Evidence map›Paper›PMID 35977936›Full record

ArticleNature communications2022

A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer.

Manijeh Goldberg, Aaron Manzi, Amritpreet Birdi, Brandon Laporte, Peter Conway, Stefanie Cantin, Vasudha Mishra, Alka Singh, Alexander T Pearson, Eric R Goldberg and 21 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Nature communications, 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 trial NCT03502148 (Phase 1/2, Open-Label, Single-Arm Safety and Efficacy Dose-Finding, Systemic Exposure, and Device Technical Effects of PRV111), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
12.3field-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.

NCT03502148 phase1 / phase2completednot on this map

Phase 1/2, Open-Label, Single-Arm Safety and Efficacy Dose-Finding, Systemic Exposure, and Device Technical Effects of PRV111 (Cisplatin Transmucosal System) in Subjects With Oral Squamous Cell Carcinoma

TypeinterventionalSponsorPrivo TechnologiesRan2018 to 2020Enrolled10ConditionsOral Squamous Cell CarcinomaArmsPRV111 (Cisplatin Transmucosal System)
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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  4. Head and neck squamous cell carcinoma: current and emerging therapeutic strategies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 12 institutions in 3 countries.

Manijeh Goldberg *David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA. mgoldberg@privotechnologies.com.ORCID http://orcid.org/0000-0002-6134-8161
Aaron Manzi *David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA.
Amritpreet BirdiPrivo Technologies, Peabody, MA, USA.
Brandon LaportePrivo Technologies, Peabody, MA, USA.
Peter ConwayPrivo Technologies, Peabody, MA, USA.
Stefanie CantinPrivo Technologies, Peabody, MA, USA.
Vasudha MishraDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.
Alka SinghDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.
Alexander T PearsonDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.ORCID http://orcid.org/0000-0003-2801-7456
Eric R GoldbergPrivo Technologies, Peabody, MA, USA.
Sam GoldbergerPrivo Technologies, Peabody, MA, USA.
Benjamin FlaumPrivo Technologies, Peabody, MA, USA.
Rifat HasinaDepartment of Surgery, Section of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, IL, USA.
Nyall R LondonDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Gary L GalliaDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Chetan BettegowdaDepartment of Neurosurgery and Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-9991-7123
Simon YoungDepartment of Oral Maxillofacial Surgery, The University of Texas Health Science Center at Houston, Houston, TX, USA.
Vlad SandulacheDepartment of Otolaryngology-Head & Neck Surgery, Baylor College of Medicine, Houston, TX, USA.
James MelvilleDepartment of Oral Maxillofacial Surgery, The University of Texas Health Science Center at Houston, Houston, TX, USA.
Jonathan ShumDepartment of Oral Maxillofacial Surgery, The University of Texas Health Science Center at Houston, Houston, TX, USA.
Sonya E O'NeillHarvard-MIT Division of Health Sciences and Technology, Massachusetts Institute of Technology, Cambridge, MA, USA.
Erkin AydinDavid H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA.ORCID http://orcid.org/0000-0001-7811-2959
Alex ZhavoronkovInsilico Medicine, Pak Shek Kok, Hong Kong.ORCID http://orcid.org/0000-0001-7067-8966
Anxo VidalDepartment of Pharmacy and Pharmaceutical Technology, University of Santiago de Compostela, Galicia, Spain.ORCID http://orcid.org/0000-0002-0866-4202
Atenea SotoDepartment of Pharmacy and Pharmaceutical Technology, University of Santiago de Compostela, Galicia, Spain.
Maria Jose AlonsoDepartment of Pharmacy and Pharmaceutical Technology, University of Santiago de Compostela, Galicia, Spain.
Ari J RosenbergDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.
Mark W LingenDepartment of Pathology, University of Chicago, Chicago, IL, USA.
Anil D'CruzDepartment of Oncology, Apollo Hospital, Mumbai, India.
Nishant AgrawalDepartment of Surgery, Section of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, IL, USA. nagrawal@surgery.bsd.uchicago.edu.ORCID http://orcid.org/0000-0002-1361-3231
Evgeny IzumchenkoDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA. izumchen@uchicago.edu.ORCID http://orcid.org/0000-0003-3500-5664
Privo Technologies (United States) · USUniversity of Chicago · USJohns Hopkins University · USThe University of Texas Health Science Center at Houston · USUniversidade de Santiago de Compostela · ESApollo Hospitals · INBaylor College of Medicine · USMACOM (United States) · USMassachusetts College of Pharmacy and Health Sciences · USMassachusetts Institute of Technology · USUniversity of Illinois Chicago · USUniversity of Massachusetts Lowell · US

