Evidence map›Paper›PMID 28964539›Full record

Trial reportJournal of the American Academy of Dermatology2017

Gefitinib for patients with incurable cutaneous squamous cell carcinoma: A single-arm phase II clinical trial.

William N William, Lei Feng, Renata Ferrarotto, Lawrence Ginsberg, Merrill Kies, Scott Lippman, Bonnie Glisson, Edward S Kim

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of the American Academy of Dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 pooled it
7.8field-weighted citation impact, top 2% 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.

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

59 citing papers in PubMed, 1 synthesis or guideline pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Cyclic AMP-regulatory element-binding protein: a novel UV-targeted transcription factor in skin cancer.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2024
    Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

8 authors at 3 institutions in 1 country.

William N WilliamDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas. Electronic address: wnwillia@mdanderson.org.
Lei FengDepartment of Biostatistics, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Renata FerrarottoDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Lawrence GinsbergDepartment of Diagnostic Radiology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Merrill KiesDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Scott LippmanDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; Moores Cancer Center, University of California San Diego, La Jolla, California.
Bonnie GlissonDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Edward S KimDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; Levine Cancer Institute, Carolinas HealthCare System, Charlotte, North Carolina.
The University of Texas MD Anderson Cancer Center · USLevine Cancer Institute · USUniversity of California, San Diego · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundPreclinical data demonstrate a key role for the epidermal growth factor receptor (EGFR) in the carcinogenesis of cutaneous squamous cell carcinomas (CSCCs). There are, however, limited data on the efficacy of EGFR inhibitors in incurable, recurrent, and/or metastatic CSCC.

objectiveTo determine the response rate to gefitinib in patients with CSCC not amenable to curative therapy including surgery or radiation.

methodsThis was a single-arm phase II study. A total of 40 patients were treated with gefitinib, 250 mg orally daily, until disease progression or intolerable toxicities. The prespecified target response rate of interest was 20%.

resultsThe overall response rate was 16% (95% confidence interval, 0.06-0.32; 6 partial responses in 37 evaluable patients). An additional 13 patients (35%) had stable disease at 8 weeks. The median durations of response and progression-free survival were 31.4 months (95% confidence interval, 3.91-not applicable) and 3.8 months (95% confidence interval, 2.2-5.7), respectively. The side effect profile was consistent with the previous experience with gefitinib in other tumor types. LIMITATIONS: This was a single-institution, single-arm study. The prespecified target response rate was not met.

conclusionGefitinib demonstrated modest activity in incurable CSCC, with a favorable adverse event profile.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Squamous CellErbB ReceptorsFemaleGefitinibHumansMaleMiddle AgedQuinazolinesSkin NeoplasmsAntineoplastic AgentsErbB ReceptorsGefitinibQuinazolinesclinical trialcutaneous squamous cell carcinomaepidermal growth factor receptorgefitinibskin cancertyrosine kinase inhibitor

Identifiers

PMID28964539
PMCPMC5685879
OpenAlexW2759377993

What OpenQuestion holds

Textmetadata
LicenceTDM
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.