Evidence map›Paper›PMID 38280218›Full record

Trial reportThe oncologist2024

The Relationship Between Health-Related Quality of Life and Overall Survival in Patients With Advanced Renal Cell Carcinoma in CheckMate 214.

David Cella, Toni K Choueiri, Melissa Hamilton, Steven I Blum, Cristina Ivanescu, Karl Karu, Flavia Ejzykowicz, Robert J Motzer

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02231749 (A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
6.8field-weighted citation impact, top 4% of its field
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.

NCT02231749 phase3completednot on this map

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2025Enrolled1,096ConditionsAdvanced Renal Cell Carcinoma, Metastatic Renal Cell CarcinomaArmsNivolumab, Ipilimumab, Sunitinib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Triplet Strategies in Metastatic Clear Cell Renal Cell Carcinoma: A Worthy Option in the First-Line Setting?American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023
    Trial
  3. Article
  4. Article
  5. 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

8 authors at 4 institutions in 1 country.

David CellaRobert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.ORCID 0000-0002-9881-4541
Toni K ChoueiriDana-Farber Cancer Institute, The Lank Center for Genitourinary Oncology, Boston, MA, USA.ORCID 0000-0002-9201-3217
Melissa HamiltonBristol Myers Squibb, Princeton, NJ, USA.
Steven I BlumBristol Myers Squibb, Princeton, NJ, USA.
Cristina IvanescuIQVIA, Amsterdam, The Netherlands.
Karl KaruIQVIA, Tartu, Estonia.
Flavia EjzykowiczBristol Myers Squibb, Princeton, NJ, USA.
Robert J MotzerMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Bristol-Myers Squibb (United States) · USDana-Farber Cancer Institute · USMemorial Sloan Kettering Cancer Center · USNorthwestern University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Bristol-Myers SquibbNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundIn CheckMate 214 (median follow-up, 25.2 months), nivolumab plus ipilimumab yielded greater overall survival (OS) benefit than sunitinib in patients with intermediate-/poor-risk advanced renal cell carcinoma (aRCC). Health-related quality of life (HRQoL) assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) was also more favorable for the nivolumab plus ipilimumab group than the sunitinib group. We investigated whether HRQoL scores can predict OS of patients with 5 years follow-up in CheckMate 214. PATIENTS AND

methodsCheckMate 214 was an open-label, phase III trial in previously untreated aRCC (N = 1096). Patients with intermediate-/poor-risk disease (International mRCC Database Consortium prognostic score ≥ 1; n = 847) were randomized to either nivolumab plus ipilimumab or sunitinib monotherapy. Pooled data for OS and FKSI-19 total and subscales (disease-related symptoms [DRS], DRS-physical [DRS-P], and function/well-being [FWB]) were analyzed. Relationships between HRQoL and OS were assessed using Cox proportional hazard models with baseline and longitudinal scores. Associations between HRQoL changes and OS were assessed by landmark analyses.

resultsPatients with higher FKSI-19 total and subscale scores at baseline had longer OS than patients with lower scores (HR ≤ 0.834; P < .0001). Longitudinal models indicated stronger associations between HRQoL and OS (HR ≤ 0.69; P < .001 for each). At 3 months after randomization, patients with stable/improved HRQoL versus baseline had longer median OS than patients with worsened/unobserved HRQoL versus baseline (55.9 and 26.0 months, respectively; HR = 0.56; 95% CI, 0.46-0.67; P < .0001). Results at 6-, 9-, and 12-month landmarks were consistent with these findings.

conclusionIn aRCC, patient-reported outcomes are important for HRQoL and prognostic evaluation. CLINICALTRIALS.GOV IDENTIFIER: NCT02231749; https://clinicaltrials.gov/ct2/show/NCT02231749.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsQuality of LifeAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansIpilimumabMaleMiddle AgedNivolumabSunitinibIpilimumabNivolumabSunitinibhealth-related quality of lifeimmune checkpoint inhibitorspatient-reported outcome measuresprognosisrenal cell carcinomasurvival

Identifiers

PMID38280218
PMCPMC11144972
OpenAlexW4391275588

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.