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ZEBRA trial treats early breast cancer with no effect on fertility.

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Recently aired on the ABC and Channel 9 (Monday 16th December) were the results of a trial on early breast cancer. Published in the Journal of Clinical Oncology (JCO), the ZEBRA trial involved treatment of early breast cancer with similar results to chemotherapy, however Zoladex has the reverse effect on menopause meaning fertility will resume after treatment.

The Zoladex Early Breast Cancer Research Association (ZEBRA) trial was initiated in 1990 to compare the efficacy and tolerability of goserelin with cyclophosphamide, methotrexate, 5-flurouracil chemotherapy (CMF) in pre- / perimenopausal women with node-positive early breast cancer.

A total of 1640 pre- / perimenopausal patients (less than or equal to 50 years of age) entered the trial and received either goserelin (3.6 mg every 28 days for 2 years, n=817) or CMF (6 x 28 day cycles, n=823) for the adjuvant treatment of breast cancer.

Initial results showed a highly significant interaction between treatment and oestrogen receptor (ER) status, with equivalent benefit of goserelin and CMF in patients with ER-positive tumours but superiority of CMF in patients with ER-negative tumours, (goserelin, n= 591; CMF, n=598), goserelin continues to be equivalent to CMF for disease-free survival (281 vs 269 events; hazard ratio [HR] = 1.05; 95% confidence interval [CI] 0.88, 1.24).

The median disease-free survival was 7.9 years in the goserelin group and 8.0 years in the CMF group.

At the time of this analysis, in patients with ER-positive tumours, there was a a total of 148 deaths in the goserelin group (25.0% of patients) and 154 deaths in the CMF group (25.8% patients).

The HR (0.94) and 95% CI (0.75, 1.18) for overall survival showed non-inferiority of goserelin vs CMF. In ER-negative patients (goserelin, n=144 CMF, n=160), goserelin was inferior in CMF for disease-free survival (HR=1.83; 95% CI 1.33, 2.52) and for overall survival (HR=1.64; 95% CI 1.13, 2.39).

In conclusion, at this extended follow-up goserelin continues to demonstrate equivalence vs CMF for disease-free survival in ER-positive patients. Thus, with equivalent efficacy vs CMF and proven quality of life benefits, goserelin offers and effective alternative to CMF chemotherapy in the management of patients with ER-positive, node-positive early breast cancer.

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Posted On: 16 December, 2002
Modified On: 3 December, 2013


Created by: myVMC