European Journal of Cancer
Volume 43, Issue 16 , Pages 2351-2358, November 2007

A randomised trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer – GABG-IV B-93

  • Manfred Kaufmann

      Affiliations

    • Universitäts-Frauenklinik, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany
    • Corresponding Author InformationCorresponding author: Tel.: +49 69 63 01 51 15; fax: +49 69 63 01 63 17.
  • ,
  • Erika Graf

      Affiliations

    • Medizinische Biometrie und Statistik, Universitätsklinikum Freiburg, Freiburg 79098, Germany
  • ,
  • Walter Jonat

      Affiliations

    • Universitäts-Frauenklinik, Kiel 24103, Germany
  • ,
  • Wolfgang Eiermann

      Affiliations

    • Rot-Kreuz-Krankenhaus, München 80331, Germany
  • ,
  • Sabine Vescia

      Affiliations

    • City Hospital, Hanau 63450, Germany
  • ,
  • Matthias Geberth

      Affiliations

    • Onkologische Praxis, Mannheim 68159, Germany
  • ,
  • Bettina Conrad

      Affiliations

    • Senologisches Zentrum, Kassel 34117, Germany
  • ,
  • Günther Gademann

      Affiliations

    • Universitätsklinikum, Magdeburg 39104, Germany
  • ,
  • Ute-Susann Albert

      Affiliations

    • Universitäts-Frauenklinik, Marburg 35037, Germany
  • ,
  • Sibylle Loibl

      Affiliations

    • Universitäts-Frauenklinik, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany
    • German Adjuvant Breast Cancer Study Group (GABG), 60596 Frankfurt, Germany
  • ,
  • Gunter von Minckwitz

      Affiliations

    • Universitäts-Frauenklinik, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany
    • German Adjuvant Breast Cancer Study Group (GABG), 60596 Frankfurt, Germany
  • ,
  • Martin Schumacher

      Affiliations

    • Medizinische Biometrie und Statistik, Universitätsklinikum Freiburg, Freiburg 79098, Germany
  • ,
  • for the German Adjuvant Breast Cancer Study Group (GABG)

      Affiliations

    • German Breast Group (GBG), Neu-Isenburg 63263, Germany

Received 27 April 2007; received in revised form 16 July 2007; accepted 7 August 2007. published online 26 September 2007.

Abstract 

GABG-IV B-93 is a prospective, randomised study comparing goserelin (n=384) with no further treatment (n=392) in hormone receptor (HR)-negative breast cancer patients (n=465) after 3 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) for patients with 0–3 positive lymph nodes (LN) or 4 cycles epirubicin, cyclophosphamide (EC) followed by 3 cycles CMF for patients with 4–9 positive LN. After completion of the ZEBRA trial the study was amended to enrol also HR-positive patients with 1–9+LN (n=311).

After a median follow-up of 4.7 years neither HR-negative nor HR-positive patients showed a benefit for goserelin. The adjusted estimated hazard ratio for event-free survival in HR-negative patients was 1.01 (goserelin versus control, 95% confidence interval [CI] 0.72–1.42, P=0.97) and 0.77 in HR-positive patients (95% CI 0.47–1.24, P=0.27).

These results do not support the general use of goserelin after adjuvant chemotherapy in this group of premenopausal patients.

Keywords: Breast cancer, Node-negative, Hormone receptor negative, Premenopausal, Ovarian ablation, GnRH, Goserelin

 

 The results of this study have been presented in part at the meeting of the American Society of Clinical Oncology in New Orleans, 2004.

PII: S0959-8049(07)00644-2

doi:10.1016/j.ejca.2007.08.012

European Journal of Cancer
Volume 43, Issue 16 , Pages 2351-2358, November 2007