Evidence map›Paper›PMID 23438670›Full record

Trial reportGynecologic oncology2013

A phase II evaluation of gefitinib in the treatment of persistent or recurrent endometrial cancer: a Gynecologic Oncology Group study.

Kimberly K Leslie, Michael W Sill, Edgar Fischer, Kathleen M Darcy, Robert S Mannel, Krishnansu S Tewari, Parviz Hanjani, Jason A Wilken, Andre T Baron, Andrew K Godwin and 3 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2013. 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
8.7field-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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

  1. Pooled it
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  17. New therapies for advanced, recurrent, and metastatic endometrial cancers.Gynecologic oncology research and practice · 2017
    Review
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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

13 authors at 11 institutions in 1 country.

Kimberly K LeslieUniversity of New Mexico Health Sciences Center, Albuquerque, NM 87131, United States. kimberly-leslie@uiowa.edu
Michael W Sill
Edgar Fischer
Kathleen M Darcy
Robert S Mannel
Krishnansu S Tewari
Parviz Hanjani
Jason A Wilken
Andre T Baron
Andrew K Godwin
Russell J Schilder
Meenakshi Singh
Nita J Maihle
University of New Mexico · USYale University · USAbington Memorial Hospital · USFox Chase Cancer Center · USGynecologic Oncology Group · USMarkey Cancer Center · USPhiladelphia University · USStony Brook University Hospital · USUniversity at Buffalo, State University of New York · USUniversity of California, Irvine Medical Center · USUniversity of Oklahoma Health Sciences Center · US

Funding

GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
Lead Academic Participating Site for the Development and Conduct of NCTN TrialsU10CA180798 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI MANNEL, ROBERT S., MOORE, KATHLEEN N. · 2014 to 2018
$6.7M
Targeted Therapy for Endometrial CancerR01CA099908 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI LESLIE, KIMBERLY K. · 2002 to 2023
$5.8M
Exploiting Biological Networks to Improve Clinical Treatment of Ovarian CancerR01CA140323 · NCI · UNIVERSITY OF KANSAS MEDICAL CENTER · PI GODWIN, ANDREW K. · 2010 to 2014
$2.1M
LIGAND INDEPENDENT ONCOGENIC SIGNALING BY ERBB1R01CA079808 · NCI · YALE UNIVERSITY · PI MAIHLE, NITA J. · 1999 to 2003
$1.1M
NCI NIH HHS CA27469NCI NIH HHS CA37517NCI NIH HHS R01 CA079808NCI NIH HHS R01 CA099908NCI NIH HHS R01-CA099908NCI NIH HHS R01 CA140323NCI NIH HHS R01-CA140323NCI NIH HHS R01-CA79808NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180798
6 · The paper itself

Abstract

backgroundA phase II trial was performed to evaluate the efficacy and safety of gefitinib in patients with persistent/recurrent endometrial cancer.

methodsWomen with histologically confirmed persistent/recurrent endometrial cancer were treated with 500mg oral gefitinib daily until progression or severe toxicity, with progression-free survival (PFS) at six months as the primary endpoint. Tumor expression of total epidermal growth factor receptor (EGFR), estrogen receptor (ER), progesterone receptor A (PRA) and B (PRB), Ki67, pEGFR and activated extracellular signal-regulated kinase (pERK) were examined pre- and post-treatment. EGFR was sequenced, and serum concentrations of soluble EGFR (sEGFR) at baseline also were examined.

resultsOf 29 patients enrolled, 26 were evaluable for efficacy and toxicity. Four patients experienced PFS ≥6 months, and one had a complete response which was not associated with an EGFR mutation. The concentration of sEGFR in pretreatment serum was positively correlated with overall survival (OS), but not with responsiveness to gefitinib in this small patient cohort. Expression of tumor biomarkers was not associated with PFS or OS. Co-expression of ER with PRA in primary and recurrent tumors, and pEGFR with pERK in primary tumors was observed.

conclusionsThis treatment regimen was tolerable but lacked sufficient efficacy to warrant further evaluation in this setting. The possible association between serum sEGFR concentrations and OS, and temporal changes in expression of pEGFR and pERK and the documented CR of one patient are interesting and warrant additional investigation.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorDisease-Free SurvivalEndometrial NeoplasmsErbB ReceptorsFemaleGefitinibHumansKi-67 AntigenMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsAntineoplastic AgentsBiomarkers, TumorErbB ReceptorsGefitinibKi-67 AntigenProtein Kinase InhibitorsQuinazolinesReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID23438670
PMCPMC3700732
OpenAlexW2128041405

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.