Universität zu Köln

Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter and Loibl, Sibylle (2019). NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto. J. Clin. Oncol., 37 (25). S. 2226 - 2244. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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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(2) (after study amendment, 125 mg/m(2)) or weekly sb-paclitaxel 80 mg/m(2) followed in both arms by four times epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) 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/m(2) compared with NAB-paclitaxel 150 mg/m(2). 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(2) compared with NAB-paclitaxel 150 mg/m(2). (C) 2019 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Untch, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Jackisch, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneeweiss, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmatloch, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Aktas, Bahriye UNSPECIFIED UNSPECIFIED UNSPECIFIED Denkert, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Schem, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiebringhaus, Hermann UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmel, Sherko UNSPECIFIED UNSPECIFIED UNSPECIFIED Warm, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Fasching, Peter A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Just, Marianne UNSPECIFIED UNSPECIFIED UNSPECIFIED Hanusch, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED Hackmann, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Blohmer, Jens-Uwe UNSPECIFIED UNSPECIFIED UNSPECIFIED Rhiem, Kerstin UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmitt, Wolfgang D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Furlanetto, Jenny UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerber, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Huober, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Nekljudova, Valentina UNSPECIFIED UNSPECIFIED UNSPECIFIED von Minckwitz, Gunter UNSPECIFIED UNSPECIFIED UNSPECIFIED Loibl, Sibylle UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-142963
DOI:	10.1200/JCO.18.01842
Journal or Publication Title:	J. Clin. Oncol.
Volume:	37
Number:	25
Page Range:	S. 2226 - 2244
Date:	2019
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PATHOLOGICAL COMPLETE RESPONSE; ALBUMIN-BOUND PACLITAXEL; NEOADJUVANT CHEMOTHERAPY; TRIAL; TRASTUZUMAB; WOMEN; GEPARSIXTO; GEPARSEPTO; ADJUVANT; REGIMENS Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14296