Evidence map›Paper›PMID 35288066›Full record

Trial reportEuropean urology oncology2022

Health-related Quality of Life with Adjuvant Nivolumab After Radical Resection for High-risk Muscle-invasive Urothelial Carcinoma: Results from the Phase 3 CheckMate 274 Trial.

Johannes Alfred Witjes, Matthew D Galsky, Jürgen E Gschwend, Edward Broughton, Julia Braverman, Federico Nasroulah, Mario Maira-Arce, Xiaomei Ye, Ling Shi, Shien Guo and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European urology oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02632409 (A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT02632409 phase3completednot on this map

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2026Enrolled709ConditionsVarious Advanced CancerArmsNivolumab, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Bladder cancer.Nature reviews. Disease primers · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Johannes Alfred WitjesRadboud University, Nijmegen, The Netherlands. Electronic address: Fred.witjes@radboudumc.nl.
Matthew D GalskyTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Jürgen E GschwendTechnical University of Munich, Munich, Germany.
Edward BroughtonBristol Myers Squibb, Princeton, NJ, USA.
Julia BravermanBristol Myers Squibb, Princeton, NJ, USA.
Federico NasroulahBristol Myers Squibb, Princeton, NJ, USA.
Mario Maira-ArceBristol Myers Squibb, Princeton, NJ, USA.
Xiaomei YeEvidera, Waltham, MA, USA.
Ling ShiEvidera, Waltham, MA, USA.
Shien GuoEvidera, Waltham, MA, USA.
Melissa HamiltonBristol Myers Squibb, Princeton, NJ, USA.
Dean F BajorinMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Bristol-Myers Squibb (United States) · USIthaka Harbors · USIcahn School of Medicine at Mount Sinai · USMemorial Sloan Kettering Cancer Center · USRadboud University Nijmegen · NLTechnical University of Munich · DE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe programmed death-1 (PD-1) inhibitor nivolumab prolongs disease-free survival in patients with muscle-invasive urothelial carcinoma (MIUC).

objectiveTo evaluate the effects of nivolumab on health-related quality of life (HRQoL) after radical resection in patients with MIUC. DESIGN, SETTING, AND

participantsWe used data from 709 patients in CheckMate 274 (NCT02632409; 282 with programmed death ligand 1 [PD-L1] expression ≥1%), an ongoing randomized, double-blind, placebo-controlled phase 3 trial of adjuvant nivolumab.

interventionIntravenous injection of nivolumab (240 mg) or placebo every 2 wk for ≤1 yr. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EQ-5D-3L. Linear mixed-effect models for repeated measures were used to compare nivolumab and placebo on changes in HRQoL. Time to confirmed deterioration (TTCD) of HRQoL was analyzed by Cox proportional hazards regression. RESULTS AND LIMITATIONS: In the full HRQoL evaluable population, no clinically meaningful deterioration of HRQoL was observed in either treatment arm. Moreover, nivolumab was noninferior to placebo on changes from baseline for all main outcomes. The median TTCD for fatigue was 41.0 wk for nivolumab and 44.3 wk for placebo (hazard ratio [HR]: 1.11, 95% confidence interval [CI], 0.89-1.39). For the visual analog scale, the median TTCD was not reached for nivolumab and it was 57.6 wk for placebo (HR: 0.78, 95% CI, 0.61-1.00). The median TTCD for the other main outcomes was not reached in either treatment arm. The findings were similar for patients with PD-L1 expression ≥1%.

conclusionsThese results demonstrate that nivolumab did not compromise the HRQoL of patients with MIUC in CheckMate 274. PATIENT SUMMARY: Nivolumab is being researched as a new treatment for patients with bladder cancer (urothelial carcinoma). We found that nivolumab maintained quality of life while increasing the time until cancer returns in patients whose bladder cancer had spread or grown and who had unsuccessfully tried platinum-containing chemotherapy.

Indexed as

Carcinoma, Transitional CellUrinary Bladder NeoplasmsB7-H1 AntigenHumansMusclesNivolumabPlatinumProgrammed Cell Death 1 ReceptorQuality of LifeB7-H1 AntigenNivolumabPlatinumProgrammed Cell Death 1 ReceptorAdjuvantBladder cancerImmunotherapyInvasiveNivolumabPhase 3Quality of lifeRadical cystectomyRandomized controlled trial

Identifiers

PMID35288066
PMCPMC10062393
OpenAlexW4220740895

What OpenQuestion holds

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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.