A randomised trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer - GABG-IV B-93.
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.
Kaufmann
Manfred
M
Universitäts-Frauenklinik, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany. M.Kaufmann@em.uni-frankfurt.de
Graf
Erika
E
Jonat
Walter
W
Eiermann
Wolfgang
W
Vescia
Sabine
S
Geberth
Matthias
M
Conrad
Bettina
B
Gademann
Günther
G
Albert
Ute-Susann
US
Loibl
Sibylle
S
von Minckwitz
Gunter
G
Schumacher
Martin
M
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D017273:Goserelin / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008207:Lymphatic Metastasis / Q000473:pathology; D010349:Patient Compliance; D017697:Premenopause; D011446:Prospective Studies; D016896:Treatment Outcome
D017273:Goserelin