Evidence map›Paper›PMID 36978142›Full record

Trial reportBreast cancer research : BCR2023

The effect of denosumab on disseminated tumor cells (DTCs) of breast cancer patients with neoadjuvant treatment: a GeparX translational substudy.

Pauline Wimberger, Jens-Uwe Blohmer, Petra Krabisch, Theresa Link, Marianne Just, Bruno Valentin Sinn, Eike Simon, Christine Solbach, Tanja Fehm, Carsten Denkert and 10 more

Open access · goldFull text readClinical Trial
In one paragraph

Trial report in Breast cancer research : BCR, 2023. 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
1.8field-weighted citation impact, top 13% 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, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
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

20 authors at 15 institutions in 1 country.

Pauline WimbergerDepartment of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
Jens-Uwe BlohmerGynäkologie mit Brustzentrum, Charité-Univesitätsmedizin Berlin, Berlin, Germany.
Petra KrabischKlinikum Chemnitz, Chemnitz, Germany.
Theresa LinkDepartment of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
Marianne JustOnkologische Schwerpunktpraxis Bielefeld, Bielefeld, Germany.
Bruno Valentin SinnDepartment of Pathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin, Berlin, Germany.
Eike SimonKreiskrankenhaus Torgau, Torgau, Germany.
Christine SolbachUniversitätsklinik Frankfurt, Frankfurt, Germany.
Tanja FehmUniversität Düsseldorf, Düsseldorf, Germany.
Carsten DenkertInstitut für Pathologie, Philipps Universität Marburg und Universitätsklinikum Marburg (UKGM), Marburg, Germany.
Cristin KühnKatharinen-Hospital Unna, Unna, Germany.
Kerstin RhiemUniversität Köln, Zentrum Familiärer Brust- und Eierstockkrebs, Köln, Germany.
Hans TeschCentrum für Hämatologie und Onkologie Bethanien, Frankfurt, Germany.
Sherko KümmelKliniken Essen-Mitte Evang. Huyssen-Stiftung, Essen, Germany.
Andrea PetzoldDepartment of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
Oliver StötzerGemeinschaftspraxis Hämatologie/Intern. Onkologie, München, Germany.
Cornelia MeiselDepartment of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
Jan Dominik KuhlmannDepartment of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany. jan.kuhlmann@uniklinikum-dresden.de.
Valentina NekljudovaGerman Breast Group, Neu-Isenburg, Germany.
Sibylle LoiblGerman Breast Group, Neu-Isenburg, Germany.
German Breast group · DEUniversity Hospital Heidelberg · DECardiovascular Center Bethanien · DECentrum für Integrierte Onkologie · DECharité - Universitätsmedizin Berlin · DEFreie Universität Berlin · DEGerman Cancer Research Center · DEHeinrich Heine University Düsseldorf · DEHelmholtz-Zentrum Dresden-Rossendorf · DEKatharinenhospital · DEKliniken Essen-Mitte · DEKlinikum Chemnitz · DEPhilipps University of Marburg · DEPraxis für Hämatologie und Onkologie · DEUniversity Hospital Carl Gustav Carus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDisseminated tumor cells (DTCs) in the bone marrow are observed in about 40% at primary diagnosis of breast cancer and predict poor survival. While anti-resorptive therapy with bisphosphonates was shown to eradicate minimal residue disease in the bone marrow, the effect of denosumab on DTCs, particularly in the neoadjuvant setting, is largely unknown. The recent GeparX clinical trial reported that denosumab, applied as an add-on treatment to nab-paclitaxel based neoadjuvant chemotherapy (NACT), did not improve the patient's pathologic complete response (pCR) rate. Herein, we analyzed the predictive value of DTCs for the response to NACT and interrogated whether neoadjuvant denosumab treatment may eradicate DTCs in the bone marrow.

methodsA total of 167 patients from the GeparX trial were analyzed for DTCs at baseline by immunocytochemistry using the pan-cytokeratin antibody A45-B/B3. Initially DTC-positive patients were re-analyzed for DTCs after NACT ± denosumab.

resultsAt baseline, DTCs were observed in 43/167 patients (25.7%) in the total cohort, however their presence did not predict response to nab-paclitaxel based NACT (pCR rates: 37.1% in DTC-negative vs. 32.6% DTC-positive; p = 0.713). Regarding breast cancer subtypes, the presence of DTCs at baseline was numerically associated with response to NACT in TNBC patients (pCR rates: 40.0% in DTC-positive vs. 66.7% in DTC-negative patients; p = 0.16). Overall, denosumab treatment did not significantly increase the given DTC-eradication rate of NACT (NACT: 69.6% DTC-eradication vs. NACT + denosumab: 77.8% DTC-eradication; p = 0.726). In TNBC patients with pCR, a numerical but statistically non-significant increase of DTC-eradication after NACT + denosumab was observed (NACT: 75% DTC-eradication vs. NACT + denosumab: 100% DTC-eradication; p = 1.00).

conclusionThis is the first study worldwide, demonstrating that neoadjuvant add-on denosumab over a short-term period of 24 months does not increase the DTC-eradication rate in breast cancer patients treated with NACT.

Indexed as

Breast NeoplasmsNeoplastic Cells, CirculatingTriple Negative Breast NeoplasmsDenosumabFemaleHumansNeoadjuvant TherapyPrognosisDenosumabBone marrowDenosumabDisseminated tumor cellsGeparX trialNeoadjuvant chemotherapy

Identifiers

PMID36978142
PMCPMC10045108
OpenAlexW4361209225

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read48
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.