Evidence map›Paper›PMID 24423918›Full record

Trial reportBritish journal of cancer2014

S0941: a phase 2 SWOG study of sorafenib and erlotinib in patients with advanced gallbladder carcinoma or cholangiocarcinoma.

A B El-Khoueiry, C Rankin, A B Siegel, S Iqbal, I-Y Gong, K C Micetich, O R Kayaleh, H-J Lenz, C D Blanke

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
12.3field-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.

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

58 citing papers in PubMed, 2 syntheses or guidelines pooled it, 121 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Cell of origin in biliary tract cancers and clinical implications.JHEP reports : innovation in hepatology · 2021
    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

9 authors at 5 institutions in 1 country.

A B El-KhoueiryDivision of Medical Oncology, University of Southern California, Norris Comprehensive Cancer Center, 1441 Eastlake Avenue, Suite 3459, Los Angeles, CA, USA.
C RankinSWOG Statistical Center, Seattle, WA, USA.
A B SiegelDepartments of Medicine and Surgery, Columbia University, New York, NY, USA.
S IqbalDivision of Medical Oncology, University of Southern California, Norris Comprehensive Cancer Center, 1441 Eastlake Avenue, Suite 3459, Los Angeles, CA, USA.
I-Y GongDivision of Hematology and Oncology, University of California-Davis, Sacramento, CA, USA.
K C MicetichDivision of Hematology/Oncology, Stritch School of Medicine, Loyola University, Maywood, IL, USA.
O R KayalehDepartment of Internal Medicine, Hematology Oncology Section, MD Anderson Cancer Center Orlando, Orlando, FL, USA.
H-J LenzDivision of Medical Oncology, University of Southern California, Norris Comprehensive Cancer Center, 1441 Eastlake Avenue, Suite 3459, Los Angeles, CA, USA.
C D BlankeDepartment of Medicine, Knight Cancer Institute of the Oregon Health & Science University, Portland, OR, USA.
University of Southern California · USCancer Research And Biostatistics · USColumbia University · USLoyola University Chicago · USOregon Health & Science University · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
Hawaii Minority-Based Clinical Community Oncology ProgramU10CA063844 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI BERENBERG, JEFFREY LEE · 1994 to 2014
$9.0M
KANSAS CITY COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035176 · NCI · NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM · PI GAUR, RAKESH · 1985 to 2014
$8.0M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
SWOG GRANT APPLICATION FOR LOYOLA UNIVERSITYU10CA046282 · NCI · LOYOLA UNIVERSITY CHICAGO · PI STIFF, PATRICK J · 1988 to 2013
$5.4M
SOUTHWEST ONCOLOGY GROUPU10CA020319 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI GOODMAN, GARY E · 1985 to 2013
$5.1M
SOUTHWEST ONCOLOGY GROUP/UNIVERSITY OF CALIFORNIA, DAVISU10CA046441 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI GANDARA, DAVID R · 1988 to 2013
$4.8M
NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA35090NCI NIH HHS CA37981NCI NIH HHS CA46282NCI NIH HHS CA58723NCI NIH HHS CA58882NCI NIH HHS CA63848NCI NIH HHS K23 CA149084NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575
6 · The paper itself

Abstract

backgroundGallbladder cancers and cholangiocarcinomas make up a heterogenous group of tumours with a poor prognosis in advanced stages. On the basis of evidence of dysregulation of the epidermal growth factor receptor, vascular endothelial growth factor and mitogen-activated protein kinase pathways in biliary cancers, we performed a phase 2 trial of sorafenib and erlotinib in patients with advanced biliary cancers.

methodsEligible patients were previously untreated in the advanced setting with adequate hepatic and bone marrow function. Sorafenib and erlotinib were administered continuously at 400 mg BID and 100 mg daily, respectively.

resultsThirty-four eligible patients were recruited. The study was terminated after the first stage of accrual owing to failure to meet the predetermined number of patients who were alive and progression free at 4 months. There were two unconfirmed partial responses (6%, 95% CI: 1-20%), with a median progression-free survival of 2 months (95% CI: 2-3), and median overall survival of 6 months (95% CI: 3-8 months). Grade 3 and 4 adverse events included hypertension, AST/ALT increase, bilirubin increase, diarrhoea, hypokalaemia, hypophosphatemia and rash.

conclusionsDespite compelling preclinical rationale, the combination of sorafenib and erlotinib does not have promising clinical activity in an unselected population of patients with biliary cancers. Improved patient selection based on tumour biology and molecular markers is critical for future evaluation of targeted therapies in this disease.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBile Ducts, IntrahepaticAgedAged, 80 and overBile Duct NeoplasmsCholangiocarcinomaDisease-Free SurvivalErbB ReceptorsErlotinib HydrochlorideFemaleGallbladder NeoplasmsHumansMaleMAP Kinase Signaling SystemMiddle AgedNiacinamideErbB ReceptorsErlotinib HydrochlorideNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsQuinazolinesSorafenibVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID24423918
PMCPMC3929880
OpenAlexW2012887353

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Registered trials

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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.