MACCLESFIELD, UK (PRESS RELEASE) - Wednesday 21 March 2007:6:30 AM PST - Treating locally advanced or metastatic prostate cancer patients - who experience disease progression after first-line, castration-based therapy - with 'step-up' to Combined Androgen Blockade (CAB) therapy can substantially prolong the 'hormonal response'1. This is the key finding of new research presented today at the European Association of Urology (EAU) meeting in Berlin, Germany (1).

Male hormones (also known as 'androgens', such as testosterone and its metabolite dihydrotestosterone) stimulate prostate cancer growth, so one of the most important goals in treating the disease is to reduce the amount of circulating hormone. There is currently no standard treatment for patients who experience disease progression after first-line hormonal therapy.

All patients in this new study were treated with first-line goserelin (ZOLADEX) monotherapy, administered using the ZOLADEX SafeSystem. Goserelin - a luteinising hormone-releasing hormone agonist (LHRHa) - works by reducing the level of the hormone testosterone in the body. After disease progression, patients received CAB 'step-up' treatment whereby they continued goserelin treatment but then boosted their androgen blockade by the addition of bicalutamide 50mg (CASODEX). Bicalutamide binds to receptors on tumour tissue and so prevents testosterone from binding and stimulating tumour growth.

Dr Heather Payne, Consultant in Clinical Oncology, University College Hospital, London, UK, who presented the study at EAU said: "These data tell us that CAB step-up therapy can reduce a patient's PSA count and keep it down, even after first-line, standard, hormonal therapy starts to fail.

"This is important because it gives physicians another chance to prolong a patient's response to hormonal treatment and extend the time the treatment keeps working, which means we can stave off hormone-refractory disease for longer, a disease setting that is much harder to treat."

Dr Payne presented an on-going analysis from 122 patients with locally advanced or metastatic prostate cancer who were treated with first-line goserelin (ZOLADEX) monotherapy. Goserelin has proven survival benefits across a broad range of prostate cancer settings, including adjuvant (2,3,4) neoadjuvant (5) and monotherapy in locally advanced disease (6,7). After disease progression, all 122 patients received CAB 'step-up' treatment, by the addition of bicalutamide 50mg (CASODEX) to their existing goserelin treatment in order to boost their androgen blockade.

The retrospective analysis shows (1):
• One in three (30.3%) patients experienced a PSA response (defined as a PSA decrease >50% at first assessment, followed by a subsequent PSA decrease at the second assessment point); in the overall study population of 122 patients, three out of four (74.6%) experienced at least a partial PSA response.
• For the 30.3% of patients who had a PSA response, the median time to treatment failure in this group was 291 days; in the overall study population, the median time to treatment failure following CAB was 193 days.

CAB should be used more often & have clearer guidelines - international survey reveals
At the same meeting, Dr Payne also co-authored new research (8) that showed physicians are supportive of CAB treatment. Seventy-one percent of physicians who took part in an international survey felt that CAB should be used more often for treating patients with advanced prostate cancer (8). The survey comprised the views and perceptions of 339 oncologists and urologists from 92 countries. While almost all survey respondents (95%) treating patients with advanced prostate cancer said they used CAB, less than half of them (47%) did so in more than 50% of their patients.

When exploring factors that could encourage increased CAB usage, 66% of physicians cited the need for clinical evidence. The survey explored physicians' views on current clinical guidelines for the management of advanced prostate cancer with CAB and showed that more than half of the respondents (52%) believe that the guidelines are too numerous, lack clarity or are outdated.

Dr Heather Payne commented: "While these survey findings show there is a good overall level of support for CAB, it seems very clear that the clinical community would welcome improved guidelines and greater clarity on the benefits of CAB, to ensure that patients with advanced prostate cancer have access to this treatment and the greatest chance for extending survival."

