Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study.
The Zoladex In Pre-menopausal Patients (ZIPP) study was designed to determine whether addition of goserelin ('Zoladex') and/or tamoxifen to adjuvant therapy (radiotherapy and/or chemotherapy), provided benefit to pre- or peri-menopausal women with operable, early breast cancer. A combined analysis of four randomised trials using a core protocol was performed. Patients (n = 2710) were randomised into a 2 x 2 factorial trial based on goserelin and tamoxifen (n = 1800) or randomised to receive goserelin or not (n = 910; some received elective tamoxifen) for 2 years. The analysis presented here compares women who did (n = 1354) or did not (n = 1356) receive goserelin. After a median follow-up of 5.5 years, goserelin provided a significant benefit for event-free survival (hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.69, 0.92; P = 0.002) and overall survival (HR 0.81; 95% CI 0.67, 0.99; P = 0.038). Goserelin was well tolerated. These data show that the addition of goserelin to standard adjuvant therapy is more effective than standard therapy alone in pre-menopausal women with early breast cancer.
Department of Surgery, University College London, Institute of Surgical Studies, 67-73 Riding House Street, Charles Bell House, London W1W 7EJ, United Kingdom.
M
M
Baum
A
A
Hackshaw
J
J
Houghton
Rutqvist
T
T
Fornander
B
B
Nordenskjold
A
A
Nicolucci
R
R
Sainsbury
D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D017273:Goserelin / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017697:Premenopause; D016032:Randomized Controlled Trials as Topic; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen; D017273:Goserelin