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| |  ECCO11: Single Monthly Injections with Faslodex (Fulvestrant) as Effective as Anastrazole in Post-Menopausal Advanced Breast Cancer By Ana Hidalgo-Simón LISBON, PORTUGAL -- October 24, 2001 -- The new oestrogen receptor down-regulator, Faslodex (fulvestrant), has proved to be as effective as the aromatase inhibitor, anastrazole, and slightly better tolerated. The main advantage of Faslodex, however, seems to be its once-a-month administration. Dr. Anthony Howell, from Christie Hospital in Manchester, England presented results of combined analysis from two retrospective, multicenter, phase III trials on Faslodex yesterday (Oct. 23) at ECCO11, the European Cancer Conference, in Lisbon, Portugal. One trial was conducted in the United States, the other in several other countries. Patients participating in these studies were post-menopausal women with progressing cancers despite endocrine treatment for advanced breast cancer. They were randomised to either Faslodex 250 mg once a month by intramuscular injection (n=428) or to the aromatase inhibitor anastrazole 1 mg a day orally (n=423). Most of the patients included in the studies (98 percent) had been treated with tamoxifen. Placebo injections and placebo pills were administered to protect therapy blinding. Approximately 83 percent of patients in each treatment had progressed by the time the analysis was performed. The median time to progression was 5.5 months for the Faslodex arm of the study and 4.1 for the anastrazole arm. The clinical benefits rates were estimated as 43.5 percent and 40.9 percent, respectively. Both drugs were well tolerated and withdrawals due to adverse events were very rare. Two patients out of 423 (0.5 percent) withdrew because of an injection site reaction. Adverse events included gastrointestinal disturbances, hot flushes, vaginitis and weight gain. The only event that showed a statistically significant difference between the treatment arms was joint disorders (5.4 percent for Faslodex versus 10.6 percent for anastrazole, p=0.003). Quality of life was also assessed but found to be similar with both treatments. "Faslodex, was at least as effective and at least as well tolerated as anastrazole. The once-a-month administration provides a clear advantage that enhances compliance and makes this new agent a valuable option for these patients," Dr Howell concluded. This study was sponsored by AstraZeneca.
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