Evidence map›Paper›PMID 29310623›Full record

Observational studyBMC cancer2018

Trastuzumab without chemotherapy in the adjuvant treatment of breast cancer: subgroup results from a large observational study.

Peter Dall, Thorsten Koch, Thomas Göhler, Johannes Selbach, Andreas Ammon, Jochen Eggert, Nidal Gazawi, Daniela Rezek, Arthur Wischnik, Carsten Hielscher and 4 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

9 citing papers in PubMed, 17 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

14 authors at 8 institutions in 1 country.

Peter DallDepartment of Obstetrics and Gynaecology and Breast Cancer Center, Städtisches Klinikum Lüneburg, Bögelstraße 1, D-21339, Lüneburg, Germany. peter.dall@klinikum-lueneburg.de.
Thorsten KochBreast Center, Klinikum Nürnberg Nord, Prof.-Ernst-Nathan-Str. 1, D-90419, Nürnberg, Germany.
Thomas GöhlerOnkozentrum Dresden/Freiberg, Leipziger Str. 118, D-01127, Dresden, Germany.
Johannes SelbachOncology Practice, Altmarkt 20 - 24, D-47166, Duisburg, Germany.
Andreas AmmonOncology Practice, Nikolausberger Weg 36, D-37073, Göttingen, Germany.
Jochen EggertOncology Practice, Xantener Str. 40, D-47441, Moers, Germany.
Nidal GazawiGyneco-Oncology Practice, Lampestr. 1, D-04107, Leipzig, Germany.
Daniela RezekGynecology Department, Marien-Hospital, Pastor-Janßen-Str. 8-38, D-46483, Wesel, Germany.
Arthur WischnikDepartment of Gynecology, Klinikum Augsburg, Stenglinstr. 2, D-86156, Augsburg, Germany.
Carsten HielscherGyneco-Oncology Practice, Große Parower Str. 47 - 53, D-18435, Stralsund, Germany.
Nicolas SchleifRoche Pharma AG, Emil-Barell-Str. 1, D-79639, Grenzach-Wyhlen, Germany.
Ursula CirrincioneWiSP Research Institute, Karl-Benz-Str. 1, D-40764, Langenfeld, Germany.
Axel HinkeWiSP Research Institute, Karl-Benz-Str. 1, D-40764, Langenfeld, Germany.ORCID 0000-0002-6037-8836
Gabriele Feisel-SchwickardiDepartment of Obstetrics and Gynecology and Breast Cancer Center, Klinikum Kassel, Mönchebergstr. 41 - 43, D-34125, Kassel, Germany.
Klinikum Kassel · DEKlinikum Lüneburg · DEMarien Hospital Wesel · DENuremberg Hospital · DEOnkozentrum Dresden · DERoche Pharma AG (Germany) · DEUniversity Hospital Augsburg · DEUniversity of Applied Sciences Stralsund · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe topic of trastuzumab therapy without chemotherapy in early breast cancer (EBC) has been repeatedly discussed at international consensus meetings, but is compromised by the lack of solid evidence from clinical studies.

methodsAn observational study database of patients with EBC receiving trastuzumab-containing (neo)adjuvant therapy was screened to identify those patients who did not receive cytostatic agents.

resultsOf 3935 patients, 232 (6%) were identified who received no chemotherapy, being characterized by older age, worse performance status, and/or less aggressive histology. Relapse-free survival in this cohort was 84% (95% confidence interval [CI] 78-89%) at 3 years and 80% (95% CI 74-87%) at 5 years. However, these rates were significantly worse than those in the group of patients who received chemotherapy (hazard ratio 1.49; 95% CI 1.06-2.09; P = 0.022). A similar pattern was observed for overall survival, with marginally non-significant inferiority in the group receiving no chemotherapy (hazard ratio 1.56; 95% CI 1.00-2.44; P = 0.052). Survival rates in patients receiving no chemotherapy were 93% (95% CI 88-97%) and 87% (95% CI 81-93%) at 3 and 5 years, respectively. These findings were confirmed by a propensity score analysis accounting for selection bias.

conclusionsTrastuzumab plus chemotherapy should remain the preferred option in all patients with HER2-positive EBC with an indication for adjuvant treatment. However, a limited proportion of patients will need an alternative treatment approach, either because of contraindications or the patient's preference. In these selected patients, trastuzumab monotherapy, eventually combined with endocrine agents, might be a reasonable option offering favorable long-term outcomes by addressing the high-risk profile associated with HER2-positive disease.

Indexed as

AdultAgedAged, 80 and overBreast NeoplasmsDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoplasm StagingTrastuzumabERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumabHER2-positiveMonotherapyOverall survivalPropensity score analysisRelapse-free survival

Identifiers

PMID29310623
PMCPMC5759796
OpenAlexW2783200533

What OpenQuestion holds

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LicenceCC BY
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.