Evidence map›Paper›PMID 21654521›Full record

Trial reportJournal of immunotherapy (Hagerstown, Md. : 1997)

A phase 2 trial of bevacizumab and high-dose interferon alpha 2B in metastatic melanoma.

Valerie P Grignol, Thomas Olencki, Kiran Relekar, Cynthia Taylor, Amanda Kibler, Cheryl Kefauver, Lai Wei, Michael J Walker, Helen X Chen, Kari Kendra and 1 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of immunotherapy (Hagerstown, Md. : 1997). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% 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

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. ECOG phase II trial of graded-dose peginterferon α-2b in patients with metastatic melanoma overexpressing basic fibroblast growth factor (E2602).Clinical cancer research : an official journal of the American Association for Cancer Research · 2013
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Review
  13. Hypoxia-dependent drivers of melanoma progression.Journal of experimental & clinical cancer research : CR · 2021
    Review
  14. Review
  15. Review
  16. VEGFR2-targeted antibody fused with IFNActa pharmaceutica Sinica. B · 2021
    Article
  17. Review
  18. Review
  19. Review
  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

11 authors at 4 institutions in 1 country.

Valerie P GrignolDivision of Surgical Oncology, The Ohio State University, Columbus, OH 43210, USA.
Thomas Olencki
Kiran Relekar
Cynthia Taylor
Amanda Kibler
Cheryl Kefauver
Lai Wei
Michael J Walker
Helen X Chen
Kari Kendra
William E Carson
Clinical Trial Investigators · USPalmetto Hematology Oncology · USThe Ohio State University · USNational Cancer Institute · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
TWO SIGNAL REQUIREMENT FOR NATURAL KILLER IMMUNITYP01CA095426 · NCI · OHIO STATE UNIVERSITY · PI BYRD, JOHN C. · 2002 to 2016
$29.6M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA076576 · NCI · OHIO STATE UNIVERSITY · PI GREVER, MICHAEL R · 1998 to 2013
$9.1M
ONOCOLOGY TRAINING GRANTT32CA009338 · NCI · OHIO STATE UNIVERSITY · PI BYRD, JOHN C., POLLOCK, RAPHAEL E. · 1985 to 2018
$8.3M
TAS:: 75 0850 ::TAS RECOVERY ACT - ACTNOW CLINICAL TRIAL 8472N01CM62207 · NCI · OHIO STATE UNIVERSITY RESEARCH FDN · PI VILLALONA, MIGUEL A · 2007 to 2011
$2.3M
A Program of Immune-Based Treatments for CancerK24CA093670 · NCI · OHIO STATE UNIVERSITY · PI CARSON, WILLIAM E. · 2002 to 2012
$1.7M
NCI NIH HHS K24 CA093670NCI NIH HHS N01 CM062207NCI NIH HHS N01CM62207NCI NIH HHS P01 CA095426NCI NIH HHS P30 CA016058NCI NIH HHS P30 CA16058NCI NIH HHS T32 CA009338NCI NIH HHS U01 CA076576NCI NIH HHS U01 CA76576PHS HHS PPG 6001409
6 · The paper itself

Abstract

Bevacizumab is a humanized recombinant monoclonal antibody that neutralizes vascular endothelial growth factor, an agent with proangiogenic effects in melanoma. Interferon alpha (IFN-α) has antiangiogenic properties through its ability to downregulate basic-fibroblast growth factor levels. We hypothesized that the coadministration of these agents would lead to tumor regression. Patients with metastatic melanoma received bevacizumab 15 mg/kg intravenously on day 1 of the 2-week cycle. IFN-α was administered thrice weekly at 5 MU/m subcutaneously during cycle 1 and was increased to 10 MU/m during cycle 2. Patients were restaged every 6 cycles. Patients with stable disease or a response continued with therapy. Baseline serum vascular endothelial growth factor and fibroblast growth factor were measured. Twenty-five patients were accrued. Mean age was 58.4 years. Eleven patients required IFN-α dose reductions due to toxicity. Common grade 3 toxicities associated with IFN-α included fatigue and myalgia. Bevacizumab administration was associated with grade 2-3 proteinuria in 6 patients. Grade 4 adverse events were pulmonary embolus (1), myocardial infarction (1), and stroke (1). Six patients had a partial response, and 5 patients exhibited stable disease that lasted more than 24 weeks (range: 30 to 122 wk). Median progression-free survival and overall survival were 4.8 and 17 months, respectively. Significantly lower fibroblast growth factor levels were observed in patients with a partial response compared to those with stable or progressive disease (P=0.040). Administration of bevacizumab with IFN led to a clinical response in 24% of patients with stage IV melanoma and stabilization of disease in another 20% of patients. This regimen has activity in advanced melanoma.

Indexed as

AdultAgedAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabFemaleFibroblast Growth Factor 2HumansInterferon-alphaInterferon alpha-2MaleMelanomaMiddle AgedRadiographyAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabFibroblast Growth Factor 2Interferon-alphaInterferon alpha-2Recombinant ProteinsVascular Endothelial Growth Factor A

Identifiers

PMID21654521
PMCPMC3116950
OpenAlexW1985126174

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.