Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer: A randomised controlled trial

Sisto Perdonà, Riccardo Autorino, Sabino De Placido, Massimo D'Armiento, Antonio Gallo, Rocco Damiano, Domenico Pingitore, Luigi Gallo, Marco De Sio, Angelo Raffaele Bianco, Giuseppe Di Lorenzo

Research output: Contribution to journalArticle

Abstract

Background: Gynaecomastia and breast pain are frequent adverse events with bicalutamide monotherapy, and might cause some patients to withdraw from treatment. We aimed to compare tamoxifen with radiotherapy for prevention and treatment of gynaecomastia, breast pain, or both during bicalutamide monotherapy for prostate cancer. Methods: 51 patients were randomly assigned to 150 mg bicalutamide per day, 50 patients to 150 mg bicalutamide per day and to 10 mg tamoxifen per day for 24 weeks, and 50 patients to 150 mg bicalutamide per day and radiotherapy (one 12-Gy fraction on the day of starting bicalutamide). 35 of the 51 patients allocated bicalutamide alone developed gynaecomastia or breast pain and were subsequently randomly allocated to tamoxifen (n=17) or radiotherapy (n=18) soon after symptoms started (median 180 days, range 160-195). Gynaecomastia and breast pain were assessed once a month. Severity of gynaecomastia was scored on the basis of the largest diameter. Breast pain was scored as none, mild, moderate, or severe. The primary outcome was frequency of gynaecomastia or breast pain; secondary outcomes were safety and tolerability, relapse-free survival, as assessed by concentration of prostate specific antigen, and quality of life. Analyses were by intention to treat. Results: 35 of 51 patients assigned bicalutamide alone developed gynaecomastia, compared with four of 50 assigned bicalutamide and tamoxifen (odds ratio [OR] 0·1 [95% CI 0·08-0·12], p=0·0009), and with 17 of 50 assigned bicalutamide and radiotherapy (0·51 [0·47-0·54], p=0·008). Breast pain was seen in 29 of 51 patients allocated bicalutamide alone, compared with three allocated bicalutamide and tamoxifen (0·1 [0·07-0·11], p=0·009), and with 15 allocated bicalutamide and radiotherapy (0·43 [0·40-0·45], p=0·02) In 35 patients assigned bicalutamide alone who subsequently developed gynaecomastia, breast pain, or both, tamoxifen significantly reduced the frequency of gynaecomastia (0·2 [0·18-0·22], p=0·02). Interpretation: Antioestrogen treatment with tamoxifen could help patients with prostate cancer to tolerate the hypergonadotropic effects of bicalutamide monotherapy.

Original languageEnglish
Pages (from-to)295-300
Number of pages6
JournalThe Lancet Oncology
Volume6
Issue number5
DOIs
Publication statusPublished - May 2005

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Mastodynia
Tamoxifen
Prostatic Neoplasms
Radiotherapy
Randomized Controlled Trials
Therapeutics
bicalutamide
Intention to Treat Analysis
Estrogen Receptor Modulators

ASJC Scopus subject areas

  • Oncology

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Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer : A randomised controlled trial. / Perdonà, Sisto; Autorino, Riccardo; De Placido, Sabino; D'Armiento, Massimo; Gallo, Antonio; Damiano, Rocco; Pingitore, Domenico; Gallo, Luigi; De Sio, Marco; Bianco, Angelo Raffaele; Di Lorenzo, Giuseppe.

In: The Lancet Oncology, Vol. 6, No. 5, 05.2005, p. 295-300.

