Evidence map›Paper›PMID 18421051›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008

Phase II trial of lapatinib for brain metastases in patients with human epidermal growth factor receptor 2-positive breast cancer.

Nancy U Lin, Lisa A Carey, Minetta C Liu, Jerry Younger, Steven E Come, Matthew Ewend, Gordon J Harris, Elizabeth Bullitt, Annick D Van den Abbeele, John W Henson and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01934894 (Phase II Study With Lead-in Safety Cohort of Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases), which is not on this map. Cited by 205 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
205citing papers in PubMed, 4 pooled it
37.2field-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.

NCT01934894 phase2terminatednot on this mapstarted 2014, after this paper: background citation

Phase II Study With Lead-in Safety Cohort of Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases

TypeinterventionalSponsorSCRI Development Innovations, LLCRan2014 to 2017Enrolled11ConditionsMetastatic Breast Cancer With Intracranial MetastasesArmscabazitaxel, lapatinib
3 · Its place in the literature

Who cites it

205 citing papers in PubMed, 4 syntheses or guidelines pooled it, 459 citations in OpenAlex.

  1. Pooled it
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  4. Lapatinib for treatment of advanced or metastasized breast cancer: systematic review.Sao Paulo medical journal = Revista paulista de medicina · 2009
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  19. Advancements in targeted therapy for gastric cancer.Therapeutic advances in gastroenterology · 2026
    Review
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145 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 4 institutions in 1 country.

Nancy U LinDana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115, USA.
Lisa A Carey
Minetta C Liu
Jerry Younger
Steven E Come
Matthew Ewend
Gordon J Harris
Elizabeth Bullitt
Annick D Van den Abbeele
John W Henson
Xiaochun Li
Rebecca Gelman
Harold J Burstein
Elizabeth Kasparian
David G Kirsch
Ann Crawford
Fred Hochberg
Eric P Winer
Dana-Farber Cancer Institute · USUniversity of North Carolina at Chapel Hill · USBeth Israel Deaconess Medical Center · USGeorgetown University · US

Funding

VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI A. Heather Eliassen · 1985 to 2026
$330.6M
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
Variation in Receptor Tyrosine Kinases and Breast Cancer RiskP50CA089393 · NCI · DANA-FARBER CANCER INSTITUTE · PI HARRIS, LYNDSAY NORINE · 2000 to 2009
$28.8M
3D Cerebral Vessel Location for Surgical PlanningR01EB000219 · NIBIB · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BULLITT, ELIZABETH · 2002 to 2008
$3.0M
NCI NIH HHS CA58223NCI NIH HHS CA89393NCI NIH HHS P30 CA006516NCI NIH HHS P50 CA058223NCI NIH HHS P50 CA089393NCRR NIH HHS M01 RR000046NCRR NIH HHS M01RR00046NIBIB NIH HHS R01 EB000219NIBIB NIH HHS R01EB000219
6 · The paper itself

Abstract

purposeOne third of women with advanced human epidermal growth factor receptor 2 (HER-2)-positive breast cancer develop brain metastases; a subset progress in the CNS despite standard approaches. Medical therapies for refractory brain metastases are neither well-studied nor established. We evaluated the safety and efficacy of lapatinib, an oral inhibitor of epidermal growth factor receptor (EGFR) and HER-2, in patients with HER-2-positive brain metastases. PATIENTS AND

methodsPatients had HER-2-positive breast cancer, progressive brain metastases, prior trastuzumab treatment, and at least one measurable metastatic brain lesion. Patients received lapatinib 750 mg orally twice a day. Tumor response was assessed by magnetic resonance imaging every 8 weeks. The primary end point was objective response (complete response [CR] plus partial response [PR]) in the CNS by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary end points included objective response in non-CNS sites, time to progression, overall survival, and toxicity.

resultsThirty-nine patients were enrolled. All patients had developed brain metastases while receiving trastuzumab; 37 had progressed after prior radiation. One patient achieved a PR in the brain by RECIST (objective response rate 2.6%, 95% conditional CI, 0.21% to 26%). Seven patients (18%) were progression free in both CNS and non-CNS sites at 16 weeks. Exploratory analyses identified additional patients with some degree of volumetric reduction in brain tumor burden. The most common adverse events (AEs) were diarrhea (grade 3, 21%) and fatigue (grade 3, 15%).

conclusionThe study did not meet the predefined criteria for antitumor activity in highly refractory patients with HER-2-positive brain metastases. Because of the volumetric changes observed in our exploratory analysis, further studies are underway utilizing volumetric changes as a primary end point.

Indexed as

AdultAgedAntineoplastic AgentsBrain NeoplasmsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleHumansLapatinibMiddle AgedProspective StudiesProtein Kinase InhibitorsQuinazolinesTreatment OutcomeAntineoplastic AgentsErb-b2 Receptor Tyrosine KinasesLapatinibProtein Kinase InhibitorsQuinazolines

Identifiers

PMID18421051
PMCPMC4524351
OpenAlexW2119997685

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.