Universität zu Köln

Schneeweiss, Andreas, Michel, Laura L., Moebus, Volker, Tesch, Hans, Klare, Peter, Hahnen, Eric, Denkert, Carsten, Kast, Karin, Pohl-Rescigno, Esther, Hanusch, Claus, Link, Theresa, Untch, Michael, Jackisch, Christian, Blohmer, Jens-Uwe ORCID: 0000-0002-7969-250X, Fasching, Peter A., Solbach, Christine, Schmutzler, Rita K., Huober, Jens, Rhiem, Kerstin, Nekljudova, Valentina, Luebbe, Kristina and Loibl, Sibylle (2022). Survival analysis of the randomised phase III GeparOcto trial comparing neoadjuvant chemotherapy of intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for patients with high-risk early breast cancer. Eur. J. Cancer, 160. S. 100 - 112. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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Abstract

Background: GeparOcto demonstrated that pathological complete response (pCR) of intense dose-dense epirubicin, paclitaxel and cyclophosphamide (iddEPC) was comparable to weekly paclitaxel/non-pegylated liposomal doxorubicin (plus carboplatin (PM(Cb) in triple negative breast cancer [TNBC]) in high-risk early breast cancer (BC). Here, we report time-to event secondary end-points. Patients and methods: Patients were randomised to receive 18 weeks of E (150 mg/m(2)) followed by P (225 mg/m(2)) followed by C (2000 mg/m2), each q2w or weekly P (80 mg/m(2)) plus M (20 mg/m2) plus, in TNBC, Cb (AUC 1.5). Patients with human epidermal growth factor receptor 2-positive (HER2+)BC received trastuzumab (6[loading dose 8]mg/kg q3w) and pertuzumab (420[840]mg q3w) with P and C cycles. Results: 945 patients started treatment (iddEPC n = 470; PM(Cb) n = 475). After a median follow-up of 47.0 (range 1.6-61.5) months, 162 (75 in iddEPC; 87 in PM(Cb)) invasive disease-free survival (iDFS) events and 79 (41 in iddEPC; 38 in PM(Cb)) deaths were reported. No significant difference was observed in 4-year iDFS (81.9% iddEPC versus 79.7% PM(Cb), HR = 1.16 [95%CI 0.85-1.59], log-rank p = 0.334) or 4-year overall survival (OS) (90.3% iddEPC versus 90.6% PM(Cb), HR = 0.90 [95%CI 0.58-1.40], log-rank p = 0.637) overall and in HER2+ and TNBC subgroups. HR+/HER2BC patients, however, had significantly better 4-year iDFS (77.9% iddEPC versus 62.5% PM, HR = 2.11 [95%CI 1.08-4.10], log-rank p = 0.025) and 4-year OS with iddEPC (94.7% iddEPC versus 80.1% PM, HR = 3.26 [95%CI 1.06-10.00], log-rank p = 0.029). Conclusion: While there was no difference in survival for the entire cohort, the HR+/HER2subgroup significantly benefits from iddEPC. This supports the concept of an additional effect of NACT beyond pCR in patients with HR+/HER2 - BC. (C) 2021 Elsevier Ltd. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schneeweiss, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Michel, Laura L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moebus, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Tesch, Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED Klare, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Hahnen, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Denkert, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Kast, Karin UNSPECIFIED UNSPECIFIED UNSPECIFIED Pohl-Rescigno, Esther UNSPECIFIED UNSPECIFIED UNSPECIFIED Hanusch, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED Link, Theresa UNSPECIFIED UNSPECIFIED UNSPECIFIED Untch, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Jackisch, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Blohmer, Jens-Uwe UNSPECIFIED orcid.org/0000-0002-7969-250X UNSPECIFIED Fasching, Peter A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Solbach, Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmutzler, Rita K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Huober, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Rhiem, Kerstin UNSPECIFIED UNSPECIFIED UNSPECIFIED Nekljudova, Valentina UNSPECIFIED UNSPECIFIED UNSPECIFIED Luebbe, Kristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Loibl, Sibylle UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-695084
DOI:	10.1016/j.ejca.2021.10.011
Journal or Publication Title:	Eur. J. Cancer
Volume:	160
Page Range:	S. 100 - 112
Date:	2022
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1879-0852
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PATHOLOGICAL COMPLETE RESPONSE; TRASTUZUMAB; BEVACIZUMAB; COMBINATION; GEPARSIXTO Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69508