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New published data - prostate cancer

02.02.2006


New published data show that bicalutamide (Casodex) 150mg plus radiotherapy significantly extends survival in men with locally advanced prostate cancer compared to radiotherapy alone



New data published in the February 2006 edition of the British Journal of Urology International (BJUI) confirm that bicalutamide 150mg improves the chance of survival by 35 per cent (hazard ratio = 0.65; 95% CI = 0.44 to 0.95, p = 0.03)1 in men with locally advanced prostate cancer (when the disease has spread into the capsule of the prostate or through the prostate into the surrounding tissue) when given bicalutamide 150mg as adjuvant to radiotherapy compared to radiotherapy alone. Bicalutamide 150mg is the only anti-androgen for which this has been shown.1

Also the data from the largest ever treatment study in prostate cancer show that in locally advanced disease, bicalutamide 150mg adjuvant to radiotherapy or radical prostatectomy reduces the risk of disease progression by 31 per cent (hazard ratio = 0.69; 95% CI = 0.58 to 0.82, p < 0.001) leading to a significant survival benefit of 35 per cent when used as adjuvant to radiotherapy.1, In addition, in men with locally advanced prostate cancer, when bicalutamide 150mg was given as monotherapy (alone) there was a 40 per cent reduction in risk, which extended survival free of progression by a median of 2.9 years, showing a trend towards improved survival.2


Commenting on the data, Dr Heather Payne, Consultant in Clinical Oncology, Middlesex Hospital, London stated: "A diagnosis of prostate cancer is truly devastating for the patient. A treatment that both extends a patient’s life and delays the recurrence of the disease whilst maintaining a man’s quality of life is the ultimate goal when managing this condition. This new data from the EPC Trial Programme demonstrates that bicalutamide 150mg meets these vital needs and will have this effect for men with locally advanced prostate cancer."

Results also confirm that treatment with bicalutamide 150mg significantly reduces the risk of bone metastases by 36 per cent in men with locally advanced prostate cancer compared to watchful waiting and by 23 per cent when added to radiotherapy or radical prostatectomy alone.2 Bone metastases are a symptom of disease progression and can include bone and back pain that can cause difficulty in walking and carrying out other daily activities and in more advanced cases can lead to spinal cord compression. By delaying disease progression, bicalutamide 150mg helps men with locally advanced prostate cancer to maintain an active lifestyle.

Patients with locally advanced prostate cancer have a significant risk of their disease progressing, seriously impacting quality of life. Therefore, therapies that improve progression-free survival whilst allowing patients to maintain a normal lifestyle are vital in managing the disease. In addition to improving progression-free survival, bicalutamide 150mg alone demonstrates equal efficacy to castration and provides patients with significant quality of life benefits. Compared with castration, bicalutamide 150mg provides better maintenance of physical capacity and sexual interest.3, Bicalutamide 150mg also maintains bone mineral density, which is lost with castration and is associated with an increased risk of fractures.

The EPC Trial Programme has followed 8,113 patients for an average of 7.4 years in 23 different countries. Patients will continue to be followed up for both disease progression and survival for a minimum period of 10 years after the last patient was enrolled into the study. The 3rd Analysis of the EPC Programme gives additional confirmation that bicalutamide 150mg is a proven treatment option for men with locally advanced prostate cancer delaying disease progression.

In the UK, bicalutamide (Casodex) 150 mg is indicated for patients with locally advanced prostate cancer (T3-T4, any N, MO; T1-T2, N+, MO). Bicalutamide (Casodex) 150mg is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. Bicalutamide (Casodex) 150mg is also indicated for the management of patients with locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

Rosie Allan | alfa
Further information:
http://www.bjui.org
http://www.hillandknowlton.com

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