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J Clin Oncol. 2019 May 13:JCO1801842. doi: 10.1200/JCO.18.01842. [Epub ahead of print]

NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto.

Author information

1
1 Helios Klinikum Berlin-Buch, Berlin, Germany.
2
2 Sana Klinikum, Offenbach, Germany.
3
3 Nationales Centrum für Tumorerkrankungen, Heidelberg, Germany.
4
4 St Elisabeth Krankenhaus Kassel, Kassel, Germany.
5
5 Klinik und Poliklinik für Frauenheilkunde Leipzig, Leipzig, Germany.
6
6 Charité-Universitätsmedizin Berlin, Berlin, Germany.
7
7 Universitätsklinikum Kiel, Kiel, Germany.
8
8 St Barbara-Klinik Hamm-Heessen, Hamm, Germany.
9
9 Interdisziplinäres Brustzentrum an den Kliniken Essen-Mitte, Essen, Germany.
10
10 Brustzentrum im Krankenhaus Köln-Holweide, Cologne, Germany.
11
11 Universitätsklinikum Erlangen, Erlangen, Germany.
12
12 Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, Germany.
13
13 Klinikum zum Roten Kreuz, Munich, Germany.
14
14 Marien Hospital Witten, Witten, Germany.
15
15 Klinik für Gynäkologie am Campus Charité Mitte, Berlin, Germany.
16
16 Uniklinik Köln, Cologne, Germany.
17
17 German Breast Group, Neu-Isenburg, Germany.
18
18 Universitäts-Frauenklinik, Rostock, Germany.
19
19 Universitätsklinikum Ulm, Ulm, Germany.

Abstract

PURPOSE:

The GeparSepto trial demonstrated that weekly nanoparticle albumin-bound (NAB)-paclitaxel significantly improves the pathologic complete remission rate compared with weekly solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide as neoadjuvant treatment in patients with primary breast cancer (BC). Here, we report data on long-term outcomes.

METHODS:

Patients with histologically confirmed primary BC were randomly assigned in a 1:1 ratio to 12 times weekly NAB-paclitaxel 150 mg/m2 (after study amendment, 125 mg/m2) or weekly sb-paclitaxel 80 mg/m2 followed in both arms by four times epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks. Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received dual antibody treatment with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) concurrently to chemotherapy and continued for 1 year.

RESULTS:

A total of 1,206 patients started treatment, 606 with NAB-paclitaxel and 600 with sb-paclitaxel. After a median follow-up of 49.6 months (range, 0.5 to 64.0 months), 243 invasive disease-free survival (iDFS) events were reported (143 in the sb-paclitaxel and 100 in the NAB-paclitaxel arm). At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m2 compared with NAB-paclitaxel 150 mg/m2.

CONCLUSION:

The significantly higher pathologic complete response rate with NAB-paclitaxel translated into a significantly improved iDFS in patients with early BC as compared with sb-paclitaxel. PSN improved much faster under NAB-paclitaxel 125 mg/m2 compared with NAB-paclitaxel 150 mg/m2.

PMID:
31082269
DOI:
10.1200/JCO.18.01842

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