Korean J Urol.  2014 May;55(5):315-320. 10.4111/kju.2014.55.5.315.

Efficacy of Bicalutamide 150-mg Monotherapy Compared With Combined Androgen Blockade in Patients With Locally Advanced Prostate Cancer

• Kang YJ
• Kim KH
• Lee KS

• KMID: 1988408
• DOI: http://doi.org/10.4111/kju.2014.55.5.315

Abstract

PURPOSE
We compared the efficacy, survival rate, and adverse events between bicalutamide 150-mg monotherapy and combined androgen blockade (CAB) in men with locally advanced prostate cancer.
MATERIALS AND METHODS
From March 2003 to July 2012, we retrospectively included 74 patients who were treated for more than 3 months and were followed up for more than 6 months. 25 men were treated with bicalutamide 150-mg only (group 1) and 49 men received CAB (group 2). Serum prostate-specific antigen (PSA) change, survival rate, and adverse events were compared between the 2 groups.
RESULTS
The PSA levels before and after treatment were 37.0+/-32.8 ng/mL and 9.5+/-27.0 ng/mL in group 1 (p<0.001) and 50.2+/-40.0 ng/mL and 20.0+/-35.8 ng/mL in group 2 (p<0.001). Mean survival rates were 78.9% in group 1 and 52.3% in group 2 (p=0.055). There were no statistically significant differences in adverse events between the 2 groups (p=0.304). The International Index of Erectile Function 5 (IIEF-5) score before treatment was 19.3+/-5.9 in group 1 and 18.3+/-5.8 in group 2 (p=0.487). The IIEF-5 score after treatment was 17.1+/-6.3 in group 1 and 14.0+/-6.1 in group 2, which was a statistically significant difference (p=0.036).
CONCLUSIONS
The PSA change, mean survival rate, and adverse events in patients with locally advanced prostate cancer treated with bicalutamide 150-mg and CAB did not differ significantly. However, sexual function was better in the bicalutamide 150-mg group. Therefore, bicalutamide 150-mg monotherapy could be considered as a treatment for locally advanced prostate cancer in patients concerned about sexual function.

Keyword

Bicalutamide; Prostatic neoplasms; Therapy

MeSH Terms

Humans
Male
Prostate-Specific Antigen
Prostatic Neoplasms*
Retrospective Studies
Survival Rate
Prostate-Specific Antigen

Figure

• 

  FIG. 1 Cumulative survival of patients according to treatment assignment. Survival rates of both group decreased over time, however, they had no statistically significant difference (p=0.197). CAB, combined androgen blockade.

Reference

1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010; 127:2893–2917.

2. Statistics Korea [Internet]. Daejeon: Statistics Korea;2012 Mar 10. Available from: http://kostat.go.kr/portal/english/index.action.

3. Meng MV, Carroll PR. Treatment of locally advanced prostate cancer. In : Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, editors. Campbell-Walsh urology. 10th ed. Philadelphia: Saunders;2012. p. 2903–2920.

4. Ischia J, Gleave M. Radical prostatectomy in high-risk prostate cancer. Int J Urol. 2013; 20:290–300.

5. Bolla M, Van Tienhoven G, Warde P, Dubois JB, Mirimanoff RO, Storme G, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010; 11:1066–1073.

6. Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, et al. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011; 378:2104–2111.

7. Cooperberg MR, Moul JW, Carroll PR. The changing face of prostate cancer. J Clin Oncol. 2005; 23:8146–8151.

8. Sridharan S, Dal Pra A, Catton C, Bristow RG, Warde P. Locally advanced prostate cancer: current controversies and optimisation opportunities. Clin Oncol (R Coll Radiol). 2013; 25:499–505.

9. Kupelian P. External beam radiation therapy: role of androgen deprivation. World J Urol. 2003; 21:190–199.

10. Abrahamsson PA. Treatment of locally advanced prostate cancer: a new role for antiandrogen monotherapy? Eur Urol. 2001; 39:Suppl 1. 22–28.

11. Iversen P, Johansson JE, Lodding P, Lukkarinen O, Lundmo P, Klarskov P, et al. Bicalutamide (150 mg) versus placebo as immediate therapy alone or as adjuvant to therapy with curative intent for early nonmetastatic prostate cancer: 5.3-year median follow-up from the Scandinavian Prostate Cancer Group Study Number 6. J Urol. 2004; 172(5 Pt 1):1871–1876.

12. Wirth MP, See WA, McLeod DG, Iversen P, Morris T, Carroll K, et al. Bicalutamide 150 mg in addition to standard care in patients with localized or locally advanced prostate cancer: results from the second analysis of the early prostate cancer program at median followup of 5.4 years. J Urol. 2004; 172(5 Pt 1):1865–1870.

13. Koh JS, Lee CB, Suh HJ, Lee YB, Cho DH, Lee JY. Efficacy of bicalutamide monotherapy in locally advanced prostate cancer. Korean J Urol. 2004; 45:108–113.

14. Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Baert L, Tammela T, 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; 51:389–396.

15. Kim DG, Chang HJ, Lee KS. The therapeutic effect of monotherapy and combined therapy for androgen blockade in patients with metastatic prostate cancer. Korean J Urol. 2003; 44:12–16.

16. Broulik PD, Starka L. Effect of antiandrogens casodex and epitestosterone on bone composition in mice. Bone. 1997; 20:473–475.

17. Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, et al. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998; 33:447–456.

18. Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, et al. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000; 164:1579–1582.

19. Iversen P. Quality of life issues relating to endocrine treatment options. Eur Urol. 1999; 36:Suppl 2. 20–26.

20. Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, et al. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998; 339:1036–1042.

21. Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP, et al. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010; 105:1074–1081.