Evidence map›Paper›PMID 39548483›Full record

ArticleBMC cancer2024

Adverse events after nivolumab and ipilimumab combined immunotherapy in advanced renal cell carcinoma: a multicentre experience in Poland.

Renata Pacholczak-Madej, Artur Drobniak, Łukasz Stokłosa, Anna Bidas, Jolanta Dobrzańska, Aleksandra Grela-Wojewoda, Agnieszka Roman, Daria Tusień-Małecka, Jerzy Walocha, Paweł Blecharz and 1 more

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

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Immune Checkpoint Inhibitors in Clear Cell Renal Cell Carcinoma (ccRCC).International journal of molecular sciences · 2025
    Review
  6. Article
  7. Observational
  8. Article
  9. Observational
  10. 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

11 authors.

Renata Pacholczak-MadejDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland. Renata.pacholczak@uj.edu.pl.
Artur DrobniakDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland.
Łukasz StokłosaDepartment of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland.
Anna BidasDepartment of Clinical Oncology, Holy Cross Cancer Center, Kielce, Poland.
Jolanta DobrzańskaDepartment of Oncology, Jagiellonian University Medical College, Krakow, Poland.
Aleksandra Grela-WojewodaDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Krakow, Poland.
Agnieszka RomanDepartment of Clinical Oncology, Ludwik Rydygier Hospital, Krakow, Poland.
Daria Tusień-MałeckaClinical and Experimental Oncology Clinic, Institute of Oncology, Karol Marcinkowski Medical University, Poznań, Poland.
Jerzy WalochaDepartment of Anatomy, Medical College, Jagiellonian University, Krakow, Poland.
Paweł BlecharzDepartment of Gynecological Oncology, Krakow Branch, Maria Sklodowska-Curie National Research Institute of Oncology, Garncarska 11 Street, Krakow, 31-115, Poland.
Mirosława PuskulluogluDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Krakow, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) have been employed in the adjuvant and metastatic setting of renal cell carcinoma (RCC) treatment. Among ICIs, combined immunotherapy has the highest risk for immune-related adverse events (irAEs). We aimed to document the incidence of irAEs in RCC patients treated with nivolumab and ipilimumab as data from the European population remain limited. MATERIALS AND

methodsWe analysed data from 88 RCC patients treated with nivolumab + ipilimumab between May 2022 and June 2024 across six high-volume oncology units in Poland. We reviewed irAEs and estimated their impact on survival parameters via univariate and multivariate Cox proportional hazards regression models, along with log-rank tests.

resultsWith a median follow-up of 11.3 months, the median overall survival (OS) was not reached, whereas the median progression-free survival (PFS) was 12.8 months (6.3-19.3). A total of 74 irAEs were recorded in 50 patients. The most frequent events were endocrine (n = 20, 27%), hepatic (n = 15, 17%), general (n = 12, 13.6%), and cutaneous (n = 11, 12.5%). The occurrence of irAEs was associated with a 60% lower risk of disease progression (hazard ratio 0.44, 95% confidence interval 0.2-0.87, p = 0.018) without impacting OS and higher disease control rate (n = 45, 90% vs. n = 24, 63.2%, p = 0.004). In contrast, patients with hepatotoxicity had poorer outcomes, with a 2.6-fold greater risk of death (p = 0.05).

conclusionsIrAEs may serve as a predictive factor for the efficacy of the nivolumab + ipilimumab regimen in RCC patients. Special attention is needed for hepatotoxicity, as it can significantly impact survival outcomes.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellIpilimumabKidney NeoplasmsNivolumabAdultAgedAged, 80 and overDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmune Checkpoint InhibitorsImmunotherapyMaleMiddle AgedPolandImmune Checkpoint InhibitorsIpilimumabNivolumabAdverse eventsImmunotherapyNivolumab and ipilimumabRenal cell carcinomaSurvival analysis

Identifiers

PMID39548483
PMCPMC11566080

What OpenQuestion 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 OpenQuestion graph.