GAIN2 trial overall survival with intense versus tailored dose dense chemotherapy in early breast cancer

GAIN-2 trial evaluated the optimal intense dose-dense (idd) strategy for high-risk early breast cancer. This study reports the secondary endpoints pathological complete response (pCR) and overall survival (OS). Patients (n = 2887) were randomized 1:1 between idd epirubicin, nab-paclitaxel, and cyclo...

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Main Authors: Möbus, Volker (Author) , Lück, Hans-Joachim (Author) , Ladda, Ekkehart (Author) , Klare, Peter (Author) , Engels, Knut (Author) , Schmidt, Marcus (Author) , Schneeweiss, Andreas (Author) , Grischke, Eva-Maria (Author) , Wachsmann, Grischa (Author) , Forstbauer, Helmut (Author) , Untch, Michael (Author) , Marmé, Frederik (Author) , Blohmer, Jens-Uwe (Author) , Jackisch, Christian (Author) , Huober, Jens (Author) , Stickeler, Elmar (Author) , Reinisch, Mattea (Author) , Link, Theresa (Author) , Sinn, Bruno (Author) , Janni, Wolfgang (Author) , Denkert, Carsten (Author) , Seiler, Sabine (Author) , Solbach, Christine (Author) , Schmatloch, Sabine (Author) , Rey, Julia (Author) , Loibl, Sibylle (Author)
Format: Article (Journal)
Language:English
Published: 30 July 2024
In: npj Breast cancer
Year: 2024, Volume: 10, Issue: 1, Pages: 1-10
ISSN:2374-4677
DOI:10.1038/s41523-024-00675-x
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41523-024-00675-x
Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41523-024-00675-x
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Author Notes:Volker Möbus, Hans-Joachim Lück, Ekkehart Ladda, Peter Klare, Knut Engels, Marcus Schmidt, Andreas Schneeweiss, Eva-Maria Grischke, Grischa Wachsmann, Helmut Forstbauer, Michael Untch, Frederik Marmé, Jens-Uwe Blohmer, Christian Jackisch, Jens Huober, Elmar Stickeler, Mattea Reinisch, Theresa Link, Bruno Sinn, Wolfgang Janni, Carsten Denkert, Sabine Seiler, Christine Solbach, Sabine Schmatloch, Julia Rey & Sibylle Loibl
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Summary:GAIN-2 trial evaluated the optimal intense dose-dense (idd) strategy for high-risk early breast cancer. This study reports the secondary endpoints pathological complete response (pCR) and overall survival (OS). Patients (n = 2887) were randomized 1:1 between idd epirubicin, nab-paclitaxel, and cyclophosphamide (iddEnPC) versus leukocyte nadir-based tailored regimen of dose-dense EC and docetaxel (dtEC-dtD) as adjuvant therapy, with neoadjuvant therapy allowed after amendment. At median follow-up of 6.5 years (overall cohort) and 5.7 years (neoadjuvant cohort, N = 593), both regimens showed comparable 5-year OS rates (iddEnPC 90.8%, dtEC-dtD 90.0%, p = 0.320). In the neoadjuvant setting, iddEnPC yielded a higher pCR rate than dtEC-dtD (51.2% vs. 42.6%, p = 0.045). Patients achieving pCR had significantly improved 5-year iDFS (88.7% vs. 70.1%, HR 0.33, p < 0.001) and OS rates (93.9% vs. 83.1%, HR 0.32, p < 0.001), but OS outcomes were comparable regardless of pCR status. Thus, iddEnPC demonstrates superior pCR rates compared to dtEC-dtD, yet with comparable survival outcomes.
Item Description:Gesehen am 07.02.2025
Physical Description:Online Resource
ISSN:2374-4677
DOI:10.1038/s41523-024-00675-x