Bannerbild German Brest Group

May 2019: Long-term outcomes of the GeparSepto study


The long-term follow-up data of the phase III GeparSepto (GBG 69) study that aimed to compare weekly nab-paclitaxel with weekly sb-paclitaxel followed by epirubicin plus cyclophosphamide (EC) as neoadjuvant treatment in patients with primary breast cancer has been published in the Journal of Clinical Oncology.

Between July 30, 2012 and December 23, 2013 a total of 1,373 patients within 69 German sites were screened for eligibility of whom 1,229 were randomised. Of the 1,206 patients who started treatment 73.3% (444/606) randomised in the nab-paclitaxel arm and 79.5% (477/600) in the sb-paclitaxel arm completed the taxane and EC therapy. The pCR Pathological complete response (pCR=ypT0 ypN0) was significantly higher after nab-paclitaxel compared to sb-paclitaxel (38.4% vs 29.0%; OR=1.53 [95%CI 1.20-1.95]; unadjusted p<0.001) (Untch M. et al. Lancet Oncol 2016). After a median follow-up of 49.6 months (range 0.5-64.0 months), 243 invasive disease-free survival (iDFS) events were reported. The 4-year iDFS was significantly better in patients treated with nab-paclitaxel compared to sb-paclitaxel (84.0% vs 76.3%; HR=0.66 [95%CI 95%CI 0.51-0.86]; p=0.002), whereas overall survival did not significantly differ between the two treatment arms (89.7% vs 87.2%, respectively; HR=0.82 [95%CI 0.59-1.16]; p=0.260). These data demonstrated that the higher pCR rate translated into an improved iDFS after nab-paclitaxel compared to sb-paclitaxel treatment. Furthermore, 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/m2 compared with nab-paclitaxel 150 mg/m2. Hence, the long-term results support the use of nab-paclitaxel 125 mg/m2 instead of sb-paclitaxel in patients with early BC.

Untch M, Jackisch C, Schneeweiss A, Schmatloch S, Aktas B, Denkert C, Schem C, Wiebringhaus H, Kümmel S, Warm M, Fasching PA, Just M, Hanusch C, Hackmann J, Blohmer JU, Rhiem K, Schmitt WD, Furlanetto J, Gerber B, Huober J, Nekljudova V, von Minckwitz G, Loibl S. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto. J Clin Oncol. 2019 May 13. [Epub ahead of print]


  • 02.05.2019 GBG Research at ESMO Breast Cancer 2019

    Data of several GBG research projects will be presented at the ESMO Breast Cancer 2019, which takes place from 2 to 4 May in Berlin, Germany.

    Mehr ...
  • 10.04.2019 Results from E-VITA trial conducted with HER2-positive metastatic breast cancer patients

    We are pleased to inform you that the results of the E-VITA study that evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER2-positive metastatic breast cancer has been published in the Anticancer Drugs.

    Mehr ...
  • 01.03.2019 Evaluation of sCAIX as predictive marker for efficacy of neoadjuvant bevacizumab

    A translational research study performed with samples obtained from a cohort of patients with HER2-negative breast cancer enrolled in the neoadjuvant GeparQuinto (GBG 44) trial has been published in the International Journey of Cancer.

    Mehr ...
  • 01.02.2019 Results of the GeparOcto trial

    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.

    Mehr ...

GBG Forschungs GmbH
Martin-Behaim-Str. 12 | 63263 Neu-Isenburg | Fax +49 6102 7480-440

+49 6102 7480-0 | nfGBGd