Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole.
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.
Saltzstein
D
D
Urology San Antonio Research PA, Pasteur Medical Plaza, 7909 Fredericksburg Drive, Suite 115, San Antonio, TX 78229, USA. dsaltzstei@aol.com
Sieber
P
P
Morris
T
T
Gallo
J
J
D000368:Aged; D000369:Aged, 80 and over; D000077384:Anastrozole; D000813:Anilides / Q000009:adverse effects* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects* / Q000627:therapeutic use*; D001941:Breast Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D004311:Double-Blind Method; D006177:Gynecomastia / Q000139:chemically induced* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects* / Q000627:therapeutic use*; D010146:Pain / Q000139:chemically induced / Q000517:prevention & control; D010919:Placebos; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D013629:Tamoxifen / Q000494:pharmacology / Q000627:therapeutic use*; D013739:Testosterone / Q000097:blood; D014105:Tosyl Compounds; D016896:Treatment Outcome; D014230:Triazoles / Q000009:adverse effects* / Q000627:therapeutic use*
D000813:Anilides; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D010919:Placebos; D014105:Tosyl Compounds; D014230:Triazoles; D013629:Tamoxifen; D000077384:Anastrozole; D013739:Testosterone; C053541:bicalutamide