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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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Hauptverfasser: Möbus, Volker (VerfasserIn) , Lück, Hans-Joachim (VerfasserIn) , Ladda, Ekkehart (VerfasserIn) , Klare, Peter (VerfasserIn) , Engels, Knut (VerfasserIn) , Schmidt, Marcus (VerfasserIn) , Schneeweiss, Andreas (VerfasserIn) , Grischke, Eva-Maria (VerfasserIn) , Wachsmann, Grischa (VerfasserIn) , Forstbauer, Helmut (VerfasserIn) , Untch, Michael (VerfasserIn) , Marmé, Frederik (VerfasserIn) , Blohmer, Jens-Uwe (VerfasserIn) , Jackisch, Christian (VerfasserIn) , Huober, Jens (VerfasserIn) , Stickeler, Elmar (VerfasserIn) , Reinisch, Mattea (VerfasserIn) , Link, Theresa (VerfasserIn) , Sinn, Bruno (VerfasserIn) , Janni, Wolfgang (VerfasserIn) , Denkert, Carsten (VerfasserIn) , Seiler, Sabine (VerfasserIn) , Solbach, Christine (VerfasserIn) , Schmatloch, Sabine (VerfasserIn) , Rey, Julia (VerfasserIn) , Loibl, Sibylle (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 30 July 2024
In: npj Breast cancer
Year: 2024, Jahrgang: 10, Heft: 1, Pages: 1-10
ISSN:2374-4677
DOI:10.1038/s41523-024-00675-x
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41523-024-00675-x
Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41523-024-00675-x
Volltext
Verfasserangaben: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

MARC

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520 |a 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. 
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