Largest Prostate Cancer Study Shows 42 per cent Drop in Risk of Disease Progression

Toronto, Ontario, 20 June 2001 – A once daily dose that slows disease progression offers new hope for hundreds of thousands of men around the world diagnosed with prostate cancer each year.

The first results of the largest ever trial in prostate cancer, the Early Prostate Cancer (EPC) Programme, showed that, in comparison with standard care alone (surgery, radiotherapy or watchful waiting), bicalutamide 150mg (Casodex™) reduces the risk of the cancer progressing by 42 per cent and reduces the risk of the cancer spreading to the bones by approximately 33 per cent. In addition, in patients taking bicalutamide 150mg there was a significant delay in prostate-specific antigen (PSA) rise – a second indicator that the disease is under better control.

As with most cancers, prostate cancer patients have a better chance of survival if diagnosed early. Current standard treatment for early prostate cancer (i.e. surgery, radiotherapy or watchful waiting) is not always successful, as there is often disease recurrence or progression. The growth of prostate cancer is known to be stimulated by the male (androgenic) hormone, testosterone, and therefore the early use of an anti-androgen (a drug which blocks the testosterone receptor), in addition to standard treatment, could improve the outlook for men with prostate cancer. A similar approach has proved very successful in the treatment of breast cancer, where the use of tamoxifen (Nolvadex^®, an anti-estrogen), in addition to standard treatment, has been shown to improve the survival of women with early disease.

"Progression of prostate cancer is associated with a number of serious complications such as anaemia, urinary obstruction, kidney failure, severe pain and pathological fractures caused by bone metastases. I believe that these first promising results from the EPC Programme will offer real hope for prostate cancer patients as we are already able to show a significant reduction in the risk of disease progression," said Dr. Yves Fradet, Professor of Surgery/Urology and Chairman of the Department of Surgery at Laval University in Quebec, and a Principal Investigator in the EPC Programme. "These results, although requiring further follow-up to assess their impact on patients survival, already provide hope to the patients."

"The EPC Programme results are very exciting and will undoubtedly trigger discussion around the role of adjuvant hormonal therapy in the treatment of early prostate cancer. Inevitably, there will be some reservation regarding the preliminary nature of the data, which does not yet include any information on survival," said Dr. Jack Barkin, Chief of Urology at Humber River Regional Hospital in Toronto, Ontario. "Nonetheless, prolonging the time to clinical progression will result in significant benefits for patients with early prostate cancer, especially those at high risk of experiencing the morbidity associated with disease progression."

The data will be presented on June 27^th, 2001 at the Canadian Urology Association (CUA) meeting in Toronto, Ontario. The data have already been submitted to the UK regulatory authorities and will be submitted to other regulatory authorities around the world during the course of 2001. The aim of such submissions is to provide clinicians and patients with an additional treatment option for localized and locally advanced prostate cancer.

The majority of side effects reported were predicted from the mode of action of the drug. Breast swelling and breast pain were the most frequent, but in the majority of patients, these were mild to moderate, frequently resolving or improving when therapy was withdrawn.

The EPC Programme involved a total of 8,113 men with localized and locally advanced prostate cancer and was carried out in Europe, North America, Scandinavia, South Africa, Australia, Israel and Mexico.¹ In Canada, 14 centres participated in the study and 318 patients were involved. Patients were randomized to receive bicalutamide 150mg once daily or placebo, in addition to standard care.

Despite an increase in public awareness and screening, prostate cancer does not have the same level of public recognition as other forms of cancer, such as breast cancer. Yet, it is the second most commonly diagnosed male cancer in Canada, as well as many western countries, after lung cancer. According to the National Cancer Institute of Canada, it is estimated that nearly 17,800 new cases of prostate cancer will be diagnosed and 4,300 men will die from the disease in Canada during 2001.²

The Canadian leader in cancer treatments, AstraZeneca Canada Inc. has an extensive cancer drug portfolio for breast (Arimidex^® and Nolvadex^®), prostate (Casodex™, Zoladex^®) and colorectal cancer. Committed to Canadian health care, AstraZeneca Canada Inc. currently invests over $1.5 million every week on research and development. With more than 65 ongoing basic and clinical research projects in Canada, AstraZeneca Canada Inc.’s active research and development program aims to find innovative treatments for many forms of cancer.

AstraZeneca is one of the leading pharmaceutical companies with a formidable product portfolio spanning seven major therapeutic areas: cardiovascular, gastrointestinal, oncology, pain control, respiratory, central nervous system, and infection. AstraZeneca’s brands include Casodex™, Zoladex^®, Atacand^®, Losec^®, Zestril^®, Xylocaine^®, Pulmicort^®, Zomig^® and Seroquel^®. The Canadian headquarters and manufacturing facilities of AstraZeneca are located in Mississauga, Ontario, with a state-of-the-art basic research centre based in Montréal, Québec.

References:

1. WA See, D McLeod, P Iversen, M Wirth. The Bicalutamide Early Prostate Cancer Program. Demography. Urol Onc 2001;vol6: 43-47.
2. National Cancer Institute of Canada, Canadian Cancer Statistics 2001, Toronto, Canada

Editor’s notes

• Men with localized and locally advanced prostate cancer (classed as T1b-4N0-1M0 (TNM 1997)) have been randomized on a 1:1 basis to receive bicalutamide 150mg (Casodex™) daily or placebo in addition to their standard care. Recruitment to the programme closed in July 1998, and the study is continuing. Study endpoints include time to clinical progression, overall survival and tolerability. Patient age at enrolment ranged from 38 to 93 years (mean 67 years).
• Bicalutamide (Casodex™) is a well-tolerated, once-daily, non-steroidal antiandrogen, currently used in treating the more advanced stages of prostate cancer in conjunction with other hormonal treatments (at a dose of 50 mg per day).
• Further background information on prostate cancer and its management can be found at www.prostartonline.com.