Evidence map›Paper›PMID 36434392›Full record

ArticleNature cancer2022

A phase I/Ib trial and biological correlate analysis of neoadjuvant SBRT with single-dose durvalumab in HPV-unrelated locally advanced HNSCC.

Laurel B Darragh, Michael M Knitz, Junxiao Hu, Eric T Clambey, Jennifer Backus, Andrew Dumit, Von Samedi, Andrew Bubak, Casey Greene, Timothy Waxweiler and 20 more

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Nature cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 64 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 2 pooled it
8.5field-weighted citation impact, top 1% 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.

NCT03635164 phase1completednot on this map

Phase I/Ib Trial of Radiotherapy in Combination With Durvalumab (MEDI4736) Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma of the Head and Neck (HNSCC)

TypeinterventionalSponsorUniversity of Colorado, DenverRan2018 to 2023Enrolled21ConditionsSquamous Cell Carcinoma of the Head and NeckArmsDurvalumab, Stereotactic Body Radiation Therapy (SBRT), Standard of Care Therapy
NCT06219980 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

A Phase II Study of SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx

TypeinterventionalSponsorSun Yat-sen UniversityRan2023 to 2026Enrolled25ConditionsSBRTArmsSBRT+chemoimmunotherapy
NCT07756190 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase II Study of Radscopal Radiotherapy Combined With Immunotherapy as First-Line Treatment for Chemotherapy-Ineligible Patients With De Novo Metastatic Nasopharyngeal Carcinoma

TypeinterventionalSponsorSun Yat-sen UniversityRan2026 to 2030Enrolled28ConditionsNasopharyngeal Carcinoma (NPC), Metastatic Nasopharyngeal CarcinomaArmsSintilimab, ipilimumab, Radscopal Radiotherapy
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.

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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 5 institutions in 1 country.

Laurel B DarraghRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.ORCID http://orcid.org/0000-0002-6445-7988
Michael M KnitzRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.ORCID http://orcid.org/0000-0002-5786-9837
Junxiao HuDepartment of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Denver, Aurora, CO, USA.
Eric T ClambeyDepartment of Anesthesiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Jennifer BackusRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Andrew DumitRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Von SamediDepartment of Pathology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Andrew BubakDepartment of Neurology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Casey GreeneDepartment of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Denver, Aurora, CO, USA.
Timothy WaxweilerRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Sanjana MehrotraDepartment of Pathology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Shilpa BhatiaRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Jacob GadwaRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Thomas BickettRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.ORCID http://orcid.org/0000-0002-9905-9998
Miles PiperRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Kareem FakhouryRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Arthur LiuDepartment of Radiation Oncology, University of Colorado, Poudre Valley Hospital, Fort Collins, CO, USA.
Joshua PetitDepartment of Radiation Oncology, University of Colorado, Poudre Valley Hospital, Fort Collins, CO, USA.
Daniel BowlesDivision of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.
Ashesh ThakerDepartment of Radiology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.ORCID http://orcid.org/0000-0001-5238-0429
Kimberly AtiyehDepartment of Otolaryngology Head and Neck Surgery, University of Colorado, Memorial South Hospital, Colorado Springs, CO, USA.
Julie GoddardDepartment of Otolaryngology Head and Neck Surgery, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Robert HoyerDivision of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.
Adrie Van BokhovenDepartment of Pathology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.ORCID http://orcid.org/0000-0002-6059-2429
Kimberly JordanDepartment of Immunology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Antonio JimenoDivision of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.
Angelo D'AlessandroDepartment of Biochemistry and Molecular Genetics, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
David RabenRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA.
Jessica D McDermottDivision of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.
Sana D KaramRadiation Oncology, University of Colorado Denver at Anschutz Medical Campus, Aurora, CO, USA. sana.karam@cuanschutz.edu.ORCID http://orcid.org/0000-0003-1676-5967
University of Colorado Anschutz Medical Campus · USUniversity of Colorado Denver · USColorado School of Public Health · USPoudre Valley Hospital · USUniversity of Colorado Hospital · US

