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EU HEALTH SPECIAL

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Prostate Cancer in Europe: Future Advancements in Screening,

Treatment and Control

gov gazette_healthsupplement.indd 45 18/5/11 17:04:25

EU HEALTH SPECIAL

Prostate Cancer in Europe: Future Advancements in Screening, Treatment and Control

47 Commissioner John Dalli, European Commissioner

for Health and Consumer Policy

48 Susan Galbraith, Vice-President and Head of Oncology,

Innovative Medicines, AstraZenica

49 Professor Jonathan Waxman BSc MD FRCP, Professor of Oncology,

Imperial College, London

50 Matthew Kemp. Senior Director, Global Marketing and

Commercial Operations, Dendreon Corporation

51 Dr Sylvie Rottey MD, PhD, Ghent University Hospital

52 Jane Gri� ths, Company Group Chairman, Janssen Europe,

Middle East and Africa, Janssen Pharmaceutical Companies

of Johnson & Johnson

53 Mark Emberton, Professor of Interventional Oncology,

UCLH/UCL Comprehensive Biomedical Research Centre, London, UK

54 Debasish Roychowdhury, SVP and Head of SANOFI’s Global Oncology Division

55 Professor Dr Maurizio Pianezza, Senior Medical O� cer in General Surgery

at Genoa’s Azienda Ospedale Università San Martino

(San Martino Hospital-University)

56 Edwina Baskin-Bey, Sue Jones, Astellas Pharma Europe Ltd,

Frank Perabo, Kevin Hartley, Stephan Holmstrom, Steve van Os,

Astellas Pharma Global Development, Europe

57 Dr Antoine Abi-Aad, M.D.,Urology, Parc Leoplod Clinic, Belgium

58 Prostate Cancer in Europe, Bayer Healthcare

Contributors


GOVERNMENT GAZETTE MAY 2011 47

EU Health Special

By John Dalli, European Commissioner for Health and Consumer Policy

Prostate Cancer in Europe

Cancer represents great suff ering

and premature death to millions of

Europeans and their families. Every

year, close to 2,5 million EU citizens are

diagnosed with cancer. Cancer remains the

second most common cause of death in the

EU, claiming 1,2 million lives every year.

At the same time, inequalities in cancer

prevention, diagnosis and care across the EU

are a cause for concern. � is is why working

together to combat cancer is one of the

longest-standing areas of EU cooperation in

health.

Following three successive Europe against

Cancer action programmes starting back

in 1987, the Commission launched the

European Partnership for Action Against

Cancer in 2009.

� e Partnership aims to support Member

States in their eff orts to reduce new cases

of cancer by half a million by 2020 and

to develop integrated cancer plans by

the end of the Partnership. To this end,

the Partnership provides a framework

for identifying and sharing information,

capacity and expertise in cancer prevention,

control, research and care.

By engaging a wide range of stakeholders

within this Partnership, the Commission is

leading a collective eff ort with a common

commitment to address cancer. Partners

include non governmental organisations,

researchers, patients' groups, industry,

organisations of health professionals and

national authorities across the EU. � is

approach should help reduce inequalities

by helping Member States to prevent and

control cancer more effi ciently across the

EU.

One third of all cancers are preventable.

Health promotion and early detection of

cancer are therefore among the key areas on

which the Partnership works. One specifi c

cancer prevention activity is the European

Code Against Cancer with two central

messages: "Certain cancers may be avoided

by adopting healthier lifestyles", and "cancers

may be cured, or the prospects of cure

greatly increased, if they are detected at an

early stage".

When we speak about cancer, however, we

need to take into account that cancer is not

one disease but many.

� e most frequent

types in the European

Union are lung,

colorectal and breast

cancer, followed by

prostate cancer.

Back in 2003,

Member States

adopted Council

recommendations

that foresee

implementing

national screening

programmes for

breast, cervical

and colorectal

cancer, with quality

assurance, taking into

account European

Guidelines. Since then, the European

Commission has developed guidelines

on quality assurance in screening for

these three types of cancer and supported

Member States in their eff orts to develop

screening programmes.

In addition to these three types of cancer,

prostate cancer is undeniably a common

cancer among men particularly those

aged over 65 years of age, even though

its death rates remain lower than for lung

and colorectal cancer. � e increase in

the incidence of prostate cancer in many

countries during the 1990s and 2000s was

largely attributable to the greater use of

prostate-specifi c antigen (PSA) diagnostic

tests(1). � e extent to which mortality

has been aff ected by such early diagnosis

and improved treatment has yet to be

fully established, and the various possible

causes of this disease still need to be fully

determined.

Taking into account the insuffi cient evidence

on whether or not the benefi ts of early

detection could outweigh the risks, when

the Council adopted its recommendation on

screening back in 2003, it excluded prostate

cancer screening from the recommendation.

Instead, it was decided that the case for

prostate cancer should be reviewed at a

later stage, building on the results of the still

on-going European Randomized Study of

Screening for Prostate Cancer and the US

National Cancer Institute's Prostate, Lung,

Colorectal and Ovarian Cancer Trial. Both

studies will need to continue for several

years before they yield conclusive results.

When they do, then the time will be ripe to

re-examine evidence and consider possible

recommendations on prostate cancer

screening. Until then, health professionals

alone need to ascertain, how and in which

cases to recommend testing for prostate

cancer.

� e European Partnership for Action

Against Cancer goes beyond prevention

and screening and also includes actions

to identify and disseminate good practice

in cancer-related health care, as well as

coordination of cancer research and health

information and data. In addition, through

its mechanisms, the Partnership will

also off er the opportunity for the cancer

community to discuss new developments in

cancer prevention and control.

In conclusion, action against cancer,

regardless of the type, is a key component

of European health policy. � e European

Commission is keen to play its part in

supporting eff orts to prevent, diagnose and

treat cancer.

(1) Health at a Glance: Europe 2010; OECD

2010. Available from: http://www.oecd-

ilibrary.org/social-issues-migration-health/

health-at-a-glance-europe-2010_health_

glance-2010-en


GOVERNMENT GAZETTE MAY 201148

EU Health Special

The EU Debate on Prostate Cancer

By Susan Galbraith, Vice President and Head of Oncology, Innovative Medicines, AstraZeneca

Prostate cancer remains one of the most common malignancies, is still under-researched and is not well

served by novel therapies, particularly when tumours progress to the more deadly castrate resistant phase.

