Evidence map›Paper›PMID 23703789›Full record

Trial reportHepatology (Baltimore, Md.)2013

Radiological-pathological analysis of WHO, RECIST, EASL, mRECIST and DWI: Imaging analysis from a prospective randomized trial of Y90 ± sorafenib.

Michael Vouche, Laura Kulik, Rohi Atassi, Khairuddin Memon, Ryan Hickey, Daniel Ganger, Frank H Miller, Vahid Yaghmai, Michael Abecassis, Talia Baker and 4 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00846131 (A Single-Center Proof of Concept Pilot Study to Evaluate the Safety, Efficacy, and Tolerability of Sorafenib Combined With Therasphere in Subjects With Hepatocellular Carcinoma Awaiting Liver Transplantation.), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
5.7field-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.

NCT00846131 phase1completednot on this map

A Single-Center Proof of Concept Pilot Study to Evaluate the Safety, Efficacy, and Tolerability of Sorafenib Combined With Therasphere in Subjects With Hepatocellular Carcinoma Awaiting Liver Transplantation.

TypeinterventionalSponsorNorthwestern UniversityRan2009 to 2016Enrolled24ConditionsHepatocellular CarcinomaArmsSorafenib, Yttrium-90 (Y-90)
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Prediction of hepatocellular carcinoma response toCancer imaging : the official publication of the International Cancer Imaging Society · 2019
    Article
  9. Review
  10. Article
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  15. 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

14 authors at 1 institution in 1 country.

Michael VoucheDepartment of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Northwestern University, Chicago, IL.
Laura Kulik
Rohi Atassi
Khairuddin Memon
Ryan Hickey
Daniel Ganger
Frank H Miller
Vahid Yaghmai
Michael Abecassis
Talia Baker
Mary Mulcahy
Ritu Nayar
Robert J Lewandowski
Riad Salem
Northwestern University · US

Funding

Functional MRI Monitoring of Hepatic ChemoembolizationR01CA126809 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LARSON, ANDREW CHRISTIAN · 2008 to 2011
$1.2M
NCI NIH HHS R01 CA126809
6 · The paper itself

Abstract

unlabelledThe aim of this study was to compare radiological and pathological changes and test the adjunct efficacy of Sorafenib to Y90 as a bridge to transplantation in hepatocellular carcinoma (HCC). 15 patients with 16 HCC lesions were randomized to Y90 without (Group A, n = 9) or with Sorafenib (Group B, n = 7). Size (WHO, RECIST), enhancement (EASL, mRECIST) and diffusion-weighted imaging criteria (apparent diffusion coefficient, ADC) measurements were obtained at baseline, then at 1 and every 3 months after treatment until transplantation. Percentage necrosis in explanted tumors was correlated with imaging findings. 100%, 50%-99% and <50% pathological necrosis was observed in 6 (67%), 1 (11%), and 2 (22%) tumors in Group A and 3 (42%), 2 (28%), and 2 (28%) in Group B, respectively (P = 0.81). While ADC (P = 0.46) did not change after treatment, WHO (P = 0.06) and RECIST (P = 0.08) response at 1 month failed to reach significance, but significant responses by EASL (P < 0.01/0.03) and mRECIST (P < 0.01/0.03) at 1 and 3 months were observed. Response was equivalent by EASL or mRECIST. No difference in response rates was observed between groups A and B at 1 and 3 months by WHO, RECIST, EASL, mRECIST or ADC measurements. Despite failing to reach significance, smaller baseline size was associated with complete pathological necrosis (CPN) (RECIST: P = 0.07; WHO: P = 0.05). However, a cut-off size of 35 mm was predictive of CPN (P = 0.005). CPN could not be predicted by WHO (P = 0.25 and 0.62), RECIST (P = 0.35 and 0.54), EASL (P = 0.49 and 0.46), mRECIST (P = 0.49 and 0.60) or ADC (P = 0.86 and 0.93).

conclusionThe adjunct of Sorafenib did not augment radiological or pathological response to Y90 therapy for HCC. Equivalent significant reduction in enhancement at 1 and 3 months by EASL/mRECIST was noted. Neither EASL nor mRECIST could reliably predict CPN.

Indexed as

AgedCarcinoma, HepatocellularDiffusion Magnetic Resonance ImagingFemaleHumansLiver NeoplasmsMaleMicrospheresMiddle AgedNiacinamidePhenylurea CompoundsProspective StudiesSorafenibTechnetium Tc 99m Aggregated AlbuminWorld Health OrganizationYttrium RadioisotopesNiacinamidePhenylurea CompoundsSorafenibTechnetium Tc 99m Aggregated AlbuminYttrium Radioisotopes

Identifiers

PMID23703789
PMCPMC5097874
OpenAlexW1999757855

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.