Funding

University of Colorado Cancer Center Support Grant - Lung Cancer Patient-Derived Xenografts with Autologous Human Immune SystemsP30CA046934 · NCI · UNIVERSITY OF COLORADO DENVER · PI James V Degregori · 1988 to 2026
$117.0M
Resuscitation Strategies for Achieving Thrombo-inflammatory HomeostasisRM1GM131968 · NIGMS · UNIVERSITY OF COLORADO DENVER · PI COHEN, MITCHELL, D'ALESSANDRO, ANGELO · 2019 to 2023
$11.3M
Treating recurrent HNSCC with radiation and dual TGF-Beta/PD-L1.P50CA261605 · NCI · UNIVERSITY OF COLORADO DENVER · PI JIMENO, ANTONIO, WANG, XIAO-JING · 2021 to 2025
$10.1M
The Impact of Oxidative Stress on Erythocyte BiologyR01HL148151 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI D'ALESSANDRO, ANGELO, KARAFIN, MATTHEW S · 2019 to 2022
$8.9M
The role of ferroptosis in red cell aging in vivo and in vitroR01HL146442 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI Angelo D'Alessandro, Adam N. Goldfarb · 2019 to 2026
$5.4M
Tackling Treg mediated resistance to radiation and anti-PDL1 in HNSCCsR01DE028529 · NIDCR · WASHINGTON UNIVERSITY · PI SANA D KARAM · 2019 to 2026
$3.7M
Interactions between the ADORA2b/Sphk1axis and the AE1-Hb switch in red blood cell aging in vivo and in vitroR01HL149714 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI D'ALESSANDRO, ANGELO · 2020 to 2023
$2.6M
Role of EphB4-ephrin-B2 interaction in regulating crosstalk between cancer cell and vascular tumor microenvironment in head and neck cancerR01DE028282 · NIDCR · UNIVERSITY OF COLORADO DENVER · PI KARAM, SANA D · 2019 to 2023
$2.4M
MIRAGES: Metabolic Investigation of Red blood cells as a function of Aging, Genetics, Environment, and StorageR21HL150032 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI D'ALESSANDRO, ANGELO · 2020 to 2021
$414k
Regulation of transendothelial migration of Tregs in irradiated HNSCCs by EphB4-ephrinB2 interactionF31DE029997 · NIDCR · UNIVERSITY OF COLORADO DENVER · PI DARRAGH, LAUREL B · 2021 to 2023
$131k
NCI NIH HHS P30 CA046934NCI NIH HHS P50 CA261605NHLBI NIH HHS R01 HL146442NHLBI NIH HHS R01 HL148151NHLBI NIH HHS R01 HL149714NHLBI NIH HHS R21 HL150032NIDCR NIH HHS F31 DE029997NIDCR NIH HHS R01 DE028282NIDCR NIH HHS R01 DE028529NIGMS NIH HHS RM1 GM131968
6 · The paper itself

Abstract

Five-year survival for human papilloma virus-unrelated head and neck squamous cell carcinomas remain below 50%. We assessed the safety of administering combination hypofractionated stereotactic body radiation therapy with single-dose durvalumab (anti-PD-L1) neoadjuvantly (n = 21) ( NCT03635164 ). The primary endpoint of the study was safety, which was met. Secondary endpoints included radiographic, pathologic and objective response; locoregional control; progression-free survival; and overall survival. Among evaluable patients at an early median follow-up of 16 months (448 d or 64 weeks), overall survival was 80.1% with 95% confidence interval (95% CI) (62.0%, 100.0%), locoregional control and progression-free survival were 75.8% with 95% CI (57.5%, 99.8%), and major pathological response or complete response was 75% with 95% exact CI (51.6%, 100.0%). For patients treated with 24 Gy, 89% with 95% CI (57.1%, 100.0%) had MPR or CR. Using high-dimensional multi-omics and spatial data as well as biological correlatives, we show that responders had: (1) an increase in effector T cells; (2) a decrease in immunosuppressive cells; and (3) an increase in antigen presentation post-treatment.

Indexed as

Head and Neck NeoplasmsPapillomavirus InfectionsRadiosurgeryAntibodies, MonoclonalHumansNeoadjuvant TherapySquamous Cell Carcinoma of Head and NeckAntibodies, Monoclonaldurvalumab

Identifiers

PMID36434392
PMCPMC9701140
OpenAlexW4310297838

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.