Evidence map›Paper›PMID 27407058›Full record

Trial reportHead & neck2016

Cutaneous head and neck melanoma in OPTiM, a randomized phase 3 trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma.

Robert H I Andtbacka, Sanjiv S Agarwala, David W Ollila, Sigrun Hallmeyer, Mohammed Milhem, Thomas Amatruda, John J Nemunaitis, Kevin J Harrington, Lisa Chen, Mark Shilkrut and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Head & neck, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
6.6field-weighted citation impact, top 3% 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

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  3. Review
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  6. Article
  7. Virus nanotechnology for intratumoural immunotherapy.Nature reviews bioengineering · 2024
    Article
  8. Review
  9. Review
  10. Article
  11. Therapy with oncolytic viruses: progress and challenges.Nature reviews. Clinical oncology · 2023
    Review
  12. Immunotherapy and Biomarkers in Sarcoma.Current treatment options in oncology · 2022
    Review
  13. Review
  14. Review
  15. Review
  16. Article
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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

12 authors at 11 institutions in 2 countries.

Robert H I AndtbackaUniversity of Utah Huntsman Cancer Institute, Salt Lake City, Utah.
Sanjiv S AgarwalaSt. Luke's University Hospital and Temple University, Philadelphia, Pennsylvania.
David W OllilaUniversity of North Carolina, Chapel Hill, North Carolina.
Sigrun HallmeyerAdvocate Lutheran General Hospital, Park Ridge, Illinois.
Mohammed MilhemUniversity of Iowa Hospitals and Clinics, Iowa City, Iowa.
Thomas AmatrudaMinnesota Oncology, Fridley, Minnesota.
John J NemunaitisMary Crowley Cancer Research Center, Dallas, Texas.
Kevin J HarringtonThe Institute of Cancer Research/The Royal Marsden Hospital, London, UK.
Lisa ChenAmgen, Inc, Thousand Oaks, California.
Mark ShilkrutAmgen, Inc, Thousand Oaks, California.
Merrick RossThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Howard L KaufmanRutgers Cancer Institute of New Jersey, Rutgers, New Jersey.
Amgen (United States) · USAdvocate Lutheran General Hospital · USMary Crowley Cancer Research Center · USMinnesota Oncology · USRoyal Marsden Hospital · GBRutgers, The State University of New Jersey · USTemple University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Iowa Hospitals and Clinics · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · US

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
6 · The paper itself

Abstract

backgroundCutaneous head and neck melanoma has poor outcomes and limited treatment options. In OPTiM, a phase 3 study in patients with unresectable stage IIIB/IIIC/IV melanoma, intralesional administration of the oncolytic virus talimogene laherparepvec improved durable response rate (DRR; continuous response ≥6 months) compared with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

methodsRetrospective review of OPTiM identified patients with cutaneous head and neck melanoma given talimogene laherparepvec (n = 61) or GM-CSF (n = 26). Outcomes were compared between talimogene laherparepvec and GM-CSF treated patients with cutaneous head and neck melanoma.

resultsDRR was higher for talimogene laherparepvec-treated patients than for GM-CSF treated patients (36.1% vs 3.8%; p = .001). A total of 29.5% of patients had a complete response with talimogene laherparepvec versus 0% with GM-CSF. Among talimogene laherparepvec-treated patients with a response, the probability of still being in response after 12 months was 73%. Median overall survival (OS) was 25.2 months for GM-CSF and had not been reached with talimogene laherparepvec.

conclusionTreatment with talimogene laherparepvec was associated with improved response and survival compared with GM-CSF in patients with cutaneous head and neck melanoma. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1752-1758, 2016.

Indexed as

AdultAgedDisease-Free SurvivalFemaleGranulocyte-Macrophage Colony-Stimulating FactorHead and Neck NeoplasmsHumansInjections, IntralesionalKaplan-Meier EstimateMaleMelanomaMiddle AgedMultivariate AnalysisNeoplasm InvasivenessNeoplasm StagingOncolytic VirotherapyGranulocyte-Macrophage Colony-Stimulating Factorcancer immunotherapycutaneous head and neck melanomaoncolytic virustalimogene laherparepvec

Identifiers

PMID27407058
PMCPMC5129499
OpenAlexW2494135329

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.