Evidence map›Paper›PMID 23006498›Full record

ArticleThe oncologist2012

Phase I study and biomarker analysis of lapatinib and concurrent radiation for locally advanced breast cancer.

Randall J Kimple, Janet K Horton, Chad A Livasy, Janiel M Shields, Julia A Lawrence, Wingkeung M Chiu, Anastasia Ivanova, David W Ollila, Lisa A Carey, Jan S Halle and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in The oncologist, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 16 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 3 institutions in 1 country.

Randall J KimpleDepartment of Human Oncology, University of Wisconsin School of Medicine and Public Health, 1111 Highland Ave., Madison 53705, USA. rkimple@humonc.wisc.edu
Janet K Horton
Chad A Livasy
Janiel M Shields
Julia A Lawrence
Wingkeung M Chiu
Anastasia Ivanova
David W Ollila
Lisa A Carey
Jan S Halle
Carolyn I Sartor
E Claire Dees
University of North Carolina at Chapel Hill · USWake Forest University · USUniversity of Wisconsin–Madison · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KATHERINE A. HOADLEY · 1992 to 2026
$59.3M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
Role of Downstream Signaling in EGFR/HER2 Inhibitor RadiosentitizationR01CA115888 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SHIELDS, JANIEL M · 2006 to 2009
$753k
Phase I Radiosensitization Study of GW572016 in Recurrent Breast CancerR21CA119590 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DEES, ELIZABETH CLAIRE · 2006 to 2007
$404k
NCI NIH HHS CA115888NCI NIH HHS P50 CA058223NCI NIH HHS P50-CA58223NCI NIH HHS R01 CA115888NCI NIH HHS R21 CA119590NCRR NIH HHS M01 RR000046NCRR NIH HHS RR00046
6 · The paper itself

Abstract

purposeThis phase I study assessed the toxicity and safety of combining daily lapatinib with radiation therapy. Sequential tumor biopsies were obtained to evaluate changes in biomarkers, such as epidermal growth factor receptor (EGFR) and human EGFR-2 (HER2) signaling pathways.

methodsEligibility for this dose-escalation study included unresectable and locally recurrent or chemotherapy-refractory and locally advanced breast cancer, and adequate organ function. Patients underwent three serial biopsies: at baseline, after 1 week of lapatinib alone, and after 1 week of lapatinib and radiation. Endpoints included determination of toxicity, maximum tolerated dose, and analysis of the effect of lapatinib with or without radiation on EGFR and HER2 signaling pathways by immunohistochemistry.

resultsDoses of lapatinib up to 1,500 mg/day were well tolerated. Toxicity of grade 3 or more was limited to radiation dermatitis and pain. Out of 19 patients treated, in field responses per response evaluation criteria in solid tumors criteria were complete in four patients and partial in six patients. Serial biopsies were obtained in 16 patients with no complications. Total Her2 was relatively unchanged while phospho-Her2, phospho-Akt, and phospho-ERK showed variable responses to both lapatinib alone and dual therapy with lapatinib and radiation.

conclusionsThe combination of lapatinib and radiation was well tolerated in this patient cohort. Overall local response rates were comparable to those reported in other studies in this patient population. Biopsies were safely performed at all time points. Inhibition of HER2 and downstream signaling pathways was identified, although no strong correlation with response was seen.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBiopsyBreast NeoplasmsCohort StudiesErb-b2 Receptor Tyrosine KinasesErbB ReceptorsFemaleHumansImmunohistochemistryLapatinibMaximum Tolerated DoseMiddle AgedProto-Oncogene Proteins c-aktBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesErbB ReceptorsLapatinibProto-Oncogene Proteins c-aktQuinazolines

Identifiers

PMID23006498
PMCPMC3528381
OpenAlexW2153321830

What OpenQuestion holds

Textmetadata
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.