� ere is a signifi cant opportunity to develop new therapies that delay the progression to castrate-resistant disease and to treat castrate resistant prostate cancer (CRPC) once it has occurred.

� e potential impact and use of novel technologies such as circulating tumour cells to enhance drug development for prostate cancer, is high. � ere are also signifi cant challenges to realising these potential opportunities for which we need innovative solutions if we are to make signifi cant progress in treating this important disease.

Barriers to faster development of new therapies

Globally, the gold standard clinical endpoint for regulatory approval of a new prostate cancer therapy continues to be overall survival leading to large, long clinical studies. In Europe, regulatory scientifi c advice has been given that progression free survival can be a registration endpoint in prostate cancer due to the confounding that can be expected with overall survival as a primary endpoint.

Progression free survival has not gained global endorsement as a surrogate for overall survival due to the diffi culties in assessing progression of bony disease, leading to poor correlation with overall survival, particularly in Cancer Resistant Prostrate Cancer (CRPC).

Consideration is now given to alternate measures of patient bene� t, such as sustained pain control, but having access to alternative clinical endpoints that better predict overall survival is critical if we are to accelerate the successful conduct of prostate cancer clinical trials.

A key question is; how can we increase our confi dence in investing in a pivotal Phase III trial without having to conduct a Phase II study measuring the same overall survival endpoint?

Alternative endpoints do exist. � ey include changes in prostate-specifi c antigen (PSA) dynamics, changes in the numbers of circulating tumour cells and standard Response Evaluation Criteria in Solid Tumors (RECIST) criteria. However, their predictive value remains uncertain. Recently it has been shown that circulating tumour cell (CTC) number measured before and after treatment, is predictive of overall survival in patients with metastatic CRPC and that this may be a more robust endpoint than PSA alone.

In patients with CRPC, measuring a suite of endpoints may be another way to increase confi dence that a drug is having some meaningful clinical benefi t. � is approach has been successfully applied to the early clinical evaluation of new anti-androgen therapies such as abiraterone in metastatic CRPC. However, it is not yet known if the correlation between these endpoints and overall survival will continue to apply in earlier disease settings or with other novel target agents that do not work via the androgen receptor (AR directly controls PSA).

PSA has long held hope as a biomarker of disease progression. Unfortunately however, post-therapy changes in PSA levels do not predict the benefi t of long-term treatment for all patients with CRPC. We therefore urgently need new robust molecular markers that will allow faster decision making in early clinical development.

Understanding the heterogeneity of prostate cancer

Prostate tumours show tremendous biological heterogeneity, with some patients dying of metastatic disease within 2-3 years of diagnosis and others dying with their prostate cancer rather than from it.

� ere is an urgent need to better understand the heterogenity of prostate cancer so that we can separate patient subgroups that may require more aggressive treatment from those that require less treatment.

Recently, a major step forward has been achieved by demonstrating the feasibility of integrative genomic profi ling of individual prostate tumours. � is holds the promise that we can identify molecular subtypes of disease, that can be treated with individual targeted therapies.

Correlating these molecular classifi cations

with clinical outcome to see if they identify

the high-risk patient, is a logical next-step.

To do all this will require access to tissues

that accurately refl ect the disease state from

a spatial as well as temporal perspective.

After removal of the primary tumour and

after disease progression, residual tumour

metastasises to relatively inaccessible sites

such as bone. Circulating tumour cells may

off er a surrogate ‘tissue’ that represents

the genetic make-up of the primary or

metastatic tumour at any moment in time.

Recent studies have provided some hope

that we can measure in CTCs, genetic

characteristics such as PTEN (phosphatase

and tensin homolog) status, and mutations

in the androgen receptor. If this technology

proves to be robust enough this will be

a major advance towards establishing a

relatively non-invasive blood test that could

predict responsiveness to new molecularly

targeted agents. � is is another key step

in speeding the development of novel

medicines for prostate cancer.

In conclusion, AstraZeneca is committed

to the development of novel therapies for

prostate cancer and to collaborating with

our many partners to address the challenges

and opportunities in this.

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EU Health Special

By Jonathan Waxman B Sc MD FRCP, Professor of Oncology, Imperial College London

Prostate cancer represents a major

cause of morbidity and mortality

within the western world. Death

rates have tripled over the last 30 years, and

prostate cancer is now the most common

malignancy of man, and second most

common cause of male cancer deaths.

For many years prostate cancer remained

a Cinderella illness, with little interest in

research and prevention. However, over the

last decade there have been major changes

in the public’s view of this disease, and a

fl owering of investment by pharmaceutical

companies driven by the market and its

possibilities.

In many cancers outcomes have been

improved as a result of population

screening. Early detection has been shown

to be an important way to reduce mortality

in common cancers, such as breast, colon

and cervix.

Breast cancer death rates have fallen by

30% in the West, and in most countries the

prospects are for an 80% chance of survival.

� ese advances have been due almost

entirely to screening. As a result, screening

of breast cancer has a broad consensus of

support, and a widespread uptake within

the population. Colorectal cancer develops

over many years as a result of an aggregation

of molecular changes. � ese changes

lead a pre-malignant polyp to become an

invasive polyp, and ultimately full blown

malignant disease. � ere is excellent

evidence that screening colonoscopies

at 10 yearly intervals reduce the chance

of this progression to invasive cancer.

Unfortunately colorectal cancer screening

by colonoscopy is a luxury for the wealthy,

and is not advised for the general population

because of screening costs. Cervical cancer

screening is also of great importance, with

death rates reduced by 50% as a result of

conventional screening processes. Cervical

cancer death rates are likely to fall further

with the advent of molecular screening

methodologies and with the development of

immunisation programmes.

Screening for many other common

cancers is not as successful, and there is

an overwhelming body of evidence that

suggests that screening for lung, ovarian and

upper GI cancer is of little benefi t.

But what of prostate cancer, the

commonest male cancer? � ere are two

major diffi culties with screening normal

populations for prostate cancer. � e fi rst

problem is the lack of an eff ective screening

tool. Current screening uses PSA testing.

PSA blood testing has limited effi cacy.

When normal populations are screened,

PSA levels above the normal range and in

the range 4 – 10 mg/ml lead to a diagnosis of

prostate cancer in just 25% of normal men.

In contrast, a normal PSA level does not

predicate for an absence of prostate cancer

because 2.5% of normal men with normal

PSA levels have cancer.

Should prostate cancer be confi ned to

the prostate, then the patient is off ered

three management options. � ese are

surveillance, radiotherapy and surgery.

