The Pharmaceutical Journal
Vol 269 No 7211 p207
17 August 2002

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Journal of Urology (www.jurology.com)

Bicalutamide shows promise as early treatment in prostate cancer

Immediate treatment with bicalutamide (Casodex) reduces the risk of tumour progression in patients with localised or locally advanced prostate cancer, an ongoing study suggests (Journal of Urology 2002;168:429). The results, presented earlier this year at a European Association of Urology meeting, show that the drug also reduces the risk of bone metastases by a third.

Dr William See and colleagues from the Casodex early prostate cancer trialist group analysed data from three ongoing, double-blind trials in which 8,113 patients were randomised to receive either bicalutamide 150mg daily or placebo, in addition to standard care (radical prostatectomy, radiotherapy or watchful waiting).

Results from the three trials show that 363 patients (9.0 per cent) in the bicalutamide group showed evidence of clinical progression compared with 559 patients (13.8 per cent) in the standard care alone group (hazard ratio 0.58, 95 per cent confidence interval 0.51–0.66, P<0.0001). The researchers comment that reductions in disease progression were seen across the entire patient population, irrespective of primary treatment or disease stage. However, they say that benefits of reduced disease progression must be balanced with morbidity associated with long-term hormonal therapy.

The researchers found that the incidence of bone metastases was reduced by 33 per cent in patients treated with bicalutamide (214 events compared with 321 events in the standard care alone group). No difference between the two groups was observed in terms of survival. The researchers comment that it is important to demonstrate a direct survival benefit of early treatment because differences in time to progression do not necessarily translate into improved survival. However, they say that the lack of improvement was probably due to the fact that relatively few deaths (6 per cent) had occurred and that only some had been related to prostate cancer (<2 per cent).

The most frequently reported adverse events in the bicalutamide group were gynaecomastia plus breast pain (53.1 per cent), breast pain alone (19.7 per cent) and gynaecomastia alone (13.1 per cent). Each was reported by less than 5 per cent of standard care patients. The incidence of hot flushes, decreased libido and impotence was relatively low, say the researchers.