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Zoladex (Goserelin) As Effective As Standard Chemotherapy In Early Breast Cancer BRUSSELS, BELGIUM -- September 27, 2000 -- Results from the ZEBRA (Zoladex in Early Breast Cancer Research Association Trial) study show that treatment with Zoladex (goserelin) is as effective as standard chemotherapy for pre/perimenopausal women with hormone-sensitive, node-positive early breast cancer. For these women, chemotherapy is currently the accepted standard treatment approach following initial surgery. However, chemotherapy is frequently associated with harrowing side effects including hair loss, severe nausea and vomiting, and the risk of life-threatening infection. ZEBRA is the largest ever study comparing hormonal therapy with standard chemotherapy. The study involved 1,640 pre and perimenopausal women with early breast cancer randomised to receive either Zoladex (3.6 mg every 28 days for two years) (n= 817) or six times 28 day cycles of standard chemotherapy (n= 823). Primary end points were disease-free and overall survival and tolerability. In the hormone-sensitive group of patients (73 percent) , Zoladex was shown to be equivalent to standard chemotherapy in terms of disease-free survival (HR=1.01, 95 percent CI 0.84-1.20). In addition, Zoladex was not associated with the distressing and debilitating side effects routinely observed with chemotherapy. The incidence of typical side effects of chemotherapy e.g. alopecia, nausea and vomiting (despite use of anti-emetics in over 97 percent of chemotherapy patients ) and infection were all substantially higher in the chemotherapy group compared to the 'Zoladex'-treated patients (43 percent vs. 4 percent, 56 percent vs. 5 percent and 13 percent vs. 5 percent, respectively). Both treatments were associated with menopausal symptoms, such as vaginal dryness and hot flushes. However, while the incidence of menopausal symptoms was initially lower in the chemotherapy treated group, (vaginal dryness: 14 percent vs. 24 percent ; hot flushes: 42 percent vs. 72 percent, respectively), these remained virtually unchanged post-treatment, while on cessation of Zoladex treatment, the incidence of these effects fell to below that experienced by the chemotherapy group (vaginal dryness: 12 percent vs. 9 percent ; hot flushes: 37 percent vs. 17 percent, respectively). Professor Walter Jonat, Direktor der Klinik fur Gynaecologie und Gerburtshilt, at the University of Kiel, Germany, presenting the ZEBRA results today on behalf of the trialists' group commented, 'The benefits of Zoladex in advanced disease are already well established. The ZEBRA study was set up to find out whether these benefits would also be seen in the treatment of early breast cancer, and to find out whether Zoladex would prove to be as effective as chemotherapy for these young women.' 'I am delighted to say that our results show conclusively that Zoladex is as effective as chemotherapy in young women with hormone-sensitive early breast disease.' continued Prof Jonat. 'This means that physicians and patients now have a real choice in treatment following initial surgery. Chemotherapy, while effective for a lot of women, is associated with a number of well-known and traumatic side-effects, such as hair loss, and exhausting bouts of nausea and vomiting which many of our patients find difficult to bear. Zoladex , on the other hand, seems to be well tolerated and now offers this patient group an effective alternative treatment option for their breast cancer.' Related Link: Zoladex (goserelin). E-mail this page to a friend or colleague! To print, use this version