Evidence map›Paper›PMID 24132922›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2013

Phase I trial of preoperative chemoradiation plus sorafenib for high-risk extremity soft tissue sarcomas with dynamic contrast-enhanced MRI correlates.

Janelle M Meyer, Kelly S Perlewitz, James B Hayden, Yee-Cheen Doung, Arthur Y Hung, John T Vetto, Rodney F Pommier, Atiya Mansoor, Brooke R Beckett, Alina Tudorica and 8 more

Open access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
5.4field-weighted citation impact, top 4% 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

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  7. TThe Iowa orthopaedic journal · 2023
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  12. The botanical drug PBI-05204, a supercritical COFrontiers in pharmacology · 2022
    Article
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  14. Review
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  18. Article
  19. Radiotherapy in soft-tissue sarcoma of the extremities.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Review
  20. Article
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

18 authors at 4 institutions in 1 country.

Janelle M MeyerAuthors' Affiliations: Loyola University Chicago, Maywood, Illinois; Providence Cancer Center, Newberg; Oregon Health and Science University; Oregon Health and Science University Knight Cancer Institute; Oregon Health and Science University Advanced Imaging Research Center, Portland, Oregon; and Seattle Cancer Care Alliance, Seattle, Washington.
Kelly S Perlewitz
James B Hayden
Yee-Cheen Doung
Arthur Y Hung
John T Vetto
Rodney F Pommier
Atiya Mansoor
Brooke R Beckett
Alina Tudorica
Motomi Mori
Megan L Holtorf
Aneela Afzal
William J Woodward
Eve T Rodler
Robin L Jones
Wei Huang
Christopher W Ryan
Advanced Imaging Research (United States) · USOregon Health & Science University · USSeattle Cancer Care Alliance · USProvidence Newberg Medical Center · US

Funding

OREGON CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024140 · NCRR · OREGON HEALTH & SCIENCE UNIVERSITY · PI ORWOLL, ERIC S. · 2006 to 2011
$61.1M
Understanding the origins of rapid recurrence of pancreatic cancer after resectionP30CA069533 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI Luiz Eduardo Bertassoni · 1997 to 2026
$60.5M
Shutter-Speed Model DCE-MRI for Assessment of Response to Cancer TherapyU01CA154602 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI HUANG, WEI, RYAN, CHRISTOPHER WALTER · 2011 to 2015
$2.9M
Shutter-Speed DCE-MRI Discrimination of Benign and Malignant Breast DiseaseR01CA120861 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI HUANG, WEI · 2007 to 2009
$928k
NCI NIH HHS P30 CA069533NCI NIH HHS R01 CA120861NCI NIH HHS U01 CA154602NCRR NIH HHS UL1 RR024140
6 · The paper itself

Abstract

purposeWe conducted a phase I trial of the addition of sorafenib to a chemoradiotherapy regimen in patients with high-risk (intermediate/high grade, >5 cm) extremity soft tissue sarcoma undergoing limb salvage surgery. We conducted a correlative study of quantitative dynamic contrast-enhanced MRI (DCE-MRI) to assess response to treatment. EXPERIMENTAL

designPatients were treated at increasing dose levels of sorafenib (200 mg daily, 400 mg daily, 400 mg twice daily) initiated 14 days before three preoperative and three postoperative cycles of epirubicin/ifosfamide. Radiation (28 Gy) was administered during cycle 2 with epirubicin omitted. The primary objective was to determine the maximum tolerated dose (MTD) of sorafenib. DCE-MRI was conducted at baseline, after 2 weeks of sorafenib, and before surgery. The imaging data were subjected to quantitative pharmacokinetic analyses.

resultsEighteen subjects were enrolled, of which 16 were evaluable. The MTD of sorafenib was 400 mg daily. Common grade 3-4 adverse events included neutropenia (94%), hypophosphatemia (75%), anemia (69%), thrombocytopenia (50%), and neutropenic fever/infection (50%). Of note, 38% developed wound complications requiring surgical intervention. The rate of ≥95% histopathologic tumor necrosis was 44%. Changes in DCE-MRI biomarker ΔK(trans) after 2 weeks of sorafenib correlated with histologic response (R(2) = 0.67, P = 0.012) at surgery.

conclusionThe addition of sorafenib to preoperative chemoradiotherapy is feasible and warrants further investigation in a larger trial. DCE-MRI detected changes in tumor perfusion after 2 weeks of sorafenib and may be a minimally invasive tool for rapid assessment of drug effect in soft tissue sarcoma.

Indexed as

AdultChemoradiotherapyCombined Modality TherapyFemaleHumansMagnetic Resonance ImagingMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingNiacinamidePhenylurea CompoundsPreoperative PeriodRadiographySarcomaSorafenibNiacinamidePhenylurea CompoundsSorafenib

Identifiers

PMID24132922
PMCPMC3869565
OpenAlexW2133704112

What OpenQuestion holds

Textmetadata
LicenceTDM
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.