Analysis of results of bicalutamide monotherapy versus castration in patients with non-metastatic locally advanced prostate cancer during 6.3-year follow-up
https://doi.org/10.17650/1726-9776-2008-4-1-48-54
Abstract
Objective. Monotherapy with nonsteroid antiandrogens may be used in a number of patients with advanced prostate cancer (PC). We present the results of analysis of survival and safety of treatment in patients with nonmetastatic (M0) locally advanced PC treated with bicalutamide, 150 mg, or castrated in two studies.
Materials and methods: These were pooled data of two open-labeled multicenter studies of the identical design. The patients with PC (T3— 4) were randomized to treatment with bicalutamide, 150 mg/day or castration (bilateral orchiectomy or goserelin acetate, 3.6 mg, once every 28 days) in a ratio of 2:1.
Results: 480 patients with locally advanced PC were randomized. During a median follow-up of 6.3 years, mortality was 56%. There were significant differences in overall survival (relative risk 1.05; the upper 95% CI 1.31; p=0.70) and in interval before progression (1.20; 1.45; p=0.11) between both groups. Bicalutamide therapy was ascertained to have an advantage in two life quality indices: sexual function (p=0.029) and physical capacities (p=0.046). The most common adverse reactions were hot flushes in the castration group and breast pain and gynecomastia in the bicalutamide group. The frequency of other side effects of the therapy was low. Bicalutamide was well tolerated. The drug used during the study had to be discontinued due to adverse reactions only in several cases. There were no new problems associated with the safety of bicalutamide therapy during a long-term follow-up.
Conclusion: Monotherapy with bicalutamide in a dose of 150 mg is an attractive alternative to castration in patients with locally advanced PC in whom hormonal treatment is indicated.
About the Authors
P. IversenRussian Federation
C. J. Tyrrel
Russian Federation
A. V. Kaisary
Russian Federation
J. B. Anderson
Russian Federation
H. van Poppel
Russian Federation
T. L.J. Tammela
Russian Federation
M. Chamberlain
Russian Federation
K. Carrol
Russian Federation
I. Melezinek
Russian Federation
References
1. Landis S.H., Murray T., Bolden S. et al. Cancer statistics, 1999. CA Cancer J Clin 1999;49: 8.
2. Kirby R. Treatment options for early prostate cancer. Urology 1998;52:948.
3. Cassileth B.R., Soloway M.S., Vogelzang N.J. et al. Patients' choice of treatment in stage D prostate cancer. Urology 1989; 33 (Suppl): 57.
4. Fossa S.D., Aass N., Opjordsmoen S. Assessment of quality of life in patients with prostate cancer. Semin Oncol 1994;21: 657.
5. Lucas M.D., Strijdom S.C., Berk M. et al. Quality of life, sexual functioning and sex role identity after surgical orchi-dectomy in patients with prostatic cancer. Scand J Urol Nephrol 1995;29: 497.
6. Daniell H.W., Dunn S.R., Ferguson D.W. et al. Progressive osteoporosis during androgen deprivation therapy for prostate cancer. J Urol 2000;163: 181.
7. van Basten J.P., van Driel M.F., Jonker-Pool G. et al. Sexual functioning in testosterone-supplemented patients treated for bilateral testicular cancer. Br J Urol 199779: 461.
8. Eastell R., Boyle I.T., Compston J. et al. Management of male osteoporosis: report of the UK Consensus Group. QJM 1998;91: 71.
9. Jackson J.A., Riggs M.W., Spiekerman A.M. Testosterone deficiency as a risk factor for hip fractures in men: a case-control study. Am J Med Sci 1992;304: 4.
10. Verhelst J., Denis L., van Vliet P. et al. Endocrine profiles during administration of the new non-steroidal anti-androgen Casodex in prostate cancer. Clin Endocrinol (Oxf) 1994;41: 525.
11. Kolvenbag G.J., Nash A. Bicalutamide dosages used in the treatment of prostate cancer. Prostate 1999;39: 47.
12. Boccardo F., Rubagotti A., Barichello M. et al. Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer patients: results of an Italian Prostate Cancer Project study. J Clin Oncol 1999;17: 2027.
13. Chatelain C., Rousseau V., Cosaert J. French multicentre trial comparing Casodex (ICI 176,334) monotherapy with castration plus nilutamide in metastatic prostate cancer: a pre-liminary report. Eur Urol 1994; 26 (Suppl): 10.
14. Chatelain C., Fourcade R.O., Delchambre J. Bicalutamide (Casodex®) versus combined androgen blockade (CAB): open French multicentre study in patients with metastatic prostate cancer. Br J Urol 1997; 80 (Suppl): 283, abstract 1111.
15. Tyrrell C.J., Kaisary A.V., Iversen P. et al. A randomized comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol 1998;33: 447.
16. Iversen P., Tyrrell C.J., Kaisary A.V. et al. Casodex (bicalutamide) 150-mg monotherapy compared with castration in patients with previously untreated nonmetastatic prostate cancer: results from two multicenter randomized trials at a median follow-up of 4 years. Urology 1998;51: 389.
17. Cleary P.D., Morrissey G., Oster G. Health-related quality of life in patients with advanced prostate cancer: a multinational perspective. Qual Life Res 1995;4: 207.
18. Iversen P. Quality of life issues relating to endocrine treatment options. Eur Urol 1999; 36 (Suppl): 20,
19. Mazur D.J., Hickam D.H. Patient preferences: survival vs quality-of-life considerations. J Gen Intern Med 1993;8: 374.
20. Tyrrell C.J. Gynaecomastia: aetiology and treatment options. Prost Cancer Frost Dis 1999;2: 167.
Review
For citations:
Iversen P., Tyrrel C.J., Kaisary A.V., Anderson J.B., van Poppel H., Tammela T.L., Chamberlain M., Carrol K., Melezinek I. Analysis of results of bicalutamide monotherapy versus castration in patients with non-metastatic locally advanced prostate cancer during 6.3-year follow-up. Cancer Urology. 2008;4(1):48-54. (In Russ.) https://doi.org/10.17650/1726-9776-2008-4-1-48-54
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