� e outlook for each of these treatment

options for screen detected prostate cancer

is similar, with an entire absence of any

evidence base that active treatment leads to

survival gain. Should the patient be found to

have metastatic disease, then similarly, there

is no evidence that early treatment improves

upon survival chance.

So the issue for the European Union is that

accurate diagnostic tools for prostate cancer

don’t exist and there is no improvement in

overall mortality from prostate cancer as a

result of screening and early treatment.

Unlike women, men are little interested

in proactive measures to reduce their

likelihood of later illness. In this context,

there is very

limited uptake

from men of

off ers to be

screened for

prostate cancer.

Current rates

in the United

Kingdom for

screening for

PSA are around

2–4%.

So how should

European

Union policy

be progressed

in order to

decrease

prostate cancer death rates? � e European

Union might wish to consider promoting the

development of better tests and treatment,

and developing policy to reduce the

exposure of men to the causes of prostate

cancer.

� ere are two important risk factors for

prostate cancer. One is a family history and

the other is diet. All attempts to date have

failed to identify a single gene responsible

for the disease, although multiple genetic

factors have been found to be associated

with increased risk of developing prostate

cancer. However, there is likely to be a

genetic cause for prostate cancer as men

with a history of prostate cancer aff ecting

their brothers have a risk of the disease

which is up to 2.5 fold higher than for men

without a family history. � e development

of prostate cancer is associated strongly with

a diet containing a high proportion of meat,

smoked foods and dairy products. .

In summary, the European Union would

be best advised to consider a broad-based

approach to dealing with prostate cancer.

Investment is needed in public health and

education attempting to change the diet

of our population, in identifying genetic

causes of prostate cancer, in fi nding a better

screening test and improving treatment.

As a result it may be that the changes that

we have seen to mortality rates from many

common cancers can be at last off ered to

patients with prostate cancer.

Prostate Cancer in Europe: A Personal View

©iStockphoto.com/Damrongpan



EU Health Special

Prostate Cancer

By Matthew Kemp, Senior Director, Global Marketing and Commercial Operations, Dendreon Corporation

Prostate cancer is the most common malignancy in men in

Europe. It accounted for approximately 370,733 new cases and

89,629 deaths in 2008(1). While many men experience disease

control following primary therapy, approximately 20% to 40% of

these patients eventually experience disease recurrence. Men with

recurrent disease typically have an elevated prostate specifi c antigen

(PSA) level. Androgen deprivation is commonly used as the follow-

up therapy and achieves temporary tumor control or regression in

80% to 85% of treated patients.

Over time, virtually all patients become resistant to androgen

deprivation therapy and their disease spreads to distant sites, most

commonly to bones and/or regional lymph nodes. Management

of this castration resistant state, know as either castration-resistant

prostate cancer (CRPC) or hormone refractory prostate cancer

(HRPC), presents a signifi cant clinical challenge.

Current treatment options include secondary hormone therapy,

chemotherapy, and investigational agents that are exploring diff erent

approaches to tackling this disease. One such agent available in

the United States, Provenge (sipuleucel-T), is designed to work

diff erently than hormone therapy or chemotherapy.

PROVENGE is an autologous cellular immunotherapy. � is type of

therapy is designed to stimulate an immune response to cancer cells.

An immune response is started by a specialized class of immune

cells called antigen-presenting cells (APCs). APCs take up antigens

from their surroundings and process the antigens into fragments

that are then displayed on the APC’s surface. Once displayed, these

antigens can be recognized by specifi c classes of immune cells called

T lymphocytes (T-cells), which are activated as a result of their

engagement with APCs and combat disease by seeking antigen-

bearing cells directly.

PROVENGE is designed to target the prostate cancer antigen

prostatic acid phosphatase (PAP), an antigen that is expressed in

more than 95 percent of all prostate cancers. As reported in � e

New England Journal of Medicine, clinical trials conducted in the

USA have already demonstrated that PROVENGE can extend

survival by several months in men with metastatic CRPC(2).

Because PROVENGE is an autologous cellular immunotherapy, each

dose must be individually manufactured for each patient, using their

own immune cells. � is personalized medicine marks the beginning

of a new stage in the administration of individualized cancer care.

Clinical trials planned for PROVENGE in the EU include an open-

label study in European men with metastatic CRPC. � is study

will increase experience with supply chain and manufacture of

PROVENGE in the EU. In addition, a clinical trial is planned in the

EU to evaluate the safety and effi cacy of treatment with PROVENGE

plus ADT compared with treatment with ADT only in men with

metastatic androgen dependent prostate cancer (mADPC).

� e European Union (EU) has and will continue to serve a vital role

in the process of developing and introducing medical advancements

in the management of prostate cancer across Europe. As further

novel technologies are applied in the treatment of prostate and

other cancers, it is important that the EU continues its eff orts to

provide incentives for small and medium enterprises (SMEs) to

conduct EU-based research and development. Additionally, further

work by the EU to harmonize the processes for conducting clinical

trials in the various member states will hasten their safe and timely

implementation.

� e establishment of the Committee for Advanced � erapies (CAT)

at the EMA is also a welcomed step forward, ensuring there is a

common approach to the requirements for registration of such

treatments. � e CAT is well positioned to ensure safe introduction

of novel therapies in the EU by working with sponsors at an early

stage to create appropriate development and risk management plans.

Novel therapies like Provenge that involve manipulation of patients’

cells also present unique challenges, particularly those associated

with the safe movement of tissues across the EU while respecting

data privacy. Eff orts to harmonize tissue traceability systems

across the EU are important to ensure the EU can manufacture

such therapies in a cost-eff ective manner. It is also inevitable that

advanced therapies requiring complex, individualized manufacturing

processes will present new dilemmas for all member state

reimbursement systems. � ese dilemmas will need to be tackled in

a transparent manner that takes into account all attributes of such

treatments.

Predictable access to novel investigational agents through clinical

trials and newly approved products will continue to ensure

CRPC patients across Europe can play an important role in the

development of new therapies and benefi t from eff ective and safe

treatments in a timely manner.

Note: PROVENGE is not approved for marketing in the EU at this

time. It was approved for marketing in the USA in April 2010.

(1) Ferlay J, et al. Estimates of cancer incidence and mortality in

Europe in 2008. European Journal of Cancer. Volume 46, Issue 4 ,

Pages 765-781, March 2010.

