CasodexTM (bicalutamide 50mg) in Combination Therapy for Prostate Cancer Reduces Risk of Death by 20%

Main Category: Cancer / Oncology
Article Date: 06 Jun 2004 - 24:00 PDT


CasodexTM (bicalutamide 50mg) in Combination Therapy for Prostate Cancer Reduces Risk of Death by 20%, Compared to Castration Alone

News from the 40th Annual meeting of the American Society of Clinical Oncology (ASCO)

New Orleans, 6 June 2004: More men with advanced prostate cancer look set to be offered combination hormone treatment as a result of new data presented today. The data show a potential significant reduction in risk of death by 20% (95% CI, 2% to 34%) for prostate cancer patients, achieved by adding the non-steroidal anti-androgen 'Casodex' (bicalutamide 50mg) to a luteinizing hormone-releasing hormone agonist (LHRHa), compared to castration alone.1 In addition, the improvement in side effects of the treatment could make it more acceptable than earlier combinations which were less well tolerated.

"The results from this new reassessment of the data suggest that combination therapy using bicalutamide 50mg may provide benefits beyond other (over older) anti-androgen combinations for patients with metastatic prostate cancer", said Dr Paul Schellhammer, Program Director of the Virginia Prostate Center and Professor of Urology, Eastern Virginia Medical School, Virginia, USA, and one of the study authors.

He went on to say: "This data should stimulate physician reassessment of combination therapy as it suggests that bicalutamide in addition to castration may provide a survival benefit and an improved tolerability profile."

Data from this reassessment provides an indirect comparison of 'Casodex' 50mg in combination with castration versus castration alone, using two sets of published data. The first comprises evidence from the Prostate Cancer Trialists' Collaborative Group (PCTCG),2 a meta-analysis of 27 trials with a total of 8,275 patients, which was published in the Lancet. The second is data published by Dr Schellhammer in the journal Urology3 from a large randomised, multicentre trial comparing bicalutamide and flutamide combination therapies. This demonstrated a 13% (p = 0.15) but not significant decrease in the risk of death with the 'Casodex' combination, compared with the flutamide combination. The 'Casodex' combination was also better tolerated with a significantly lower incidence of diarrhoea than with the flutamide combination.

Thus the study authors conclude that there is a 98.5% probability that 'Casodex' 50mg in combination with an LHRHa provides a survival advantage over castration alone,1 and that the best estimate of the effect is a 20% reduction in the risk of death.

Dr Laurence Klotz, Professor of Surgery at University of Toronto, Sunnybrook & Women's College Health Sciences Centre, Canada, and another of the study authors comments: "Combination therapy usage differs greatly across the world, with up to 60% of all prostate cancer patients in Japan receiving combination therapy versus limited usage in many European countries. This disparity predominantly stems from the fact that patients poorly tolerated early combinations and there was little evidence to support the newer, better-tolerated treatments. However, the reassessment data confirming that bicalutamide may offer patients benefits in terms of survival should help give physicians the confidence to try combination therapy again in those patients in which it is appropriate."

He also added: "The 20% improvement in mortality translates into a 8-12 month survival benefit in patients with metastatic disease, and possibly more in men with non-metastatic disease. This is highly clinically significant, and compares very favourably in terms of cost per month of survival to the benefit achieved by many standard chemotherapeutic regimens used for advanced cancer."

When physicians are considering the treatment components of combination therapy, they should take into account the lifestyle of the patient and choose treatments that appropriately balance tolerability and survival in the context of individual patients. Demonstration of a 20% reduction in the risk of death suggests a valuable treatment for patients with advanced disease.

Mr John Page, President/CEO of Us TOO International Prostate Cancer Education and Support Network, Illinois, USA, said: "Any treatment option that has the potential to offer patients with advanced prostate cancer an opportunity to extend their lives and look to a more hopeful and positive future with their families and friends without a significant degradation in quality is certainly welcomed."

:End:

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

Methodology

The new data1 combines two existing data sets to calculate an estimate of the likely survival benefit of 'Casodex' 50mg in combination with an LHRHa over castration alone, by multiplying the hazard ratio for the 'Casodex' vs flutamide combination from Schellhammer, with the hazard ratio from the flutamide combination vs castration alone. A hazard ratio for the benefit of 'Casodex' is obtained which equates to a 20% reduction in the risk of death for Casodex plus castration vs castration alone. This methodology has been applied in other oncology areas e.g. colon cancer4 and was utilised during the FDA approval for capecitabine.

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 top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

1. Klotz L et al. Bicalutamide combination therapy versus castration alone: a combined analysis of historical data. Presented at ASCO, New Orleans, USA, 2004. Br J Urol 2004; In Press.
2. Prostate Cancer Trialists' Collaborative Group. Lancet 2000; 355:1491-1498.
3. Schellhammer P et al. Urology 1997; 50: 330-336.
4. Rothmann M et al. Am Heart Journal 2001; 141: 26-32.

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