Sherko Kümmel1, Stefan Paepke2, Jens Huober3, Christian Schem4, Michael Untch5, Jens Uwe Blohmer6, Wolfgang Eiermann7, Bernd Gerber8, Claus Hanusch9, Jörn Hilfrich10, Christian Jackisch11, Andreas Schneeweiss12, Carsten Denkert7, Knut Engels13, Peter Klare14, Peter A Fasching15, Gunter von Minckwitz16, Nicole Burchardi16, Sibylle Loibl16. 1. Breast Unit, Kliniken Essen-Mitte, Germany. Electronic address: s.kuemmel@kliniken-essen-mitte.de. 2. TU München, Germany. 3. Frauenklinik Ulm, Germany. 4. Universitätsklinikum Schleswig-Holstein, Kiel, Germany. 5. HELIOS Klinikum Berlin-Buch, Berlin, Germany. 6. Charité, Universitätsmedizin Berlin, Germany. 7. Interdisziplinäres Onkologisches Zentrum München, Germany. 8. Klinikum Südstadt Rostock, Germany. 9. Rotkreuzklinikum München, Germany. 10. Eilenriede Klinik Hannover, Germany. 11. Sana Klinikum Offenbach GmbH, Germany. 12. Universitätsklinikum Heidelberg, Germany. 13. Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss, Germany. 14. Praxisklinik Berlin, Germany. 15. Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. 16. German Breast Group, Neu-Isenburg, Germany.
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.
RCT Entities:
BACKGROUND: The GENEVIEVE study compared the pathological complete response (pCR) rate (ypT0/is ypN0/+) in patients with operable humanepidermal 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.
Authors: Jana de Boniface; Renske Altena; Cecilia Haddad Ringborg; Kate A Bolam; Yvonne Wengström Journal: PLoS One Date: 2022-10-13 Impact factor: 3.752