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Annals of Oncology 15:974-978, 2004
© 2004 European Society for Medical Oncology

Original Paper

Finasteride and bicalutamide as primary hormonal therapy in patients with advanced adenocarcinoma of the prostate

Received 1 October 2003; revised 30 January 2004; accepted 3 February 2004

Background:

Medical or surgical castration is effective in advanced prostate cancer but with profound side-effects, particularly on sexual function. Effective, less toxic therapies are needed. This study examined whether the addition of finasteride to high-dose bicalutamide enhanced disease control, as measured by additional decreases in serum prostate-specific antigen (PSA).

Patients and methods:

Forty-one patients with advanced prostate cancer received bicalutamide (150 mg/day). Finasteride (5 mg/day) was added at first PSA nadir. Serum PSA was measured every 2 weeks until disease progression. Questionnaires were administered to assess sexual function.

Results:

Median follow-up is 3.9 years. At the first PSA nadir, median decrease in PSA from baseline was 96.5%. Thirty of 41 patients (73%) achieved a second PSA nadir and median decrease of 98.5% from baseline. Median time to each nadir was 3.7 and 5.8 weeks, respectively. Median time to treatment failure was 21.3 months. Toxicities were minor, including gynecomastia. Seventeen of 29 (59%) and 12 of 24 (50%) men had normal sex drive at baseline and at second PSA nadir, respectively. One-third of men had spontaneous erection at both time points.

Conclusion:

Finasteride provides additional intracellular androgen blockade when added to bicalutamide. Duration of control is comparable to castration, with preserved sexual function in some patients.

M.-H. Tay1, D. S. Kaufman2, M. M. Regan3, S. B. Leibowitz1, D. J George1, P. G. Febbo1, J. Manola3, M. R. Smith2, I. D. Kaplan4, P. W. Kantoff1 and W. K. Oh1,*

1 Lank Center for Genitourinary Oncology, Division of Solid Tumor Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA; 2 Department of Medical Oncology, Massachusetts General Hospital, Boston, MA; 3 Department of Biostatistical Science, Dana-Farber Cancer Institute, Boston, MA; 4 Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA

Key words: bicalutamide, finasteride, prostate, potency


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