Evidence map›Paper›PMID 32073648›Full record

Trial reportCancer2020

A randomized phase 2 network trial of tivantinib plus cetuximab versus cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma.

Sara E Kochanny, Francis P Worden, Douglas R Adkins, Dean W Lim, Julie E Bauman, Stephanie A Wagner, Ryan J Brisson, Theodore G Karrison, Walter M Stadler, Everett E Vokes and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 4% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 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

11 authors at 8 institutions in 1 country.

Sara E KochannyThe University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.ORCID 0000-0003-3755-1175
Francis P WordenDivision of Hematology/Oncology, Department of Internal Medicine, University of Michigan Hospital and Health Systems, Ann Arbor, Michigan.
Douglas R AdkinsSiteman Cancer Center, Washington University, St. Louis, Missouri.
Dean W LimDepartment of Medicine, City of Hope, Duarte, California.
Julie E BaumanDepartment of Hematology and Oncology, University of Arizona Cancer Center, Phoenix, Arizona.ORCID 0000-0002-1398-6636
Stephanie A WagnerSimon Cancer Center, Indiana University, Indianapolis, Indiana.
Ryan J BrissonOakland University William Beaumont School of Medicine, Rochester, Michigan.ORCID 0000-0002-5691-267X
Theodore G KarrisonThe University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.
Walter M StadlerThe University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.ORCID 0000-0002-0435-2527
Everett E VokesThe University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.ORCID 0000-0002-8645-8068
Tanguy Y SeiwertKimmel Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland.ORCID 0000-0001-7919-8272
University of Chicago · USCity Of Hope National Medical Center · USIndiana University Health · USJohns Hopkins University · USOakland University · USUniversity of Arizona · USUniversity of Michigan · USWashington University in St. Louis · US

Funding

The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
NKLAM--A NOVEL GENE REQUIRED FOR NK FUNCTIONR01CA062201 · NCI · UNIVERSITY OF ARKANSAS MED SCIS LTL ROCK · PI KORNBLUTH, JACKI · 1994 to 1996
–
NCI NIH HHS N01 CM062201NCI NIH HHS UM1 CA186691NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

backgroundMET signaling is a well described mechanism of resistance to anti-EGFR therapy, and MET overexpression is common in head and neck squamous cell carcinomas (HNSCCs). In the current trial, the authors compared the oral MET inhibitor tivantinib (ARQ197) in combination with cetuximab (the TC arm) versus a control arm that received cetuximab monotherapy (C) in patients with recurrent/metastatic HNSCC.

methodsIn total, 78 evaluable patients with cetuximab-naive, platinum-refractory HNSCC were enrolled, including 40 on the TC arm and 38 on the C arm (stratified by human papillomavirus [HPV] status). Patients received oral tivantinib 360 mg twice daily and intravenous cetuximab 500 mg/m

resultsThe response rate was 7.5% in the TC arm (N = 3; 1 complete response) and 7.9% in the C arm (N = 3; not significantly different [NS]). The median progression-free survival in both arms was 4 months (NS), and the median overall survival was 8 months (NS). Both treatments were well tolerated, with a trend toward increased hematologic toxicities in the TC arm (12.5% had grade 3 leukopenia). The response rate in 31 HPV-positive/p16-positive patients was 0% in both arms, whereas the response rate in HPV-negative patients was 12.7% (12.5% in the TC arm and 13% in the C arm). Fifteen patients received tivantinib monotherapy, and no responses were observed.

conclusionsCombined tivantinib plus cetuximab does not significantly improve the response rate or survival compared with cetuximab alone but does increase toxicity in an unselected HNSCC population. Cetuximab responses appear to be limited to patients who have HPV-negative HNSCC. MET-aberration-focused trials for HNSCC and the use of higher potency, selective MET inhibitors remain of interest.

Indexed as

Administration, IntravenousAdministration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCetuximabDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPyrrolidinonesARQ 197CetuximabPyrrolidinonesQuinolinescetuximabhead and neck squamous cell carcinomahuman mesenchymal-epithelial transition factor (c-MET)metastatic diseaserecurrent diseasetivantinib

Identifiers

PMID32073648
PMCPMC8011819
OpenAlexW3006910168

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.