Efficacy and safety of nab-paclitaxel 125 mg/m2and nab-paclitaxel 150 mg/m2compared to paclitaxel in early high-risk breast cancer. Results from the neoadjuvant randomized GeparSepto study (GBG 69).
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.



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/m2and cyclophosphamide 600 mg/m2on day 1 for four 3-week cycles.



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/m2for 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).



Nab-paclitaxel 125 mg/m2was associated with a better safety profile and compliance without compromising the efficacy compared to nab-paclitaxel 150 mg/m2.
German Breast Group, GBG Forschungs GmbH, Martin Behaim Strasse 12, 63263, Neu-Isenburg, Germany. Jenny.Furlanetto@GBG.de.
Jenny
J
Furlanetto
Sana Klinikum Offenbach, Offenbach, Germany.
Christian
C
Jackisch
Helios Klinikum Berlin-Buch, Berlin, Germany.
Michael
M
Untch
National Center for Tumor Disease, University Hospital Heidelberg, Heidelberg, Germany.
Andreas
A
Schneeweiss
Elisabeth Krankenhaus Kassel, Kassel, Germany.
Sabine
S
Schmatloch
University Women's Hospital Essen, Essen, Germany.
Bahriye
B
Aktas
Institute of Pathology and German Cancer Consortium (DKTK), Charité-University Hospital, Berlin, Germany.
Carsten
C
Denkert
St. Barbara Klinik Heessen, Hamm, Germany.
Hermann
H
Wiebringhaus
Interdisziplinäres Brustzentrum an den Kliniken Essen-Mitte, Essen, Germany.
Sherko
S
Kümmel
Brustzentrum in Krankenhaus Köln-Holweide, Cologne, Germany.
Mathias
M
Warm
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde, Munich, Germany.
Stefan
S
Paepke
Onkologische Schwerpunktpraxis, Bielefeld, Germany.
Marianne
M
Just
Klinikum zum Roten Kreuz München, Munich, Germany.
Claus
C
Hanusch
Marien Hospital Witten, Witten, Germany.
John
J
Hackmann
Frauenklinik an der Charité-University Hospital, Berlin, Germany.
Jens Uwe
JU
Blohmer
Klinik Mutterhaus der Borromäerinnen, Trier, Germany.
Michael
M
Clemens
Universitäts-Frauenklinik, Magdeburg, Germany.
Serban Dan
SD
Costa
Universitäts-Frauenklinik, Rostock, Germany.
Bernd
B
Gerber
German Breast Group, GBG Forschungs GmbH, Martin Behaim Strasse 12, 63263, Neu-Isenburg, Germany.
Valentina
V
Nekljudova
German Breast Group, GBG Forschungs GmbH, Martin Behaim Strasse 12, 63263, Neu-Isenburg, Germany.
Sibylle
S
Loibl
German Breast Group, GBG Forschungs GmbH, Martin Behaim Strasse 12, 63263, Neu-Isenburg, Germany.
Gunter
G
von Minckwitz
D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects
C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel
Early breast cancer; Nab-paclitaxel 125 mg/m2; Nab-paclitaxel 150 mg/m2; Neoadjuvant treatment