Evidence map›Paper›PMID 25352401›Full record

ArticleHead & neck2016

Phase I study of vandetanib with radiation therapy with or without cisplatin in locally advanced head and neck squamous cell carcinoma.

Vasiliki A Papadimitrakopoulou, Steven J Frank, Ezra W Cohen, Fred R Hirsch, Jeffrey N Myers, John V Heymach, Heather Lin, Hai T Tran, Changhu R Chen, Antonio Jimeno and 4 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Head & neck, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. 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

14 authors.

Vasiliki A PapadimitrakopoulouDepartment of Thoracic Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
Steven J FrankDepartment of Radiation Oncology, MD Anderson Cancer Center, Houston, Texas.
Ezra W CohenDepartment of Medicine, University of Chicago, Chicago, Illinois.
Fred R HirschUniversity of Colorado Cancer Center, Aurora, Colorado.
Jeffrey N MyersDepartment of Head and Neck Surgery, University of Texas, MD Anderson Cancer Center, Houston, Texas.
John V HeymachDepartment of Thoracic Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
Heather LinDepartment of Biostatistics, MD Anderson Cancer Center, Houston, Texas.
Hai T TranDepartment of Thoracic Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
Changhu R ChenDepartment of Radiation Oncology, University of Toledo, Toledo, Ohio.
Antonio JimenoDivision of Medical Oncology, Department of Medicine, University of Colorado, Aurora, Colorado.
Lucien NedziDepartment of Radiation Oncology, Southwestern Medical Center, Dallas, Texas.
Joseph R VasselliAstraZeneca Pharmaceuticals, Wilmington, Delaware.
Elizabeth S LoweAstraZeneca Pharmaceuticals, Wilmington, Delaware.
David RabenDepartment of Oncology, University of Colorado, Aurora, Colorado.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Targeting the p53 pathway for reversal of oral premalignancyP50CA097007 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI MILLS, GORDON B. · 2002 to 2012
$26.1M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA097007NCI NIH HHS P50 CA097007 10
6 · The paper itself

Abstract

backgroundVandetanib, added to cisplatin and radiation therapy (RT) overcomes chemoradiation therapy (CRT) and epidermal growth factor receptor (EGFR) inhibitor resistance in head and neck squamous cell carcinoma (HNSCC) lines and models.

methodsPatients with previously untreated HNSCC received vandetanib daily for 14 days (starting dose 100 mg) and then vandetanib + RT (2.2 Gy/day, 5 days/week) for 6 weeks (regimen 1) or vandetanib + RT (2 Gy/day, 5 days/week) + cisplatin (30 mg/m(2) weekly) for 7 weeks (regimen 2). The primary objective was the maximum tolerated dose (MTD) of vandetanib with RT +/- cisplatin.

resultsOf 33 treated patients, 30 completed therapy (regimen 1, n = 12; regimen 2, n = 18). MTD in regimen 2 was 100 mg (3 dose limiting toxicities [DLTs] at 200 mg), whereas regimen 1 was stopped because of poor recruitment (1 DLT at 200 mg). Most common grade ≥3 adverse events (AEs) were dysphagia (30%), stomatitis (33%), and mucosal inflammation (27%). Five patients discontinued vandetanib because of AEs.

conclusionVandetanib with CRT was feasible.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemoradiotherapyCisplatinFemaleHead and Neck NeoplasmsHumansMaleMaximum Tolerated DoseMiddle AgedPiperidinesProtein-Tyrosine KinasesQuinazolinesSquamous Cell Carcinoma of Head and NeckCisplatinPiperidinesProtein-Tyrosine KinasesQuinazolinesvandetanibcisplatinhead and neck squamous cell cancerradiation therapyvandetanib

Identifiers

PMID25352401
PMCPMC4414661

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.