Evidence map›Paper›PMID 17330838›Full record

Trial reportCancer2007

A phase II and pharmacodynamic study of gefitinib in patients with refractory or recurrent epithelial ovarian cancer.

Edwin M Posadas, Meghan S Liel, Virginia Kwitkowski, Lori Minasian, Andrew K Godwin, Mahrukh M Hussain, Virginia Espina, Bradford J Wood, Seth M Steinberg, Elise C Kohn

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00049556 (Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor, ZD1839), which is not on this map. Cited by 64 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing 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.

NCT00049556 phase2completednot on this map

Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor, ZD1839 (Iressa; Gefitinib), in Patients With Epithelial Ovarian Cancer or Cervical Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2002 to 2006ConditionsCervical Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity CancerArmsgefitinib, immunohistochemistry staining method, surface-enhanced laser desorption/ionization-time of flight mass spectrometry, biopsy, sentinel lymph node biopsy
3 · Its place in the literature

Who cites it

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

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  19. Integrative Kinome Profiling Identifies mTORC1/2 Inhibition as Treatment Strategy in Ovarian Clear Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
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4 more citing papers are in PubMed but not listed here.

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

10 authors.

Edwin M PosadasLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.
Meghan S Liel
Virginia Kwitkowski
Lori Minasian
Andrew K Godwin
Mahrukh M Hussain
Virginia Espina
Bradford J Wood
Seth M Steinberg
Elise C Kohn

Funding

Therapeutic Micro RNA Strategies for Ovarian CancerP50CA083638 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GODWIN, ANDREW K., GOLEMIS, ERICA A. · 1999 to 2013
$33.6M
BIOSTATISTICS AND DATA MANAGEMENT SECTIONZ01SC007202 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI STEINBERG, SETH M · 1996 to 2008
$1.5M
SIGNAL TRANSDUCTION THERAPY--CLINICALZ01SC009375 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI KOHN, ELISE C. · 1996 to 2008
$878k
Navigation tools for Image Guided Minimally invasive TherapiesZ01CL040011 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2008 to 2008
$25k
Intramural NIH HHS Z01 SC009375NCI NIH HHS P50 CA083638NCI NIH HHS P50 CA83638
6 · The paper itself

Abstract

backgroundThe primary objective of this study was to evaluate the biochemical effects of gefitinib on its target signal-transduction pathways in patients with recurrent epithelial ovarian cancer (EOC). The secondary objectives included assessing clinical activity and toxicity and determining the association between biochemical and clinical outcomes.

methodsTwenty-four heavily pretreated patients with EOC who had good end-organ function and performance status and who had measurable disease received gefitinib 500 mg daily. Prospectively planned core-needle tumor biopsies were obtained before treatment and after 4 weeks. Protein expression of total and phosphorylated (p) epidermal growth factor receptor (EGFR), protein kinase B (AKT), and extracellular regulated kinase (ERK) was quantified in microdissected tumor cells using tissue lysate array proteomics.

resultsAll tumor samples had detectable levels of EGFR and p-EGFR. A decrease in the quantity of both EGFR and p-EGFR was observed with gefitinib therapy in >50% of patients. This was not associated with clinical benefit, nor were responses observed. However, trends for increased gastrointestinal and skin toxicity were observed with greater phosphorylation or quantities of EGFR, ERK, and AKT in tumor samples (P </= .05). Gefitinib had limited clinical activity as monotherapy despite documented target inhibition.

conclusionsThe results from this study demonstrated that gefitinib inhibited the phosphorylation of EGFR in EOC tumor cells, providing proof of target in a clinical setting. Combinatorial therapy with molecular therapeutics against complementary targets may prove successful.

Indexed as

Adenocarcinoma, Clear CellAdultAgedAntineoplastic AgentsCarcinoma, EndometrioidCarcinoma, PapillaryCystadenocarcinoma, SerousDisease-Free SurvivalErbB ReceptorsFemaleGefitinibHumansMiddle AgedMitogen-Activated Protein Kinase 1Neoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialAntineoplastic AgentsErbB ReceptorsGefitinibMitogen-Activated Protein Kinase 1Proto-Oncogene Proteins c-aktQuinazolines

Identifiers

PMID17330838
PMCPMC2778218

What OpenQuestion holds

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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.