Marianne Just (Bielefeld, Germany)

Schwerpunktpraxis Bielefeld

Author Of 1 Presentation

 Conference Calendar
Poster Display session (ID 9)

94P - Patient quality of life (QoL) from the GeparX trial on the addition of denosumab (Dmab) added to two different nab-paclitaxel (nP) regimens as neoadjuvant chemotherapy (NACT) in primary breast cancer (BC) (ID 106)

Presentation Number
94P
Lecture Time
12:15 - 12:15
Speakers
Authors
Session Name
Poster Display session (ID 9)
Room
Exhibition area
Date
Wed, 04.05.2022
Time
12:15 - 13:00

Abstract

Background

GeparX (NCT02682693) investigated efficacy and safety of adding Dmab to standard NACT and two different nP schedules for primary BC. Addition of Dmab to NACT did not improve pCR rates. nP weekly (q1w) significantly increased pCR rate compared to d1,8 q3w schedule, but was associated with higher toxicity (Blohmer et al. Cancer Res 2020). Here we present QoL.

Methods

Patients (pts) were randomized to receive or not receive Dmab 120mg s.c. q4w for 6 cycles and to either nP 125mg/m2 q1w or d1,8 q3w for 4 cycles, followed by 4x epirubicin/cyclophosphamide (q2w/q3w). QoL was assessed at baseline (BL), after nP, at end of treatment and 90 days (d) post-surgery (PS) using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) questionnaire, FACT-Taxane Trial Outcome Index (TOI), FACT-G total score, and FACT-Taxane total score scales. Higher mean scores indicate better functioning and QoL. Mixed models including BL value as a random effect and treatment, time, and treatment by time interaction as fixed effects were used to compare the QoL scores based on the safety set. Primary endpoint was the mean score change from BL to 90d PS.

Results

Between 02/2017 and 03/2019, 780 pts were randomized and started treatment, of whom 768 were eligible for QoL analyses. BL parameters were well balanced. Questionnaire completion response remained >70% throughout the trial. Addition of Dmab did not change the QoL scores at any time point. Pts receiving nP q1w reported significantly lower mean scores of physical/functional well-being and FACT-G total score (p<0.001) compared to pts receiving nP d1,8 q3w. The decreased well-being with nP q1w partly persists 90d PS. The mean scores of additional concerns, FACT-Taxane TOI and FACT-Taxane total scores significantly differed favouring nP d1,8 q3w in all post-BL assessments (p<0.001). Social/family and emotional aspects were not affected by the regime.

Conclusions

nP q1w led to a significantly higher pCR rate but is associated with decreased QoL compared to nP d1,8 q3w, which is consistent with the higher toxicity reported for nP q1w. Benefit and risks need to be discussed with the pts.

Clinical trial identification

NCT02682693.

Legal entity responsible for the study

German Breast Group.

Funding

GeparX was financially supported by Amgen and BMS (Celgene).

