Evidence map›Paper›PMID 37589219›Full record

Trial reportThe oncologist2024

Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma.

Toni K Choueiri, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Stefan Symeonides, Jaroslav Hajek, Thomas Ferguson, Yen-Hwa Chang, Jae Lyun Lee, Naomi Haas and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 NCT03142334 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab), which is not on this map. Cited by 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 pooled it
5.9field-weighted citation impact, top 3% 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.

NCT03142334 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2026Enrolled994ConditionsRenal Cell CarcinomaArmsPembrolizumab, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
  7. Review
  8. Observational
  9. Article
  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

21 authors at 18 institutions in 10 countries.

Toni K ChoueiriDepartment of Medical Oncology, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-9201-3217
Piotr TomczakDepartment of Medical Oncology, Poznan University of Medical Sciences, Poznan, Poland.
Se Hoon ParkDepartment of Hematology and Oncology, Sungkyunkwan University Samsung Medical Center, Seoul, South Korea.
Balaji VenugopalDepartment of Medical Oncology, The Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.
Stefan SymeonidesDepartment of Medical Oncology, Edinburgh Cancer Centre, NHS Lothian, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK.
Jaroslav HajekDepartment of Medical Oncology, Fakultní Nemocnice Ostrava, Ostrava, Czech Republic.
Thomas FergusonDepartment of Medical Oncology, Fiona Stanley Hospital, Perth, Western Australia, Australia.
Yen-Hwa ChangDepartment of Urology, Taipei Veterans General Hospital, Taipei, Taiwan.
Jae Lyun LeeDepartment of Oncology, Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea.
Naomi HaasDivision of Hematology and Oncology, Abramson Cancer Center, Philadelphia, PA, USA.
Piotr SawryckiChemotherapy Department, Wojewódzki Szpital Zespolony im. L. Rydygiera, Torun, Poland.
Naveed SarwarDepartment of Surgery and Cancer, Imperial College Healthcare NHS Trust, London, UK.
Marine Gross-GoupilDepartment of Medical Oncology, University Hospital Bordeaux-Hôpital Saint-André, Bordeaux, France.
Antoine Thiery-VuilleminDepartment of Medical Oncology, University Hospital Jean Minjoz, Besançon, France.
Mauricio MahaveDepartment of Oncology, Fundación Arturo López Pérez FALP, Santiago, Chile.
Go KimuraDepartment of Urology, Nippon Medical School Hospital, Tokyo, Japan.
Rodolfo F PeriniMerck & Co., Inc., Rahway, NJ, USA.
Todd L SaretskyMerck & Co., Inc., Rahway, NJ, USA.
Rituparna BhattacharyaMerck & Co., Inc., Rahway, NJ, USA.
Lei XuMerck & Co., Inc., Rahway, NJ, USA.
Thomas PowlesDepartment of Oncology, Royal Free Hospital NHS Trust, University College London, London, UK.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USBeatson West of Scotland Cancer Centre · GBBrigham and Women's Hospital · USCentre Hospitalier Universitaire de Besançon · FRFiona Stanley Hospital · AUFundación Arturo López Pérez · CLHôpital Saint-André · FRImperial College Healthcare NHS Trust · GBNHS Lothian · GBNippon Medical School Hospital · JPPoznan University of Medical Sciences · PLProvincial Polyclinical Hospital in Toruń · PLSamsung Medical Center · KRSidney Kimmel Cancer Center · USTaipei Veterans General Hospital · TWThe Royal Free Hospital · GBUlsan College · KRUniversity Hospital Ostrava · CZ

Funding

Merck Sharp & Dohme LLC
6 · The paper itself

Abstract

backgroundIn patients with renal cell carcinoma (RCC) enrolled in the phase III KEYNOTE-564 trial (NCT03142334), disease-free survival (DFS) following nephrectomy was prolonged with use of adjuvant pembrolizumab therapy versus placebo. Patient-reported outcomes (PROs) provide an important measure of health-related quality of life (HRQoL) and can complement efficacy and safety results. PATIENTS AND

methodsIn KEYNOTE-564, 994 patients were randomly assigned to receive pembrolizumab 200 mg (n = 496) or placebo (n = 498) intravenously every 3 weeks for ≤17 cycles. Patients who received ≥1 dose of treatment and completed ≥1 HRQoL assessment were included in this analysis. HRQoL end points were assessed using the EORTC QLQ-C30, FKSI-DRS, and EQ VAS. Prespecified and exploratory PRO end points were mean change from baseline in EORTC QLQ-C30 GHS/QoL score, EORTC QLQ-C30 physical function subscale score, and FKSI-DRS score.

resultsNo clinically meaningful difference in least squares mean scores for pembrolizumab versus placebo were observed at week 52 for EORTC QLQ-C30 GHS/QoL (-2.5; 95% CI -5.2 to 0.1), EORTC QLQ-C30 physical functioning (-0.87; 95% CI -2.7 to 1.0), and FKSI-DRS (-0.7; 95% CI -1.2 to -0.1). Most PRO scores remained stable or improved for the EORTC QLQ-C30 GHS/QoL (pembrolizumab, 54.3%; placebo, 67.5%), EORTC QLQ-C30 physical functioning (pembrolizumab, 64.7%; placebo, 68.8%), and FKSI-DRS (pembrolizumab, 58.2%; placebo, 66.3%).

conclusionsAdjuvant treatment with pembrolizumab did not result in deterioration of HRQoL. These findings together with the safety and efficacy findings support adjuvant pembrolizumab treatment following nephrectomy.

trial registrationClinicaltrials.gov Identifier: NCT03142334.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Renal CellKidney NeoplasmsHumansPatient Reported Outcome MeasuresQuality of LifeAntibodies, Monoclonal, Humanizedpembrolizumabhealth-related quality of lifenephrectomypembrolizumabrenal cell carcinoma

Identifiers

PMID37589219
PMCPMC10836324
OpenAlexW4385897718

What OpenQuestion holds

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LicenceCC BY-NC
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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.