Evidence map›Paper›PMID 25913680›Full record

Trial reportCancer2015

A phase 2 trial of lenvatinib (E7080) in advanced, progressive, radioiodine-refractory, differentiated thyroid cancer: A clinical outcomes and biomarker assessment.

Maria E Cabanillas, Martin Schlumberger, Barbara Jarzab, Renato G Martins, Furio Pacini, Bruce Robinson, Judith C McCaffrey, Manisha H Shah, Donald L Bodenner, Duncan Topliss and 10 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 8 pooled it
17.2field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 8 syntheses or guidelines pooled it, 187 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review

27 more citing papers are in PubMed but not listed here.

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

20 authors at 16 institutions in 7 countries.

Maria E CabanillasDepartment of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Martin SchlumbergerDepartment of Nuclear Medicine and Endocrine Oncology, Gustave Roussy Institute and Université Paris-Sud, Villejuif, France.
Barbara JarzabDepartment of Nuclear Medicine and Endocrine Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice Poland, Wybrzeze Armii Krajowej 15, 44-101 Gliwice, Poland.
Renato G MartinsDepartment of Thoracic/Head and Neck Oncology, School of Medicine, University of Washington, Seattle, Washington.
Furio PaciniSection of Endocrinology, University of Siena, Siena, Italy.
Bruce RobinsonFaculty of Medicine, Cancer Genetics Unit, Kolling Institute, Royal North Shore Hospital, University of Sydney, New South Wales, Australia.
Judith C McCaffreyH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
Manisha H ShahOhio State University Comprehensive Cancer Center, Columbus, Ohio.
Donald L BodennerDepartment of Geriatrics, University of Arkansas for Medical sciences, Little Rock, Arkansas.
Duncan ToplissDepartment of Endocrinology and Diabetes, The Alfred Hospital, Melbourne, Victoria, Australia.
Corina AndresenEisai Inc, Woodcliff Lake, New Jersey.
James P O'BrienEisai Inc, Woodcliff Lake, New Jersey.
Min RenEisai Inc, Woodcliff Lake, New Jersey.
Yasuhiro FunahashiEisai Inc, Andover, Massachusetts.
Roger AllisonCancer Care Services, The Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
Rossella EliseiDepartment of Endocrinology, University of Pisa, Pisa, Italy.
Kate NewboldDepartment of Oncology, Royal Marsden Hospital, London, United Kingdom.
Lisa F LicitraFoundation for Cancer Research and Treatment, National Tumor Institute, Milan, Italy.
Steven I ShermanDepartment of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Douglas W BallThe Johns Hopkins University School of Medicine, Baltimore, Maryland.
Eisai (United States) · USThe University of Texas MD Anderson Cancer Center · USJohns Hopkins University · USNational Cancer Institute · MYRoyal Brisbane and Women's Hospital · AURoyal Marsden Hospital · GBRoyal North Shore Hospital · AUThe Alfred Hospital · AUThe Maria Sklodowska-Curie National Research Institute of Oncology · PLThe Ohio State University · USUniversité Paris-Sud · FRUniversity of Arkansas for Medical Sciences · USUniversity of Pisa · ITUniversity of Siena · ITUniversity of South Florida · USUniversity of Washington · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundLenvatinib is an oral, multitargeted tyrosine kinase inhibitor of the vascular endothelial growth factor receptors 1 through 3 (VEGFR1-VEGFR3), fibroblast growth factor receptors 1 through 4 (FGFR1-FGFR4), platelet-derived growth factor receptor α (PDGFRα), ret proto-oncogene (RET), and v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) signaling networks implicated in tumor angiogenesis. Positive phase 1 results in solid tumors prompted a phase 2 trial in patients with advanced, radioiodine-refractory, differentiated thyroid cancer (RR-DTC).

methodsFifty-eight patients with RR-DTC who had disease progression during the previous 12 months received lenvatinib 24 mg once daily in 28-day cycles until disease progression, unmanageable toxicity, withdrawal, or death. Previous VEGFR-targeted therapy was permitted. The primary endpoint was the objective response rate (ORR) based on independent imaging review. Secondary endpoints included progression-free survival (PFS) and safety. Serum levels of 51 circulating cytokines and angiogenic factors also were assessed.

resultsAfter ≥14 months of follow-up, patients had an ORR of 50% (95% confidence interval [CI], 37%-63%) with only partial responses reported. The median time to response was 3.6 months, the median response duration was 12.7 months, and the median PFS was 12.6 months (95% CI, 9.9-16.1 months). The ORR for patients who had received previous VEGF therapy (n = 17) was 59% (95% CI, 33%-82%). Lower baseline levels of angiopoietin-2 were suggestive of tumor response and longer PFS. Grade 3 and 4 treatment-emergent adverse events, regardless of their relation to treatment, occurred in 72% of patients and most frequently included weight loss (12%), hypertension (10%), proteinuria (10%), and diarrhea (10%).

conclusionsIn patients with and without prior exposure to VEGF therapy, the encouraging response rates, median time to response, and PFS for lenvatinib have prompted further investigation in a phase 3 trial. Cancer 2015;121:2749-2756. © 2015 American Cancer Society.

Indexed as

AdultAgedAntineoplastic AgentsBiomarkers, TumorDisease ProgressionFemaleHumansIodine RadioisotopesMaleMiddle AgedPhenylurea CompoundsProtein Kinase InhibitorsProto-Oncogene MasQuinolinesThyroid NeoplasmsTreatment OutcomeAntineoplastic AgentsBiomarkers, TumorIodine RadioisotopeslenvatinibMAS1 protein, humanPhenylurea CompoundsProtein Kinase InhibitorsProto-Oncogene MasQuinolinesbiomarkersdifferentiated thyroid cancerlenvatinibmultikinase inhibitorphase 2radioiodine refractory

Identifiers

PMID25913680
PMCPMC4803478
OpenAlexW1571830205

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.