(2) Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T

immunotherapy for castration-resistant prostate cancer. N Engl J

Med. 2010;363:411-422.

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EU Health Special

Castrate Resistant Prostate Cancer

By Sylvie Rottey, MD, PhD, Ghent University Hospital

Androgen suppression is the fi rst line treatment of metastatic prostate cancer. Even patients with castration refractory disease should have continued androgen suppression.

Patients with castrate resistant prostate cancer should receive second line hormonal therapy (anti-androgen). Several other hormonal manipulations can follow this treatment: corticosteroids, estrogens, ketoconazole.

Docetaxel using a 3 weekly schedule should be considered for symptomatic and/or rapidly progressive metastatic castration resistant disease. In a large international multicentre stage III trial (TAX327), 2 diff erent schedules of docetaxel were compared with mitoxantrone (all arms combined with prednisolone). Patients (n=1006) were randomized between weekly docetaxel 30mg/m² for 5 weeks out of 6, 3 weekly docetaxel 75mg/m² and mitoxantrone 12mg/m² every 3 weeks.

Median survival was 19.2 months in the 3-weekly docetaxel arm and 16.3 months in the mitoxantrone arm. A signifi cant improvement in quality of life was seen in 1/4th of the patients treated with docetaxel. A 50% decrease in PSA was seen in almost half of these patients and reduction in pain was seen in > 30% of patients. � e side eff ects of docetaxel chemotherapy included grade III-IV neutropenia (32% in 3 weekly arms, 1.5% in the weekly arm). Other side eff ects were: fatigue, alopecia, diarrhea, neuropathy, peripheral edema.

� ree-weekly docetaxel was superior to the other treatments in its palliative eff ects and in prolongation of survival. Docetaxel was

studied also in combination with estramustine and seemed aff ective

as well but was more toxic.

Following these data, docetaxel + prednisone became the standard

chemotherapy regimen for fi rst line treatment of castration resistant

prostate cancer and are widely used in Europe in this patient

population.

Standard second line treatment options providing gain in survival,

interesting PSA and clinical response after docetaxel were not

available for several years.

Cabazitaxel, a novel tubulin-binding taxane was tested in a phase III

trial in men with castration resistant prostate cancer pretreated with

docetaxel (whose disease progressed during or after treatment with a

docetaxel containing regimen). � e trial includes 755 men that were

allocated to mitoxantrone (12 mg/m² every 3 weeks) or cabazitaxel

(25 m/m² every 3 weeks).

Median survival was 15.1 months in the cabazitaxel group and 12.7

months in the mitoxantrone group. � e most signifi cant grade 3 side

eff ects in the cabazitaxel group were neutropenia (82%) and diarrhea

(6%). PSA response was 39% in the cabazitaxel group, the pain

response rate 9%.

� e data suggest that cabazitaxel counts for a survival benefi t to

patients unlikely to benefi t from further docetaxel treatment.

©iStockphoto.com/DarioEgidi



EU Health Special

Cancer Does Not Discriminate: Our Health Policies Shouldn�t EitherBy Jane Gri� ths, Company Group Chairman, Janssen Europe, Middle East & Africa , Janssen Pharmaceutical Companies of Johnson & Johnson

The UK government and its European counterparts should harness the opportunity presented by this year’s

European Week Against Cancer (25-31 May) to discuss and identify the future needs of health policies to address the changing face of cancer.

� e European Week Against Cancer takes place against the backdrop of governments seeking to cut health and other budgets in the wake of the worst global economic crisis since the Great Depression. An increasingly ageing population further compounds this problem. A diffi cult balancing act therefore presents itself as governments look to manage smaller health budgets while continuing to address public health challenges and provide high quality healthcare.

One consequence of the ageing population is an increase in the prevalence of cancer. � e increasing incidence of cancer coupled with tighter budgets may lead Europe to a crisis point. Cancer does not make any distinctions, and is everybody’s problem regardless of age or sex or socio-economic background. No one company, no one academic institution, and no one government can solve the challenge presented by cancer.

Much has been done to address women’s cancers such as cervical and breast cancer both by the UK government and the European Union (EU). � e European Commission produced European guidelines for quality assurance in both cervical and breast cancer screening and diagnosis to assist national governments with cancer screening.

Health ministers from all the EU Member States have also agreed to have a national and multi-year cancer plan from 2013. In parallel to this, ministers committed to improving the screening of breast, colorectal and uterine cancer and ensuring greater coherence in terms of research.

Attention must now be paid by European governments to speci� cally address men�s cancers. This will be a vital component to achieving the EU�s aim to reduce the number of new cancer cases in the EU by 15% by 2020.

Prostate cancer is the most common cancer in men in the UK. In 2008, around 338,000 men were diagnosed with prostate cancer in Europe (EU-27), and more than 70,000 men in Europe (EU-27) died from prostate cancer. � e incidence of prostate cancer is set to rise exponentially: over the last 30 years alone, prostate cancer rates in Great Britain have almost tripled. In Ireland alone, the prevalence is predicted to rise by 275% by the year 2020 due to the changing demographic and earlier diagnosis.

Future health policies need to better refl ect the impact of men’s cancers alongside women’s cancers, and address the rising incidence coupled with the low understanding by men about male cancers. Much can be learned from the initiatives and successes achieved to date for women’s cancers, and applied to male cancers. Sharing best practice across Europe for prostate cancer screening and diagnosis, and driving national action plans to help prioritise and manage the increasing incidence of prostate cancer is a vital step to improving patient outcomes. UK and EU level actors need to commit to better addressing male cancers, and identify future action and collaboration to help raise awareness amongst men, to share best practice, and to use EU frameworks to pool Member State knowledge.

� e successes achieved in raising awareness about women’s cancers and securing these high on health policy agendas are attributed not just to policy makers but the incredible eff orts of very active and eff ective women’s cancer advocacy and patient groups. � e landscape of advocates for male cancers will need more funding and support to help grow their initiatives and activities to a similar level.

Health policies on male and other cancers will also need to adapt to the changing face of cancer. Innovative

treatments are helping to turn cancer from a killer into a chronic condition. For example, more than three-quarters of men diagnosed with prostate cancer now survive the disease beyond fi ve years. In the 1970s it was less than a third.

Janssen is committed to transforming cancer to a preventable, chronic or curable disease by pursuing oncology and innovation in cancer. We are working hard to fi nd solutions that meet the unmet needs of cancer patients by extending the lives of cancer patients whilst also improving the quality of their lives.

