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

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 no...

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Bibliographic Details
Published in:European journal of cancer (1990) 2007-11, Vol.43 (16), p.2351-2358
Main Authors: Kaufmann, Manfred, Graf, Erika, Jonat, Walter, Eiermann, Wolfgang, Vescia, Sabine, Geberth, Matthias, Conrad, Bettina, Gademann, Günther, Albert, Ute-Susann, Loibl, Sibylle, von Minckwitz, Gunter, Schumacher, Martin
Format: Article
Language:English
Subjects:
Adult
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Biological and medical sciences
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - mortality
Breast Neoplasms - pathology
Disease-Free Survival
Female
Follow-Up Studies
GnRH
Goserelin
Goserelin - administration & dosage
Goserelin - adverse effects
Hematology, Oncology and Palliative Medicine
Hormone receptor negative
Humans
Lymphatic Metastasis - pathology
Medical sciences
Node-negative
Ovarian ablation
Patient Compliance
Pharmacology. Drug treatments
Premenopausal
Premenopause
Prospective Studies
Treatment Outcome
Tumors
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Summary: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.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2007.08.012