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

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Volker Möbus - , University Hospital Frankfurt (Author)
  • Hans Joachim Lück - , Gynäkologisch-Onkologische Praxis Hannover (Author)
  • Ekkehart Ladda - , Onkologische Praxis Neumarkt (Author)
  • Peter Klare - , Berlin Brustzentrum (Author)
  • Knut Engels - , Zentrum für Pathologie (Author)
  • Marcus Schmidt - , University Medical Center Mainz (Author)
  • Andreas Schneeweiss - , German Cancer Research Center (DKFZ) (Author)
  • Eva Maria Grischke - , University Hospital Tübingen (Author)
  • Grischa Wachsmann - , Kreiskliniken Böblingen gGmbH (Author)
  • Helmut Forstbauer - , GOSPL - Gesellschaft für onkologische Studien Troisdorf (Author)
  • Michael Untch - , HELIOS Klinikum Berlin-Buch (Author)
  • Frederik Marmé - , Heidelberg University  (Author)
  • Jens Uwe Blohmer - , Charité – Universitätsmedizin Berlin (Author)
  • Christian Jackisch - , Sana Clinics Group (Author)
  • Jens Huober - , Ulm University (Author)
  • Elmar Stickeler - , RWTH Aachen University (Author)
  • Mattea Reinisch - , Charité – Universitätsmedizin Berlin, University of Duisburg-Essen (Author)
  • Theresa Link - , Department of Gynecology and Obstetrics, University Hospital Carl Gustav Carus Dresden (Author)
  • Bruno Sinn - , Charité – Universitätsmedizin Berlin (Author)
  • Wolfgang Janni - , Ulm University (Author)
  • Carsten Denkert - , University Hospital Gießen and Marburg (Author)
  • Sabine Seiler - , German Breast Group (Author)
  • Christine Solbach - , University Hospital Frankfurt (Author)
  • Sabine Schmatloch - , Elisabeth Krankenhaus Kassel (Author)
  • Julia Rey - , German Breast Group (Author)
  • Sibylle Loibl - , German Breast Group (Author)

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.

Details

Original languageEnglish
Article number66
Journalnpj Breast Cancer
Volume10
Issue number1
Publication statusPublished - Dec 2024
Peer-reviewedYes