Evidence map›Paper›PMID 35192411›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA).

Alan L Ho, Marek Dedecjus, Lori J Wirth, R Michael Tuttle, William B Inabnet, Jan Tennvall, Fernanda Vaisman, Lars Bastholt, Andrew G Gianoukakis, Patrice Rodien and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01843062 (A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients With Differentiated Thyroid Cancer), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT01843062 phase3terminatednot on this map

A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients With Differentiated Thyroid Cancer

TypeinterventionalSponsorAstraZenecaRan2013 to 2019Enrolled233ConditionsDifferentiated Thyroid CancerArmsSelumetinib, Placebo, Radioactive Iodine Therapy
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 9 countries.

Alan L HoDepartment of Medicine, Head and Neck Medical Oncology, Memorial Sloan Kettering Cancer Center and Weill-Cornell New York Presbyterian Hospital, New York, NY.ORCID 0000-0002-6885-3742
Marek DedecjusMaria Skłodowska-Curie Institute, Oncology Center, Warsaw, Poland.ORCID 0000-0003-3485-8219
Lori J WirthMassachusetts General Hospital, Boston, MA.ORCID 0000-0002-2629-2289
R Michael TuttleMemorial Sloan Kettering Cancer Center, New York, NY.
William B InabnetDepartment of Surgery, University of Kentucky College of Medicine, Lexington, KY.
Jan TennvallLund University and Skåne University Hospital, Department of Clinical Sciences, Oncology, Lund, Sweden.
Fernanda VaismanNational Cancer Institute, Rio de Janeiro, Brazil.ORCID 0000-0002-6835-7108
Lars BastholtOdense University Hospital, Odense, Denmark.ORCID 0000-0001-5478-9826
Andrew G GianoukakisThe Lundquist Research Institute at Harbor-UCLA Medical Center, Torrance, CA.
Patrice RodienCentre Hospitalier Universitaire d'Angers, Angers, France.
Ralf PaschkeCumming School of Medicine, University of Calgary, Calgary, Canada.
Rossella EliseiEndocrinology Unit, Department of Clinical and Experimental Medicine, University Hospital of Pisa, Pisa, Italy.
David ViolaEndocrinology Unit, Department of Clinical and Experimental Medicine, University Hospital of Pisa, Pisa, Italy.ORCID 0000-0001-7683-152X
Karen SoAstraZeneca, Cambridge, United Kingdom.
Danielle CarrollAstraZeneca, Cambridge, United Kingdom.
Tina HoveyPHASTAR, London, United Kingdom.
Bhavana ThakreOncology R&D, AstraZeneca, Gaithersburg, MD.
James A FaginMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-2365-2517
ASTRA investigator group
Memorial Sloan Kettering Cancer Center · USAstraZeneca (United Kingdom) · GBAzienda Ospedaliera Universitaria Pisana · ITAstraZeneca (United States) · USCentre Hospitalier Universitaire d'Angers · FRUniversity of Calgary · CAUniversity of California, Los Angeles · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
SPORE in Thyroid CancerP50CA172012 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI FAGIN, JAMES A · 2014 to 2018
$10.3M
124I-NaI PET: Building block for precision medicine in metastatic thyroid cancerR01CA201250 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI HUMM, JOHN L, LARSON, STEVEN MARK · 2016 to 2020
$3.5M
Improving efficacy of radioiodine treatment of thyroid cancerR01CA249663 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI FAGIN, JAMES A, HO, ALAN L. · 2021 to 2025
$2.3M
Targeting MEK to Restore Radioiodine Efficacy for RAI-Refractory Thyroid CancerR01CA184724 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI HO, ALAN L. · 2015 to 2017
$1.7M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA172012NCI NIH HHS R01 CA184724NCI NIH HHS R01 CA201250NCI NIH HHS R01 CA249663
6 · The paper itself

Abstract

purposeSelumetinib can increase radioactive iodine (RAI) avidity in RAI-refractory tumors. We investigated whether selumetinib plus adjuvant RAI improves complete remission (CR) rates in patients with differentiated thyroid cancer (DTC) at high risk of primary treatment failure versus RAI alone.

methodsASTRA (ClinicalTrials.gov identifier: NCT01843062) is an international, phase III, randomized, placebo-controlled, double-blind trial. Patients with DTC at high risk of primary treatment failure (primary tumor > 4 cm; gross extrathyroidal extension outside the thyroid gland [T4 disease]; or N1a/N1b disease with ≥ 1 metastatic lymph node(s) ≥ 1 cm or ≥ 5 lymph nodes [any size]) were randomly assigned 2:1 to selumetinib 75 mg orally twice daily or placebo for approximately 5 weeks (no stratification). On treatment days 29-31, recombinant human thyroid-stimulating hormone (0.9 mg)-stimulated RAI (

resultsFour hundred patients were enrolled (August 27, 2013-March 23, 2016) and 233 randomly assigned (selumetinib, n = 155 [67%]; placebo, n = 78 [33%]). No statistically significant difference in CR rate 18 months after RAI was observed (selumetinib n = 62 [40%]; placebo n = 30 [38%]; odds ratio 1.07 [95% CI, 0.61 to 1.87];

conclusionPostoperative pathologic risk stratification identified patients with DTC at high risk of primary treatment failure, although the addition of selumetinib to adjuvant RAI failed to improve the CR rate for these patients. Future strategies should focus on tumor genotype-tailored drug selection and maintaining drug dosing to optimize RAI efficacy.

Indexed as

AdenocarcinomaThyroid NeoplasmsBenzimidazolesDouble-Blind MethodHumansIodine RadioisotopesAZD 6244BenzimidazolesIodine Radioisotopes

Identifiers

PMID35192411
PMCPMC9851689
OpenAlexW4213427186

What OpenQuestion holds

Textmetadata
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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.