Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto—GBG 84): A randomised phase III trial

Schneeweiss A, Moebus V, Tesch H, Hanusch C, Denkert C, Luebbe K, Huober J, Klare P, Kuemmel S, Untch M, Kast K, Jackisch C, Thomalla J, Ingold-Heppner B, Blohmer JU, Rezai M, Frank M, Engels K, Rhiem K, Fasching P, Nekljudova V, Von Minckwitz G, Loibl S (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Book Volume: 106

Pages Range: 181-192

DOI: 10.1016/j.ejca.2018.10.015

Abstract

Background: GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet®) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC). Patients and methods: Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m ² ) followed by P (225 mg/m ² ) followed by C (2000 mg/m ² ), each q2w for 3 cycles or weekly P (80 mg/m ² ) plus M (20 mg/m ² ) plus, in TNBC, Cb (area under curve (AUC) 1.5). HER2-positive BC patients additionally received trastuzumab (6 [loading dose 8]mg/kg q3w) and pertuzumab (420 [840]mg q3w) with all P and C cycles. Primary end-point was pathological complete response (pCR, ypT0/is ypN0), secondary end-points included other pCR definitions, pCR in stratified subpopulations, tolerability and compliance. This trial is registered with ClinicalTrials.gov number NCT02125344. Results: 945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77–1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died. Conclusions: In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective dose-dense regimens feasible in daily practice.

Authors with CRIS profile

Involved external institutions

Diakoniekrankenhaus Henriettenstiftung Germany (DE) GBG Forschungs GmbH (German Breast Group) Germany (DE) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Luisenkrankenhaus Düsseldorf Germany (DE) HELIOS Kliniken Germany (DE) Charité - Universitätsmedizin Berlin Germany (DE) Deutsches Krebsforschungszentrum (DKFZ) Germany (DE) Universitätsklinikum Ulm Germany (DE) Rotkreuzklinikum München Germany (DE) Universitätsklinikum Köln Germany (DE) Kliniken Essen-Mitte Germany (DE) Sana Klinikum Offenbach Germany (DE) Ortenau Klinikum Germany (DE) Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss Germany (DE) Klinikum Frankfurt Höchst Germany (DE) Centrum für Hämatologie und Onkologie Bethanien Germany (DE) Praxis für Hämatologie und Onkologie Koblenz Germany (DE)

How to cite

APA:

Schneeweiss, A., Moebus, V., Tesch, H., Hanusch, C., Denkert, C., Luebbe, K.,... Loibl, S. (2019). Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto—GBG 84): A randomised phase III trial. European Journal of Cancer, 106, 181-192. https://dx.doi.org/10.1016/j.ejca.2018.10.015

MLA:

Schneeweiss, Andreas, et al. "Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto—GBG 84): A randomised phase III trial." European Journal of Cancer 106 (2019): 181-192.

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