NAB-paclitaxel improves disease-free survival in early breast cancer: GBG 69-GeparSepto
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 p...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
May 13, 2019
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| In: |
Journal of clinical oncology
Year: 2019, Volume: 37, Issue: 25, Pages: 2226-2234 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.18.01842 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1200/JCO.18.01842 Verlag: https://ascopubs.org/doi/10.1200/JCO.18.01842 
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| Author Notes: | 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, and Sibylle Loibl |
| Summary: | 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. |
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| Item Description: | Gesehen am 10.10.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.18.01842 |