Research output: Contribution to journalArticle

Perdonà, S, Autorino, R, De Placido, S, D'Armiento, M, Gallo, A, Damiano, R, Pingitore, D, Gallo, L, De Sio, M, Bianco, AR & Di Lorenzo, G 2005, 'Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer: A randomised controlled trial', The Lancet Oncology, vol. 6, no. 5, pp. 295-300. https://doi.org/10.1016/S1470-2045(05)70103-0
Perdonà, Sisto ; Autorino, Riccardo ; De Placido, Sabino ; D'Armiento, Massimo ; Gallo, Antonio ; Damiano, Rocco ; Pingitore, Domenico ; Gallo, Luigi ; De Sio, Marco ; Bianco, Angelo Raffaele ; Di Lorenzo, Giuseppe. / Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer : A randomised controlled trial. In: The Lancet Oncology. 2005 ; Vol. 6, No. 5. pp. 295-300.
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abstract = "Background: Gynaecomastia and breast pain are frequent adverse events with bicalutamide monotherapy, and might cause some patients to withdraw from treatment. We aimed to compare tamoxifen with radiotherapy for prevention and treatment of gynaecomastia, breast pain, or both during bicalutamide monotherapy for prostate cancer. Methods: 51 patients were randomly assigned to 150 mg bicalutamide per day, 50 patients to 150 mg bicalutamide per day and to 10 mg tamoxifen per day for 24 weeks, and 50 patients to 150 mg bicalutamide per day and radiotherapy (one 12-Gy fraction on the day of starting bicalutamide). 35 of the 51 patients allocated bicalutamide alone developed gynaecomastia or breast pain and were subsequently randomly allocated to tamoxifen (n=17) or radiotherapy (n=18) soon after symptoms started (median 180 days, range 160-195). Gynaecomastia and breast pain were assessed once a month. Severity of gynaecomastia was scored on the basis of the largest diameter. Breast pain was scored as none, mild, moderate, or severe. The primary outcome was frequency of gynaecomastia or breast pain; secondary outcomes were safety and tolerability, relapse-free survival, as assessed by concentration of prostate specific antigen, and quality of life. Analyses were by intention to treat. Results: 35 of 51 patients assigned bicalutamide alone developed gynaecomastia, compared with four of 50 assigned bicalutamide and tamoxifen (odds ratio [OR] 0·1 [95{\%} CI 0·08-0·12], p=0·0009), and with 17 of 50 assigned bicalutamide and radiotherapy (0·51 [0·47-0·54], p=0·008). Breast pain was seen in 29 of 51 patients allocated bicalutamide alone, compared with three allocated bicalutamide and tamoxifen (0·1 [0·07-0·11], p=0·009), and with 15 allocated bicalutamide and radiotherapy (0·43 [0·40-0·45], p=0·02) In 35 patients assigned bicalutamide alone who subsequently developed gynaecomastia, breast pain, or both, tamoxifen significantly reduced the frequency of gynaecomastia (0·2 [0·18-0·22], p=0·02). Interpretation: Antioestrogen treatment with tamoxifen could help patients with prostate cancer to tolerate the hypergonadotropic effects of bicalutamide monotherapy.",
author = "Sisto Perdon{\`a} and Riccardo Autorino and {De Placido}, Sabino and Massimo D'Armiento and Antonio Gallo and Rocco Damiano and Domenico Pingitore and Luigi Gallo and {De Sio}, Marco and Bianco, {Angelo Raffaele} and {Di Lorenzo}, Giuseppe",
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T1 - Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer

