Meeting
2018 ASCO Annual Meeting
Investigating denosumab as an add-on neoadjuvant treatment for RANK/L-positive or RANK/L-negative primary breast cancer and two different nab-paclitaxel schedules: 2x2 factorial design (GeparX)—An iterim safety analysis.
Authors
Sherko Kummel
Kliniken Essen Mitte, Essen, Germany
Sherko Kummel , Pauline Wimberger , Gunter Von Minckwitz , Valentina Nekljudova , Carsten Denkert , Marianne Just , Claus Hanusch , Oliver J Stoetzer , Jens Bodo Huober , Manfred Hofmann , Christian Jackisch , Jens U. Blohmer , Valentina Vladimirova , Andreas Schneeweiss , Michael Untch , Sibylle Loibl
Organizations
Kliniken Essen Mitte, Essen, Germany, Universitätsklinikum Carl Gustav Carus TU Dresden, Dresden, Germany, German Breast Group (GBG), Neu-Isenburg, Germany, Institut für Pathologie, Charité-Universitätsmedizin Berlin, Berlin, Germany, Onkologische Schwerpunktpraxis, Bielefeld, Germany, Rotkreuzklinikum, Frauenklinik, Munich, Germany, Medizinisches Zentrum für Hämatologie und Onkologie, München, Germany, Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Ulm, Ulm, Germany, Klinik für Gynäkologie und Geburtshilfe, Marienhospital, Stuttgart, Germany, Sana Klinikum Offenbach GmbH, Offenbach, Germany, Brustzentrum Charité-Universitätsmedizin, Berlin, Germany, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany, HELIOS Klinikum Berlin-Buch, Berlin, Germany
Research Funding
Other
Background: The GeparX study aims to investigate whether denosumab, an antibody targeting RANKL, increases the pCR rate when added to an anthracycline/taxane containing neoadjuvant chemotherapy (NACT) in patients (pts) with primary breast cancer (BC). Methods: GeparX enrolles pts with primary BC cT1c-cT4d, after central assessment of HER2, HR, TILs, Ki67. 778 pts will be randomized to NACT+/-denosumab (120mg s.c. q4w for 6 cycles), stratified by lymphocyte predominant BC (LPBC, ≤50% vs > 50%), subtype (HER2-/HR+ vs triple negative (TNBC) vs HER2+), and epirubicin/cyclophosphamide schedule (EC, q2w vs q3w). Secondarily, pts are randomized to different nab-paclitaxel schedules (nP): nP 125mg/m² weekly or nP 125mg/m² day 1,8 q22 followed by EC. Pts with TNBC receive carboplatin (AUC 2) and with HER2+ BC ABP 980 (trastuzumab biosimilar)+pertuzumab. Co-primary objectives compare the pCR (ypT0 ypN0) rates of NACT+/-denosumab and the pCR rates between nP 125 weekly and nP 125 d1,8 q22. Secondary objectives are toxicity; compliance amongst others. An interim safety analysis is planned after the first 200 pts have completed nP treatment. Results: A total of 202 pts randomized to denosumab and the nP treatment (101 pts with weekly and 101 pts with nP d1,8 q22) were included in the interim analysis. Overall, median age was 50 years [range 23-76]; 38.6% of pts were cN+ and 5% had LPBC, 102 pts (50.5%) had HER2-/HR+ BC; 82 (40.6%) had TNBC and 18 pts (8.9%) HER2+ BC. Overall, 13.5% with and 13.1% w/o denosumab discontinued nP. 21.0 % of pts with nP weekly vs 5.3% with nP d1,8 q22 discontinued nP mainly due to AEs (17.0% vs 3.2%). During nP treatment 24 SAEs with nP weekly vs 25 SAEs with nP d1,8 q22 were reported. 17 (16.7%) SAEs were reported in the HER2-/HR+ cohort, 29 (35.4%) for the TNBC (with carboplatin) and 3 (16.7%) in the HER2+ cohort (dual-blockade, no carboplatin). Conclusions: The addition of denosumab to NACT does not increase toxicity. Weekly nP resulted in a higher rate of treatment discontinuations mainly due to non-serious AEs. The addition of carboplatin resulted in a higher rate of SAEs. Clinical trial information: NCT02682693
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Abstract Details
Session Type
Poster Session
Session Title
Breast Cancer—Local/Regional/Adjuvant
Track
Breast Cancer
Sub Track
Neoadjuvant Therapy
Clinical Trial Registration Number
NCT02682693
Citation
J Clin Oncol 36, 2018 (suppl; abstr 569)
DOI
10.1200/JCO.2018.36.15_suppl.569
Abstract #
569
Poster Bd #
61
Abstract Disclosures
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