Both the industry and governments have a shared responsibility for driving continued innovation that improves patient outcomes and for facilitating access to treatments which meet evolving patient needs. In bringing together a broad range of European and national level stakeholders, the European Week Against Cancer provides an important platform to assess the changing face of cancer, and to identify health strategies that will help all those aff ected by cancer.

©iStockphoto.com/wragg



EU Health Special

Addressing the Problems of Over-Diagnosis and Over-Treatment in Early Prostate CancerBy Mark Emberton, Professor of Interventional Oncology, UCLH/UCL Comprehensive Biomedical Research Centre, London, UK

Prostate cancer is the most common

male cancer and probably the most

controversial in terms of how it is

managed. � e two largest errors that result

from the current pathway are the problems

over-diagnosis and over-treatment. Just

under half of men currently screened may

fall into this category. � e problem of under-

diagnosis (clinically important prostate

cancer that is systematically missed) and

either late treatment or no treatment is also

a problem, but one that we are currently

unable to quantify.

� e best way to avoid over-treatment

would be avoid diagnosing cancers that

are of no clinical signifi cance and the

diagnosis of which cannot confer any

benefi t to the individual. � e best way to

reduce the burden of over-treatment – as

there will always be some – is to devise

treatments that are less harmful, more easily

applied and considerably less expensive to

administer.

Currently, most men who undergo

treatment for localized prostate cancer will

experience side-eff ects, many of which are

permanent. � ese are mainly genito-urinary

(incontinence, erectile and ejaculatory

dysfunction) and rectal (bleeding/soiling/

pain) and result from collateral iatrogenic

harm to the tissues surrounding the prostate

during the process of whole-gland surgery or

radiotherapy.

As well as conferring harm, current

treatments, are also becoming more and

more expensive. In radiotherapy, we have

seen a move from conformal techniques to

intensity modulation and dose escalation,

adding to the cost of treatment. � ese

relatively new techniques are being replaced

by even more complex systems that require

imaged guidance and high capital cost

facilities such as Cyberknife™ and Proton

beam radiation. In surgery we have also

seen a similar escalation in complexity and

in cost. A small incision using traditional

instruments has been replaced by a

£1.5million capital requirement (master-

slave robot) with high consumable and

maintenance costs. Yet, side-eff ects after

robotic surgery are possibly worse (Hu et al,

2009) and cancer control may be less secure

(Hu et al, 2011).

Because of the technical profi ciency

demanded by the current whole gland

treatments they are associated with long

learning curves. Improvements in outcome

occur much later in the adoption curve than

we would like – so late that few surgeons

doing radical prostatectomy could ever hope

to reach this point in a working life (Vickers,

2011). � e implication is that the majority

of patients will receive care that is inferior to

the best that can be achieved.

Investing in more expensive treatments that

are increasingly diffi cult to administer is

unlikely to be a winning strategy. We need

a novel, simple, cost-eff ective technological

solution with a low threshold to clinical

adoption. � e missing element, when we

compare prostate cancer to all other solid

organ cancer pathways is knowledge of

tumour location and extent. Both diagnostic

biopsy and treatment are conducted without

any knowledge on where the cancer is –

’blind’ biopsy and whole-gland treatment

– especially as the cancer occupies only a

small proportion of the gland.

Multi-parametric MRI (mp-MRI) can be

used to detect and localise early prostate

cancer. It is widely available, is safe, and

both the conduct and reporting have

been standardized (Dickinson et al, 2011).

Because of the high negative predictive value

of mp-MRI for clinically important disease

it is likely that a negative result could be

used to inform a man that a biopsy might be

safely avoided.

For those that do have an abnormality

on MRI it should be possible to use that

information to improve both detection rates

and the characterisation of the cancer – as a

targeted biopsy is much more likely to hit a

cancer than the current blinded and random

approach (90% versus 25%).

� e coupling of imaging and targeted

sampling will provide, for the fi rst time in

prostate cancer, information on location

and focality. Given that most cancers

occupy no more than 1-2cc of volume, it

seems plausible that a therapy directed at

the cancer and not at the prostate might

be entertained. Our own, preliminary

data, has shown that a targeted approach

to treatment, focal cancer ablation rather

than whole-gland surgery/radiotherapy, is

desirable (from the patients’ perspective)

feasible and signifi cantly reduces treatment

related side-eff ects (Ahmed et al, 2011).

� e challenge is to make mp-MRI

information usable to clinicians of all

skill levels for targeting both biopsies and

treatment. We anticipate that the enabling

technology of image fusion/registration will

both transform the diagnostic arena and

also open up the fi eld of focal (as opposed to

whole-gland) therapy.

� e potential benefi ts of such an approach

are: fewer biopsies, better biopsies, better

risk stratifi cation and more appropriate

treatment allocation.

References

Vickers A, Savage C, Bianco F, Mulhall 1.

J, Sandhu J, Guillonneau B, Cronin A,

Scardino P. Cancer control and functional

outcomes after radical prostatectomy as

markers of surgical quality: analysis of

heterogeneity between surgeons at a single

cancer center. Eur Urol. 2011 Mar;59(3):317-

22. Epub 2010 Nov 10.

Dickinson L, Ahmed HU, Allen C, 2.

Barentsz JO, Carey B, Futterer JJ, Heijmink

SW, Hoskin PJ, Kirkham A, Padhani AR,

Persad R, Puech P, Punwani S, Sohaib

AS, Tombal B, Villers A, van der Meulen

J, Emberton M. Magnetic resonance

imaging for the detection, localisation,

and characterisation of prostate cancer:

recommendations from a European

consensus meeting. Eur Urol. 2011

Apr;59(4):477-94. Epub 2010 Dec 21.

Ahmed HU, Freeman A, Kirkham A, 3.

Sahu M, Scott R, Allen C, Van der Meulen

J, Emberton M. Focal therapy for localized

prostate cancer: a phase I/II trial. J Urol.

2011 Apr;185(4):1246-54. Epub 2011 Feb 22.



EU Health Special

Prostate Cancer in Europe: SANOFI�s ViewBy Debasish Roychowdhury, SVP and Head of SANOFI’s Global Oncology Division

Cancer of the prostate (PCa) is now recognized as one of the most important medical problems facing the male

population. In Europe, PCa is the most common solid neoplasm, with an incidence rate of 214 cases per 1000 men. Furthermore, PCa is currently the second most common cause of cancer death in men. (Ref EAU 2010 guidelines). Prostate cancer aff ects mostly elderly males and is often associated with co-morbidities. � ere has been a dearth of new treatments approved over the last few decades to tackle this growing health problem in an aging population.

