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9 April 2001
RESULTS FROM LARGEST EVER PROSTATE CANCER STUDY SHOW ASTRAZENECA'S CASODEX ALMOST HALVES RISK OF DISEASE PROGRESSION

First analysis of results from the largest ever study of its type announced today at the 16th annual meeting of the European Association of Urology shows that AstraZeneca's treatment, Casodex™ (bicalutamide) 150mg, cuts the risk of disease progression by almost half in patients with localised or locally advanced prostate cancer.

Evidence from one of the three trials in the bicalutamide (Casodex™) 150mg Early Prostate Cancer (EPC) Programme presented at the meeting in Geneva, Switzerland, also shows that time to prostate-specific antigen (PSA) doubling was significantly delayed in patients on Casodex™ 150mg compared with standard treatment alone. These findings give new hope that the mortality associated with prostate cancer could be reduced by early use of Casodex™.

Sales of Casodex™ have grown substantially since the treatment was first introduced in 1995. In 2000, Casodex's™ worldwide sales of $433m showed a 31 per cent increase compared with the previous year. Casodex™ is one of five important AstraZeneca products whose growth is being fuelled by life cycle initiatives.

Chris Brinsmead, Vice-President Oncology, said: "These promising results give us confidence that Casodex™ for this use could be of tremendous benefit to patients by treating the disease in the early stages. The indication for early prostate cancer could add significantly to the value of Casodex™, which has been developed during the past few years through similar extensions of use."

The Bicalutamide 150mg (Casodex™) Early Prostate Cancer (EPC) Programme is the largest randomised clinical trial ever conducted in Prostate Cancer. It was set up to examine whether adding Casodex™ 150mg immediately to standard care (watchful waiting, radical prostatectomy or radiotherapy) can reduce the risk of disease progression and improve survival when compared to standard care alone. The Programme comprises of three similar studies, which have enrolled 8,113 male patients in 23 countries* aged 38 to 93 years, with localised and locally advanced prostate cancer. The first results presented today were extracted from Study 24, one of the three studies that was conducted in Europe, South Africa, Australia, Israel and Mexico.

Combined results from the three studies forming the EPC programme will be presented at the American Society of Clinical Oncology (ASCO) meeting, San Francisco, in May 2001 and at the American Urological Association (AUA) meeting, Anaheim, in June 2001.

The data formed the basis of a regulatory submission in the UK and will be submitted to other regulatory authorities around the world during the course of 2001, with the aim of providing clinicians and patients with an additional treatment option for EPC. This is two years ahead of schedule.

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, and yet it is the second most commonly diagnosed male cancer in many western countries after lung cancer  [1]. In 2000, it was estimated that in the USA alone 180,400 men were diagnosed with prostate cancer, and 31,900 died as a result  [2].

Further enquires to:

Media Relations

Steve Brown
+44 (0)20 7304 5033

Lucy Williams
+44 (0)20 7304 5034


Investor Relations

Michael Olsson
+44 (0)20 7304 5087


Note to News Editors:

  • The bicalutamide 150mg (Casodex™) Early Prostate Cancer (EPC) Programme comprises three randomised, double-blind, placebo-controlled trials of similar design which are being conducted in distinct geographical areas (Study 023: Canada and USA Study 024: Europe, South Africa, Australia, Israel and Mexico, Study 025: Scandinavia). Men with localised and locally advanced prostate cancer (classed as T1b-4N0-1M0 (TNM 1997)) have been randomised 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 follow-up is ongoing. Study endpoints include time to clinical progression, overall survival and tolerability. Patient age at enrolment ranged from 38 to 93 years (mean 67 years). Results from the first analysis of Study 24 show that after a median follow-up of 2.6 years, the risk of disease progression was significantly reduced by 43 per cent in patients receiving Casodex™ 150mg compared with those receiving standard care alone. In addition, time to prostate-specific antigen (PSA) doubling, one of the measured endpoints, was significantly delayed with 84 per cent of patients receiving Casodex™ not having experienced PSA doubling, compared with 63 per cent of those patients receiving standard care alone.
  • Bicalutamide (Casodex™) is a well-tolerated, once-daily, non-steroidal antiandrogen, currently used in treating the more advanced stages of prostate cancer both as monotherapy (at the dose of 150 mg per day) and in conjunction with other hormonal treatments (at a dose of 50 mg per day).


[1] Reis LA, Kosary CI, Hankey BF et al. SEER Cancer Statistics Review 1973-1996. Bethesda, National Cancer Institute, 1998

[2] American Cancer Society, Cancer Facts and Figures 2000: http://www.cancer.org/statistics/cff2000/selectedcancers.html#prostate



*USA, Canada, Australia, Austria, Belgium, Czech Republic, Eire, France, Germany, Holland, Hungary, Israel, Italy, Mexico, Poland, Portugal, South Africa, Spain, UK, Denmark, Finland, Norway, Sweden



Casodex™ is a trademark, property of the AstraZeneca group of companies.

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