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Breast Cancer Research and Treatment

, Volume 163, Issue 3, pp 495–506 | Cite as

Efficacy and safety of nab-paclitaxel 125 mg/m2 and nab-paclitaxel 150 mg/m2 compared to paclitaxel in early high-risk breast cancer. Results from the neoadjuvant randomized GeparSepto study (GBG 69)

  • Jenny FurlanettoEmail author
  • Christian Jackisch
  • Michael Untch
  • Andreas Schneeweiss
  • Sabine Schmatloch
  • Bahriye Aktas
  • Carsten Denkert
  • Hermann Wiebringhaus
  • Sherko Kümmel
  • Mathias Warm
  • Stefan Paepke
  • Marianne Just
  • Claus Hanusch
  • John Hackmann
  • Jens Uwe Blohmer
  • Michael Clemens
  • Serban Dan Costa
  • Bernd Gerber
  • Valentina Nekljudova
  • Sibylle Loibl
  • Gunter von Minckwitz
Clinical trial

Abstract

Purpose

The GeparSepto study demonstrated that the use of nab-paclitaxel instead of paclitaxel prior to anthracycline-based chemotherapy could lead to a significantly increased pCR rate, especially in the triple negative subpopulation. We report efficacy and safety for patients treated with two different doses of nab-paclitaxel in comparison to weekly solvent-formulated paclitaxel.

Methods

Patients were treated for 12 weeks with either intravenous nab-paclitaxel 150 mg/m2 (nP150) weekly, after study amendment 125 mg/m2 (nP125) weekly or solvent-based paclitaxel 80 mg/m2 (P80) weekly followed by epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 on day 1 for four 3-week cycles.

Results

229 patients received nP150, 377 nP125. Baseline characteristics were fairly balanced between these two sequential cohorts as well as compared to 601 patients receiving P80 except for hormone receptor status, HER2 status, and Ki67. Taxane treatment was discontinued in 26.8% (nP150), 16.6% (nP125), and 13.3% of (P80) patients, respectively. Median relative total dose intensity (mRTDI) based on 125 mg/m2 for nP was 103% with nP150, 95% with nP125, 99% with P80 before and 98% with P80 after the amendment. PSN grade 3–4 was observed in 14.5% of patients with nP150, 8.1% of patients with nP125 (p = 0.018), and 2.7% of patients with P80. Overall pCR before the amendment was 33.6% after nP150 and 23.5% after P80 (OR 1.65 [95% CI 1.10–2.50]; p = 0.022); pCR after the amendment was 41.4% after nP125, and 32.4% after P80 (1.48 [95% CI 1.10–1.99]; p = 0.013).

Conclusions

Nab-paclitaxel 125 mg/m2 was associated with a better safety profile and compliance without compromising the efficacy compared to nab-paclitaxel 150 mg/m2.

Keywords

Early breast cancer Neoadjuvant treatment Nab-paclitaxel 125 mg/m2 Nab-paclitaxel 150 mg/m2 

Notes

Acknowledgements

We would like to thank all investigators and patients that participated in the GeparSepto study.

Funding

The trial was sponsored by GBG Forschungs GmbH with financial support from Celgene and Roche.

Compliance with ethical standards

Conflict of interest

Denkert C: Shareholder and cofounder of Sividon Diasgnostics Cologne, Hanusch C: Honoraria by Celgene and Roche, Jakisch C: Honoraria by Celgene, Loibl S: Institution received research grants by Celgene and Roche, von Minckwitz G: Institution received research grants by Celgene and Roche. All other authors have declared no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the GeparSepto study.

Supplementary material

10549_2017_4200_MOESM1_ESM.pdf (37 kb)
Supplementary material 1 (PDF 36 kb)
10549_2017_4200_MOESM2_ESM.pdf (9 kb)
Supplementary material 2 (PDF 9 kb)

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Copyright information

© Springer Science+Business Media New York 2017

Authors and Affiliations

  • Jenny Furlanetto
    • 1
    Email author
  • Christian Jackisch
    • 2
  • Michael Untch
    • 3
  • Andreas Schneeweiss
    • 4
  • Sabine Schmatloch
    • 5
  • Bahriye Aktas
    • 6
  • Carsten Denkert
    • 7
  • Hermann Wiebringhaus
    • 8
  • Sherko Kümmel
    • 9
  • Mathias Warm
    • 10
  • Stefan Paepke
    • 11
  • Marianne Just
    • 12
  • Claus Hanusch
    • 13
  • John Hackmann
    • 14
  • Jens Uwe Blohmer
    • 15
  • Michael Clemens
    • 16
  • Serban Dan Costa
    • 17
  • Bernd Gerber
    • 18
  • Valentina Nekljudova
    • 1
  • Sibylle Loibl
    • 1
  • Gunter von Minckwitz
    • 1
  1. 1.German Breast Group, GBG Forschungs GmbHNeu-IsenburgGermany
  2. 2.Sana Klinikum OffenbachOffenbachGermany
  3. 3.Helios Klinikum Berlin-BuchBerlinGermany
  4. 4.National Center for Tumor DiseaseUniversity Hospital HeidelbergHeidelbergGermany
  5. 5.Elisabeth Krankenhaus KasselKasselGermany
  6. 6.University Women’s Hospital EssenEssenGermany
  7. 7.Institute of Pathology and German Cancer Consortium (DKTK)Charité-University HospitalBerlinGermany
  8. 8.St. Barbara Klinik HeessenHammGermany
  9. 9.Interdisziplinäres Brustzentrum an den Kliniken Essen-MitteEssenGermany
  10. 10.Brustzentrum in Krankenhaus Köln-HolweideCologneGermany
  11. 11.Klinikum rechts der Isar der TU München, Klinik und Poliklinik für FrauenheilkundeMunichGermany
  12. 12.Onkologische SchwerpunktpraxisBielefeldGermany
  13. 13.Klinikum zum Roten Kreuz MünchenMunichGermany
  14. 14.Marien Hospital WittenWittenGermany
  15. 15.Frauenklinik an der Charité-University HospitalBerlinGermany
  16. 16.Klinik Mutterhaus der BorromäerinnenTrierGermany
  17. 17.Universitäts-FrauenklinikMagdeburgGermany
  18. 18.Universitäts-FrauenklinikRostockGermany

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