Poland between May 2022 and December 2024. Data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and immune-related adverseevents (irAEs) were analyzed using Kaplan-Meier survival estimates and Cox proportional hazards models, with p-value <0.05 considered statistically significant.

resultsWith a limited median follow-up of 10.9 months, median PFS was 12.8 months (95% CI:7.0-18.6), and median OS was not reached. ORR and DCR were 34.5% and 66.2%,respectively. In intermediate-risk patients, ORR and DCR were higher than in poor-risk patients without statistical significance. IrAEs occurred in 61.4% of patients, with grade 3/4 irAEs in 25.5%. Karnofsky Performance Status < 80%, central nervous system metastases, and hepatic irAEs were associated with poorer survival in a multivariate analysis (

conclusionsThis study confirms the real-world efficacy and safety of NIVO+IPI in mRCC, demonstrating outcomes comparable to clinical trials.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellIpilimumabKidney NeoplasmsNivolumabAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedPolandRetrospective StudiesTreatment OutcomeIpilimumabNivolumabadverse eventsimmunotherapyNivolumab and ipilimumabreal-world evidencerenal cell carcinoma

Identifiers

PMID40391586
PMCPMC12150655

What OpenQuestion holds

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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 OpenQuestion graph.