npj Breast Cancer (Jul 2024)

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

  • 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

DOI
https://doi.org/10.1038/s41523-024-00675-x
Journal volume & issue
Vol. 10, no. 1
pp. 1 – 10

Abstract

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Abstract 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.