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  1. OncologyPRO
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  3. ESMO Congress 2022

Poster session 01

168P - Long-term survival of a randomised, open-label, phase II study comparing the efficacy and safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE)

Date

10 Sep 2022

Session

Poster session 01

Topics

Tumour Site

Breast Cancer

Presenters

Jens Huober

Citation

Annals of Oncology (2022) 33 (suppl_7): S55-S84. 10.1016/annonc/annonc1038

Authors

J. Huober1, W. Janni2, M. Untch3, J. Blohmer4, D. Zahm5, C. Hanusch6, C. Jackisch7, G. Heinrich8, A. Schneeweiss9, C. Denkert10, T. Link11, K.E. Rhiem12, J. Furlanetto13, C. Solbach14, P. Klare15, V. Nekljudova16, N. Filmann16, S. Loibl17

Author affiliations

  • 1 Universitätsklinikum Ulm And Interdisziplinäre Medizinische Dienste, Kantonsspital St.Gallen, Brustzentrum, 9007 - St. Gallen/CH
  • 2 Dpt. Obst&gyn, Universitätsklinikum Ulm, 89070 - Ulm/DE
  • 3 Gynäkologie Und Geburtshilfe, Helios Klinikum Berlin-Buch, 13125 - Berlin/DE
  • 4 Gynäkologie Mit Brustzentrum, Charité – Universitätsmedizin Berlin, 10117 - Berlin/DE
  • 5 Brustzentrum, SRH Wald-Klinikum Gera GmbH, 07548 - Gera/DE
  • 6 Gynäkologie Und Geburtshilfe, Rotkreuzklinikum München, 80634 - Munich/DE
  • 7 Gynäkologie Und Geburtshilfe, Sana Klinikum Offenbach, 63069 - Offenbach am Main/DE
  • 8 Frauenheilkunde Und Geburtshilfe, Schwerpunktpraxis der Gynäkologie und Onkologie, 15517 - Fürstenwalde/Spree/DE
  • 9 Nationales Centrum Für Tumorerkrankungen, Universitätsklinikum und Deutsches Krebsforschungszentrum, Heidelberg, 69115 - Heidelberg/DE
  • 10 Institut Für Pathologie, Philipps Universität Marburg und Universitätsklinikum Marburg (UKGM), 35033 - Marburg/DE
  • 11 Department Of Gynecology And Obstetrics, Technische Universität Dresden, 01307 - Dresden/DE
  • 12 Zentrum Familiärer Brust- Und Eierstockkrebs, Universitätsklinikum Köln, 50937 - Köln/DE
  • 13 Medicine & Research, German Breast Group, 63263 - Neu-Isenburg/DE
  • 14 Senology And Breast Center, University Hospital Frankfurt, 60590 - Frankfurt am Main/DE
  • 15 Frauenheilkunde Und Geburtshilfe, Praxisklinik Berlin, 10367 - Berlin/DE
  • 16 Statistics, German Breast Group, 63263 - Neu-Isenburg/DE
  • 17 Medicine And Research, German Breast Group, 63263 - Neu-Isenburg/DE

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Abstract 168P

Background

The GENEVIEVE study (NCT01779479) compared the pathological complete response (pCR) rate in patients with operable triple-negative (TNBC) or luminal B/human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC) treated with either cabazitaxel or weekly paclitaxel. Primary analyses showed no short-term effect of cabazitaxel in TNBC or luminal B/HER2- primary BC, while there seemed to be no differences in drug exposure and patient compliance between the two arms (Kümmel et al. Eur J Cancer 2017). Here, we report long-term survival data.

Methods

GENEVIEVE randomised patients with cT2-3 any cN or cT1, cN+/pNSLN+ and centrally confirmed TNBC or luminal B/HER2-negative BC to receive either cabazitaxel 25 mg/m2 q3w for 4 cycles or paclitaxel 80 mg/m2 weekly for 12 weeks. All patients had the opportunity to receive anthracycline-containing chemotherapy before (if core biopsy detects invasive tumour residuals after end of study treatment) or after surgery. Primary endpoint was pCR (ypT0/is ypN0/+) rate. Secondary time-to-event endpoints included invasive disease-free survival (iDFS) and overall survival (OS). The time-to-event endpoints analysis is planned with mature follow-up of at least 5 years after a follow-up completeness of at least 70%.

Results

Between April 2013 and June 2015, 333 patients were randomised and started treatment with 74.7% and 83.2% of patients completing treatment in the cabazitaxel and paclitaxel arms, respectively. Baseline characteristics were well balanced. Patients in cabazitaxel arm had a significantly lower pCR rate compared to the paclitaxel arm (1.2% vs 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). Follow-up is still ongoing. The minimum follow-up completeness of 70% will be reached July 2022 with an expected median follow-up of 91 months.

Conclusions

Results on the time-to-event endpoints will be presented at the meeting.

