Evidence map›Paper›PMID 40296503›Full record

ArticleHead & neck2025

Prospective Pilot Study of Second Primary Tumor Prevention With Erlotinib and Celecoxib in Early-Stage Squamous Cell Carcinoma of the Head and Neck: Long-Term Follow-Up.

Pauline Kim, Nabil F Saba, Ashley McCook-Veal, Yuan Liu, Adam M Klein, Jonathan J Beitler, Amy Chen, Fadlo R Khuri, Dong M Shin

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Head & neck, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00400374 (Phase I Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT00400374 phase1completednot on this map

Phase I Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcinoma of Head and Neck

TypeinterventionalSponsorEmory UniversityRan2007 to 2016Enrolled10ConditionsHead and Neck CancerArmsErlotinib, Celecoxib
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Therapeutic targeting of COX-2 in head and neck cancer: Mechanistic and clinical perspectives.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
    Review
  2. Therapeutic targeting of COX-2 in head and neck cancer: Mechanistic and clinical perspectives.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
    Review
  3. Celecoxib in oncology: targeting the COX-2/PGEFrontiers in pharmacology · 2025
    Review
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

9 authors.

Pauline KimWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0009-0001-4706-8120
Nabil F SabaWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0000-0003-4972-1477
Ashley McCook-VealWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Yuan LiuWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Adam M KleinWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Jonathan J BeitlerWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0000-0001-6833-6430
Amy ChenWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Fadlo R KhuriWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Dong M ShinWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0000-0002-8245-4174

Funding

Personalized vaccine immunotherapy in combination with anti-PD 1 antibody for recurrent or metastatic squamous cell carcinoma of the head and neckR01CA262123 · NCI · EMORY UNIVERSITY · PI DONG M SHIN, Periasamy Selvaraj · 2023 to 2026
$2.6M
Second Primary Tumor Prevention w/EGFR TKIs & COX-2 inhibitors in H & N CancerR01CA112643 · NCI · EMORY UNIVERSITY · PI SHIN, DONG M · 2006 to 2011
$1.6M
NCI NIH HHS R01 CA112643NCI NIH HHS R01CA112643NCI NIH HHS R01 CA262123NCI NIH HHS R01CA262123
6 · The paper itself

Abstract

backgroundPatients with early-stage head and neck squamous cell carcinoma (HNSCC) have an increased risk for secondary primary tumors (SPT) after definitive treatment. The aim of this pilot trial was to investigate the safety and efficacy of erlotinib and celecoxib in preventing SPTs.

methodsTen patients with stage I/II HNSCC who completed definitive treatment received erlotinib with celecoxib for 6 months. Primary objectives were safety assessment and SPT-free survival after completion of erlotinib and celecoxib. Secondary objectives included assessing overall survival (OS) and progression-free survival (PFS).

resultsWith a median follow-up of 9 (1.7-15.3) years, the median time to SPT-free survival was not reached. The estimated SPT-free survival was 78.8% at 15 years. Two patients had local recurrence, but none of our subjects developed mucosal squamous cell carcinoma at any site.

conclusionAll three doses of erlotinib and the fixed dose of celecoxib were well tolerated with excellent SPT-free survival with long-term follow-up.

trial registrationClinicaltrials.gov identifier: NCT00400374.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCelecoxibErlotinib HydrochlorideNeoplasms, Second PrimarySquamous Cell Carcinoma of Head and NeckAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm StagingPilot ProjectsProspective StudiesTreatment OutcomeCelecoxibErlotinib Hydrochloridecelecoxibchemopreventionerlotinibhead and neck cancerHNSCC

Identifiers

PMID40296503
PMCPMC12339201

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.