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Drugs

, Volume 62, Issue 17, pp 2471–2479 | Cite as

Bicalutamide

In Early-Stage Prostate Cancer
  • Christopher I. Carswell
  • David P. Figgitt
Adis New Indication Profile

Abstract

  • ▴ Bicalutamide is an oral, once-daily nonsteroidal antiandrogen. Its efficacy in localised or locally advanced prostate cancer is currently being investigated as part of the Early Prostate Cancer (EPC) programme.

  • ▴ In the EPC programme, bicalutamide 150 mg/day, as an adjunct to radiotherapy, radical prostatectomy or watchful waiting, significantly reduced the risk of objective disease progression, the incidence of bone metastases and the risk of prostate specific antigen progression compared with placebo (p < 0.0001 for all three parameters) after a median follow-up of 3 years. Survival data are currently immature, with an overall mortality rate of 6% in both treatment arms.

  • ▴ In two nonblind, randomised trials, bicalutamide 150 mg/day monotherapy was as effective as medical or surgical castration in terms of overall survival in patients with locally advanced nonmetastatic prostate cancer. After a median follow-up of 6.3 years, median survival was 63.5 and 69.9 months for bicalutamide and castration, respectively; time to disease progression was also similar between treatment groups. Bicalutamide recipients reported a significantly smaller loss in sexual interest and a better physical capacity than recipients of castration (p ≤0.05 for both parameters).

  • ▴ Bicalutamide is well tolerated in studies of up to 6.3 years’ duration.

