Evidence map›Paper›PMID 26453566›Full record

Trial reportInvestigational new drugs2015

A phase II study evaluating axitinib in patients with unresectable, recurrent or metastatic head and neck cancer.

Paul L Swiecicki, Lili Zhao, Emily Belile, Assuntina G Sacco, Douglas B Chepeha, Irina Dobrosotskaya, Matthew Spector, Andrew Shuman, Kelly Malloy, Jeffrey Moyer and 8 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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

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

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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

18 authors at 4 institutions in 1 country.

Paul L SwiecickiUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA. pswiecic@med.umich.edu.
Lili ZhaoUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Emily BelileUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Assuntina G SaccoUniversity of California San Diego Moores Cancer Center, La Jolla, CA, USA.
Douglas B ChepehaUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Irina DobrosotskayaDepartment of Oncology, Henry Ford Hospital, Detroit, MI, USA.
Matthew SpectorUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Andrew ShumanUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Kelly MalloyUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Jeffrey MoyerUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Erin McKeanUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Scott McLeanUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Gregory T WolfUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Avraham EisbruchUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Mark PrinceUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Carol BradfordUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Thomas CareyUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Francis P WordenUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Michigan Center for Translational Pathology · USUniversity of Michigan–Ann Arbor · USHenry Ford Hospital · USUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAxitinib is an oral, potent, small molecule tyrosine kinase inhibitor with selective inhibition of VEGFR 1,2, 3, as well as inhibition of potential downstream effectors of the EGFR pathway. Given the upregulation of EGFR and VEGFR in head and neck squamous cell carcinoma, treatment with axitinib holds promise as a rational targeted therapy. PATIENTS AND

methodsPatients with unresectable, recurrent or metastatic head and neck squamous cell carcinoma were included in this open label, single arm, phase II trial. Primary endpoint was 6 month progression free survival. All patients received single agent axitinib with planned dose escalation based on tolerability. A planned interim efficacy analysis was performed after enrollment of 30 patients.

resultsForty-two patients were registered, 30 were evaluable. While treatment was well-tolerated with no severe bleeding events, only 19 patients were able to achieve full planned dose. The best overall response rate was 6.7% (two partial responses) with a disease control rate of 76.7%. Median progression free survival was 3.7 months (95% Confidence Interval (CI): 3.5-5.7) and overall survival was 10.9 months (95% CI: 6.4-17.8). Exploratory analysis demonstrated that patients with a smaller sum of diameter of target lesions experienced improved response rates, and better progression-free and overall survival.

conclusionTreatment with single agent axitinib should be considered due to acceptable toxicity profile and favorable median overall survival compared to standard therapies.

Indexed as

AdultAgedAged, 80 and overAxitinibCarcinoma, Squamous CellFemaleHead and Neck NeoplasmsHumansHypertensionImidazolesIndazolesMaleMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsSurvival RateAxitinibImidazolesIndazolesProtein Kinase InhibitorsAxitinibHead and neck cancerSquamous cell carcinomaTyrosine kinase inhibitorVascular endothelial growth factor receptor

Identifiers

PMID26453566
OpenAlexW1913970044

What OpenQuestion holds

Textmetadata
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.