� e natural history of prostate cancer has often an indolent clinical course. Nevertheless, the majority of patients have clinically signifi cant disease requiring therapy. While screening for breast cancer with mammography is widely encouraged by governmental programs in the European Union (EU), screening for prostate cancer with prostate-specifi c antigen (PSA) tests, although often encouraged by physicians, is not part of governmental screening programs. ERSPC (European Randomized Study of Screening for Prostate Cancer) study has shown that PSA-based screening reduced the rate of death from prostate cancer by 20% but was associated with a high risk of over treatment.

In men with localized PCa and a life expectancy > 10 years, the goal of treatment by any approach (surgery or radiotherapy) must be eradication of disease. In advanced metastatic PCa, hormonal therapy (androgen deprivation) is the standard therapy, but does not cure the patient. Until the mid-90’s, PCa was considered resistant to systemic chemotherapy; mitoxantrone had been used for disease palliation but did not result in a survival benefi t. � e completion of the large sanofi -aventisTaxotere pivotal study in 2004 (TAX327) provided for the fi rst time a signifi cant improvement of the survival of patients with PCa treated with systemic chemotherapy. � e recent approval of new treatments (eg. Cabazitaxel, Sipuleucel-T) heralds the opportunity to translate this progress in technology development to the benefi t of patients. However, logical combinations and sequences are needed to improve outcomes and move closer to a cure and sanofi -aventis is actively collaborating with the research community to address these questions. It is self-evident from our understanding of cancer biology that multiple concomitant therapies will be required to cure prostate cancer or transform it into a chronic disease. � e neoadjuvant setting provides the ideal opportunity to combine multiple modalities (anti-androgen therapy, radiation and cytotoxic chemotherapy) to target the stem cells as well as a micrometastatic disease. � is setting also aff ords the opportunity to correlate the biology of the disease with outcomes and validate prognostic and predictive markers. Studies in the neoadjuvant setting

and early disease settings will be long and likely to be confounded by cross-over downstream unless the research community can validate a surrogate, for example disease (or metastasis) free survival. Patients with advanced stage castrate resistant prostate cancer stand to benefi t from the availability of the newly approved chemotherapy, Jevtana (cabazitaxel), the newly approved vaccine, Provenge (sipuleucel-T), and the novel hormonal therapy, abiraterone, which is currently under review by the EMA. � e challenge facing clinicians is how to use the treatments optimally. Identifi cation of subsets of castrate-resistant tumors, via gene-expression CTC studies, that continue to be sensitive to androgen receptor (AR) or that are AR insensitive will allow for individualization of care. � ere is preliminary data to show correlation of AR insensitive cells with the SRC kinase pathway, suggesting alternative strategies in this group of patients. � e survival of castrate resistant cancer cells is dependent on regulation of several essential survival pathways and suppression of apoptosis. � ese include PI3-kinase/AKT/mTOR signaling pathway. Here too the availability of targeted agents makes it possible to evaluate the impact of targeting this survival pathway utilizing novel-novel combination studies. SANOFI is committed to research and development in PCa, working with the academic and healthcare community, through more basic understanding of the disease and better target validation, chemistry as well as diagnostics. Effi ciencies will be realized through the ongoing co-development of drugs such as Jevtana and abiraterone as well as inclusion of novel pipeline targeted pathway agents (eg. PI3K inhibitors). SANOFI is incorporating translational components in its clinical trials and also exploring antibodies and miRNAs as well as novel hormonal agents.

Other barriers to advancement in PCa include issues relating to a better representation of target population in clinical trials and the absence of a surrogate for overall survival. Restrictions on enrollment of senior adults (>70 years of age) in the recruitment of clinical trials, either directly by restricting the age limit or indirectly by protocol exclusions for comorbidities or poor performance, has limited data accrual on treatment in this patient population. SANOFI is actively engaged with experts in this fi eld to raise awareness of this matter and the distinction between chronological versus biological age. In general, assessing the therapeutic response in PCa has been a challenge. Treatment can be assessed using the guidelines for the evaluation of treatment response in solid tumors, RECIST (Response Evaluation Criteria In Solid Tumors), however, 80-90% of PCa patients do not have bi-dimensionally measurable disease. Many studies use PSA as a marker of response, even though there is no consensus about the magnitude and duration of a decline in PSA level that constitutes a clinically signifi cant response.

Measurement of serum PSA and PSA dynamics

(doubling time) correlate with the progression

of the disease. � e evaluation of molecular

markers of disease response is just beginning.

A validated intermediate end-point for overall

survival is lacking; this remains one of the critical

impediments to drug development.

� ere is a growing body of evidence to suggest

that circulating tumor cells (CTCs) are of

predictive value in advanced disease and may

prove to be a surrogate for overall survival.

Identifi cation of a valid surrogate for overall

survival has the potential to accelerate the

development of the many novel agents that

have become available for evaluation in clinical

trials for the treatment of this disease. Studies

have shown that circulating tumour cells (CTC)

and tumour DNA are commonly found in the

peripheral blood of cancer patients. Advanced,

metastatic, prostate cancer patients have much

higher levels of these than patients with other

solid tumour types. Furthermore, studies have

shown that these both have prognostic utility

with higher levels associating with poor outcome.

Moreover, changes in these circulating biomarkers

following treatment associate with response to

treatment. SANOFI has included correlative

sub-studies to its large clinical trials to enhance

the understanding of and the validation of this

technology and enable approval and patient access

to new treatments.

Treatment decisions for patients with PCa are

today based on information derived by clinical

and histopathological staging, and are evolving to

include assessment of serum markers. � e advent

of newer diagnostic technologies are needed to

gather data at genomic and transcriptional level

with the goal of making individualized medicine a

reality. � e variation in genotype and phenotype

and the impact of these on treatment planning

is only beginning to be unraveled. � is is now an

area of active research.

� e needs of the patient with prostate cancer are

challenging and multifaceted. We support the

initiative of the European School of Oncology (1) to clarify best-practice and recognize the

importance and contribution of research.

Progress in advancing the outcomes for patients

with prostate cancer is dependent on eff ective

collaboration, both multi professional (Doctors,

Nurses, Pharmacists, support staff ) as well as

multi-stakeholder (Patient Advocacy Groups,

Academic Medical Units, Pharmaceutical

Companies, Governments). We believe the

unique capabilities and expertise in the EU can

contribute towards advancing progress in the

management of PCa.