Keywords

Prostate Cancer Bone Mineral Density Androgen Receptor Radical Prostatectomy Advanced Prostate Cancer 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    American Cancer Society. 2000 facts and figures. Selected cancers: prostate [online]. Available from URL: http://www.cancer.org/statistics/cff2000/selectedcancers.html [Accessed 2002 May 30]. 2000
  2. 2.
    Anderson J. Bicalutamide treatment for locally advanced prostate cancer. Hosp Med 2000 Sep; 61(9): 660–3PubMedGoogle Scholar
  3. 3.
    Fitzpatrick JM. New developments in the pharmacological management of prostate cancer. BJU Int 2000 Apr; 85 Suppl. 2: 31–7PubMedCrossRefGoogle Scholar
  4. 4.
    National Cancer Institute. Prostate Cancer: Treatment. Stage Information [online]. Available from URL: http://www.cancer.gov [Accessed 2002 Jun 10].
  5. 5.
    Vicini FA, Kestin LL, Stromberg JS, et al. Brachytherapy boost techniques for locally advanced prostate cancer. Oncology 1999 Apr; 13: 491–503PubMedGoogle Scholar
  6. 6.
    Pisters LL. The challenge of locally advanced prostate cancer. Semin Oncol 1999 Apr; 26: 202–16PubMedGoogle Scholar
  7. 7.
    Middleton RG, Thompson IM, Austenfeld MS, et al. Prostate cancer clinical guidelines panel summary report on the management of clinically localized prostate cancer. J Urol 1995; 154: 2144–8PubMedCrossRefGoogle Scholar
  8. 8.
    Roach III M, Lu J, Pilepich MV, et al. Long-term survival after radiotherapy alone: radiation therapy oncology group prostate cancer trials. J Urol 1999; 161: 864–8PubMedCrossRefGoogle Scholar
  9. 9.
    Pound CR, Partin AW, Eisenberger MA, et al. Natural history of progression after PSA elevation following radical prostatectomy. JAMA 1999; 281(17): 1591–7PubMedCrossRefGoogle Scholar
  10. 10.
    Reese DM. Choice of hormonal therapy for prostate cancer. Lancet 2000 Apr 29; 355: 1474–5PubMedCrossRefGoogle Scholar
  11. 11.
    Goa KL, Spencer CM. Bicalutamide in advanced prostate cancer. A review. Drugs Aging 1998 May; 12(5): 401–22CrossRefGoogle Scholar
  12. 12.
    Casodex international prescribing information. Cheshire, UK: Astra Zeneca, 2000 MarGoogle Scholar
  13. 13.
    Masiello D, Cheng S, Bubley GJ, et al. Bicalutamide functions as an androgen receptor antagonist by assembly of a transcriptionally inactive receptor. J Biol Chem 2002 Jul 19; 277: 26321–6PubMedCrossRefGoogle Scholar
  14. 14.
    Tyrrell CJ, Denis L, Newling D, et al. Casodex™ 10–200 mg daily used as monotherapy for the treatment of patients with advanced prostate cancer. Eur Urol 1998; 33: 39–53PubMedCrossRefGoogle Scholar
  15. 15.
    Cockshott ID, Cooper KJ, Sweetmore DS, et al. The pharmacokinetics of Casodex in prostate cancer patients after single and during multiple dosing. Eur Urol 1990; 18 Suppl 3: 10–7PubMedGoogle Scholar
  16. 16.
    Cockshott ID, Oliver SD, Young JJ, et al. The effect of food on the pharmacokinetics of the bicalutamide (‘Casodex’) enantiomers. Biopharm Drug Dispos 1997 Aug; 18(6): 499–507PubMedCrossRefGoogle Scholar
  17. 17.
    McKillop D, Boyle GW, Cockshott ID, et al. Metabolism and enantioselective pharmacokinetics of Casodex in man. Xenobiotica 1993 Nov; 23(11): 1241–53PubMedCrossRefGoogle Scholar
  18. 18.
    Wirth M, Tyrrell C, Wallace M, et al. Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression. Urology 2001 Aug; 58: 146–51PubMedCrossRefGoogle Scholar
  19. 19.
    See WA, Wirth MP, McLeod DG, et al. Bicalutamide (Casodex) 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(2): 429–35PubMedCrossRefGoogle Scholar
  20. 20.
    Iversen P, Tyrrell CJ, Kaisary AV, 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 Mar; 51(3): 389–96PubMedCrossRefGoogle Scholar
  21. 21.
    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 Nov; 164(5): 1579–82PubMedCrossRefGoogle Scholar
  22. 22.
    See W, McLeod DG, Wirth M, et al. Bicalutamide (Casodex) 150 mg as immediate or adjuvant therapy in 8113 men with localized or locally advanced prostate cancer [abstract]. J Urol 2001 May; 165 (Abstr. Suppl.): 389Google Scholar
  23. 23.
    Iversen P, Tammela TLJ, Vaage S, et al. A randomised comparison of bicalutamide (‘Casodex”) 150 mg versus placebo as immediate therapy either alone or as adjuvant to standard care for early non-metastatic prostate cancer. First report from the Scandinavian Prostatic Cancer Group Study No. 6. Eur Urol 2002 Sep; 42(3): 204–11Google Scholar
  24. 24.
    See WA, Mcleod D, Iverson P, et al. The bicalutamide Early Prostate Cancer Program: Demography. Urol Oncol 2001; 6: 43–7PubMedCrossRefGoogle Scholar
  25. 25.
    Gleason DF, Mellinger GT, and the Veterans Administration Cooperative Urological Research Group. Prediction of prognosis for prostatic adenocarcinoma by combined histological grading and clinical staging. J Urol 1974 Jan; 111(1): 58–64PubMedGoogle Scholar
  26. 26.
    Iversen P, Melezinek I, Schmidt A. Nonsteroidal anti-androgens: a therapeutic option for patients with advanced prostate cancer who wish to retain sexual interest and function. Br J Urol Int 2001; 87: 47–56CrossRefGoogle Scholar
  27. 27.
    Tyrell CJ, Blake GM, Iversen P, et al. Casodex may preserve bone mineral density of patients with advanced prostate cancer [abstract]. Br J Urol Int 2000; 86 Suppl. 3: M6.1.09Google Scholar
  28. 28.
    Sieber PR, Keiller DL, Kahnoski RJ, et al. Bone mineral density is maintained during bicalutamide (‘Casodex‘) treatment [abstract no 783][online]. Available from URL: http://www.asco.org [Accessed 2002 Oct 9]
  29. 29.
    AstraZeneca. Casodex 150 International Data Sheet[online]. Available from http://www.prostateline.com [Accessed 2002 June 6]
  30. 30.
    Casodex prostate cancer monotherapy survival is similar to castration — U.K. FDC Pink 1999 Jul 5; 61: 15Google Scholar
  31. 31.
    AstraZeneca. AstraZeneca receives FDA priority review for CASODEX (R) 150mg, for early stage prostate cancer. Media Rel 2002 Feb 20, 2Google Scholar

Copyright information

© Adis International Limited 2002

Authors and Affiliations

  • Christopher I. Carswell
    • 1
  • David P. Figgitt
    • 1
  1. 1.Adis International LimitedMairangi Bay, AucklandNew Zealand

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