Data Shows Hormonal Therapy With Zoladex(REG) (Goserelin) Allows Men With Prostate Cancer To Outlive Their Disease

Main Category: Prostate / Prostate Cancer
Also Included In: Endocrinology;  Men's health
Article Date: 04 Sep 2007 - 1:00 PDT

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Adjuvant androgen deprivation therapy with ZOLADEX (goserelin) achieves long-term control of poor prognosis, non-metastatic prostate cancer, allowing men to outlive their disease and have a mortality risk comparable to the general population, according to research published in Prostate Cancer and Prostatic Diseases(1).

The authors conclude that adjuvant goserelin should be reclassified as a treatment of 'curative' intent for men with poor prognosis, non-metastatic prostate cancer and call for current clinical guidelines to reflect this.

While this research shows adjuvant therapy with goserelin allows men with poor prognosis, non-metastatic prostate cancer to outlive their disease, a separate survey of men with locally advanced or metastatic prostate cancer, published in Current Medical Research and Opinion this month, reveals that control of their cancer and outliving their disease were the most important factors for patients in choosing their hormonal therapy. However, more than one quarter of the men surveyed felt they were not aware of all treatment options available to them(2).

Dr Neil Fleshner, Division of Urology, Princess Margaret Hospital, Toronto, Canada, the lead author of the paper which calls for the reclassification of goserelin as a treatment of 'curative' intent, commented: "Historically, Luteinizing Hormone-Releasing Hormone agonists (LHRHa's) were a treatment for palliation of metastatic prostate cancer, and physicians today still consider adjuvant hormonal therapy as a palliative treatment option, despite the number of trials showing positive survival results for men with non-metastatic, poor prognosis cancer. The findings fundamentally challenge this notion, clearly showing that treatment with adjuvant goserelin provides long-term control of non-metastatic, poor prognosis prostate cancer such that a significant number of men are outliving their disease."

Survival data supports concept of 'cure'

The researchers reviewed survival data from four long-term, randomised, controlled clinical studies in men with non-metastatic, poor prognosis prostate cancer who received adjuvant hormonal therapy with goserelin following their primary treatment (radical prostatectomy or radiation therapy)(2,3,4,5).

The authors reviewed goserelin as it is the most widely researched LHRHa(6) and is unique amongst LHRHas as it has been studied as an adjuvant therapy in a number of randomised, controlled survival studies with a follow-up of more than five years(3,4,5,6). From these findings, the researchers assessed whether the potential for cure was achieved using an amended definition of cure specific to prostate cancer, defined as:
1) when the disease-free survival curve flattens out after 10-15 years following treatment and
2) when the overall survival rate approaches that of an age-related healthy male population(1).

Their findings showed that:

• Across all four trials, long-term disease control was achieved in a sizable proportion of men with non-metastatic prostate cancer and a poor prognosis (poor prognosis is defined as having a prostate specific antigen (PSA) level >20ng/mL and high Gleason scores >8 amongst other criteria) who received adjuvant goserelin.
• The disease-free survival (Kaplan-Meier) curves flattened during long-term follow up, indicating that many men are not relapsing.
• Importantly, the overall survival curves indicate that patients were not experiencing significant additional mortality associated with the side-effects of long-term goserelin use.

Findings challenge current guidelines

In moving forward, Dr Fleshner commented: "The European Association of Urology and the American Society of Clinical Oncology treatment guidelines do not currently classify adjuvant hormonal therapy as being a potentially curative treatment. It is worth noting that generally similar long-term results with tamoxifen adjuvant to surgery in women with breast cancer led to this drug being classified as a treatment of curative intent. We believe that adjuvant goserelin should be reclassified as a treatment of curative intent for patients with poor prognosis, non-metastatic prostate cancer."

Patient survey highlights need for patient information on hormonal therapies

While this research shows adjuvant therapy with goserelin allows men with poor prognosis, non-metastatic prostate cancer to outlive their disease, the recently published survey(2) of men with locally advanced or metastatic prostate cancer reveals that control of their cancer and outliving their disease were the most important factors for patients in choosing their hormonal therapy, with patients rating side effects as relatively unimportant in comparison (selected by only 3% of men)(2). However, more than one quarter of the men surveyed felt they were not aware of all treatment options available to them. The survey involved 382 men from six countries around the world, who had received ongoing hormonal therapy for at least a year, with goserelin being the most commonly used therapy(2).

The findings of this survey underline the need for physicians to recognise that their prostate cancer patients desire more information about their disease and the hormonal therapy options available to them, and to not exclude hormonal therapy options on the basis of potential side effects alone.

Prostate cancer primarily affects men over the age of 50(7), and is the most commonly diagnosed male cancer in many western countries, with one man diagnosed every three minutes and a life lost to the disease every six minutes(8).

Notes:

About the patient survey(2):

• The research study, sponsored by AstraZeneca, was conducted and analysed by Fast Forward Research, an independent market research company
• A total of 382 complete responses were generated from men with locally advanced and metastatic prostate cancer
• The survey was conducted across six countries: France, Germany, Italy, Spain, UK, USA

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(7), having first been licensed in 1987, and has the broadest range of indications of any LHRH agonists(10). 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 cancer(10).

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 $26.475 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 FTSE4Good Index.

'ZOLADEX' is a trademark of the AstraZeneca group of companies.

For more information please visit:

http://www.astrazenecapressoffice.com
http://www.astrazeneca.com
http://www.prostateline.com
http://www.zoladex.net

For further information, please contact:

Peter Edwards
Prostate Franchise Global PR Manager
AstraZeneca

Or
Aoife Gallagher
Cohn & Wolfe


References:

1) C. Hardy et al. Attitudes of prostate cancer patients towards the diagnosis and treatment of their disease: findings from a multinational survey. Current Medical Research and Opinion 2007. Vol. 23, No. 9, 2107 - 2116

2) 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

3) Pilepich MV, Winter K, Lawton CA et al. Androgen suppression adjuvant to definitive radiotherapy in carcinomas of the prostate - long term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys 2005; 61: 1285-90

4) Bolla M, Collette L, Blank L 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

5) Hanks GE, Pajak TF, Porter A et al. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol 2003; 21: 3972-8

6) Roach M 3rd, Izaguirre A. Expert Opin Pharmacother. 2007 Feb;8(2):257-64

7) Kirby RS et al. Prostate cancer and sexual function. Prostate cancer and prostatic diseases 1998:1:179-184

8) http://www-dep.iarc.fr/globocan/globocan.html Cancer Incidence, Mortality and Prevalence worldwide. Version 1.0 IARC CancerBase No. 5 Lyon, IARCpress, 2001

9) AstraZeneca. Data on file

10) ZOLADEX (goserelin) International Prescribing Information

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