Notes to Editors

About the international survey:
• The International CAB survey, sponsored by AstraZeneca, was conducted and analysed by Fast Forward Research, an independent market research company
• A total of 339 complete responses were generated from oncologists and urologists in 92 different countries worldwide
• The survey was available online and also made available at medical congresses

About combined androgen blockade (CAB):
Combined androgen blockade in prostate cancer refers to the concurrent administration of an anti-androgen and either an LHRHa (medical castration) or surgical castration to block both the production of testicular androgens (testosterone) and residual adrenal androgens from stimulating prostate cancer cells. The combined action of these treatments works to provide maximum blockade of androgens (such as testosterone) that stimulate prostate cancer growth.

About ZOLADEX (goserelin):
ZOLADEX (goserelin) has been available for 20 years and has over 4.7 million years of patient exposure (9). It is the most widely researched Luteinizing Hormone-Releasing Hormone (LHRH) agonist, having first been licensed in 1987, and has the broadest range of indications of any LHRH agonists10. It has been shown to achieve clinical benefit as adjuvant and neoadjuvant therapy in locally advanced prostate cancer; and as monotherapy or as the LHRHa component as part of combined androgen blockade (CAB) in advanced prostate cancer10. ZOLADEX (goserelin) is only available as ZOLADEX SafeSystem, a unique patented delivery system designed to protect health care professionals from the risk of needle-stick injury.

About CASODEX (bicalutamide):
CASODEX (bicalutamide) is an oral non-steroidal anti-androgen for the treatment of prostate cancer and is the world's leading anti-androgen, available in all major European countries and the USA as a 50mg tablet, and in Japan as an 80mg tablet. CASODEX (bicalutamide) 50mg was first launched in 1995 as a combination treatment (with surgical or medical castration) for advanced prostate cancer and was subsequently launched as a 150mg dose for extended use either as a monotherapy or adjuvant treatment for locally advanced disease. For further information about CASODEX (bicalutamide) and about prostate cancer, please visit www.casodex.net or www.prostateline.com

About AstraZeneca:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.
'CASODEX', 'ZOLADEX' and 'ZOLADEX SafeSystem' are trademarks of the AstraZeneca group of companies.

For more information visit:
www.astrazenecapressoffice.com
www.astrazeneca.com

For further information, please contact:
Peter Edwards - Prostate Franchise Global PR Manager - AstraZeneca - Telephone:+44 1625 232 685 - Mobile: +44 7747 118 498 - This email address is being protected from spam bots, you need Javascript enabled to view it
Aoife Gallagher - Cohn & Wolfe - Telephone: +44 207 331 2324 - Mobile: +44 7813 096 161 - This email address is being protected from spam bots, you need Javascript enabled to view it

References
• 1. Payne, Gillatt. Step-up from castration to combined androgen blockade may prolong hormonal response in locally advanced prostate cancer. Session title: Management options in metastatic prostate cancer; Presented at EAU, Berlin, March 2007. Poster session; Wednesday March 21, 2007 from 14:30 to 16:00
• 2. Bolla M et al. Long term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet 2002: 360; 103-8
• 3. Messing EM et al. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol 2006: 7; 472-79
• 4. Pilepich MV et al. Androgen suppression adjuvant to definitive radiotherapy in carcinomas of the prostate - long term results of Phase III RTOG 85-31. Int J Rad Oncol Biol Phys 2005; 61 (5): 1285-1290
• 5. Pilepich MV et al. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys 2001; 50: 1243-52
• 6. Kaisary AV et al. Comparison of LHRH analogue (ZOLADEX) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol 1991; 67: 502-8
• 7. Vogelzang, NJ et al. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomised trial. Urology 1995; 46: 220-226
• 8. Castro-diaz, Gillatt, Payne, Akaza. Combined androgen blockage is underused in advanced prostate cancer: findings from an international survey. Session title: Management options in metastatic prostate cancer. Presented at EAU, Berlin, March 2007. Poster session; Wednesday March 21, 2007 from 14:30 to 16:00
• 9. AstraZeneca. Data on file
• 10. ZOLADEX (goserelin) International Prescribing Information

  

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