Clinical trial identification

NCT01779479.

Editorial acknowledgement

Legal entity responsible for the study

GBG Forschungs GmbH.

Funding

GBG Forschungs GmbH and Sanofi-Aventis, Germany.

Disclosure

J. Huober: Financial Interests, Personal and Institutional, Research Grant: Lilly, Novartis, BMS (Celgene); Financial Interests, Personal, Other, Travel expenses: Roche, Pfizer; Financial Interests, Personal, Other: Gilead, Daiichi, AstraZeneca, Seagen, MSD, AbbVie; Financial Interests, Institutional, Research Grant: Hexal. W. Janni: Other, Institutional, Research Grant: Sanofi Genzyme. M. Untch: Non-Financial Interests, Personal, Other, All fees to the institution/employer: Amgen GmbH, AstraZeneca, Celgene GmbH, Daiichi Sankyo, Eisai, Lilly Int., MSD Merck, Myriad Genetics, Pfizer GmbH, Roche Pharma AG, Sanofi Aventis Deutschland GmbH, Novartis, Clovis Oncology; Financial Interests, Personal, Other, All fees to the institution/employer: Lilly Deutschland, Pierre Fabre, Seatlle Genetics, Seagen, GSK, Gilead. C. Hanusch: Financial Interests, Personal, Other: Roche, Novartis, AstraZeneca. C. Jackisch: Financial Interests, Personal, Other: Roche, AstraZeneca, Pfizer, Exact Sciences, Lilly, Novartis. A. Schneeweiss: Financial Interests, Personal and Institutional, Research Grant, Travel expenses, Honoraria: Celgene, Roche; Financial Interests, Institutional, Research Grant: AbbVie; Financial Interests, Personal, Other, Honoraria, Travel expenses: Pfizer; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Novartis, MSD, Tesaro, Lilly, Seagen, Gilead, GSK, Bayer, Amgen, Pierre Fabre. C. Denkert: Other, Institutional, Research Grant: Myriad, Roche; Financial Interests, Personal and Institutional, Royalties: VmScope digital pathology software; Financial Interests, Personal and Institutional, Advisory Role, Consulting fees: MSD Oncology, Daiichi Sankyo, Lilly, Merck, AstraZeneca, Molecular Health; Financial Interests, Personal and Institutional, Advisory Role, Consulting fees, Support for attending meetings and/or travel: Roche; Other, Personal and Institutional, Other, Patent for Therapy response: WO2015114146A1, WO2010076322A1; Other, Personal and Institutional, Other, Paten for cancer immunotherapy: WO2020109570A1; Non-Financial Interests, Personal, Ownership Interest, cofounder and shareholder until 2016: Sividon Diagnostics. T. Link: Financial Interests, Personal, Other: Amgen, Roche, Novartis, Lilly, GSK, Tesaro, Myriad, Esai; Non-Financial Interests, Personal, Other: Gilead, Daiichi Sankyo, MSD, Clovis, Pfizer; Non-Financial Interests, Other: Celgene. S. Loibl: Financial Interests, Institutional, Research Grant, honorarium for Ad Boards, paid to institute: AbbVie, Celgene; Financial Interests, Institutional, Other, honorarium for Ad Boards, paid to institute: Amgen, BMS, Eirgenix, GSK, Lilly, Merck; Financial Interests, Institutional, Research Grant, honorarium for Ad Boards & Lectures, paid to institute: AstraZeneca; Non-Financial Interests, Institutional, Research Grant, honorarium for Ad Board, paid to institute / Medical Writing: Gilead; Non-Financial Interests, Institutional, Research Grant, honorarium for Ad Board & Lectures, paid to institute / Medical Writing: Novartis, Pfizer; Financial Interests, Institutional, Other, honorarium for Ad Board & Lecture, paid to institute: Pierre Fabre; Non-Financial Interests, Institutional, Other, honorarium for Ad Boards, paid to institute / Medical Writing: Seagen; Non-Financial Interests, Institutional, Research Grant, honorarium for Ad Board & Lecture, paid to institute / Medical Writing: Daiichi Sankyo; Financial Interests, Institutional, Other, honorarium for Ad Board, paid to institute: Sanofi; Non-Financial Interests, Institutional, Research Grant, honorarium for Ad Boards & Lectures, paid to institute / Medical Writing: Roche; Other, Institutional, Other, Patent for Immunsignature in TNBC, paid to institute: EP14153692.0; Other, Institutional, Other, Patent for Signature for CDK 4/6 Inhibitor, paid to institute: EP21152186.9; Other, Institutional, Other, Patent for Predicting response to an Anti-HER2 containing therapy, paid to institute: EP15702464.7; Other, Institutional, Other, Paten for GeparNuevo, paid to institute: EP19808852.8; Other, Institutional, Royalties, VM Scope GmbH, paid to institute: Digital Ki67 Evaluator. All other authors have declared no conflicts of interest.

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