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) 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 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.

Patients with HER2-negative/hormone receptor-positive breast cancer derived the same relative improvement in iDFS as the whole cohort and the triple-negative breast cancer (TNBC).

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; 37:2226-2234


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