PTU - Polskie Towarzystwo Urologiczne
list of articles:

What are the benefits of adding bicalutamide (CasodexTM) to standard care for non-metastatic prostate cancer?
Article published in Urologia Polska 2007/60/3.

authors

Peter Iversen
Department of Urology, Rigshospitalet, Copenhagen, Denmark

keywords

prostate, prostatic neoplasms, bicalutamide, androgen antagonists, radiotherapy, prostatectomy, stercz, nowotwory stercza, bikalutamid, antagoni¶ci receptorów dla androgenów, radioterapia, prostatektomia

summary

Adjuvant castration therapy using goserelin (ZOLADEXTM) prolongs survival in men with locally advanced prostate cancer who undergo radiotherapy or in those with node-positive disease who undergo radical prostatectomy. However, castration is associated with side effects that limit its use in patients for whom sexual function and physical ability are priorities. The addition of bicalutamide (CASODEXTM) 150 mg to standard care for localised or locally advanced, non-metastatic prostate cancer is being investigated in the Early Prostate Cancer programme. This paper reviews the data from the third analysis of the programme at a median 7.4 years' followup. One finding was that patients with localised disease do not benefit from the addition of bicalutamide 150 mg to standard care. However, bicalutamide 150 mg improved objective progression-free survival in patients with locally advanced disease, irrespective of the standard care received (hazard ratio [HR] 0.65; 95% CI [confidence interval] 0.57, 0.74; p<0.001). In patients with locally advanced disease receiving radiotherapy, the addition of bicalutamide 150 mg significantly reduced the risk of death by 35% (HR 0.65; 95% CI 0.44, 0.95; p=0.03). This is the first evidence of an overall survival benefit with a non-castration-based hormonal therapy in this setting and, importantly, the magnitude of this benefit is comparable with that of adjuvant goserelin in a similar population. As bicalutamide 150 mg is associated with quality-of-life advantages including maintenance of sexual function and physical ability, it offers an attractive alternative to castration for patients with locally advanced disease who wish to maintain an active lifestyle.

references

  1. Aus G, Abbou CC, Bolla M et al: European Association of Urology Guidelines on Prostate Cancer. Available at http://www.uroweb.org/files/uploaded_ files/guidelines/07%20Prostate%20Cancer.pdf. Accessed 19 December 2005.
  2. Pilepich MV, Winter K, Lawton CA et al: Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma – long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys 2005, 61, 1285-1290.
  3. Roach III M, Lu J, Pilepich MV et al: Four prognostic groups predict long- -term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys 2000, 47, 609-615.
  4. Bill-Axelson A, Holmberg L, Ruutu M et al: Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2005, 352, 1977- 1984.
  5. Messing EM, Manola J, Yao J et al: Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol 2006, 7, 472-479.
  6. Johansson J-E, Holmberg L, Johansson S et al: Fifteen-year survival in prostate cancer. A prospective, population-based study in Sweden. JAMA 1997, 277, 467-471.
  7. Bolla M, Collette L, Blank L et al: Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet 2002, 360, 103-108.
  8. Iversen P, Tyrrell CJ, Kaisary AV 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.
  9. Berruti A, Dogliotti L, Terrone C et al: Changes in bone mineral density, lean body mass and fat content as measured by dual energy x-ray absorptiometry in patients with prostate cancer without apparent bone metastases given androgen deprivation. J Urol 2002, 167, 2361-2367.
  10. Sieber PR, Keiller DL, Kahnoski RJ et al: Bicalutamide 150 mg maintains bone mineral density during monotherapy for localized or locally advanced prostate cancer. J Urol 2004, 171, 2272-2276.
  11. Smith MR, Eastham J, Gleason DM et al: Randomized controlled trial of zoledronic acid to prevent bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer. J Urol 2003, 169, 2008-2012.
  12. Smith MR, McGovern FJ, Zietman AL et al: Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer. N Engl J Med 2001, 345, 948-955.
  13. Smith MR, Fallon MA, Goode MJ: Cross-sectional study of bone turnover during bicalutamide monotherapy for prostate cancer. Urology 2003, 61, 127-131.
  14. McLeod DG, Iversen P, See WA et al: Bicalutamide 150 mg plus standard care versus standard care alone for early prostate cancer. BJU Int 2006, 97, 247-254.
  15. Iversen P, Johansson JE, Lodding P et al: Bicalutamide 150 mg in addition to standard care for patients with early non-metastatic prostate cancer: updated results from the Scandinavian Prostate Cancer Period Group-6 Study after a median follow-up period of 7.1 years. Scand J Urol Nephrol 2006, 40, 441-452.
  16. See WA, McLeod D, Iversen P, Wirth M: The bicalutamide Early Prostate Cancer program: demography. Urol Oncol 2001, 6, 43-47.
  17. See WA, Wirth MP, McLeod DG et al: Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: first analysis of the early prostate cancer program. J Urol 2002, 168, 429-435.
  18. Wirth MP, See WA, McLeod D 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, 1865-1870.
  19. Tyrrell CJ, Payne H, Tammela TL et al: Prophylactic breast irradiation with a single dose of electron beam radiotherapy (10 Gy) significantly reduces the incidence of bicalutamide-induced gynecomastia. Int J Radiat Oncol Biol Phys 2004, 60, 476-483.
  20. Van Poppel H, Tyrrell CJ, Haustermans K et al: Efficacy and tolerability of radiotherapy as treatment for bicalutamide-induced gynaecomastia and breast pain in prostate cancer. Eur Urol 2005, 47, 587-592.
  21. Saltzstein D, Sieber P, Morris T, Gallo J: Prevention and management of bicalutamide- induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole. Prostate Cancer Prostatic Dis 2005, 8, 75-83.
  22. Boccardo F, Rubagotti A, Battaglia M et al: Evaluation of tamoxifen and anastrozole in the prevention of gynecomastia and breast pain induced by bicalutamide monotherapy of prostate cancer. J Clin Oncol 2005, 23, 808-815.
  23. Smith MR, Goode M, Zietman AL et al: Bicalutamide monotherapy versus leuprolide monotherapy for prostate cancer: effects on bone mineral density and body composition. J Clin Oncol 2004, 22, 2546-2553.
  24. Payne H: Editorial: what is the role of antiandrogen therapy in the treatment of prostate cancer? J Cancer Res Clin Oncol 2006, 132 (Suppl 13), S1-S6.
  25. See WA, Tyrrell CJ: The addition of bicalutamide 150 mg to radiotherapy significantly improves overall survival in men with locally advanced prostate cancer. J Cancer Res Clin Oncol 2006, DOI 10.1007/s00432-006-0132-6.

correspondence

Peter Iversen MD
Department of Urology D-2112
University of Copenhagen, Rigshospitalet
Blegdamsvej 9, 2100
Copenhagen, Denmark
tel. +45 3545 2314, fax +45 3545 2158
piv@rh.hosp.dk