Evidence map›Paper›PMID 19255327›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Phase II trial of sorafenib in metastatic thyroid cancer.

Richard T Kloos, Matthew D Ringel, Michael V Knopp, Nathan C Hall, Mark King, Robert Stevens, Jiachao Liang, Paul E Wakely, Vasyl V Vasko, Motoyasu Saji and 7 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01700699 (Impact of BRAFV600E Intratumor Heterogeneity on the Efficacy of Tyrosine Kinase Inhibitors in the Treatment of Radioiodine-resistant Thyroid Cancer), which is not on this map. Cited by 208 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
208citing papers in PubMed, 17 pooled it
39.5field-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.

NCT01700699 unknown statusnot on this mapstarted 2012, after this paper: background citation

Impact of BRAFV600E Intratumor Heterogeneity on the Efficacy of Tyrosine Kinase Inhibitors in the Treatment of Radioiodine-resistant Thyroid Cancer

TypeobservationalSponsorUniversity of SalernoRan2012 to 2013Enrolled50ConditionsDifferentiated Thyroid Cancer
3 · Its place in the literature

Who cites it

208 citing papers in PubMed, 17 syntheses or guidelines pooled it, 543 citations in OpenAlex.

  1. SEOM-GETNE-TTCC Clinical guideline thyroid cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  2. 2021 American Thyroid Association Guidelines for Management of Patients with Anaplastic Thyroid Cancer.Thyroid : official journal of the American Thyroid Association · 2021
    Guideline
  3. Pooled it
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  8. Guideline
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  14. Spinal metastasis in thyroid cancer.Head & neck oncology · 2012
    Pooled it
  15. Pooled it
  16. SEOM clinical guidelines for the treatment of thyroid cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2011
    Guideline
  17. Angiogenesis-inhibitors for metastatic thyroid cancer.The Cochrane database of systematic reviews · 2010
    Pooled it
  18. Trial
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148 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

17 authors at 1 institution in 1 country.

Richard T KloosOhio State University, Department of Internal Medicine, Molecular Virology, Immunology, and Genetics, Pathology, Radiology, Center for Biostatistics, Ohio State University, Columbus, OH 43210, USA.
Matthew D Ringel
Michael V Knopp
Nathan C Hall
Mark King
Robert Stevens
Jiachao Liang
Paul E Wakely
Vasyl V Vasko
Motoyasu Saji
Jennifer Rittenberry
Lai Wei
Daria Arbogast
Minden Collamore
John J Wright
Michael Grever
Manisha H Shah
The Ohio State University · US

Funding

PHASE I TRIALS OF ANTICANCER AGENTSU01CA076576 · NCI · OHIO STATE UNIVERSITY · PI GREVER, MICHAEL R · 1998 to 2013
$9.1M
Targeting RAF and VEGF Signaling in Thyroid CancerR21CA112903 · NCI · OHIO STATE UNIVERSITY · PI SHAH, MANISHA H · 2005 to 2006
$400k
NCI NIH HHS N01 CM57018NCI NIH HHS R21 CA112903NCI NIH HHS U01 CA076576NCI NIH HHS U01 CA76576
6 · The paper itself

Abstract

purposeBased on the pivotal role of Ras-Raf-MAP-ERK signaling and vascular endothelial growth factor (VEGF) in papillary thyroid cancer (PTC), we conducted a phase II clinical trial of sorafenib targeting RAF and VEGF receptor kinases in PTC. PATIENTS AND

methodsThe primary end point was the objective response rate. Secondary end points included response correlation with serum thyroglobulin (Tg); functional imaging; tumor genotype; and signaling inhibition in tumor biopsies. Using a Simon minimax two-stage design, 16 or 25 chemotherapy-naïve metastatic PTC patients were to be enrolled in arm A (accessible tumor for biopsy). Arm B patients had other subtypes of thyroid carcinoma or prior chemotherapy, and did not require tumor biopsies. Patients received 400 mg orally twice per day of sorafenib. Response was assessed every 2 months using RECIST (Response Evaluation Criteria in Solid Tumors).

resultsOf 41 PTC patients, six patients had a partial response (PR; 15%; 95% CI, 6 to 29) and 23 patients (56%; 95% CI, 40 to 72) had stable disease longer than 6 months. Median duration of PR was 7.5 months (range, 6 to 14). Median progression-free survival was 15 months (95% CI, 10 to 27.5). In 14 (78%) of 18 Tg-assessable PTC patients, Tg declined more than 25%. Common grade 3 adverse events included hand-foot skin reaction, musculoskeletal pain, and fatigue. BRAF mutation was detected in 17 (77%) of 22 PTCs analyzed. Four of 10 paired tumor biopsies from PTC patients showed a reduction in levels of vascular endothelial growth factor receptor phosphorylation, ERK phosphorylation, and in VEGF expression during sorafenib therapy. No PRs were noted among non-PTC patients.

conclusionSorafenib is reasonably well-tolerated therapy with clinical and biologic antitumor activity in metastatic PTC.

Indexed as

Adenocarcinoma, PapillaryAdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesDisease-Free SurvivalFemaleHumansMaleMiddle AgedNiacinamidePhenylurea CompoundsPyridinesSorafenibThyroglobulinAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsPyridinesSorafenibThyroglobulin

Identifiers

PMID19255327
PMCPMC2668972
OpenAlexW2155008672

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.