Evidence map›Paper›PMID 27943153›Full record

Trial reportTargeted oncology2017

Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma: North Central Cancer Treatment Group Trial N0745 (Alliance).

Joleen M Hubbard, Michelle R Mahoney, William S Loui, Lewis R Roberts, Thomas C Smyrk, Zoran Gatalica, Mitesh Borad, Shaji Kumar, Steven R Alberts

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Targeted oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00867321 (Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

NCT00867321 phase1 / phase2completednot on this map

Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2009 to 2013Enrolled24ConditionsLiver CancerArmsbevacizumab, sorafenib tosylate
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 30 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
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  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Recent progress in treatment of hepatocellular carcinoma.American journal of cancer research · 2020
    Review
  16. Is the era of sorafenib over? A review of the literature.Therapeutic advances in medical oncology · 2020
    Review
  17. Article
  18. Review
  19. 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 4 institutions in 1 country.

Joleen M HubbardMayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.
Michelle R MahoneyAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
William S LouiCancer Research Center of Hawaii, Honolulu, HI, USA.
Lewis R RobertsMayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.
Thomas C SmyrkMayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.
Zoran GatalicaCreighton University Medical Center, Omaha, NE, USA.
Mitesh BoradMayo Clinic, Scottsdale, AZ, USA.
Shaji KumarMayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.
Steven R AlbertsMayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA. Alberts.steven@mayo.edu.
Mayo Clinic · USCancer Center of Hawaii · USCHI Health Creighton University Medical Center - Bergan Mercy · USMayo Clinic in Arizona · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
GEISINGER CLINICAL ONCOLOGY PROGRAMU10CA035448 · NCI · WEIS CENTER FOR RESEARCH-GEISINGER CLINC · PI GORAK, EDWARD J. · 1985 to 2014
$6.9M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI NIH HHS N01 CA035431NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA035448NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA232760
6 · The paper itself

Abstract

backgroundAngiogenesis has been a major target of novel drug development in hepatocellular carcinoma (HCC). It is hypothesized that the combination of two antiangiogenic agents, sorafenib and bevacizumab, will provide greater blockade of angiogenesis.

objectiveTo determine the optimal dose, safety, and effectiveness of dual anti-angiogenic therapy with sorafenib and bevacizumab in patients with advanced HCC. PATIENTS AND

methodsPatients with locally advanced or metastatic HCC not amenable for surgery or liver transplant were eligible. The phase I starting dose level was bevacizumab 1.25 mg/kg day 1 and 15 plus sorafenib 400 mg twice daily (BID) days 1-28. In the phase II portion, patients were randomized to receive bevacizumab and sorafenib at the maximum tolerated dose (MTD) or sorafenib 400 mg BID.

resultsSeventen patients were enrolled in the phase I component. Dose-limiting toxicities included grade 3 hand/foot skin reaction, fatigue, hypertension, alanine/aspartate aminotransferase increase, dehydration, hypophosphatemia, creatinine increase, hypoglycemia, nausea/vomiting, and grade 4 hyponatremia. Seven patients were enrolled in the phase II component at the MTD: sorafenib 200 mg BID days 1-28 and bevacizumab 2.5 mg/kg every other week; 57% (4/7) had grade 3 AEs at least possibly related to treatment. No responses were observed in the phase II portion. Estimated median time to progression and survival were 8.6 months (95% CI: 0.4-16.3) and 13.3 months (95% CI 4.4 - not estimable), respectively.

conclusionsThe MTD of the combination is sorafenib 200 mg twice daily on days 1-28 plus bevacizumab 2.5 mg/kg on days 1 and 15 of a 28-day cycle. In the phase II portion of the trial, concerns regarding excessive toxicity, low efficacy, and slow enrollment led to discontinuation of the trial. (Clinical Trials ID: NCT00867321.).

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBevacizumabCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNeoplasm MetastasisNiacinamidePhenylurea CompoundsSorafenibYoung AdultAntineoplastic AgentsBevacizumabNiacinamidePhenylurea CompoundsSorafenib

Identifiers

PMID27943153
PMCPMC5586602
OpenAlexW2560364793

What OpenQuestion holds

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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.