New Research(1) Calls for Reclassification of Zoladex as Curative

จันทร์ 13 พฤศจิกายน 2549 เวลา 17:51 น.

MACCLESFIELD--13 Nov--PRNewswire-AsiaNet/InfoQuest

Findings Challenge Historical Assumptions & Current Guidelines for

Treating Non-Metastatic Poor Prognosis Prostate Cancer With Adjuvant LHRHas

New research presented today at the 28th Congress of the Societe

Internationale d'Urologie (SIU), Cape Town, South Africa demonstrates that

adjuvant androgen-deprivation therapy with ZOLADEX (goserelin) can consistently

control prostate cancer, allowing men to out-live their disease(1). The

researchers 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.

The research highlights other cancer treatments that have been reclassified

as 'curative,' including cisplatinum-based chemotherapies that revolutionized

testicular cancer treatment so that the disease is eradicated in a substantial

proportion of men, and long-term results with tamoxifen used after surgery in

women with breast cancer, which led to the drug being reclassified as a

treatment of curative intent.

Dr. Neil Fleshner, Division of Urology, Princess Margaret Hospital,

Toronto, Canada, who presented the research, commented: "Our analysis of four

long-term studies clearly shows that treatment with adjuvant goserelin provides

long-term control of non-metastatic, poor prognosis prostate cancer such that a

significant number of men are out-living their disease. Historically, LHRHas

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, which is an important message for clinicians and men

alike as it means the current way we view and use this drug is outmoded,

meaning some men may not be receiving the best chance of cure."

Concept of 'cure' in cancer

The concept of 'cure' in oncology is emotive and fraught with

complications: currently the diagnostic technology that allows physicians to

determine whether all cancer cells are eradicated does not exist. Because of

this, oncologists are reluctant to use the term 'cure.' A definition of cure

for cancer was first established in the 1970s, which proposed that cure exists

for disease-free survivors whose overall survival rate is similar to that of an

age- and sex-related matched population(2). This concept first led to the

five-year survival rates becoming widely accepted as an indication of the

success of a cancer treatment.

However, advances in treatments, earlier detection, and increasing

international collaboration and data sharing have made the five-year survival

concept obsolete for many cancers. A review of other genitourinary cancers

(bladder cancer, testicular cancer, and renal cancer) by the researchers

indicates that cure varies with tumour type and disease stage. They found, for

example, a five-year follow-up of patients with transitional cell

muscle-invasive bladder cancer treated with a combination of chemotherapy and

radiation or surgery was insufficient as the survival curve has not yet

flattened, and a follow-up period greater than five years to evaluate cure was

needed due to the progression of invasive bladder cancer(3).

Is it possible to 'cure' patients with poor-prognosis non-metastatic

prostate cancer?

The researchers reviewed survival data from four long-term, randomized,

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)(4),(5),(6),(7) .

The researchers reviewed goserelin as it is the most widely researched LHRHa

and is unique amongst LHRHas as it has been studied as an adjuvant therapy in a

number of randomized, controlled survival studies with a follow-up of more than

five years. 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

sizeable proportion of men with non metastatic prostate cancer and a

poor prognosis (poor prognosis is defined as having 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

Guidelines outmoded

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."

Notes to Editors

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 leading positions in gastrointestinal,

oncology, cardiovascular, neuroscience and respiratory 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 visit:

www.astrazenecapressoffice.com

www.astrazeneca.com

www.zoladex.com

www.prostateline.com

References:

(1) N. Fleshner et al. Adjuvant androgen deprivation therapy augments

cure and long-term cancer control in men with poor prognosis,

nonmetastatic prostate cancer. Presented at SIU, Cape Town, November

2006

(2) Frei III E, Gehan EA. Definition of cure for Hodgkin's disease.

Cancer Res 1971; 31: 1828-33

(3) Fellin G, Graffer U, Bolner A, Ambrosini G, Caffo O, Luciani L.

Combined chemotherapy and radiation with selective organ preservation

for muscle-invasive bladder carcinoma. A single-institution phase II

study. Br J Urol 1997; 80: 44-9

(4) 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

(5) 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

(6) 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 randomized

trial. Lancet 2002; 360: 103-8

(7) 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

SOURCE: AstraZeneca

CONTACT: Peter Edwards,

Prostate Franchise Global Brand PR Manager,

AstraZeneca,

+44-1625-232-685,

Mobile: +44-7747-118-498;

Rebecca Hibble,

Cohn & Wolfe,

Telephone: +44 207 331 5336,

Mobile: +44 7813 096 161,

[email protected]

Web site: http://www.astrazeneca.com

http://www.astrazenecapressoffice.com

http://www.zoladex.com

http://www.prostateline.com

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