Evidence map›Paper›PMID 22885469›Full record

Trial reportGynecologic oncology2012

Lapatinib and potential prognostic value of EGFR mutations in a Gynecologic Oncology Group phase II trial of persistent or recurrent endometrial cancer.

Kimberly K Leslie, Michael W Sill, Heather A Lankes, Edgar G Fischer, Andrew K Godwin, Heidi Gray, Russell J Schilder, Joan L Walker, Krishnansu Tewari, Parviz Hanjani and 2 more

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

Trial report in Gynecologic oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
12.0field-weighted citation impact, top 1% 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

46 citing papers in PubMed, 105 citations in OpenAlex.

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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

12 authors at 11 institutions in 1 country.

Kimberly K LeslieThe University of Iowa, Iowa City, IA 52242, USA. kimberly-leslie@uiowa.edu
Michael W Sill
Heather A Lankes
Edgar G Fischer
Andrew K Godwin
Heidi Gray
Russell J Schilder
Joan L Walker
Krishnansu Tewari
Parviz Hanjani
Ovadia Abulafia
Peter G Rose
Fox Chase Cancer Center · USAbington Memorial Hospital · USCleveland Clinic · USGynecologic Oncology Group · USOklahoma City University · USRoswell Park Comprehensive Cancer Center · USSUNY Downstate Health Sciences University · USUniversity of California, Irvine Medical Center · USUniversity of Iowa · USUniversity of New Mexico · USUniversity of Washington · 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
Gynecologic Oncology Group Specimen BankingU24CA114793 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 2005 to 2014
$7.0M
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
NCI NIH HHS CA 11479NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS R01 CA099908NCI NIH HHS R01 CA140323NCI NIH HHS R01CA99908NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U24 CA114793
6 · The paper itself

Abstract

objectiveA phase II trial was performed to evaluate the efficacy and safety of the tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and HER2, lapatinib, and to explore EGFR, HER2 (EGFR2), phosphorylated ERK MAP kinase (pERK), and Ki67 expression, as well as EGFR mutations in persistent/recurrent endometrial cancer (EC).

methodsWomen with histologically-confirmed, measurable, persistent/recurrent EC following one or two prior regimens were eligible and treated with 1500 mg oral lapatinib daily until progression or severe toxicity. A 2-stage group sequential design was used to evaluate the regimen with 6 month PFS as the primary endpoint. The trial had a 10% type I error rate with 90% power. EGFR, HER2, pERK, and Ki67 were evaluated by immunohistochemistry (IHC) from hysterectomy specimens, pre-treatment biopsies, and post-treatment biopsies (when available). Exons 18-21 of EGFR were sequenced.

resultsThree patients of 30 evaluable had PFS ≥6 months, one had a partial response, seven had stable disease, 21 had progressive disease and one was indeterminate. Three mutations in EGFR were identified. Two of these, L688F and K754E, were not associated with response or PFS. However, a newly identified mutation in exon 18, E690K, occurred in the patient with a partial response and progression-free survival extending past six months.

conclusionWhile lapatinib has limited activity in unselected cases, the identification of a previously unreported mutation in EGFR (E690K) with a response suggests that lapatinib may be beneficial in some cases of EC.

Indexed as

Genes, erbB-1AdenocarcinomaAdultAgedAntineoplastic AgentsBiomarkers, TumorDNA Mutational AnalysisDrug Administration ScheduleEndometrial NeoplasmsFemaleGenetic MarkersHumansImmunohistochemistryLapatinibMiddle AgedMutationAntineoplastic AgentsBiomarkers, TumorGenetic MarkersLapatinibQuinazolines

Identifiers

PMID22885469
PMCPMC3518448
OpenAlexW2034116358

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.