Evidence map›Paper›PMID 36464853›Full record

Trial reportCancer medicine2023

Health-related quality-of-life analyses from a multicenter, randomized, double-blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day.

Matthew H Taylor, Sophie Leboulleux, Yury Panaseykin, Bhavana Konda, Christelle de La Fouchardiere, Brett G M Hughes, Andrew G Gianoukakis, Young Joo Park, Ilia Romanov, Monika K Krzyzanowska and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02702388 (A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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.

NCT02702388 phase2completednot on this map

A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

TypeinterventionalSponsorEisai Inc.Ran2017 to 2020Enrolled241ConditionsThyroid CancerArmsLenvatinib, Lenvatinib matching placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
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

17 authors at 14 institutions in 7 countries.

Matthew H TaylorEarle A. Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.
Sophie LeboulleuxDepartment of Nuclear Medicine and Endocrine Oncology, Gustave Roussy and University Paris Saclay, Villejuif, France.
Yury PanaseykinA. Tsyb Medical Radiological Research Center, branch of the NMRС of Radiology, Obninsk, Russian Federation.
Bhavana KondaDivision of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Ohio, Columbus, USA.
Christelle de La FouchardiereMedical Oncology Department, Centre Léon Bérard, Lyon, France.ORCID 0000-0003-2291-5693
Brett G M HughesDepartment of Cancer Care Services, Royal Brisbane and Women's Hospital, University of Queensland, Queensland, Australia.
Andrew G GianoukakisThe Lundquist Institute at Harbor-UCLA Medical Center, David Geffen School of Medicine at UCLA, California, Los Angeles/Torrance, USA.
Young Joo ParkDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Ilia RomanovDepartment of Head & Neck Tumors, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation.
Monika K KrzyzanowskaDepartment of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Ontario, Toronto, Canada.
Diana GarbinskyRTI Health Solutions, Research Triangle Park, North Carolina, USA.
Bintu SherifRTI Health Solutions, Research Triangle Park, North Carolina, USA.
Jie Janice PanGlobal Value and Access (GV&A), Oncology, Eisai Inc., New Jersey, Nutley, USA.
Terri A BinderOncology Clinical Research, Eisai Inc., New Jersey, Nutley, USA.
Nicholas SauterOncology Clinical Research, Eisai Inc., New Jersey, Nutley, USA.
Ran XieBiostatistics, Eisai Inc., New Jersey, Nutley, USA.
Marcia S BroseDepartment of Medical Oncology, Sidney Kimmel Cancer Center, Jefferson University (previous affiliation: Department of Otorhinolaryngology: Head and Neck Surgery, Abramson Cancer Center, University of Pennsylvania), Pennsylvania, Philadelphia, USA.
Eisai (United States) · USRTI Health Solutions · USCentre Léon Bérard · FRInstitut Gustave Roussy · FRMedical Radiological Research Center · RUPrincess Margaret Cancer Centre · CAProvidence Portland Medical Center · USRussian Cancer Research Center NN Blokhin · RUSeoul National University · KRSidney Kimmel Cancer Center · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe University of Queensland · AUUCLA Medical Center · USValve (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase 2 double-blind Study 211, a starting dose of lenvatinib 18 mg/day was compared with the approved starting dose of 24 mg/day in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Predefined criteria for noninferiority for efficacy in the 18 mg arm were not met; safety was similar in both arms. Impact of lenvatinib treatment on health-related quality-of-life (HRQoL) was a secondary endpoint of Study 211.

methodsPatients with RR-DTC were randomly assigned to a blinded starting dose of lenvatinib 18 mg/day or 24 mg/day. HRQoL was assessed at baseline, every 8 weeks until Week 24, then every 16 weeks, and at the off-treatment visit, using the EQ-5D-3L and FACT-G instruments. Completion and compliance rates, mean change from baseline, and times to first and definitive deterioration were evaluated.

resultsBaseline EQ-5D and FACT-G scores, and overall changes from baseline, were comparable between patients in the lenvatinib 18 mg/day (n = 77) and 24 mg/day arms (n = 75). For the 18 mg versus 24 mg arms, least squares mean differences were -0.42 (95% CI -4.88, 4.03) for EQ-5D-VAS and 0.47 (95% CI -3.45, 4.39) for FACT-G total. Time to first deterioration did not significantly favor either arm; EQ-5D-VAS HR [18 mg/24 mg] 0.93 (95% CI 0.61-1.40), EQ-5D-HUI HR [18 mg/24 mg] 0.68 (95% CI 0.44-1.05), FACT-G total HR [18 mg/24 mg] 0.73 (95% CI 0.48-1.12). Time to definitive deterioration did not significantly favor either arm, though EQ-5D-VAS showed a trend in favor of the 24 mg arm (HR [18 mg/24 mg] 1.72; 95% CI 0.99-3.01); EQ-5D-HUI HR [18 mg/24 mg] was 0.96 (95% CI 0.57-1.63), FACT-G total HR [18 mg/24 mg] was 0.72 (95% CI 0.43-1.21).

conclusionsIn Study 211, HRQoL for patients in the lenvatinib 18 mg/day arm was not statistically different from that of patients in the 24 mg/day arm. These data further support the use of the approved lenvatinib starting dose of 24 mg/day in patients with RR-DTC. CLINICALTRIALS: GOV NUMBER: NCT02702388.

Indexed as

AdenocarcinomaThyroid NeoplasmsDouble-Blind MethodHumansIodine RadioisotopesPhenylurea CompoundsQuality of LifeQuinolinesIodine RadioisotopeslenvatinibPhenylurea CompoundsQuinolinesdose intensityHRQoLkinase inhibitorlenvatinibquality of liferadioiodine-refractory differentiated thyroid cancer

Identifiers

PMID36464853
PMCPMC9972135
OpenAlexW4310706560

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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.