T2 - A randomised controlled trial

AU - Perdonà, Sisto

AU - Autorino, Riccardo

AU - De Placido, Sabino

AU - D'Armiento, Massimo

AU - Gallo, Antonio

AU - Damiano, Rocco

AU - Pingitore, Domenico

AU - Gallo, Luigi

AU - De Sio, Marco

AU - Bianco, Angelo Raffaele

AU - Di Lorenzo, Giuseppe

PY - 2005/5

Y1 - 2005/5

N2 - Background: Gynaecomastia and breast pain are frequent adverse events with bicalutamide monotherapy, and might cause some patients to withdraw from treatment. We aimed to compare tamoxifen with radiotherapy for prevention and treatment of gynaecomastia, breast pain, or both during bicalutamide monotherapy for prostate cancer. Methods: 51 patients were randomly assigned to 150 mg bicalutamide per day, 50 patients to 150 mg bicalutamide per day and to 10 mg tamoxifen per day for 24 weeks, and 50 patients to 150 mg bicalutamide per day and radiotherapy (one 12-Gy fraction on the day of starting bicalutamide). 35 of the 51 patients allocated bicalutamide alone developed gynaecomastia or breast pain and were subsequently randomly allocated to tamoxifen (n=17) or radiotherapy (n=18) soon after symptoms started (median 180 days, range 160-195). Gynaecomastia and breast pain were assessed once a month. Severity of gynaecomastia was scored on the basis of the largest diameter. Breast pain was scored as none, mild, moderate, or severe. The primary outcome was frequency of gynaecomastia or breast pain; secondary outcomes were safety and tolerability, relapse-free survival, as assessed by concentration of prostate specific antigen, and quality of life. Analyses were by intention to treat. Results: 35 of 51 patients assigned bicalutamide alone developed gynaecomastia, compared with four of 50 assigned bicalutamide and tamoxifen (odds ratio [OR] 0·1 [95% CI 0·08-0·12], p=0·0009), and with 17 of 50 assigned bicalutamide and radiotherapy (0·51 [0·47-0·54], p=0·008). Breast pain was seen in 29 of 51 patients allocated bicalutamide alone, compared with three allocated bicalutamide and tamoxifen (0·1 [0·07-0·11], p=0·009), and with 15 allocated bicalutamide and radiotherapy (0·43 [0·40-0·45], p=0·02) In 35 patients assigned bicalutamide alone who subsequently developed gynaecomastia, breast pain, or both, tamoxifen significantly reduced the frequency of gynaecomastia (0·2 [0·18-0·22], p=0·02). Interpretation: Antioestrogen treatment with tamoxifen could help patients with prostate cancer to tolerate the hypergonadotropic effects of bicalutamide monotherapy.

AB - Background: Gynaecomastia and breast pain are frequent adverse events with bicalutamide monotherapy, and might cause some patients to withdraw from treatment. We aimed to compare tamoxifen with radiotherapy for prevention and treatment of gynaecomastia, breast pain, or both during bicalutamide monotherapy for prostate cancer. Methods: 51 patients were randomly assigned to 150 mg bicalutamide per day, 50 patients to 150 mg bicalutamide per day and to 10 mg tamoxifen per day for 24 weeks, and 50 patients to 150 mg bicalutamide per day and radiotherapy (one 12-Gy fraction on the day of starting bicalutamide). 35 of the 51 patients allocated bicalutamide alone developed gynaecomastia or breast pain and were subsequently randomly allocated to tamoxifen (n=17) or radiotherapy (n=18) soon after symptoms started (median 180 days, range 160-195). Gynaecomastia and breast pain were assessed once a month. Severity of gynaecomastia was scored on the basis of the largest diameter. Breast pain was scored as none, mild, moderate, or severe. The primary outcome was frequency of gynaecomastia or breast pain; secondary outcomes were safety and tolerability, relapse-free survival, as assessed by concentration of prostate specific antigen, and quality of life. Analyses were by intention to treat. Results: 35 of 51 patients assigned bicalutamide alone developed gynaecomastia, compared with four of 50 assigned bicalutamide and tamoxifen (odds ratio [OR] 0·1 [95% CI 0·08-0·12], p=0·0009), and with 17 of 50 assigned bicalutamide and radiotherapy (0·51 [0·47-0·54], p=0·008). Breast pain was seen in 29 of 51 patients allocated bicalutamide alone, compared with three allocated bicalutamide and tamoxifen (0·1 [0·07-0·11], p=0·009), and with 15 allocated bicalutamide and radiotherapy (0·43 [0·40-0·45], p=0·02) In 35 patients assigned bicalutamide alone who subsequently developed gynaecomastia, breast pain, or both, tamoxifen significantly reduced the frequency of gynaecomastia (0·2 [0·18-0·22], p=0·02). Interpretation: Antioestrogen treatment with tamoxifen could help patients with prostate cancer to tolerate the hypergonadotropic effects of bicalutamide monotherapy.

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