Evidence map›Paper›PMID 29719302›Full record

Trial reportOncology2018

A Randomized Phase II Open-Label Multi-Institution Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma.

Melanie B Thomas, Elizabeth Garrett-Mayer, Munazza Anis, Kate Anderton, Tricia Bentz, Andie Edwards, Alan Brisendine, Geoffrey Weiss, Abby B Siegel, Johanna Bendell and 3 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 7 pooled it
3.2field-weighted citation impact, top 7% 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

32 citing papers in PubMed, 7 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Objective Response Predicts Survival in Advanced Hepatocellular Carcinoma Treated with Systemic Therapies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Evolving therapeutic landscape of advanced hepatocellular carcinoma.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  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

13 authors at 8 institutions in 1 country.

Melanie B ThomasHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA, mthomas@gibbscc.org.
Elizabeth Garrett-MayerHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Munazza AnisHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Kate AndertonHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Tricia BentzHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Andie EdwardsHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Alan BrisendineHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Geoffrey WeissDepartment of Oncology, University of Virginia, Charlottesville, Virginia, USA.
Abby B SiegelNew York-Presbyterian Hospital, Columbia University, New York, New York, USA.
Johanna BendellGI Oncology Research, Sarah Canon Research Institute, Nashville, Tennessee, USA.
Ari BaronCalifornia Pacific Medical Center, San Francisco, California, USA.
Vinay DuddalwarNorris Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.
Anthony El-KhoueiryNorris Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.
Medical University of South Carolina · USMUSC Hollings Cancer Center · USUniversity of Southern California · USCalifornia Pacific Medical Center · USCanon (United States) · USNewYork–Presbyterian Hospital · USSpartanburg Regional Healthcare System · USUniversity of Virginia · US

Funding

Translational Science Laboratory Shared ResourceP30CA138313 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Jian Ouyang · 2009 to 2026
$42.7M
NCI NIH HHS P30 CA138313
6 · The paper itself

Abstract

objectivesTo investigate the clinical efficacy and tolerability of the combination of bevacizumab (B) and erlotinib (E) compared to sorafenib (S) as first-line treatment for patients with advanced hepatocellular carcinoma (HCC).

methodsA total of 90 patients with advanced HCC, Child-Pugh class A-B7 cirrhosis, and no prior systemic therapy were randomly assigned (1: 1) to receive either 10 mg/kg B intravenously every 14 days and 150 mg E orally daily (n = 47) (B+E) or 400 mg S orally twice daily (n = 43). The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), time to progression, and safety and tolerability.

resultsThe median OS was 8.55 months (95% CI: 7.00-13.9) for patients treated with B+E and 8.55 months (95% CI: 5.69-12.2) for patients receiving S. The hazard ratio (HR) for OS was 0.92 (95% CI: 0.57-1.47). The median EFS was 4.37 months (95% CI: 2.99-7.36) for patients receiving B+E and 2.76 months (95% CI: 1.84-4.80) for patients receiving S. The HR for EFS was 0.67 (95% CI: 0.42-1.07; p = 0.09), favoring B+E over S. When OS was assessed among patients who were Child-Pugh class A, the median OS was 11.4 months (95% CI: 7.5-15.7) for patients treated with B+E (n = 39) and 10.26 months (95% CI: 5.9-13.0) for patients treated with S (n = 38) (HR = 0.88; 95% CI: 0.53-1.46).

conclusionsThere was no difference in efficacy between the B+E and S arms, although the safety and tolerability profile tended to favor B+E over S based on competing risk analysis.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, HepatocellularDisease-Free SurvivalErlotinib HydrochlorideHumansLiver NeoplasmsMiddle AgedNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsAngiogenesis InhibitorsAntineoplastic Agents, ImmunologicalBevacizumabErlotinib HydrochlorideNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsSorafenibBevacizumabClinical trialEpidermal growth factorErlotinibHepatocellular carcinomaHepatomaSorafenibTargeted therapiesVascular endothelial growth factor

Identifiers

PMID29719302
PMCPMC7725004
OpenAlexW2800280019

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.