Evidence map›Paper›PMID 27548104›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2016

Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer.

Bruce Robinson, Martin Schlumberger, Lori J Wirth, Corina E Dutcus, James Song, Matthew H Taylor, Sung-Bae Kim, Monika K Krzyzanowska, Jaume Capdevila, Steven I Sherman and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
6.4field-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.

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

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
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  11. Observational
  12. BRAFThyroid research · 2025
    Article
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  18. The importance of early-stage blood pressure control in thyroid cancer patients treated with lenvatinib from the perspective of dose intensity.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
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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

11 authors at 10 institutions in 7 countries.

Bruce RobinsonKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Martin SchlumbergerKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Lori J WirthKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Corina E DutcusKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
James SongKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Matthew H TaylorKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Sung-Bae KimKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Monika K KrzyzanowskaKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Jaume CapdevilaKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Steven I ShermanKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Makoto TaharaKolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.
Eisai (United States) · USInstitut Gustave Roussy · FRMassachusetts General Hospital · USNational Cancer Center Hospital East · JPOregon Health & Science University · USPrincess Margaret Cancer Centre · CAThe University of Texas MD Anderson Cancer Center · USUniversity of Sydney · AUUniversity of Ulsan · KRVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextLenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT).

objectiveThe objective of the study was to characterize tumor size changes with lenvatinib treatment.

designSELECT was a phase 3, randomized, double-blind, multicenter study.

settingIn this clinical trial, tumor assessments of lenvatinib (n = 261) and placebo-treated (n = 131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals. PATIENTS: Patients with complete or partial response were defined as responders to lenvatinib (n = 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis.

interventionsLenvatinib (24 mg once daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death.

main outcome measuresThis was an exploratory analysis of key end points from SELECT, including PFS, overall response rate, and tumor reduction.

resultsThe median maximum percentage change in tumor size was -42.9% for patients receiving lenvatinib (responders, -51.9%; nonresponders, -20.2%). Tumor size reduction was most pronounced at first assessment (median, -24.7% at 8 wk after randomization); thereafter, the rate of change was slower but continuous (-1.3% per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS (P = .06).

conclusionsThe change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage.

Indexed as

Outcome Assessment, Health CareAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPhenylurea CompoundsQuinolinesThyroid NeoplasmsYoung AdultAntineoplastic AgentslenvatinibPhenylurea CompoundsQuinolines

Identifiers

PMID27548104
PMCPMC5095235
OpenAlexW2508537271

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Registered trials

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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.