Evidence map›Paper›PMID 21523723›Full record

Trial reportCancer2011

Phase 2 study of dasatinib in the treatment of head and neck squamous cell carcinoma.

Heather D Brooks, Bonnie S Glisson, B Nebiyou Bekele, Faye M Johnson, Lawrence E Ginsberg, Adel El-Naggar, Kirk S Culotta, Naoko Takebe, John Wright, Hai T Tran and 1 more

Erratum issuedAbstract 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. An erratum has been issued. Cited by 61 papers.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed
–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

61 citing papers in PubMed.

  1. Trial
  2. Erlotinib, erlotinib-sulindac versus placebo: a randomized, double-blind, placebo-controlled window trial in operable head and neck cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
    Johnson, Faye M [added]
5 · Who and what money

Authors and funding

11 authors.

Heather D BrooksDivision of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Bonnie S Glisson
B Nebiyou Bekele
Faye M Johnson
Lawrence E Ginsberg
Adel El-Naggar
Kirk S Culotta
Naoko Takebe
John Wright
Hai T Tran
Vassiliki A Papadimitrakopoulou

Funding

NCI NIH HHS N01 CM062202NCI NIH HHS N01-CM-62202
6 · The paper itself

Abstract

backgroundTreatment options for patients with advanced head and neck squamous cell carcinoma (HNSCC) are scarce. This phase 2 study was conducted to evaluate the safety, tolerability, pharmacokinetics, and efficacy of dasatinib in this setting.

methodsPatients with recurrent and/or metastatic HNSCC after platinum-based therapy were treated with dasatinib either orally or via percutaneous feeding gastrostomy (PFG). Primary endpoints were 12-week progression-free survival (PFS) and objective response rate with a 2-stage design and early withdrawal if the 12-week PFS rate was ≤20% and no patients had an objective response (OR). Forty-nine serum cytokines and angiogenic factors (CAFs) were analyzed from treated patients.

resultsOf the 15 patients enrolled, 12 were evaluable for response, and all patients were evaluable for toxicity. No OR was observed and 2 patients (16.7%) had stable disease (SD) at 8 weeks. The median treatment duration was 59 days, the median time to disease progression was 3.9 weeks, and the median survival was 26 weeks. One patient required a dose reduction, 3 patients required dose interruptions, and 4 patients were hospitalized for toxicity. Dasatinib inhibited c-Src both when administered orally and via PFG. Greater mean drug exposure, decreased half-life, and greater maximum concentration were observed in patients receiving dasatinib via PFG. Eleven baseline CAFs were associated with treatment outcome and 1 CAF, macrophage migration inhibitory factor, was found to be differentially modulated in correlation with SD versus disease progression.

conclusionsSingle-agent dasatinib failed to demonstrate significant activity in patients with advanced HNSCC, despite c-Src inhibition. The toxicity profile was consistent with that reported in other solid tumors, and the drug can be given via PFG tube.

Indexed as

Antineoplastic AgentsCarcinoma, Squamous CellChildCytokinesDasatinibDisease-Free SurvivalFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsPyrimidinesThiazolesAntineoplastic AgentsCytokinesDasatinibProtein Kinase InhibitorsPyrimidinesThiazoles

Identifiers

PMID21523723
PMCPMC3117018

What OpenQuestion holds

Textmetadata
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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.