Evidence map›Paper›PMID 19723649›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2009

A phase I trial of immunotherapy with lapuleucel-T (APC8024) in patients with refractory metastatic tumors that express HER-2/neu.

Prema P Peethambaram, Michelle E Melisko, Kristine J Rinn, Steven R Alberts, Nicole M Provost, Lori A Jones, Robert B Sims, Lisa R C Lin, Mark W Frohlich, John W Park

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 6% 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, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
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  14. Dendritic Cell Vaccines in Ovarian Cancer.Frontiers in immunology · 2020
    Review
  15. Immunotherapy in Ovarian Cancer.Surgical oncology clinics of North America · 2019
    Review
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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

10 authors at 2 institutions in 1 country.

Prema P PeethambaramMayo Clinic, Rochester, Minnesota 55905, USA. peethambaram.prema@mayo.edu
Michelle E Melisko
Kristine J Rinn
Steven R Alberts
Nicole M Provost
Lori A Jones
Robert B Sims
Lisa R C Lin
Mark W Frohlich
John W Park
Dendreon (United States) · USSwedish Medical Center · US

Funding

Tissue and Outcomes CoreP50CA058207 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRAY, JOE W. · 1992 to 2012
$32.7M
PHAGE ANTIBODY BASED PROBES OF ERBB RECEPTOR FUNCTIONU54CA090788 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI TEMPERO, MARGARET A · 2001 to 2006
$5.6M
Integrated Biomarkers to Characterize Breast Cancer RiskU01CA111234 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ESSERMAN, LAURA J · 2004 to 2009
$4.4M
NCI NIH HHS P50 CA058207NCI NIH HHS P50-CA 58207NCI NIH HHS U01 CA111234NCI NIH HHS U01 CA111234-01NCI NIH HHS U54 CA090788NCI NIH HHS U54-CA90788
6 · The paper itself

Abstract

purposeThis study aimed to evaluate the safety of, immune response induced by, and efficacy of treatment with lapuleucel-T (APC8024) in patients with HER-2/neu-expressing tumors. Lapuleucel-T is an investigational active immunotherapy product consisting of autologous peripheral blood mononuclear cells, including antigen presenting cells, which are cultured ex vivo with BA7072, a recombinant fusion antigen consisting of portions of the intracellular and extracellular regions of HER-2/neu linked to granulocyte-macrophage colony-stimulating factor. EXPERIMENTAL

designPatients with metastatic breast, ovarian, or colorectal cancer whose tumors expressed HER-2 were eligible. Patients underwent leukapheresis in week 0 and received lapuleucel-T infusions in weeks 0, 2, and 4. Patients who achieved a partial response or had stable disease through week 48 were eligible for re-treatment using the same protocol and dose as their initial treatment.

resultsEighteen patients were enrolled and treated. Patients showed an immune response to the immunizing antigen (BA7072) at week 8 compared with week 0 as measured by T lymphocyte proliferation and IFN-gamma enzyme-linked immunospot assay. Therapy was well tolerated. The majority (94.7%) of adverse events associated with treatment were grade 1 or 2. Two patients experienced stable disease lasting > 48 weeks.

conclusionsAutologous active cellular immunotherapy with lapuleucel-T stimulated an immune response specific to the immunizing antigen and seemed to be well tolerated. Further clinical studies to assess the clinical benefit for patients with HER/2-neu-expressing breast, ovarian, and colorectal cancer are warranted.

Indexed as

ImmunotherapyAdultAgedBreast NeoplasmsCancer VaccinesColorectal NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleHumansMaleMiddle AgedOvarian NeoplasmsCancer VaccinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapuleucel-T

Identifiers

PMID19723649
PMCPMC2766354
OpenAlexW2148944915

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.