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

• Published in: NPJ breast cancer Vol. 10; no. 1; pp. 66 - 10
• Main Authors: Möbus, Volker, Lück, Hans-Joachim, Ladda, Ekkehart, Klare, Peter, Engels, Knut, Schmidt, Marcus, Schneeweiss, Andreas, Grischke, Eva-Maria, Wachsmann, Grischa, Forstbauer, Helmut, Untch, Michael, Marmé, Frederik, Blohmer, Jens-Uwe, Jackisch, Christian, Huober, Jens, Stickeler, Elmar, Reinisch, Mattea, Link, Theresa, Sinn, Bruno, Janni, Wolfgang, Denkert, Carsten, Seiler, Sabine, Solbach, Christine, Schmatloch, Sabine, Rey, Julia, Loibl, Sibylle
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 30.07.2024; Nature Publishing Group; Nature Portfolio
• Subjects: 692/4028/67/1347; 692/699/67/1347; Adjuvants; Biomedical and Life Sciences; Biomedicine; Breast cancer; Cancer Research; Cancer therapies; Cell Biology; Chemotherapy; Human Genetics; Oncology; Patients; Surgery; Toxicity
• ISSN: 2374-4677; 2374-4677
• DOI: 10.1038/s41523-024-00675-x

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.