This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Boccardo, F. Articles by Montefiore, F. Search for Related Content PubMed PubMed Citation Articles by Boccardo, F. Articles by Montefiore, F. Social Bookmarking                            What's this?

Evaluation of Tamoxifen and Anastrozole in the Prevention of Gynecomastia and Breast Pain Induced by Bicalutamide Monotherapy of Prostate Cancer

From the University and National Cancer Research Institute of Genoa; University of Genoa, Genoa; University of Bari, Bari; S Anna Hospital, Como; University of Bologna, Bologna; S Maria Misericordia Hospital; University of Udine, Gemona del Friuli, Udine; City Hospital, Caltagirone; University of Cagliari, Cagliari; City Hospital, Fidenza; City Hospital, Siena; Santo Spirito Hospital, Casale Monferrato; City Hospital, Novi Ligure, Italy

Address reprint requests to Francesco Boccardo, MD, Professorial Unit of Medical Oncology (Medical Oncology B), University and National Cancer Research Institute, Largo R. Benzi 10, 16132 Genoa, Italy; e-mail: f.boccardo{at}unige.it

PURPOSE: To determine whether tamoxifen or anastrozole prevents gynecomastia and breast pain caused by bicalutamide (150 mg) without compromising efficacy, safety, or sexual functioning.

PATIENTS AND METHODS: A double-blind, placebo-controlled trial was performed in patients with localized, locally advanced, or biochemically recurrent prostate cancer. Patients (N = 114) were randomly assigned to either bicalutamide (150 mg/d) plus placebo or in combination with tamoxifen (20 mg/d) or anastrozole (1 mg/d) for 48 weeks. Gynecomastia, breast pain, prostate-specific antigen (PSA), sexual functioning, and serum levels of hormones were assessed.

RESULTS: Gynecomastia developed in 73% of patients in the bicalutamide group, 10% of patients in the bicalutamide-tamoxifen group, and 51% of patients in the bicalutamide-anastrozole group (P < .001); breast pain developed in 39%, 6%, and 27% of patients, respectively (P = .006). Baseline PSA level decreased by 50% in 97%, 97%, and 83% of patients in the bicalutamide, bicalutamide-tamoxifen, and bicalutamide-anastrozole groups, respectively (P = .07); and adverse events were reported in 37%, 35%, and 69% of patients, respectively (P = .004). There were no major differences among treatments in sexual functioning parameters from baseline to month 6. Elevated testosterone levels occurred in each group; however, free testosterone levels remained unchanged in the bicalutamide-tamoxifen group because of increased sex hormone–binding globulin levels.

CONCLUSION: Anastrozole did not significantly reduce the incidence of bicalutamide-induced gynecomastia and breast pain. In contrast, tamoxifen was effective, without increasing adverse events, at least in the short-term follow-up. These data support the need for a larger study to determine any effect on mortality.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. D. Michaelson, S. E. Cotter, P. C. Gargollo, A. L. Zietman, D. M. Dahl, and M. R. Smith Management of Complications of Prostate Cancer Treatment CA Cancer J Clin, July 1, 2008; 58(4): 196 - 213. [Abstract] [Full Text] [PDF]

				D. I. Shulman, G. L. Francis, M. R. Palmert, E. A. Eugster, and for the Lawson Wilkins Pediatric Endocrine Society Use of Aromatase Inhibitors in Children and Adolescents With Disorders of Growth and Adolescent Development Pediatrics, April 1, 2008; 121(4): e975 - e983. [Abstract] [Full Text] [PDF]

				C. B Niewoehner and A. E Schorer Gynaecomastia and breast cancer in men BMJ, March 29, 2008; 336(7646): 709 - 713. [Full Text] [PDF]

				G. D. Braunstein Gynecomastia N. Engl. J. Med., September 20, 2007; 357(12): 1229 - 1237. [Full Text] [PDF]

				D. Thonnessen and F. Wenz Radiotherapeutic Prophylaxis of Gynecomastia J. Clin. Oncol., August 20, 2005; 23(24): 5845 - 5845. [Full Text] [PDF]

				F. Boccardo and A. Rubagotti In Reply: J. Clin. Oncol., August 20, 2005; 23(24): 5846 - 5846. [Full Text] [PDF]