Evidence map›Paper›PMID 30190369›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019

A Phase II and Biomarker Study of Sorafenib Combined with Modified FOLFOX in Patients with Advanced Hepatocellular Carcinoma.

Lipika Goyal, Hui Zheng, Thomas A Abrams, Rebecca Miksad, Andrea J Bullock, Jill N Allen, Matthew B Yurgelun, Jeffrey W Clark, Avinash Kambadakone, Alona Muzikansky and 11 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 5 pooled it
4.1field-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

48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
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

21 authors at 3 institutions in 1 country.

Lipika GoyalDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts. lgoyal@partners.org.
Hui ZhengBiostatistics Center, Massachusetts General Hospital, Boston, Massachusetts.
Thomas A AbramsHarvard Medical School, Boston, Massachusetts.
Rebecca MiksadHarvard Medical School, Boston, Massachusetts.
Andrea J BullockHarvard Medical School, Boston, Massachusetts.
Jill N AllenDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Matthew B YurgelunHarvard Medical School, Boston, Massachusetts.
Jeffrey W ClarkDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Avinash KambadakoneDepartment of Radiology, Massachusetts General Hospital, Boston, Massachusetts.
Alona MuzikanskyDana-Farber Cancer Institute, Boston, Massachusetts.
Michelle KnowlesDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Aralee GalwayDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Anthony J AfflittoDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Caroline F DinicolaDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Eileen ReganDana-Farber Cancer Institute, Boston, Massachusetts.
Tai HatoHarvard Medical School, Boston, Massachusetts.
Emilie MamessierHarvard Medical School, Boston, Massachusetts.
Kohei ShigetaHarvard Medical School, Boston, Massachusetts.
Rakesh K JainHarvard Medical School, Boston, Massachusetts.
Dan G DudaHarvard Medical School, Boston, Massachusetts.
Andrew X ZhuDepartment of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Harvard University · USDana-Farber Cancer Institute · USBeth Israel Deaconess Medical Center · US

Funding

Vascular Normalization: Rolse of Perivascular CellsP01CA080124 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI JAIN, RAKESH K. · 2000 to 2016
$35.0M
Dissecting Pediatric Brain Tumor Microenvironment to Improve TreatmentR35CA197743 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI JAIN, RAKESH K. · 2015 to 2020
$5.7M
Reengineering obesity-induced abnormal microenvironment to improve PDAC treatmentR01CA208205 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI FUKUMURA, DAI, JAIN, RAKESH K. · 2017 to 2020
$2.2M
NCI NIH HHS P01 CA080124NCI NIH HHS R01 CA208205NCI NIH HHS R35 CA197743
6 · The paper itself

Abstract

purposeSorafenib is a standard first-line treatment for advanced hepatocellular carcinoma (HCC). The phase III SHARP trial showed a median time-to-progression (mTTP) of 5.5 months, overall response rate (ORR) of 2%, and median overall survival (mOS) of 10.7 months with sorafenib. FOLFOX4 has shown modest activity in advanced HCC. We evaluated the combination of sorafenib and modified (m)FOLFOX in a single-arm, multicenter phase II study. PATIENTS AND

methodsThe study included Child-Pugh A patients with advanced HCC and no prior systemic therapies. Patients received sorafenib 400 mg twice a day for 2 weeks, followed by concurrent mFOLFOX [5-fluorouracil (5-FU) 1,200 mg/m

resultsThe study enrolled 40 patients: HCV/EtOH/HBV, 43%/28%/13%; Child-Pugh A5, 70%. Notable grade 3/4 adverse events (AE) included AST/ALT elevation (28%/15%), diarrhea (13%), hyperbilirubinemia (10%), hand-foot syndrome (8%), and bleeding (8%). mTTP was 7.7 months [95% confidence interval (CI): 4.4-8.9], ORR 18%, and mOS 15.1 months (7.9-16.9). Sorafenib + mFOLFOX increased plasma PlGF, VEGF-D, sVEGFR1, IL12p70, and CAIX and CD4

conclusionsSorafenib + mFOLFOX met the prespecified endpoint with encouraging efficacy but moderate hepatotoxicity. Thus, this regimen may be effective in select patients with adequate liver reserve. Biomarker evaluations suggested a correlation between time-to-progression (TTP) and angiogenic biomarkers and circulating Tregs.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, HepatocellularCD56 AntigenCell ProliferationDrug-Related Side Effects and Adverse ReactionsFemaleFluorouracilHumansKiller Cells, NaturalLeucovorinLiver NeoplasmsMaleMiddle AgedBiomarkers, TumorCD56 AntigenFluorouracilKDR protein, humanLeucovorinNCAM1 protein, humanOrganoplatinum CompoundsPGF protein, humanPlacenta Growth FactorSorafenibVascular Endothelial Growth Factor Receptor-1Vascular Endothelial Growth Factor Receptor-2

Identifiers

PMID30190369
PMCPMC6320284
OpenAlexW2898647024

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.