Disclosure

M. Reinisch: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Somatex; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: MSD. J. Blohmer: Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Honoraria: Amgen; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Honoraria: Novartis; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Travel, Accommodations, Expenses, Honoraria: Pfizer; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role, Travel, Accommodations, Expenses, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: MSD Oncology; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: Gilead Sciences; Financial Interests, Personal, Other, Honoraria: Eisai Germany; Financial Interests, Personal, Other, Honoraria: Seattle Genetics; Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo/AstraZeneca; Financial Interests, Personal, Other, Honoraria: Exact Sciences; Financial Interests, Personal, Other, Honoraria: Molecular Health. T. Link: Financial Interests, Personal, Other, Personal Fees: Pfizer; Financial Interests, Personal, Other, Personal Fees: Roche; Financial Interests, Personal, Other, Personal Fees: Tesaro; Non-Financial Interests, Personal, Other, Personal Fees: MSD; Financial Interests, Personal, Other, Personal Fees: Amgen; Non-Financial Interests, Personal, Other, Personal Fees: Clovis; Non-Financial Interests, Institutional, Other: Celgene; Financial Interests, Personal, Other, Personal Fees: Novartis; Financial Interests, Personal, Other, Personal Fees: Lilly; Non-Financial Interests, Personal, Other, Personal Fees: GSK; Financial Interests, Personal, Other, Personal Fees: Myriad; Financial Interests, Personal, Other, Personal Fees: Eisai; Non-Financial Interests, Institutional, Other: Daiichi Sankyo; Financial Interests, Personal, Other, Personal Fees: Gilead. M. Untch: Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Amgen GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: AstraZeneca; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: BMS; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Celgene GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Daiichi Sankyo; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Eisai; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Lilly Deutschland; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Lilly Int.; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: MSD Merck; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Myriad Genetics; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Pfizer GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Roche Pharma AG; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Sanofi Aventis Deutschland GmbH; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Novartis; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Pierre Fabre; Non-Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Clovis Oncology; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Seatlle Genetics; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Seagen; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: GSK; Financial Interests, Personal and Institutional, Other, All fees to the institution/employer: Gilead. P.A. Fasching: Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Novartis; Financial Interests, Institutional, Funding, Grant, Institutional Funding: BioNTech; Financial Interests, Personal and Institutional, Research Grant, Advisory Board, Invited Speaker, Research Grant: Pfizer; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker, Advisory Board, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant, Institutional Funding: Cepheid; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Seagen; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board, Advisory Board: Hexal; Financial Interests, Personal, Advisory Board, Advisory Board: Agendia; Financial Interests, Personal, Advisory Board, Advisory Board: Sanofi Aventis; Financial Interests, Personal, Advisory Board, Advisory Board, Invited Speaker: Gilead. A. Schneeweiss: Financial Interests, Personal, Research Grant, Research Grant, Travel expenses, Honoraria: BMS; Financial Interests, Personal, Research Grant, Research Grant, Expert testimony, Travel expenses, Honoraria: Roche; Financial Interests, Institutional, Research Grant, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant, Research Grant: Molecular Partner; Financial Interests, Personal, Expert Testimony, Expert testimony, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria, Travel expenses: Pfizer; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Tesaro; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: Gilead; Financial Interests, Personal, Other, Honoraria: Seagen. P. Wimberger: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Roche Pharma GmbH; Financial Interests, Institutional, Research Grant: GSK. S. Seiler: Financial Interests, Institutional, Research Grant, Grant: Amgen; Financial Interests, Institutional, Research Grant, Grant: BMS; Financial Interests, Personal, Other, Presentations: AbbVie. J. Huober: Financial Interests, Personal, Other: Gilead; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal and Institutional, Research Grant, Grant: Lilly; Financial Interests, Personal and Institutional, Research Grant, Grant, Travel, Other: Novartis; Financial Interests, Personal, Other, Travel, Other: Pfizer; Financial Interests, Personal, Other, Travel, Other: Daiichi; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: AbbVie; Financial Interests, Personal, Other: Eisai; Financial Interests, Institutional, Research Grant, Grant: Hexal; Financial Interests, Institutional, Research Grant, Grant, Travel, Other: BMS. M. Thill: Non-Financial Interests, Personal, Other, Personal Fees: Amgen; Financial Interests, Personal, Other, Personal Fees: AstraZeneca; Non-Financial Interests, Personal, Other, Personal Fees: BMS; Financial Interests, Personal, Other, Personal Fees: Daiichi Sankyo; Financial Interests, Personal, Other, Personal Fees: Eisai; Non-Financial Interests, Personal and Institutional, Research Grant, Trial funding, Grant, Personal Fees: Exact Sciences; Financial Interests, Personal, Other, Personal Fees: Lilly; Financial Interests, Personal, Other, Personal Fees: MSD; Financial Interests, Personal, Other, Personal Fees: Hexal; Financial Interests, Personal, Other, Personal Fees: Novartis; Financial Interests, Personal, Other, Personal Fees: Pfizer; Non-Financial Interests, Personal, Other, Manuscript support, Other: PFM Medical; Non-Financial Interests, Personal, Other, Personal Fees: Roche; Financial Interests, Personal, Other, Personal Fees: Tesaro; Financial Interests, Personal, Other, Manuscript support, Other: Clovis; Financial Interests, Personal, Other, Personal Fees: Seagen; Financial Interests, Institutional, Research Grant, Grant, Trial funding: Endomagnetics; Financial Interests, Personal, Other, Personal Fees: Norgine; Non-Financial Interests, Institutional, Other: RTI Surgical; Non-Financial Interests, Institutional, Other, Manuscript support, Other: Clearcut; Financial Interests, Personal, Other, Personal Fees: Becton and Dickinson; Financial Interests, Personal, Other, Manuscript support, Other: Servier; Financial Interests, Personal, Other, Personal Fees: Gilead Sciences; Financial Interests, Personal, Other, Personal Fees: Sysmex; Non-Financial Interests, Personal, Other, Personal Fees: Neodynamics; Financial Interests, Personal, Other, Personal Fees: GSK; Financial Interests, Personal, Other, Personal Fees: Vifor; Financial Interests, Personal, Other, Personal Fees: Organon; Financial Interests, Personal, Other, Personal Fees: Viatris; Financial Interests, Personal, Other, Manuscript support, Other: Vifor. C. Jackisch: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Exact Sciences; Financial Interests, Institutional, Other: Seagen. K. Rhiem: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Amgen. C. Hanusch: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: AstraZeneca. C. Denkert: Financial Interests, Personal, Ownership Interest, Stock and Other Ownership Interests: Sividon Diagnostics; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: MSD Oncology; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Molecular Health; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Merck; Financial Interests, Personal and Institutional, Advisory Role, Consulting or Advisory Role, Research Funding: Roche; Financial Interests, Personal, Advisory Role, Consulting or Advisory Role: Lilly; Financial Interests, Institutional, Funding, Research Funding: Myriad Genetics; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: VMScope digital pathology software; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: WO2015114146A1; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: WO2010076322A1; Other, Personal, Royalties, Patents, Royalties, Other Intellectual Property: WO2020109570A1. S. Loibl: Financial Interests, Institutional, Advisory Board, Grant, Other: AbbVie; Financial Interests, Institutional, Advisory Board, Other: Amgen; Financial Interests, Institutional, Advisory Board, Grant, Other: AstraZeneca; Financial Interests, Institutional, Advisory Board, Other: Bayer; Financial Interests, Institutional, Advisory Board, Other: BMS; Financial Interests, Institutional, Advisory Board, Grant, Other: Celgene; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board, Other: Eirgenix; Financial Interests, Institutional, Advisory Board, Other: GSK; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Immunomedics/Gilead; Financial Interests, Institutional, Advisory Board, Other: Lilly; Financial Interests, Institutional, Advisory Board, Other: Merck; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Novartis; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Pfizer; Financial Interests, Institutional, Advisory Board, Other: Pierre Fabre; Financial Interests, Institutional, Advisory Board, Other: prIME/Medscape; Non-Financial Interests, Institutional, Advisory Board, Medical Writing, Other: Puma; Financial Interests, Institutional, Other, honorarium for Lecture: Samsung; Non-Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, Medical Writing: Seagen; Non-Financial Interests, Institutional, Research Grant, Grant, Medical Writing, Other: Roche; Other, Institutional, Other, Patent Pending, Immunsignature in TNBC: EP14153692.0; Other, Institutional, Other, Patent Pending, Signature for CDK 4/6 Inhibitor: EP21152186.9; Other, Institutional, Other, Patent Issued, Predicting response to an Anti-HER2 containing therapy: EP15702464.7; Other, Institutional, Other, Patent Pending, GeparNuevo: EP19808852.8; Other, Institutional, Royalties, Patent Issued, Royalties, VM Scope GmbH: Digital Ki67 Evaluator. All other authors have declared no conflicts of interest.

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