Evidence map›Paper›PMID 37943491›Full record

ArticleDermatology and therapy2023

Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629.

Åse Bratland, Eva Munoz-Couselo, Laurent Mortier, Osama Roshdy, Rene González, Jacob Schachter, Ana M Arance, Florent Grange, Nicolas Meyer, Abhishek Jagdish Joshi and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03284424 (A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 32% 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.

NCT03284424 phase2completednot on this map

A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2023Enrolled159ConditionsSquamous Cell CarcinomaArmsPembrolizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  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

18 authors at 14 institutions in 9 countries.

Åse BratlandHead and Neck Oncology, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway. brt@ous-hf.no.
Eva Munoz-CouseloDepartment of Medical Oncology, Melanoma and Other Skin Tumors Unit, Vall d'Hebron Hospital, Passeig de la Vall d'Hebron, 119, 08035, Barcelona, Spain.ORCID http://orcid.org/0000-0001-7556-7608
Laurent MortierDepartment of Dermatology, INSERM U 1189, Université Lille, Centre Hospitalier Regional Universitaire de Lille, 2, Avenue Oscar Lambret, 59037, Lille, France.
Osama RoshdyDivision of Dermatology, McGill University, 845 Sherbrooke St W, Montreal, QC, H3A 0G4, Canada.
Rene GonzálezSurgical Oncology, Centro Estatal de Cancerologiade Chihuahua, C. Ejercito Mexicano 3700, 31000, Chihuahua, Mexico.
Jacob SchachterDivision of Oncology, Level 2, Cancer Center (Oncology Institute), Sheba Medical Center-Tel Hashomer, Emek HaEla Street 1, 52621, Ramat Gan, Israel.
Ana M AranceMedical Oncology, Hospital Clinic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
Florent GrangeDermatology/Oncology, CHU Reims-Hôpital Robert Debre, Avenue du General Koenig Service de Dermatologie, 51100, Reims, France.
Nicolas MeyerOnco-Dermatology, Institut Claudius Regaud, Institut Universitaire du Cancer and CHU, 1 Avenue Irene Joliot Curie, 31059, Toulouse, France.
Abhishek Jagdish JoshiDepartment of Medical Oncology, Townsville University Hospital, 55 Keane Street, Douglas, QLD, 4814, Australia.ORCID http://orcid.org/0000-0002-7786-0039
Salem BillanHead and Neck Malignancies Unit, Rambam Health Care Campus, Technion-Israel Institute of Technology, HaAliya HaShniya St 8, 52621, Haifa, Israel.
Brett G M HughesOncology, Clinical Research Unit, Medical Oncology, Royal Brisbane and Women's Hospital, Butterfield Street, Ground Floor, Building 34, Herston, QLD, 4029, Australia.ORCID http://orcid.org/0000-0002-1811-0537
Jean-Jacques GrobDermatology, AIX-Marseille University and APHM Hospital Marseille, 264 Rue Saint Pierre, 13385, Marseille, France.
Karthik RamakrishnanMedical Oncology, Merck & Co., Inc., 2025 E Scott Ave, Rahway, NJ, 07065, USA.
Joy GeMedical Oncology, Merck & Co., Inc., 2025 E Scott Ave, Rahway, NJ, 07065, USA.
Burak GumuscuMedical Oncology, Merck & Co., Inc., 2025 E Scott Ave, Rahway, NJ, 07065, USA.
Ramona F SwabyMedical Oncology, Merck & Co., Inc., 2025 E Scott Ave, Rahway, NJ, 07065, USA.
Ralf GutzmerDepartment of Dermatology, Skin Cancer Center Hannover, Hannover Medical School, Carl-Neuberg-Str. 1, 60325, Hannover, Germany.ORCID http://orcid.org/0000-0001-7921-2820
Merck & Co., Inc., Rahway, NJ, USA (United States) · USAutonomous University of Chihuahua · MXCentre Hospitalier Universitaire de Reims · FRHospital Clínic de Barcelona · ESInserm · FRInstitut Claudius Regaud · FRMcGill University · CAMedizinische Hochschule Hannover · DEOslo University Hospital · NOSheba Medical Center · ILTechnion – Israel Institute of Technology · ILThe University of Queensland · AUTownsville Hospital · AUVall d'Hebron Institut de Recerca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAt first interim analysis of KEYNOTE-629, health-related quality of life (HRQoL) with pembrolizumab was stable or improved over 48 weeks in recurrent or metastatic (R/M) cutaneous squamous cell carcinoma (cSCC). HRQoL results from the second interim analysis in R/M or locally advanced (LA) cSCC are presented.

methodsPatients received pembrolizumab 200 mg every 3 weeks for ≤ 2 years. Change in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EQ-5D-5L scores were exploratory end points. Primary analysis was performed at week 12 to ensure adequate completion/compliance. Descriptive analyses were also conducted through weeks 48 and 75 for the LA and R/M cohorts, respectively.

resultsAt data cutoff (29 July 2020), mean scores in the LA cohort (n = 47) were stable from baseline to week 12 for EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) (-0.27 points [95% confidence interval (CI) -10.93 to 10.39]), physical functioning (-1.29 points [95% CI  -8.77 to 6.19]), and EQ-5D-5L visual analog scale (2.06 [95% CI -7.70 to 11.82]). HRQoL remained stable through week 48 in the LA cohort; 76.6% and 74.5% of patients had improved or stable GHS/QoL and physical functioning scores, respectively. HRQoL continued to show stability or improvement through week 75 in the R/M cohort (n = 99); 71.7% and 64.6% of patients had improved or stable GHS/QoL and physical functioning scores, respectively.

conclusionsPembrolizumab has demonstrated antitumor activity and manageable safety. The current analysis shows pembrolizumab treatment preserved HRQoL. Collectively, these results support pembrolizumab as standard of care for LA or R/M cSCC.

trial registrationClinicalTrials.gov, NCT03284424-September 15, 2017.

Indexed as

Advanced squamous cell carcinomaImmunotherapyPembrolizumabQuality of life

Identifiers

PMID37943491
PMCPMC10689716
OpenAlexW4388539637

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.