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Results of the GeparOcto trial

01.02.2019

We are delighted to inform you that the results of the GeparOcto phase III study designed to compare a sequential dose-dense, dose-intensified (idd) ETC (epirubicin, paclitaxel, cyclophosphamide) with weekly PM(Cb) (paclitaxel, liposomal doxorubicin, carboplatin) for neoadjuvant treatment of patients with high-risk early breast cancer have been published in the European Journal of Cancer.

In the neoadjuvant GeparOcto trial, patients with high-risk early stage breast cancer were randomized to receive treatment with intensified dose-dense epirubicin (E), paclitaxel (P), and cyclophosphamide (C; iddEPC) or weekly paclitaxel/liposomal doxorubicin (PM) plus carboplatin (Cb). An addition of trastuzumab and pertuzumab was given for the HER2-positive patients. The study primarily aimed to compare pathological complete response (pCR, ypT0/is ypN0) rates between the two treatment arms. Between 12/2014 and 06/2016, 945 patients started treatment (470 in the iddETC arm and 475 in the PM(Cb) arm). The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. The pCR rate with iddEPC was 48.3% and with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC OR=0.99 [95%CI 0.77-1.28]; p=0.979). Non-inferiority of the PM(Cb) treatment could not be shown. The pCR rates between the biological subtypes did not significantly differ. The safety analysis showed that 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. Hence, the use of PM(Cb) regimen appeared to be less feasible for treatment of patients with high-risk early stage breast cancer. iddEPC is one of the effective dose-dense regimens feasible in daily practice.

Schneeweiss A, Möbus V, Tesch H, Hanusch C, Denkert C, Lübbe K, Huober J, Klare P, Kümmel S, Untch M, Kast K, Jackisch C, Thomalla J, Ingold-Heppner B, Blohmer JU, Rezai M, Frank M, Engels K, Rhiem K, Fasching PA, Nekljudova V, von Minckwitz G, Loibl S. 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. Eur J Cancer. 2019;106:181-192.

Link in PubMed



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