Long-term outcomes of a randomized, open-label, phase II study comparing cabazitaxel versus paclitaxel as neoadjuvant treatment in patients with triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE)
ESMO Open, vol. 9, pp. 103009
Abstract
BACKGROUND: The GENEVIEVE study, comparing neoadjuvant cabazitaxel versus paclitaxel in triple-negative breast cancer (TNBC) and luminal B/human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC), previously reported significant differences in pathological complete response (pCR) rates. Effects on long-term outcome are unknown. PATIENTS AND METHODS: weekly for 12 weeks. Anthracycline-containing chemotherapy was allowed in case of histologically proven invasive residuals as neoadjuvant treatment or after surgery as adjuvant treatment. Here we report the secondary endpoints invasive disease-free survival (iDFS), distant disease-free survival (DDFS), and overall survival (OS). RESULTS: Of the 333 patients randomized, 74.7% and 83.2% completed treatment in the cabazitaxel and paclitaxel arms, respectively. After a median follow-up of 89.3 months (interquartile range 68.8-97.3 months), 80 iDFS events (43 after cabazitaxel and 37 after paclitaxel) and 47 deaths (23 after cabazitaxel and 24 after paclitaxel) were reported. IDFS rates were not significantly different between the cabazitaxel and paclitaxel arms after a 3-year (83.6% versus 85.0%) and 5-year follow-up (76.2% versus 78.3%) [hazard ratio (HR) = 1.27, 95% confidence interval 0.82-1.96, P = 0.294], respectively. DDFS rates at 3 years (88.6% versus 87.8%) and 5 years (82.1% versus 82.8%) for cabazitaxel and paclitaxel were comparable (HR = 1.15, P = 0.573). Similarly, OS rates at 3 years (91.6% versus 91.8%) and 5 years (89.2% versus 86.8%) showed no significant differences (HR = 1.05, P = 0.872). Subgroup analysis for TNBC and luminal B/HER2-negative BCs indicated no significant variations in 3- or 5-year iDFS, DDFS, or OS. CONCLUSIONS: The significant differences in pCR rates observed in both treatment arms did not significantly impact long-term outcomes for patients treated with cabazitaxel versus paclitaxel in the GENEVIEVE trial.
Authors 24
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Affiliation as printed
Klinik für Gynäkologie und Geburtsmedizin, Uniklinik Aachen, Aachen, Germany
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Kantonsspital St. Gallen · University Hospital Ulm
Affiliation as printed
Department of Interdisciplinary Medical Services, University Hospital Ulm & Cantonal Hospital St. Gallen, Breast Center, St. Gallen, Switzerland
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Helios Kliniken · Helios Hospital Berlin-Buch
Affiliation as printed
Helios Kliniken Berlin-Buch, Berlin
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Charité - Universitätsmedizin Berlin
Affiliation as printed
Gynäkologie mit Brustzentrum, Charité-Universitätsmedizin Berlin, Berlin
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Affiliation as printed
Uniklinik Ulm, Ulm
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Philipps University of Marburg · Universitätsklinikum Gießen und Marburg
Affiliation as printed
Institut für Pathologie, Philipps-University Marburg and University Hospital Marburg (UKGM)-Universitätsklinikum Marburg, Marburg
Institut für Pathologie, Philipps-University Marburg and University Hospital Marburg (UKGM)—Universitätsklinikum Marburg, Marburg
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Affiliation as printed
MediOnko-Institut GbR Berlin, Berlin
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden
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Affiliation as printed
Zentrum Familiärer Brust- und Eierstockkrebs, Universitätsklinikum Köln, Köln
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Affiliation as printed
Universitätsklinikum Erlangen, Erlangen
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Kliniken Essen-Mitte · Charité - Universitätsmedizin Berlin
Affiliation as printed
Department of Gynecology with Breast Center, Evang. Kliniken Essen-Mitte, Charité - Universitätsmedizin Berlin, Berlin
Department of Gynecology with Breast Center, Evang. Kliniken Essen-Mitte, Charité – Universitätsmedizin Berlin, Berlin
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Witten/Herdecke University · Helios Universitätsklinikum Wuppertal
Affiliation as printed
Breast Unit, University Hospital Helios, University Witten Herdecke, Wuppertal
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Affiliation as printed
SRH Waldklinikum Gera GmbH, Gera
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Affiliation as printed
Rotkreuzklinikum München, München
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Goethe University Frankfurt · University Hospital Frankfurt
Affiliation as printed
Department of Gynecology and Obstetrics, Goethe University Frankfurt, University Hospital, Frankfurt
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Affiliation as printed
Schwerpunktpraxis der Gynäkologie und Onkologie Fürstenwalde, Klinikum Offenbach
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Universitätsklinikum Tübingen · Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe
Affiliation as printed
AGO Study Group and Department of Women's Health, University Hospital Tübingen, Tübingen
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German Cancer Research Center · National Center for Tumor Diseases
Affiliation as printed
Nationales Centrum für Tumorerkrankungen, Universitätsklinikum und Deutsches Krebsforschungszentrum, Heidelberg
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Affiliation as printed
Universitätsklinik Erlangen, Erlangen
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Affiliation as printed
German Breast Group, Neu-Isenburg, Germany
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Affiliation as printed
German Breast Group, Neu-Isenburg, Germany
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Affiliation as printed
German Breast Group, Neu-Isenburg, Germany
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Affiliation as printed
Klinik für Gynäkologie und Geburtsmedizin, Uniklinik Aachen, Aachen, Germany
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S. Loibl corresponding
Affiliation as printed
German Breast Group, Neu-Isenburg, Germany. Electronic address: sibylle.loibl@gbg.de
German Breast Group, Neu-Isenburg, Germany
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