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

Michael Untch, Christian Jackisch, Andreas Schneeweiss, Sabine Schmatloch, Bahriye Aktas, Carsten Denkert, Christian Schem, Hermann Wiebringhaus, Sherko Kümmel, Mathias Warm, Peter A Fasching, Marianne Just, Claus Hanusch, John Hackmann, Jens-Uwe Blohmer, Kerstin Rhiem, Wolfgang D Schmitt, Jenny Furlanetto, Bernd Gerber, Jens Huober, Valentina Nekljudova, Gunter Von Minckwitz & Sibylle Loibl

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/m (after study amendment, 125 mg/m) or weekly sb-paclitaxel 80 mg/m followed in both arms by four times epirubicin 90 mg/m plus cyclophosphamide 600 mg/m 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% 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; = .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/m compared with NAB-paclitaxel 150 mg/m.

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/m compared with NAB-paclitaxel 150 mg/m.
   
citation Untch M, Jackisch C, Schneeweiss A, Schmatloch S, Aktas B, Denkert C, Schem C, Wiebringhaus H, Kümmel S, Warm M, Fasching P A, Just M, Hanusch C, Hackmann J, Blohmer J U, Rhiem K, Schmitt W D, Furlanetto J, Gerber B, Huober J, Nekljudova V, von Minckwitz G, Loibl S. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto. J Clin Oncol 2019; 37:2226-2234.
   
type journal paper/review (English)
date of publishing 13-05-2019
journal title J Clin Oncol (37/25)
ISSN electronic 1527-7755
pages 2226-2234
PubMed 31082269
DOI 10.1200/JCO.18.01842