Evidence map›Paper›PMID 19937365›Full record

Trial reportInvestigational new drugs2011

Phase II evaluation of eribulin mesylate (E7389, NSC 707389) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group trial S0618.

Susanne M Arnold, James Moon, Stephen K Williamson, James N Atkins, Sai-Hong I Ou, Michael LeBlanc, Susan G Urba

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Eribulin in Cancer Treatment.Marine drugs · 2015
    Review
  6. Article
  7. Review
  8. Eribulin -- a review of preclinical and clinical studies.Critical reviews in oncology/hematology · 2012
    Review
  9. Interactions of halichondrin B and eribulin with tubulin.Journal of chemical information and modeling · 2011
    Article
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

7 authors at 7 institutions in 1 country.

Susanne M ArnoldUniversity of Kentucky, Lexington, KY, USA. smarno0@uky.edu
James Moon
Stephen K Williamson
James N Atkins
Sai-Hong I Ou
Michael LeBlanc
Susan G Urba
Cancer Research And Biostatistics · USMarkey Cancer Center · USSoutheast Clinical Oncology Research Consortium · USSWOG Cancer Research Network · USUniversity of California, Irvine · USUniversity of Kansas Medical Center · USUniversity of Michigan–Ann Arbor · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
OZARKS REGIONAL COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045560 · NCI · ST. JOHN'S REGIONAL HEALTH CENTER · PI CARLSON, JAY W · 1987 to 2014
$8.2M
SOUTHWEST ONCOLOGY GROUPU10CA011083 · NCI · UNIVERSITY OF ROCHESTER · PI FRIEDBERG, JONATHAN W · 1985 to 2013
$5.5M
SOUTHWEST ONCOLOGY GROUP/UNIVERSITY OF CALIFORNIA, DAVISU10CA046441 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI GANDARA, DAVID R · 1988 to 2013
$4.8M
NCI NIH HHS CA11083NCI NIH HHS CA14028NCI NIH HHS CA22433NCI NIH HHS CA35090NCI NIH HHS CA37981NCI NIH HHS CA45377NCI NIH HHS CA45808NCI NIH HHS CA46113NCI NIH HHS CA46136NCI NIH HHS CA58686NCI NIH HHS CA58723NCI NIH HHS CA58861NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA046441NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058686NCI NIH HHS U10 CA058861NIAID NIH HHS P30 AI060354
6 · The paper itself

Abstract

purposeEribulin mesylate, an halichondrin B analog, binds to tubulin and microtubules and possesses broad anti-cancer activity. We conducted a multi-institutional Phase II trial to evaluate the response rate of eribulin mesylate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN). EXPERIMENTAL

designForty eligible patients who had not received prior chemotherapy for metastatic or recurrent SCCHN were enrolled with the following characteristics: 29 male, 11 female; median age 61.2 years; Zubrod Performance Status of 0 (48%) and 1 (53%). Thirty-three patients (83%) had metastatic disease. Primary tumor sites included: 38% oropharynx, 30% lip/oral cavity, 15% larynx, 10% hypopharynx, 5% other/unknown and 3% nasopharynx. Patients received eribulin mesylate at 1.4 mg/m² on Days 1 and 8 of an every 21-day cycle.

resultsCommon Grade 3 and 4 toxicities included: lymphopenia (15%), leukocytopenia (13%), neutropenia (10%), hyponatremia (5%), fatigue (5%), diarrhea (5%) and dyspnea (5%), with one treatment-related death due to pulmonary hemorrhage. Among 40 assessable patients, two confirmed partial responses were observed, for an estimated confirmed response rate of 5% (95% confidence interval: 1-17%). The estimated median progression-free survival is 3 months (95% confidence interval: 1-3 months) and estimated median overall survival is 7 months (95% confidence interval: 5-10 months).

conclusionsEribulin mesylate given on Days 1 and 8 of a twenty-one day cycle in metastatic or recurrent SCCHN was well tolerated, but did not result in a clinically significant median PFS. Studies of other agents should be considered in this setting.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Squamous CellDisease-Free SurvivalFemaleFuransHead and Neck NeoplasmsHumansKetonesMaleMiddle AgedNeoplasm MetastasisPolyether PolyketidesTreatment OutcomeAntineoplastic AgentseribulinFuransKetonesPolyether Polyketides

Identifiers

PMID19937365
PMCPMC2892241
OpenAlexW2019684848

What OpenQuestion holds

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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.