(1) Valdagni R et al European Journal of Cancer

47(2011) 1-7



EU Health Special

Prostate Cancer and Stem Cells

By Professor Dr Maurizio Pianezza, Senior Medical O� cer in General Surgery at Genoa’s Azienda Ospedale Università San Martino

In the physiological preservation of

biological balance, tissues renew by

means of stem or stem-like cells.

� us, during the diff erentiative processes

aimed at the confi guration of the tissue,

there is a sequence of mother stem cells,

daughter stem cells – lacking the unlimited

number of replications – and T.A.Cs

(Transit Amplifying Cells), until structural

completion. � erefore, it is possible that the

etiology of a disease should be investigated

in the "stem damage" that is transmitted

from the mother stem cell up to the

diff erentiated cell.

As regards its etiology, cancer is a disease

that should be considered as a stem damage

that is transmitted up to the fi nal tissue.

� is paradigm, in the specifi c case of

prostate cancer, has allowed us to identify

cancer stem cells thanks to membrane

receptors such as cluster of diff erentiation

133, cluster of diff erentiation 117, cluster of

diff erentiation 44, cluster of diff erentiation

166 and cluster of diff erentiation 200.

However, these membrane protein

structures – that have allowed us to identify

cancer stem cells in the prostate cancerous

tissue – did not represent a potential

reference for therapeutic purposes, at least

for the time being.

Cancer stem cells receptors are still under

study but we know that their pathological

mechanism is triggered by altered regulation

rather than by a pathological structural

isoform. What we have known for a long

time is that stem cells, most likely including

the cancer ones, can be subject to changes

in their biological function by operating

on the nuclear receptors. � is information

is confi rmed by the fact that, during

pregnancy, the mother sends endocrine-

metabolic signals that can aff ect the fetal

stem cells.

Prostate cancer, whose etiology depends

on a mutated stem cell, is also subject to

these biological rules. � us, when starting

a therapeutic treatment – currently tested

on some cases of prostate cancer resistant

to therapies – it is necessary to consider

that, as the target is the cancer stem cell

for biological healing, there may be several

endocrine-metabolic issues triggered by the

prostate cancer to preserve its biological

expression.

In unsuccessfully treated hormone-resistant

prostate cancer and neuroendocrine prostate

cancer, the evaluation of the appropriate

laboratory data can show an estrogenization

with related increase of the aromatase

function, which – if appropriately inhibited

– can aff ect the progress of the disease. A

careful study of the endocrine-metabolic

structure caused by the cancer stem cell can

therefore represent an additional way to

fi ght prostate cancer.

Another important aspect, always aiming

to aff ect the nuclear receptors featured in

the prostate cancer stem cell, is the use of

retinoic acids and vitamin D.

� e receptors of these molecules, as their

DNA is similar to their central zone, if

activated, can induce a diff erentiative,

pro-apoptotic, non caspase-dependant

process. � e receptors for retinoids are

RAR (Retinoic Acid Receptor) and XRX (X

Receptor X), while for vitamin D is VDR

(Vitamin D Receptor). It is important to

point out that these receptors dimerize in

the following ways to activate: RAR/RAR,

RAR/XRX,XRX/XRX, but also RAR/VDR

and XRX/VDR, thus a therapeutic approach

should consider this characteristic in order

to appropriately activate all the genomic

processes aimed at apoptosis.

Another mechanism to consider is the

epigenetic action of some molecules such

as sodium phenylbutyrate, valproic acid

and vorinostat that, by acting on class 1 and

2 histones with the inhibition of histone

deacetylase (HDAC), can favorably aff ect

the genome reading, with a less malignant

phenotypic expression. As a matter of fact,

the genome expression is aff ected by the

proteins of the histone octamer and their

binding variations.

� is knowledge provides us with one sure

fact: the treatment of prostate cancer can

make use of more strategies than those

already implemented. In order to do this,

it is necessary to have a new approach that

can be initially applied to patients suff ering

from prostate cancer after the unsuccessful

treatment with offi cial non-palliative

therapies.

� is new therapeutic approach could also be

applied to patients under strict monitoring,

considering that only one prostate cancer

out of three can be of clinical interest.

� e success of these treatment methods

could have a signifi cant impact on health

economy, in terms of both the sequelae

suff ered from the patient for the surgical and

radiotherapeutic approach to the disease and

costs paid by the health facilities.

� is need is confi rmed by statistical data

at European level showing that countries

like Finland, with 120 cases of prostate

cancer in a population of 100,000,000, have

the same mortality rate as Poland, with 50

cases of prostate cancer in a population of

100,000,000. In clinical practice, this means

that the current measures have signifi cant

limits against a biologically aggressive

prostate cancer.



EU Health Special

Astellas PCa Viewpoint: Standing Still or Moving Forward?By Edwina Baskin-Bey1, Frank Perabo2, Sue Jones1, Kevin Hartley2, Stephan Holmstrom2 and Steve van Os2

An industry viewpoint

The current

focus of the

pharmaceutical

industry’s development

of prostate cancer (PCa)

drugs is on patients

with advanced disease,

i.e. castration-resistant

PCa (CRPC), where

the number of aff ected

patients is far lower

than in the overall PCa

patient population,

but where the unmet

medical need is perceived

to be the greatest.

� e rationale that has

led CRPC patients to

become the principal

targeted group for PCa

drug development is

multifactorial. � e

considerations for drug

companies that appear to

be the most persuasive

include, but are not

limited to, the following:

Advanced metastatic end-stage disease may aff ord a shorter time 1.

period in which to demonstrate an improvement in overall survival;

such an improvement is usually required by European Regulatory

Authorities for PCa drug approvals (except for luteinising hormone

releasing hormone analogues).

Regulatory authorities’ and ethics committees’ expectations that 2.

safety and effi cacy will be demonstrated in advanced disease prior to

clinical studies in earlier disease.

Higher assumed interest for payers in drug therapies that prolong 3.

life, and consequently a more robust reimbursement scenario.

� e push to provide therapeutic options for patient groups that 4.

have the greatest unmet medical need.

