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Randomised, open-label, phase II study comparing the efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE)

Sherko Kümmel, Stefan Paepke, Jens Huober, Christian Schem, Michael Untch, Jens Uwe Blohmer, Wolfgang Eiermann, Bernd Gerber, Claus Hanusch, Jörn Hilfrich, Christian Jackisch, Andreas Schneeweiss, Carsten Denkert, Knut Engels, Peter Klare, Peter A Fasching, Gunter Von Minckwitz, Nicole Burchardi & Sibylle Loibl

abstract

BACKGROUND
The GENEVIEVE study compared the pathological complete response (pCR) rate (ypT0/is ypN0/+) in patients with operable human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC) treated with either cabazitaxel or paclitaxel.

METHODS
GENEVIEVE was a prospective, multicentre, randomised, open-label, phase II study comparing the efficacy and the safety of four 3-weekly cycles cabazitaxel versus 12 weeks of paclitaxel given as neoadjuvant treatment. Primary end-point was the pCR rate defined as the complete absence of invasive carcinoma on histological examination of the breast irrespective of lymph node involvement (ypT0/is, ypN0/+) after the taxane treatment. Patients could receive an anthracycline-based therapy thereafter.

RESULTS
Overall, 333 patients were randomised and started treatment with 74.7% and 83.2% of patients completing treatment in the cabazitaxel and paclitaxel arms, respectively. Patients in cabazitaxel arm had a significantly lower pCR rate compared to the paclitaxel arm (1.2% versus 10.8%; p = 0.001). A total of 42 (25.3%) patients in the cabazitaxel arm and 17 (10.2%) in the paclitaxel arm had at least one serious adverse event (p < 0.001). Dose reductions were observed in 9.6% patients in the cabazitaxel arm compared to 11.4% in the paclitaxel arm (p = 0.721). Main reason for dose reductions was non-haematological toxicities in 3.0% versus 7.8% (p = 0.087), respectively.

CONCLUSIONS
The GENEVIEVE study showed no short-term effect of cabazitaxel in triple-negative or luminal B/HER2-negative primary BC, while there seemed to be no differences in drug exposure and patient compliance between the two arms.

CLINICAL TRIALS REGISTRATION
ClinicalTrials.gov NCT01779479.
   
citation Kümmel S, Paepke S, Huober J, Schem C, Untch M, Blohmer J U, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Jackisch C, Schneeweiss A, Denkert C, Engels K, Klare P, Fasching P A, von Minckwitz G, Burchardi N, Loibl S. Randomised, open-label, phase II study comparing the efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE). Eur J Cancer 2017; 84:1-8.
   
type journal paper/review (English)
date of publishing 30-07-2017
journal title Eur J Cancer (84)
ISSN electronic 1879-0852
pages 1-8
PubMed 28768217
DOI 10.1016/j.ejca.2017.06.037