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
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,...
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2019
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| In: |
European journal of cancer
Year: 2018, Volume: 106, Pages: 181-192 |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2018.10.015 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1016/j.ejca.2018.10.015 Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S0959804918314564 
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| Author Notes: | Andreas Schneeweiss, Volker Möbus, Hans Tesch, Claus Hanusch, Carsten Denkert, Kristina Lübbe, Jens Huober, Peter Klare, Sherko Kümmel, Michael Untch, Karin Kast, Christian Jackisch, Jörg Thomalla, Barbara Ingold-Heppner, Jens-Uwe Blohmer, Mahdi Rezai, Matthias Frank, Knut Engels, Kerstin Rhiem, Peter Andreas Fasching, Valentina Nekljudova, Gunter von Minckwitz, Sibylle Loibl |
| Summary: | 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/m2) followed by P (225 mg/m2) followed by C (2000 mg/m2), each q2w for 3 cycles or weekly P (80 mg/m2) plus M (20 mg/m2) 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. |
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| Item Description: | Available online 5 December 2018 Gesehen am 24.07.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2018.10.015 |