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Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole

Prostate Cancer and Prostatic Diseases volume 8, pages 75–83 (2005)Cite this article

Abstract

A randomized, double-blind, placebo-controlled multicenter trial involving 107 men receiving bicalutamide (‘Casodex’) 150 mg/day therapy following radical therapy for prostate cancer assessed tamoxifen (‘Nolvadex’) 20 mg/day and anastrozole (‘Arimidex’) 1 mg/day for the prophylaxis and treatment of gynecomastia/breast pain. Tamoxifen, but not anastrozole, significantly reduced the incidence of gynecomastia/breast pain when used prophylactically and therapeutically. Serum testosterone levels increased with tamoxifen relative to placebo but prostate-specific antigen levels declined in all treatment groups. Further studies are needed to define the optimum tamoxifen dose and to assess any impact on cancer control. The use of tamoxifen in this setting remains to be investigated.

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Acknowledgements

We gratefully acknowledge the contribution to the trial of the following investigators: A Cantwell (Atlantic Urological Associates, Daytona Beach, FL, USA); J Ross (Mississippi Center for Clinical Research, Jackson, MI, USA); RJ Ross (Hattiesburg Clinic, Hattiesburg, MS, USA); K Tomera (Alaska Clinical Research Center, Anchorage, Alaska); N Nemoy (Cedars-Sinai Medical Center, Los Angeles, CA, USA); D Keiller (4033 3rd Avenue, San Diego, CA); and PM Knapp (Urology of Indiana; Indianapolis, IN, USA).

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Authors and Affiliations

  1. Urology San Antonio Research PA, Pasteur Medical Plaza, San Antonio, Texas, USA

    D Saltzstein

  2. Urological Associates of Lancaster, Lancaster, Pennsylvania, USA

    P Sieber

  3. AstraZeneca, Macclesfield, Cheshire, UK

    T Morris

  4. AstraZeneca, Wilmington, Deleware, USA

    J Gallo

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  1. D Saltzstein
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  2. P Sieber
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  3. T Morris
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  4. J Gallo
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Corresponding author

Correspondence to D Saltzstein.

Additional information

‘Arimidex’, ‘Casodex’, and ‘Nolvadex’ are trademarks of the AstraZeneca group of companies.

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Saltzstein, D., Sieber, P., Morris, T. et al. Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole. Prostate Cancer Prostatic Dis 8, 75–83 (2005). https://doi.org/10.1038/sj.pcan.4500782

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