Although historically and medically understandable, it may be

diffi cult for the pharmaceutical industry to continue to think in

these terms, because this will result in perpetual investigation of

new therapies only in the segment of advanced disease. In order

for us to advance PCa drug development, we may need to answer

some diffi cult and awkward questions that challenge the rationale

set out above. For instance, does the CRPC patient population

actually represent the greatest unmet need in PCa? Could patients

with less advanced PCa and a longer life expectancy have a greater

clinical need? Can drug therapy potentially cure PCa? Are disease

progression or quality of life important determinants of the value of a

drug for the treatment of earlier stage PCa?

With the current expectation of an improvement in overall survival for a drug to be considered for regulatory approval, investigating therapies for registration in earlier stage PCa is a daunting prospect for the pharmaceutical industry. Despite an indisputably larger patient population with a considerable need for life-prolonging and life-improving therapies, the focus of development is currently elsewhere. � is is disappointing, because while patients with earlier stage disease may have a lower risk of imminent death from PCa, they certainly have a greater chance of enjoying the long-term benefi ts of drug therapies, for even 10 years or more. To take this idea a step further, it may be hypothetically possible for some PCa patients to benefi t from a medicinal ‘cure’ for their disease, and potentially take back their lives and never reach the advanced stages of CPRC. If this ultimate goal cannot be attained, then disease stabilisation with minimal impact on quality of life certainly should be valued alongside overall survival. However, it is not clear how the pharmaceutical industry can target these patients with the current framework of PCa drug development. Without a fundamental change to the approach, the spotlight of developmental focus will not broaden, and consequently, many patients may continue to lose out.

While new agents become available in CRPC, there should also be a move towards making the required transformations in the treatment of PCa as a whole. � e pharmaceutical industry longs for the opportunity to provide quality treatments to all patients with PCa, but to do so we need to work with appropriate government bodies, health authorities, and payers, to redefi ne the benefi ts that are valued in a PCa drug.

1 Astellas Pharma Europe Ltd.2 Astellas Pharma Global Development, Europe

©iStockphoto.com/DNY59



EU Health Special

The Future Still Holds the Most Promising Issues for Prostate CancerBy Dr Antoine Abi-Aad, M.D.,Urology, Parc Leoplod Clinic, Belgium

Indentifying the Etiologic or the risk factors that induce prostate cancer, one of the most frequent cancers in man, would be an important step to start with!

� e worldwide variation of the incidence and mortality of prostate cancer, with the highest rates in North America and the lowest in Asian Countries and Japan strongly suggests that multi – factorial elements such as congenital grounds, environment and diet play a crucial role in the development of the carcinogenic process.

Many investigations are currently ongoing in order to reduce the incidence of prostate cancer. Chemoprevention with pharmacologic molecules, introduction of diff erent dietary nutrients and supplements are in-depth-research.

We need to defi ne the high-risk groups in whom primary prevention would be recommended so as to escape from a life-threatening disease.

Unfortunately, none of the diagnostic tools which are available at the present time are perfect. Signifi cant numbers of patients still have unnecessary biopsies.

� ere is an urgent need, which must be emphasized to all interested parties to develop and acquire a more reliable set of systems and procedures.

New diagnostic tools include Blood tests (such as a more reliable PSA – prostate specifi c antigen), Urine compounds (PCA3….)

Genetic marker(s) or applying new Imaging modalities (sophisticated ultrasound or MRI studies…).

Once prostate cancer is detected, is treatment mandatory?. We all know that not all men diagnosed with prostate cancer will die because of the disease.

A key element is to avoid overtreatment of indolent prostate cancer. � is can be achieved with a reliable and strong prognostic database.

Future research should be focused on designing a patient cartography or mapping that can diff erentiate between latent prostate cancer and the aggressive and lethal disease.

What should we expect for better treatment management?

Minimally invasive ablative treatment, focused high radiation therapy and Cryotherapy still require fi rm proofs before they can be widely recommended.

� e best treatment option is the non or less invasive with the lowest side eff ects and the greater chances of cure. It also must be aff ordable for society as a whole.

Finding the etiologic factors, reducing the incidence, better diagnostic studies, and defi ning objective prognostic materials will all contribute to a better approach in the fi eld of prostate cancer.

A long, costly and huge amount of scientifi c work is still need to be accomplished

©iStockphoto.com/jamesbenet



EU Health Special

Despite signifi cant advances in the diagnosis and treatment

of prostate cancer, the disease remains the second-most

frequently diagnosed cancer and one of the leading causes

of cancer-related death in men around the world, according to the

International Agency for Cancer Research(1). Approximately 90

percent of men with castration resistant prostate cancer (CRPC)

have radiological evidence that the cancer has metastasized, or

spread, to the bone(2). In men with CRPC, bone metastases are the

main cause of disability and death.

Currently, there is a signifi cant unmet medical need for prostate

cancer patients, especially for those with advanced disease who

have experienced bone metastases. Men living with CRPC may

experience debilitating pain secondary to bone metastases that

require management with opiates, external beam radiation therapy

and a variety of other palliative measures. � is is why the discovery

of new, approved and eff ective treatments to address this burden on

the patient is so critical.

� e fi ght against cancer has been rightly placed at the top European

political agenda in recent years, culminating with the launch of the

European Partnership for Action against Cancer by the European

Commission in 2009, which promotes the sharing of experiences

in cancer prevention and control across Member States and

stakeholders.

Prostate Cancer in Europe: Bayer�s View

Like with most common cancers, the outcome for prostate cancer

patients has signifi cantly improved due to advancements in

diagnostic methods, the development of surgical techniques and

through the development of innovative drug therapies.

From a policy perspective, Bayer believes it is important to ensure

that the right framework is in place to support continued innovation

and better prevention of cancer as well as enhance patient access to

treatment across Europe.

Bayer is committed to advancing the science of cancer and

translating this science into therapies that can help people live

longer. To this end, in September 2009, Bayer entered into a global

agreement with Algeta ASA, Oslo, Norway for the development and

commercialization of an investigational compound being evaluated

as a treatment option for patients with castration-resistant prostate

cancer and bone metastases. As it advances collaborations such as

this one, Bayer seeks to improve treatment and overall care of cancer

patients.

(1) International Agency for Cancer Research. Globocan Cancer

Fact Sheets: Prostate Cancer. Available at: http://globocan.iarc.fr/

factsheets/cancers/prostate.asp. Accessed on May 11, 2011.

(2) Sartor O. Radiopharmaceutical and chemotherapy combinations in

metastatic castrate-resistant prostate cancer: a new beginning. JCO.

2009;15:2417-2418.©iStockphoto.com/wragg


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