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From Bench to Bedside: Promoting Better Health Outcomes for Men with Advanced Prostate Cancer

Submitted by on 06 Oct 2011 – 11:30

From Bench to BedsideDr Ken J. Lee, Head of Medical Affairs Oncology Region Europe/Canada, Bayer

Today, significant advances in basic and clinical medicine have resulted in new clinical options for men living with castration-resistant (hormone-refractory) prostate cancer (CRPC).  Several new classes of treatments have either been approved for use or are under review by the European Medicines Agency. In addition, a number of other agents are in late stages of development promising to yield additional safe and effective options. Investment in basic and clinical research by government agencies, industry, and other funders is at a respectable level, and responsive legislative and regulatory policies will ensure that the European Union remains an attractive place to conduct clinical research. To ensure that men living with CRPC have access to the care they need, engagement of a broad group of stakeholders to support optimal care for this population is required.

Only months ago, docetaxel was the main treatment option for CRPC. Now, a larger number of newer compounds including but not limited to an immunotherapeutic agent, an oral androgen biosynthesis inhibitor, and a new chemotherapeutic agent may be used by medical professionals in appropriate patients. These new agents fill a gap in prostate cancer care but raise a complex question of how to ensure optimal outcomes for these patients.

Bayer HealthCare is active in the development of new innovative compounds for prostate cancer. Radium 223 chloride, exclusively licensed from Algeta ASA, is an investigational pharmaceutical agent containing an alpha-particle emitting nuclide in development for prostate cancer patients with bone metastases. Approximately 90 percent of men with CRPC have radiological evidence of bone metastases. Once cancer cells settle in the bone, they interfere with bone strength, often leading to bone pain, fracture and other complications that are the main cause of disability and death in patients with CRPC. The Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial evaluating radium 223 chloride in patients with CRPC and symptomatic bone metastases was recently stopped after meeting its primary endpoint of significantly improving overall survival at a pre-planned interim analysis. This compound, with its unique mechanism of action, may address an unmet need for an agent that can address the tumor when it has spread to the bone.

The continuum of care for men living with CRPC requires an integrated system of service and treatment delivery. Initial diagnosis usually begins with a primary care physician or a geriatrician. An abnormal finding in the clinical examination or blood tests such as the PSA may lead to a referral to an urologist or oncologist for further investigation and treatment. If a patient’s disease has progressed to CRPC, a specialised care plan should be developed. With a high incidence and prevalence of CRPC in older men, the coordinated care approach is not always followed throughout Europe. Symptoms may be ignored or disregarded as a result of a patient’s age or because of access barriers including the high cost of care, geographic location, or other factors.

Men with CRPC and their families deserve greater awareness, education and collaboration amongst all health authorities and healthcare professionals. Where appropriate, they should be able to access or enroll in clinical trials of new and innovative medicines. Bayer HealthCare wants to be a part of this effort to ensure that men with prostate cancer benefit from improved diagnosis, support, treatment, research and appropriate access to state-of-the-art medical care.

This is a new era for innovation in prostate cancer treatment. The European Union needs to prepare itself for the impact of a growing number of new therapeutic options for men with CRPC. Basic and clinical scientists, patient advocates, policy makers, and the pharmaceutical industry can ensure the optimal use of new treatments for CRPC by engaging in a positive, open and constructive dialogue about clinical endpoints, considering innovative trial designs, and ensuring thorough and rapid review of promising experimental compounds. Healthcare professionals play a vital role in coordinating care and participating in dialogue to ensure patients’ needs are met. Bayer HealthCare stands ready to work together with all stakeholders to ensure alignment around appropriate responses to this complex disease, the needs of the patient, and the data needed to make intelligent decisions about improving the care of men living with CRPC.