Evidence map›Paper›PMID 37086595›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2023

Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician's Choice.

Domenica Lorusso, Nicoletta Colombo, Antonio Casado Herraez, Alessandro D Santin, Emeline Colomba, David Scott Miller, Keiichi Fujiwara, Sandro Pignata, Sally E Baron-Hay, Isabelle Laure Ray-Coquard and 9 more

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

Trial report in European journal of cancer (Oxford, England : 1990), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03517449 (A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
4.7field-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.

NCT03517449 phase3completednot on this map

A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

TypeinterventionalSponsorEisai Inc.Ran2018 to 2025Enrolled827ConditionsEndometrial NeoplasmsArmsPembrolizumab, Lenvatinib, Paclitaxel, Doxorubicin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Combination Targeted Therapy with Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    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

19 authors at 17 institutions in 10 countries.

Domenica LorussoFondazione Policlinico Universitario Agostino Gemelli IRCCS, and Catholic University of Sacred Heart, Rome, Italy. Electronic address: domenica.lorusso@policlinicogemelli.it.
Nicoletta ColomboUniversity of Milan-Bicocca, European Institute of Oncology IRCCS, Milan, Italy.
Antonio Casado HerraezClínico San Carlos University Teaching Hospital, Madrid, Spain.
Alessandro D SantinYale University School of Medicine, New Haven, CT, USA.
Emeline ColombaGustave Roussy Cancerology Institute, Villejuif, GINECO Group, France.
David Scott MillerUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Keiichi FujiwaraSaitama Medical University International Medical Center, Hidaka, Japan.
Sandro PignataIstituto Nazionale Tumori IRCCS-Fondazione G. Pascale, Naples, Italy.
Sally E Baron-HayRoyal North Shore Hospital, St Leonards, Australia.
Isabelle Laure Ray-CoquardCentre Léon Bérard, University Claude Bernard, Lyon, GINECO Group, France.
Ronnie Shapira-FrommerSheba Medical Center, Ramat, Israel.
Yong Man KimAsan Medical Center, University of Ulsan, Seoul, Korea, Republic of South Korea.
Mary McCormackUniversity College London Hospitals NHS Foundation Trust, London, United Kingdom.
Rachid MassaadMSD (Europe), Brussels, Belgium.
Allison Martin NguyenMerck & Co., Inc., Rahway, NJ, USA.
Qi ZhaoEisai Inc., Nutley, NJ, USA.
Jodi McKenzieEisai Inc., Nutley, NJ, USA.
Vimalanand S PrabhuMerck & Co., Inc., Rahway, NJ, USA.
Vicky MakkerWeill Cornell Medical Center, New York, NY, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Eisai (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USAgostino Gemelli University Polyclinic · ITAsan Medical Center · KRHospital Clínico San Carlos · ESInstitut Gustave Roussy · FRIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITMemorial Sloan Kettering Cancer Center · USMSD (Belgium) · BERoyal North Shore Hospital · AUSaitama Medical University · JPSheba Medical Center · ILThe University of Texas Southwestern Medical Center · USUniversité Claude Bernard Lyon 1 · FRUniversity College London Hospitals NHS Foundation Trust · GBUniversity of Milan · ITYale University · US

Funding

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

Abstract

purposeLenvatinib and pembrolizumab (LEN+PEMBRO) demonstrated clinically meaningful and statistically significant improvements in efficacy versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer (aEC) in the phase 3 Study 309/KEYNOTE-775. Health-related quality-of-life (HRQoL) is reported. PATIENTS AND

methodsPatients were randomly assigned to receive LEN+PEMBRO (n = 411; LEN 20 mg/day; PEMBRO 200 mg Q3W) or TPC (n = 416; doxorubicin 60 mg/m

resultsThe latest timepoint at which the predefined rates of completion (≥60%) and compliance (≥80%) were met was week 12. HRQoL at week 12 between treatment groups was generally similar. Time to first deterioration symptom scales favoured LEN+PEMBRO for QLQ-C30 dyspnoea, and QLQ-EN24 for poor body image, tingling/numbness, and hair loss; and TPC was favoured for QLQ-C30 pain, appetite loss, and diarrhoea, and QLQ-EN24 muscular pain. While the QLQ-C30 physical functional scale favoured TPC, other functional scales were generally similar between arms. Time to definitive deterioration favoured LEN+PEMBRO on most scales.

conclusionHRQoL data from Study 309/KEYNOTE-775, with previously published efficacy and safety results, indicate that LEN+PEMBRO has an overall favourable benefit/risk profile versus TPC for the treatment of patients with aEC. CLINICALTRIALS: GOV: NCT03517449.

Indexed as

Endometrial NeoplasmsPhysiciansAntibodies, Monoclonal, HumanizedFemaleHumansPainPhenylurea CompoundsQuality of LifeQuinolinesAntibodies, Monoclonal, HumanizedlenvatinibpembrolizumabPhenylurea CompoundsQuinolinesEndometrial cancerHealth-related quality of lifeLenvatinibPatient-reported outcomesPembrolizumab

Identifiers

PMID37086595
PMCPMC11003310
OpenAlexW4360616066

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.