Evidence map›Paper›PMID 33097092›Full record

Trial reportBreast cancer research : BCR2020

Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.

Amelie de Gregorio, Lothar Häberle, Peter A Fasching, Volkmar Müller, Iris Schrader, Ralf Lorenz, Helmut Forstbauer, Thomas W P Friedl, Emanuel Bauer, Nikolaus de Gregorio and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research : BCR, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02181101 (Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT02181101 phase3completednot on this map

Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial

TypeinterventionalSponsorLudwig-Maximilians - University of MunichRan2005 to 2013Enrolled3,754ConditionsBreast NeoplasmsArmsFEC-DocGemzar adjuvant chemotherapy, FEC-Doc adjuvant chemotherapy, Zoledronic acid i.v. 2 years, Zoledronic acid i.v. 5 years
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 25 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. An insight into the therapeutic effects of isoliquiritigenin in breast cancer.Naunyn-Schmiedeberg's archives of pharmacology · 2024
    Review
  7. Article
  8. Pseudo-value regression trees.Lifetime data analysis · 2024
    Article
  9. Article
  10. Review
  11. Article
  12. Identification of Two Genetic Loci Associated with Leukopenia after Chemotherapy in Patients with Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  13. Article
  14. Article
  15. 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

25 authors at 11 institutions in 1 country.

Amelie de GregorioDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany. amelie.degregorio@uniklinik-ulm.de.ORCID 0000-0001-8273-9906
Lothar HäberleDepartment of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.
Peter A FaschingDepartment of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.
Volkmar MüllerDepartment of Gynecology, University Hamburg-Eppendorf, Hamburg, Germany.
Iris SchraderGynecologic-Oncological Practice, Hannover, Germany.
Ralf LorenzGynecologic Practice Dr. Lorenz, N. Hecker, Dr. Kreiss-Sender, Braunschweig, Germany.
Helmut ForstbauerHemato-Oncological Practice Dres Forstbauer and Ziske, Troisdorf, Germany.
Thomas W P FriedlDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Emanuel BauerDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Nikolaus de GregorioDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Miriam DenizDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Visnja FinkDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Inga BekesDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Ulrich AndergassenDepartment of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.
Andreas SchneeweissNational Center for Tumor Diseases, Division of Gynecologic Oncology and German Cancer Research Center, Heidelberg, Germany.
Hans TeschDepartment of Oncology, Onkologie Bethanien, Frankfurt, Germany.
Sven MahnerDepartment of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.
Sara Y BruckerDepartment of Gynecology and Obstetrics, Tübingen University Hospital, Tübingen, Germany.
Jens-Uwe BlohmerDepartment of Gynecology and Breast Center, Charité University Hospital Campus Charité-Mitte, Berlin, Germany.
Tanja N FehmDepartment of Gynecology and Obstetrics, Düsseldorf University Hospital, Heinrich-Heine University, Düsseldorf, Germany.
Georg HeinrichDepartment of Gynecologic Oncology, Schwerpunktpraxis für Gynäkologische Onkologie, Fürstenwalde, Germany.
Krisztian LatoDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Matthias W BeckmannDepartment of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.
Brigitte RackDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
Wolfgang JanniDepartment of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.
University Hospital Ulm · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DELudwig-Maximilians-Universität München · DECardiovascular Center Bethanien · DECharité - Universitätsmedizin Berlin · DEDüsseldorf University Hospital · DEEcologic Institute · DEGerman Cancer Research Center · DEPraxis für Hämatologie und Onkologie · DEUniversität Hamburg · DEUniversity Children's Hospital Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhen chemotherapy is indicated in patients with early breast cancer, regimens that contain anthracyclines and taxanes are established standard treatments. Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer. The SUCCESS-A trial (NCT02181101) examined the addition of gemcitabine to a standard chemotherapy regimen in high-risk early breast cancer patients.

methodsA total of 3754 patients with at least one of the following characteristics were randomly assigned to one of the two treatment arms: nodal positivity, tumor grade 3, age ≤ 35 years, tumor larger than 2 cm, or negative hormone receptor status. The treatment arms received either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by three cycles of docetaxel (FEC → Doc); or three cycles of FEC followed by three cycles of docetaxel and gemcitabine (FEC → Doc/Gem). The primary study aim was disease-free survival (DFS), and the main secondary objectives were overall survival (OS) and safety.

resultsNo differences were observed in the 5-year DFS or OS between FEC → Doc and FEC → Doc/Gem. The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94 (95% CI, 0.74 to 1.19; P = 0.60) for OS. For patients treated with FEC → Doc and FEC → Doc/Gem, the 5-year probabilities of DFS were 86.6% and 87.2%, and the 5-year probabilities of OS were 92.8% and 92.5%, respectively.

conclusionAdding gemcitabine to a standard chemotherapy does not improve the outcomes in patients with high-risk early breast cancer and should therefore not be included in the adjuvant treatment setting.

trial registrationClinicaltrials.gov NCT02181101 and EU Clinical Trials Register EudraCT 2005-000490-21. Registered September 2005.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDeoxycytidineDocetaxelEpirubicinFemaleFluorouracilGemcitabineHumansMiddle AgedPrognosisSurvival RateTreatment OutcomeCyclophosphamideDeoxycytidineDocetaxelEpirubicinFluorouracilGemcitabineChemotherapyEarly breast cancerGemcitabine

Identifiers

PMID33097092
PMCPMC7583247
OpenAlexW3094271383

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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.