Goserelin Improves Treatment Choices For Younger Women.(Brief Article)(Statistical Data Included)

2001 OCT 11 - (NewsRx.com & NewsRx.net) --

Pre- and perimenopausal women with hormone-sensitive early breast cancer can now be offered an equally effective alternative to standard chemotherapy following the regulatory approval of Zoladex (goserelin) for this indication in a number of European countries.

These approvals have been granted based on impressive data from international trials in early breast cancer involving more than 8,000 patients.

The pivotal trial in the regulatory submissions, the ZEBRA (Zoladex in Early Breast Cancer Research Association) was the largest trial ever undertaken comparing hormonal therapy with standard chemotherapy, and involved 1640 pre- and perimenopausal women who were randomized to receive either Zoladex (3.6 mg every 28 days for two years) or 6(times)28 day cycles of standard chemotherapy.

Primary endpoints were disease-free and overall survival together with tolerability. In the hormone-sensitive group of patients (74%), Zoladex was shown to be equivalent to standard chemotherapy in terms of disease-free survival (HR=1.01, 95% CI 0.84-1.20).

"Our results show conclusively that Zoladex is as effective as chemotherapy in young women with hormone-sensitive early breast disease," commented professor Walter Jonat, director of the Gynecology and Obstetrics Clinic at the University of Kiel, Germany, a principal investigator for the ZEBRA trial. "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."

The incidence of typical chemotherapy-induced side effects (e.g. alopecia, nausea and vomiting, and infection) was substantially higher in the chemotherapy group compared with the Zoladex group (43% vs. 4%, 56% vs. 5% and 13% vs. 5%, respectively) resulting in significant overall quality-of-life benefits for the Zoladex patients during the first six months of the trial (i.e. the period during which the chemotherapy patients received their treatment).