Funding

Supportive Clinical Trial Tasks for Nanotechnology-Based Treatment of Oral CancerR44CA192875 · NCI · PRIVO TECHNOLOGIES, LLC · PI GOLDBERG, MANIJEH N, KEITH, DONNA · 2015 to 2020
$5.6M
Customized Nanotechnology Based Treatment of Oral CancerR44DE023725 · NIDCR · PRIVO TECHNOLOGIES, LLC · PI GOLDBERG, MANIJEH N, KEITH, DONNA · 2016 to 2023
$5.2M
Delineating chromatin-related gene expression signatures as a function of HNSCC progressionR01DE027809 · NIDCR · UNIVERSITY OF MARYLAND BALTIMORE · PI GAYKALOVA, DARIA A, IZUMCHENKO, EVGENY (EUGENE) G · 2019 to 2023
$2.6M
Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017R01FD006325 · FDA · PRIVO TECHNOLOGIES, LLC · PI GOLDBERG, MANIJEH N, HALL, JESSE · 2019 to 2021
$1.0M
Customized nanotechnology based treatment of Oral CancerR43DE023725 · NIDCR · PRIVO TECHNOLOGIES, LLC · PI CHEN, KUANJU, GOLDBERG, MANIJEH N · 2014 to 2014
$221k
FDA HHS R01 FD006325NCI NIH HHS R44 CA192875NIDCR NIH HHS R01 DE027809NIDCR NIH HHS R43 DE023725NIDCR NIH HHS R44 DE023725
6 · The paper itself

Abstract

Despite therapeutic advancements, oral cavity squamous cell carcinoma (OCSCC) remains a difficult disease to treat. Systemic platinum-based chemotherapy often leads to dose-limiting toxicity (DLT), affecting quality of life. PRV111 is a nanotechnology-based system for local delivery of cisplatin loaded chitosan particles, that penetrate tumor tissue and lymphatic channels while avoiding systemic circulation and toxicity. Here we evaluate PRV111 using animal models of oral cancer, followed by a clinical trial in patients with OCSCC. In vivo, PRV111 results in elevated cisplatin retention in tumors and negligible systemic levels, compared to the intravenous, intraperitoneal or intratumoral delivery. Furthermore, PRV111 produces robust anti-tumor responses in subcutaneous and orthotopic cancer models and results in complete regression of carcinogen-induced premalignant lesions. In a phase 1/2, open-label, single-arm trial (NCT03502148), primary endpoints of efficacy (≥30% tumor volume reduction) and safety (incidence of DLTs) of neoadjuvant PRV111 were reached, with 69% tumor reduction in ~7 days and over 87% response rate. Secondary endpoints (cisplatin biodistribution, loco-regional control, and technical success) were achieved. No DLTs or drug-related serious adverse events were reported. No locoregional recurrences were evident in 6 months. Integration of PRV111 with current standard of care may improve health outcomes and survival of patients with OCSCC.

Indexed as

Carcinoma, Squamous CellHead and Neck NeoplasmsMouth NeoplasmsAnimalsAntineoplastic Combined Chemotherapy ProtocolsCisplatinModels, AnimalNeoplasm Recurrence, LocalQuality of LifeSquamous Cell Carcinoma of Head and NeckTissue DistributionCisplatin

Identifiers

PMID35977936
PMCPMC9385702
OpenAlexW4292324206

What OpenQuestion holds

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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.