Evidence map›Paper›PMID 22791234›Full record

Trial reportHead & neck2013

Phase II 2-arm trial of the proteasome inhibitor, PS-341 (bortezomib) in combination with irinotecan or PS-341 alone followed by the addition of irinotecan at time of progression in patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck (E1304): a trial of the Eastern Cooperative Oncology Group.

Jill Gilbert, Ju Whei Lee, Athanassios Argiris, Missak Haigentz, Lawrence Eric Feldman, Minyoung Jang, Pattatheyil Arun, Carter Van Waes, Arlene A Forastiere

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

Trial report in Head & neck, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% 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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. E3 ubiquitin ligases in nasopharyngeal carcinoma and implications for therapies.Journal of molecular medicine (Berlin, Germany) · 2023
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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

9 authors at 8 institutions in 1 country.

Jill GilbertVanderbilt University Medical Center, Nashville, Tennessee 37232, USA. jill.gilbert@vanderbilt.edu
Ju Whei Lee
Athanassios Argiris
Missak Haigentz
Lawrence Eric Feldman
Minyoung Jang
Pattatheyil Arun
Carter Van Waes
Arlene A Forastiere
National Institute on Deafness and Other Communication Disorders · USDana-Farber Cancer Institute · USJohns Hopkins University · USMontefiore Medical Center · USNational Institutes of Health · USThe University of Texas Health Science Center at San Antonio · USUniversity of Illinois Chicago · USVanderbilt University · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
Foreign Accrual - ECOGU10CA037403 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2014
$34.6M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
NF-kappaB in pathogenesis and therapy of head and neck cancerZIADC000016 · NIDCD · NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS · PI VAN WAES, CARTER · 2009 to 2022
$9.3M
ONCOLOGYU10CA049957 · NCI · VANDERBILT UNIVERSITY · PI BERLIN, JORDAN D · 1989 to 2013
$5.4M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
ONCOLOGYU10CA039229 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KIRKWOOD, JOHN MUNN · 1985 to 2013
$3.3M
ONCOLOGYU10CA014958 · NCI · YESHIVA UNIVERSITY · PI SPARANO, JOSEPH A. · 1985 to 2013
$2.2M
NCI NIH HHS CA14958NCI NIH HHS CA16116NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA39229NCI NIH HHS CA49957NCI NIH HHS CA66636NCI NIH HHS P30 CA006973NCI NIH HHS U10 CA014958NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA037403NCI NIH HHS U10 CA039229NCI NIH HHS U10 CA049957NCI NIH HHS U10 CA066636NCI NIH HHS U24 CA114737
6 · The paper itself

Abstract

backgroundConstitutive activation of nuclear factor κB (NF-κB) is associated with poor prognosis. Irinotecan demonstrates single-agent activity in head and neck cancer but activates NF-κB, promoting cell survival and resistance. Bortezomib is a proteasome inhibitor that inactivates NF-κB. PATIENTS AND

methodsWe performed a randomized phase II trial of bortezomib on days 1, 4, 8, and 11 and irinotecan on days 1 and 8 of each 21-day cycle or single-agent bortezomib on days 1, 4, 8, and 11 on a 21-day cycle. The addition of irinotecan to bortezomib was allowed in patients who progressed on bortezomib alone.

resultsThe response rate of bortezomib and irinotecan was 13%. One patient had a partial response to bortezomib alone (response rate 3%). No responses were seen in patients with addition of irinotecan at time of progression on bortezomib.

conclusionsThe bortezomib-based regimens evaluated in this study have minimal activity in recurrent or metastatic head and neck cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCamptothecinCarcinoma, Squamous CellCytokinesDisease ProgressionFemaleHead and Neck NeoplasmsHumansIrinotecanMaleMiddle AgedBoronic AcidsBortezomibCamptothecinCytokinesIrinotecanNF-kappa BPyrazines

Identifiers

PMID22791234
PMCPMC3689864
OpenAlexW1851740405

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.