Evidence map›Paper›PMID 26303828›Full record

ArticleClinical & experimental metastasis2015

Activity of T-DM1 in Her2-positive breast cancer brain metastases.

Rupert Bartsch, Anna S Berghoff, Ursula Vogl, Margaretha Rudas, Elisabeth Bergen, Peter Dubsky, Karin Dieckmann, Katja Pinker, Zsuzsanna Bago-Horvath, Arik Galid and 5 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Clinical & experimental metastasis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03190967 (Phase I/II Study of T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery), which is not on this map. Cited by 72 papers.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed
9.1field-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.

NCT03190967 phase1 / phase2terminatednot on this mapstarted 2018, after this paper: background citation

Phase I/II Study of T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2018 to 2023Enrolled12ConditionsBreast Cancer, Brain Metastasis, Brain CancerArmsT-DM1, TMZ
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 120 citations in OpenAlex.

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12 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

15 authors at 3 institutions in 1 country.

Rupert BartschComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Anna S BerghoffComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Ursula VoglDepartment of Medicine, St. Joseph Hospital, Vienna, Vienna, Austria.
Margaretha RudasComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Elisabeth BergenComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Peter DubskyComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Karin DieckmannComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Katja PinkerComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Zsuzsanna Bago-HorvathComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Arik GalidDepartment of Gynaecology, Hanusch Hospital, Vienna, Austria.
Leopold OehlerDepartment of Medicine, St. Joseph Hospital, Vienna, Vienna, Austria.
Christoph C ZielinskiComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Michael GnantComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Guenther G StegerComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria.
Matthias PreusserComprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria. matthias.preusser@meduniwien.ac.at.
Medical University of Vienna · ATComprehensive Cancer Center Vienna · ATHanusch Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Brain metastases (BM) are frequently diagnosed in metastatic Her2-positive breast cancer. Local treatment remains the standard of care but lapatinib plus capecitabine was recently established as systemic therapy option. Due to a disruption of the blood-brain/tumour-barrier at metastatic sites, even large molecules may penetrate into the central nervous system (CNS). Here, we report on the activity of T-DM1 in Her2-positive breast cancer BM. T-DM1 was administered at a dose of 3.6 mg once every 3 weeks as primary systemic therapy for BM or upon documented CNS progression after initial local treatment. Thus, this study allowed for the appraisal of T-DM1 activity in BM. Restaging was conducted every 12 weeks with MRI or whenever symptoms of disease progression occurred. Ten patients were included; in two asymptomatic subjects, T-DM1 was administered as primary therapy, while eight had progressive BM. All patients had received prior treatment with trastuzumab, six had already received lapatinib, and three pertuzumab as well. Three patients had partial remission of BM, and two patient had stable disease lasting for ≥6 months; two further patients had stable disease for <6 months while three progressed despite treatment. At 8.5 months median follow-up, intracranial PFS was 5 months, and median OS from initiation of T-DM1 was not reached. Local treatment of BM remains the standard of care; lapatinib plus capecitabine is currently the best established systemic therapy option. Still, T-DM1 apparently offers relevant clinical activity in BM and further investigation is warranted.

Indexed as

Ado-Trastuzumab EmtansineAdultAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreast NeoplasmsDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansKaplan-Meier EstimateMaytansineMiddle AgedRetrospective StudiesTrastuzumabAdo-Trastuzumab EmtansineAntibodies, Monoclonal, HumanizedAntineoplastic AgentsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesMaytansineTrastuzumabBrain metastasesBreast cancerHer2 positiveSystemic therapyT-DM1

Identifiers

PMID26303828
OpenAlexW1654286353

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.