Evidence map›Paper›PMID 32943457›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2020

Phase Ib Study of Chemoprevention with Green Tea Polyphenon E and Erlotinib in Patients with Advanced Premalignant Lesions (APL) of the Head and Neck.

Dong M Shin, Sreenivas Nannapaneni, Mihir R Patel, Qiuying Shi, Yuan Liu, Zhengjia Chen, Amy Y Chen, Mark W El-Deiry, Jonathan J Beitler, Conor E Steuer and 7 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07149506 (Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

NCT07149506 phase3enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients: a Randomized Trial

TypeinterventionalSponsorCARLOS FRANCISCO SAAVEDRA GARCIARan2025 to 2027Enrolled162ConditionsRadiation Dermatitis Acute, Radiation Dermatitis, Fibrosis, SkinArmsEpicatechin, Epigallocatechin Gallate (EGCG), Microcrystalline Cellulose NF (placebo), Saline (0.9% NaCl)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Benefits of Natural Antioxidants on Oral Health.Antioxidants (Basel, Switzerland) · 2023
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Anticarcinogenic potentials of tea catechins.Frontiers in nutrition · 2022
    Review
  15. 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 at 1 institution in 2 countries.

Dong M ShinDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia. dmshin@emory.edu.
Sreenivas NannapaneniDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Mihir R PatelDepartment of Otolaryngology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Qiuying ShiDepartment of Pathology and Laboratory Medicine, Emory University Winship Cancer Institute, Atlanta, Georgia.
Yuan LiuDepartment of Biostatistics and Bioinformatics, Emory University Winship Cancer Institute, Atlanta, Georgia.
Zhengjia ChenDepartment of Biostatistics and Bioinformatics, Emory University Winship Cancer Institute, Atlanta, Georgia.
Amy Y ChenDepartment of Otolaryngology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Mark W El-DeiryDepartment of Otolaryngology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Jonathan J BeitlerDepartment of Radiation Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Conor E SteuerDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Steven M RoserDepartment of Oral and Maxillofacial Surgery, Emory University Winship Cancer Institute, Atlanta, Georgia.ORCID 0000-0001-8436-9531
Adam M KleinDepartment of Otolaryngology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Taofeek K OwonikokoDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.ORCID 0000-0002-7724-7728
Suresh S RamalingamDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Fadlo R KhuriDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.ORCID 0000-0002-8638-7618
Zhuo G ChenDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Nabil F SabaDepartment of Hematology and Medical Oncology, Emory University Winship Cancer Institute, Atlanta, Georgia.
Emory University · US

Funding

Winship Cancer Institute Cancer Center Support GrantP30CA138292 · NCI · EMORY UNIVERSITY · PI Suresh S Ramalingam · 2009 to 2026
$47.5M
TARGETING DEATH RECEPTOR-MEDIATED APOPTOSIS FOR HEAD AND NECK CANCERP50CA128613 · NCI · EMORY UNIVERSITY · PI SHIN, DONG M · 2007 to 2011
$12.0M
NCI NIH HHS P30 CA138292NCI NIH HHS P50 CA128613
6 · The paper itself

Abstract

purposeOn the basis of synergistic effects between green tea polyphenon E (PPE) and EGFR-tyrosine kinase inhibitor in preclinical studies, we conducted a phase Ib study of the PPE and erlotinib combination in patients with advanced premalignant lesions (APL) of the oral cavity and larynx. PATIENTS AND

methodsPatients were treated with a fixed dose of PPE (200 mg three times a day) and dose escalation of erlotinib (50, 75, 100 mg daily) for 6 months with tissue biopsy at baseline and 6 months. Primary endpoints were safety and toxicity; secondary endpoints were evaluation of pathologic response, cancer-free survival (CFS), overall survival (OS), and biomarker modulation.

resultsAmong 21 enrolled patients, 19 began treatment and 17 completed 6 months of treatment with PPE and erlotinib. Main characteristics of treated patients: 15 severe dysplasia or carcinoma

conclusionsTreatment with PPE and erlotinib combination was well tolerated in patients with APLs of the head and neck, and showed a high rate of pathologic response with excellent CFS. This combination deserves further investigation for the chemoprevention and/or prevention of second primary tumors in early-stage head and neck cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCatechinErlotinib HydrochlorideFemaleHead and Neck NeoplasmsHumansKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedPrecancerous ConditionsProgression-Free SurvivalProtein Kinase InhibitorsTeaCatechinErlotinib Hydrochloridepolyphenon EProtein Kinase InhibitorsTea

Identifiers

PMID32943457
PMCPMC8016407
OpenAlexW3087052714

What OpenQuestion holds

Textmetadata
LicenceTDM
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.