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Bicalutamide 150mg plus standard care vs standard care alone for early prostate cancer.
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Authors:
McLeod DG, Iversen P, See WA et al
Journal:
BJU Int Dec 2005 - online edition.
Bicalutamide 150mg (Casodex - AstraZeneca) once daily as an addition to standard care for localized or locally advanced non-metastatic prostate cancer is being compared with placebo in the ongoing Early Prostate Cancer (EPC) programme. This is the largest study (n=8111) conducted in prostate cancer, with overall survival and objective progression free survival (PFS) being the primary end-points. The third analysis data, with 7.4 years of median follow-up are presented.
In patients with locally advanced disease (T3-4, any N; or any T, N+), bicalutamide 150mg as adjuvant therapy to radiotherapy significantly improved objective PFS (p<0.001) and overall survival (p=0.03).This difference is driven by a lower risk of prostate cancer-related deaths. The magnitude of this benefit i.e. a 35% reduction in the risk of death is similar to that observed in the RTOG 85-31 trial in which adjuvant goserelin significantly reduced the risk of death by 23% (p=0.001). With respect to bicalutamide 150mg as adjuvant therapy to radical prostatectomy, whilst to date there is no significant difference in overall survival (p=0.59), objective PFS was significantly improved (p=0.004).
In patients who would have been managed by watchful waiting, treatment with bicalutamide 150mg significantly improved objective PFS (p<0.001) and there was a trend towards better overall survival (p=0.06), driven by a lower risk of prostate cancer-related deaths.
In patients with localized disease (T1-2, N0/Nx) there is no significant difference in objective PFS or overall survival compared to placebo, when bicalutamide 150mg was added to standard therapy. The authors therefore suggest that bicalutamide 150mg should not be used as immediate therapy for patients with localised prostate cancer.
As seen in earlier analyses, bicalutamide 150mg was found to have acceptable tolerability and although gynaecomastia and breast pain are the most frequent pharmacological effects they are generally mild to moderate in >90% of cases. Other adverse events including impotence, hot flushes and decreased libido were similarly infrequent in both treatment groups. When viewed against the tolerability profiles of castration/orchidectomy and other anti-androgens, the good tolerability profile of bicalutamide means that it may be attractive to men wishing to maintain their lifestyle.
The authors conclude that adding bicalutamide 150mg to standard care provides significant benefits in patients with locally advanced disease, but patients with localized disease do not appear to benefit.
View the full publication at www.Blackwell-Synergy.com
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