Evidence map›Paper›PMID 21246525›Full record

Trial reportCancer2011

A phase 2 trial of bortezomib followed by the addition of doxorubicin at progression in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a trial of the Eastern Cooperative Oncology Group (E1303).

Athanassios Argiris, Musie Ghebremichael, Barbara Burtness, Rita S Axelrod, Ronald C Deconti, Arlene A Forastiere

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
5.3field-weighted citation impact, top 5% 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. A Phase II Study of Dovitinib in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
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  10. The Therapeutic Landscape of Salivary Gland Malignancies-Where Are We Now?International journal of molecular sciences · 2022
    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

6 authors at 6 institutions in 1 country.

Athanassios ArgirisDivision of Hematology-Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15232, USA. argirisae@upmc.edu
Musie Ghebremichael
Barbara Burtness
Rita S Axelrod
Ronald C Deconti
Arlene A Forastiere
Fox Chase Cancer Center · USHarvard University Press · USJohns Hopkins University · USThomas Jefferson University · USUniversity of Pittsburgh · USUniversity of South Florida · US

Funding

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
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ONCOLOGYU10CA027525 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GOLDSTEIN, LORI J · 1985 to 2013
$6.2M
ECOG Clinical TrialsU10CA017145 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B · 1985 to 2013
$6.1M
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
ONCOLOGYU10CA013650 · NCI · MAYO CLINIC ROCHESTER · PI HABERMANN, THOMAS MATTHEW · 1985 to 2013
$3.1M
NCI NIH HHS CA13650NCI NIH HHS CA16116NCI NIH HHS CA17145NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA27525NCI NIH HHS CA39229NCI NIH HHS CA66636NCI NIH HHS U10 CA013650NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA027525NCI NIH HHS U10 CA039229NCI NIH HHS U10 CA066636
6 · The paper itself

Abstract

backgroundBortezomib, an inhibitor of the 26S proteasome and NF-κB, may have antitumor activity in adenoid cystic carcinoma (ACC). Preclinical studies have shown synergy between bortezomib and doxorubicin.

methodsEligibility criteria included incurable ACC, any number of prior therapies but without an anthracycline, unidimensionally measurable disease, Eastern Cooperative Oncology Group performance status 0-2, and ejection fraction within normal limits. Patients with stable disease for ≥9 months were excluded. Patients received bortezomib 1.3 mg/m(2) by intravenous (IV) push on Days 1, 4, 8, and 11, every 21 days until progression. Doxorubicin 20 mg/m(2) IV on Days 1 and 8 was added at the time of progression.

resultsTwenty-five patients were enrolled, of whom 24 were eligible; the most common distant metastatic sites were the lung (n = 22) and the liver (n = 7). There was no objective response with single-agent bortezomib; best response was stable disease in 15 (71%) of 21 evaluable patients. The median progression-free survival and overall survival were 6.4 months and 21 months, respectively. Of 10 evaluable patients who received bortezomib plus doxorubicin, 1 had a partial response, and 6 had stable disease. The most frequent toxicity with bortezomib was grade 3 sensory neuropathy (16%). With bortezomib plus doxorubicin, serious toxicities seen more than once were grade 3-4 neutropenia (n = 3) and grade 3 anorexia (n = 2).

conclusionsBortezomib was well tolerated and resulted in disease stabilization in a high percentage of patients but no objective responses. The combination of bortezomib and doxorubicin was also well tolerated and may warrant further investigation in ACC.

Indexed as

Neoplasm MetastasisAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCarcinoma, Adenoid CysticDisease ProgressionDoxorubicinFemaleHead and Neck NeoplasmsHumansLiver NeoplasmsLung NeoplasmsMaleMiddle AgedBoronic AcidsBortezomibDoxorubicinPyrazines

Identifiers

PMID21246525
PMCPMC3135694
OpenAlexW2000150716

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.