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| |  AUA: Casodex (bicalutamide) potential alternative to castration in prostate cancer ATLANTA, GA -- May 1, 2000 -- Data presented at the American Urological Association's annual meeting suggested that the oral hormonal medication Casodex (R) (bicalutamide) 150-mg Tablets shows no statistically significant difference in overall survival or time to progression when compared to castration (surgical or medical) in patients with non-metastatic, locally advanced prostate cancer. "This analysis of mature data suggests that there is no significant difference in survival or time to progression between Casodex 150-mg and castration in men with locally advanced prostate cancer," said Dr. Peter Iversen, lead author of the study. "Furthermore, there may be quality of life benefits associated with treatment with Casodex 150-mg, which include greater maintenance of sexual interest, improvements in physical capacity for everyday activities, and a reduction in the incidence of hot flushes, when compared to castration. Casodex is an oral treatment, which is more acceptable to some patients." The authors reported results from a combined analysis of two studies with non-metastatic, locally advanced prostate cancer patients. A total of 480 patients were randomized to receive Casodex 150-mg once daily (n=320) or castration (medical n=138; surgical n=22). After a median follow-up of 6.3 years, there was no statistically significant difference in survival between the Casodex 150-mg group and the castration group (hazard ratio 1.05; 95 percent CI 0.81 to 1.36; p=0.70). Time to progression was also not statistically significantly different between the two groups (hazard ratio 1.20; 95 percent CI 0.96 to 1.51; p=0.107). In addition, the data also suggested quality of life benefits for the patients receiving Casodex 150-mg over the patients receiving castration, including statistically significant benefits with respect to sexual interest (p=0.029) and physical capacity (p=0.046). The most frequent adverse events reported for Casodex were gynecomastia and breast pain. The overall incidence of adverse events was similar for both treatment groups. Preliminary evidence in a sub group of patients compared with age-matched controls also suggests that unlike castration, Casodex 150-mg monotherapy may not be associated with a reduction in bone mineral density. Casodex interferes with the ability of cancer cells to use male hormones to grow. In the case of prostate cancer, the main hormone is testosterone (an androgen). Casodex is a nonsteroidal antiandrogen that works by blocking the action of androgens, such as testosterone, at the cellular level. Casodex 150-mg monotherapy is not approved for use in the US. A supplemental new drug application was submitted to the FDA earlier this year for the use of Casodex 150-mg monotherapy for the management of patients with locally advanced, non-metastatic (Stage T3-T4, NX, M0) prostate cancer. If approved, Casodex 150-mg will offer both physicians and patients the first non-castration hormonal treatment option for prostate cancer and may allow intervention with Casodex at an earlier stage. Casodex 50-mg is currently only indicated for use in combination therapy with a luteinizing hormone-releasing hormone analogue for the treatment of Stage D2 metastatic carcinoma of the prostate. Casodex 150-mg monotherapy has already been approved by the regulatory authorities in five countries, including the UK, Norway, Iceland, South Africa, and Sweden and further approvals are anticipated during 2000 in other countries. Casodex 150-mg is also being studied for use in the treatment of early stage prostate cancer in the largest ongoing prostate cancer trial in the world -- the Casodex Early Prostate Cancer (EPC) Program. Since 1995, a total of 8,113 patients worldwide have been recruited for the EPC Program, and in the U.S., the last patient has just completed therapy. The EPC Program is designed to compare the efficacy and safety of Casodex 150-mg with placebo in non-metastatic prostate cancer as an adjuvant to therapy (surgery or radiation) or as immediate therapy for men electing "watchful waiting." AstraZeneca continues its tradition of research excellence and innovation in Oncology that led to the development of its current anti-cancer therapies including: Nolvadex(R) (tamoxifen citrate) Tablets, Zoladex(R) (goserelin acetate implant), and Arimidex(R) (anastrozole) Tablets. AstraZeneca has many promising new oncology therapies in development including Iressa(TM) (ZD1839), an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TK). AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is a $7.4 billion healthcare business with approximately 9,500 employees. One out of every six men is at lifetime risk for prostate cancer. It is the second most frequently occurring malignancy in American men, after skin cancer, and represents 29 percent of all newly diagnosed cancer cases. Every three minutes a man is diagnosed with prostate cancer in the United States and a life is lost to the disease every 13 minutes. Prostate cancer is the second leading cause of cancer death among men after lung cancer. The American Cancer Society estimated 180,400 new cases in the United States during 2000. Related Links: Casodex (bicalutamide) and AstraZeneca.
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