Evidence map›Paper›PMID 31484985›Full record

Trial reportScientific reports2019

Real-world data on T-DM1 efficacy - results of a single-center retrospective study of HER2-positive breast cancer patients.

Max Hardy-Werbin, Vanesa Quiroga, Beatriz Cirauqui, Margarita Romeo, Eudald Felip, Iris Teruel, Juan Jose Garcia, Carlos Erasun, Sofia España, Marc Cucurull and 5 more

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–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.

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

17 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Observational
  6. Article
  7. Article
  8. Review
  9. Observational
  10. Primary results of ELAINA: a randomized, multicenter, open-label, phase III study of the efficacy and safety of trastuzumab emtansineTranslational breast cancer research : a journal focusing on translational research in breast cancer · 2023
    Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. The Cellular Prion Protein: A Promising Therapeutic Target for Cancer.International journal of molecular sciences · 2020
    Review
  17. Article
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.

Max Hardy-WerbinCancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
Vanesa QuirogaB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Beatriz CirauquiB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Margarita RomeoB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Eudald FelipB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Iris TeruelB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Juan Jose GarciaB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0001-5165-4168
Carlos ErasunB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Sofia EspañaB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Marc CucurullB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Elisabeth MontpradeB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Juan Carlos PardoB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Dania CarballoEscuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey, Mexico.
Jose Maria VelardeStatistical Department, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.
Mireia MargeliB-ARGO Group, Institut Català d'Oncologia, Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain. mmargeli@iconcologia.net.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

T-DM1 is an antibody drug conjugate that combines trastuzumab with emtansine via a stable thioether linker. In two phase III clinical trials, EMILIA and TH3RESA, T-DM1 was shown to be effective in HER2-positive metastatic breast cancer patients who had progressed to taxanes and trastuzumab. We have performed a real-world study to complement the findings of the clinical trials. From 2012 to 2016, 15 patients with HER2-positive breast cancer who had progressed to prior treatment received T-DM1 at our center. We have retrospectively analyzed outcomes in these patients and compared our findings with those of the two clinical trials. Progression-free survival (PFS) was 10 months compared with the 9.6 months of the EMILIA trial and the 6.2 months of the TH3RESA trial, overall survival was 34 months compared with the 29.9 months of the EMILIA trial and the 22.7 months of the TH3RESA trial. PFS was ≥12 months in five patients, three of whom attained a PFS of ≥23 months. Among five patients with metastases of the central nervous system, PFS was six months, OS was not reached, and the objective response rate was 80%. Our findings are in line with those of the EMILIA study and slightly superior to those of the TH3RESA study. In our series of patients, T-DM1 has demonstrated efficacy in the treatment of HER2-positive metastatic breast cancer. Our real-world data thus confirm and support the findings of the two major phase III trials and indicate the usefulness of T-DM1 in routine clinical practice.

Indexed as

Breast NeoplasmsAdultAgedDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansMaytansineMiddle AgedRetrospective StudiesSurvival RateTrastuzumabERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesMaytansineTrastuzumab

Identifiers

PMID31484985
PMCPMC6726763

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Registered trials

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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.