Evidence map›Paper›PMID 25784616›Full record

Trial reportHead & neck2016

Phase II trial of bevacizumab + cetuximab + cisplatin with concurrent intensity-modulated radiation therapy for patients with stage III/IVB head and neck squamous cell carcinoma.

Matthew G Fury, Han Xiao, Eric J Sherman, Shrujal Baxi, Stephanie Smith-Marrone, Karen Schupak, Richard Gewanter, Daphna Gelblum, Sofia Haque, Heiko Schoder and 7 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Head & neck, 2016. 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
–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

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

  1. Pooled it
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  17. Rationally combining anti-VEGF therapy with radiation in NF2 schwannoma.Journal of rare diseases research & treatment · 2016
    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

17 authors.

Matthew G FuryHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Han XiaoHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center Regional Network Site, Basking Ridge, New Jersey.
Eric J ShermanHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Shrujal BaxiHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Stephanie Smith-MarroneHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center Regional Network Site, Sleepy Hollow, New York.
Karen SchupakHead and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Basking Ridge, New Jersey.
Richard GewanterHead and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Commack, New York.
Daphna GelblumHead and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Commack, New York.
Sofia HaqueHead and Neck Medical Oncology Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York.
Heiko SchoderHead and Neck Medical Oncology Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York.
Jatin P ShahHead and Neck Medical Oncology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York.
Nora KatabiHead and Neck Medical Oncology Service, Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York.
Rachel KurtzmanHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Brynna LipsonHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Lisa CoxHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Nancy Y LeeHead and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York.
David G PfisterHead and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe purpose of this study was to evaluate the efficacy and tolerability of the addition of 2 monoclonal antibodies, bevacizumab and cetuximab, to 2 cycles of high-dose cisplatin administered concurrently with intensity-modulated radiation therapy (IMRT) for head and neck squamous cell carcinoma (HNSCC).

methodsPatients with newly diagnosed stage III/IVB (M0) HNSCC received cetuximab (400 mg/m(2) loading dose, followed by 250 mg/m(2) weekly), bevacizumab (15 mg/kg, days 1 and 22), and cisplatin (50 mg/m(2) , days 1, 2, 22, and 23) concurrently with IMRT (70 Gy). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety and tolerability.

resultsAmong 30 patients enrolled in this study, the primary tumor site was the oropharynx in 24 patients (p16 immunohistochemistry was positive in 17, negative in 1, and not done in 6 of the oropharyngeal tumors). Median age was 57 years (range, 38-77 years) and 27 patients had clinical stage IVA disease. All patients completed the full planned dose of radiation therapy. The most common ≥ grade 3 adverse events were lymphopenia, mucositis (functional), and dysphagia. With a median follow-up of 33.8 months, 2-year PFS was 88.5% (95% confidence interval [CI] = 68.1-96.1) and 2-year OS was 92.8% (95% CI = 74.2-98.1).

conclusionThe addition of bevacizumab and cetuximab to 2 cycles of cisplatin, given concurrently with IMRT, was well-tolerated and was associated with favorable efficacy outcomes in this patient population. © 2015 Wiley Periodicals, Inc. Head Neck 38: E566-E570, 2016.

Indexed as

Radiotherapy, Intensity-ModulatedAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Squamous CellCetuximabChemoradiotherapyCisplatinFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedBevacizumabCetuximabCisplatinbevacizumabhuman papillomavirusintensity-modulated radiation therapy (IMRT)necksquamous

Identifiers

PMID25784616
PMCPMC5398410

What OpenQuestion holds

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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.