Evidence map›Paper›PMID 19586795›Full record

Trial reportOral oncology2009

Factors associated with clinical benefit from epidermal growth factor receptor inhibitors in recurrent and metastatic squamous cell carcinoma of the head and neck.

Ezra Eddy Wyssam Cohen, Anna B Halpern, Kristen Kasza, Masha Kocherginsky, Rosalyn Williams, Everett E Vokes

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Oral oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–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.

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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. A phase II study of gefitinib for aggressive cutaneous squamous cell carcinoma of the head and neck.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012
    Trial
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. AKT can modulate theOncotarget · 2017
    Article
  17. Article
  18. Article
  19. Article
  20. 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

6 authors.

Ezra Eddy Wyssam CohenUniversity of Chicago, 5841 South Maryland Avenue, MC2115, Chicago, IL 60637, United States. ecohen@medicine.bsd.uchicago.edu
Anna B Halpern
Kristen Kasza
Masha Kocherginsky
Rosalyn Williams
Everett E Vokes

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI THOMAS F GAJEWSKI · 1985 to 2026
$122.1M
NCI NIH HHS N01 CM062201NCI NIH HHS N01-CM-17102NCI NIH HHS P30 CA014599NCI NIH HHS P30 CA14599
6 · The paper itself

Abstract

Single agent epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) have demonstrated reproducible response rates of 5-15% in treatment of squamous cell carcinomas of the head and neck (SCCHN). The subset of patients that benefits most from these agents remains unknown. We reviewed individual patient data from five clinical trials of erlotinib, lapatinib, or gefitinib to determine if there are clinical characteristics that are associated with clinical benefit defined as complete response (CR), partial response (PR), and stable disease (SD) >4months. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Three-hundred and nineteen subjects were included. Observed responses were: 1% CR, 6% PR, 24% SD >4months, 18% SD <4months, 45% progressive disease (PD), 7% not evaluable (NE). The median OS was 6.4months and the median PFS was 2.7months. The most common toxicities observed were rash (grade 1 in 37%, grade 2 in 33%, grade 3+ in 6%) and diarrhea (grade 1 in 30%, grade 2 in 10%, grade 3+ in 5%). Performance status (PS) (p=0.04), older age (p=0.02), and development of rash (p<0.01), diarrhea (p=0.03), or oral side effects (p=0.02) were independently associated with clinical benefit. Older age, better PS, and development of rash were associated with longer PFS and OS. Clinical parameters that appear to predict response to EGFR TKI include PS and age. EGFR mechanistic toxicities that develop during therapy are also highly associated with benefit and suggest a relationship between drug exposure and outcome.

Indexed as

AgedAge FactorsAntineoplastic AgentsCarcinoma, Squamous CellDisease-Free SurvivalErbB ReceptorsErlotinib HydrochlorideFemaleGefitinibHead and Neck NeoplasmsHumansLapatinibMaleMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsAntineoplastic AgentsErbB ReceptorsErlotinib HydrochlorideGefitinibLapatinibProtein Kinase InhibitorsProtein-Tyrosine KinasesQuinazolines

Identifiers

PMID19586795
PMCPMC2749898

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.