| Serretta et al. [2] |
Randomized, multicentre trial |
Arm A: tamoxifen therapy reduced BEs to 28% of patients (P < 0.001). Arm B: tamoxifen prophylaxis gave significant reduction of BEs to 44% (P < 0.001). |
Arm A: 2.4% discontinued tamoxifen and 3.6% discontinued bicalutamide. Arm B: 2.5% discontinued both treatments. |
| Bedognetti et al. [9] |
Randomized, multicentre phase 3 trial |
Arm A: daily tamoxifen prophylaxis resulted in 31.7% developing gynecomastia (P < 0.0001) and 12.2% mastalgia (P = 0.001). Arm B: tamoxifen weekly after 8 weeks of daily treatment resulted in 74.4% developing gynecomastia (P < 0.0001) and 46.1% mastalgia (P = 0.001). |
Arm A: 24%. Arm B: 22% |
| Fradet et al. [10] |
Randomized, double-blind, multicentre trial |
Arm A: increased doses of tamoxifen daily decreased the number of BEs, compared to placebo, ranging from 86.2% in the 1 mg group to 8.8% in the 20 mg group (P ≤ 0.0002). Arm B: placebo, 96.7% experienced BEs. |
Arm A: 19.8% withdrew. Arm B: 16.7% (bicalutamide monotherapy) |
| Saltzstein et al. [4] |
Randomized, double-blind, multicentre trial |
Arm A: tamoxifen prophylaxis patients were significantly (3.22 times) less likely to develop gynecomastia and/or mastodynia (relative risk estimate, 95% CI 1.28, 7.69). The difference between the anastrozole group and the placebo group was not significant (P = 0.749). Therapeutic treatment gave resolution of gynecomastia and/or mastodynia in 65.4% in the tamoxifen group and 18.8% in the anastrozole group. Arm B: placebo, 88.8% later received tamoxifen due to BEs. This treatment significantly reduced gynecomastia and/or mastodynia in 71.8%. |
13.2% withdrew. 0.9% (one patient) withdrew due to increased serum AST and ALT levels. |
| Boccardo et al. [7] |
Randomized, double-blind, multicentre trial |
Arm A: 10% of the tamoxifen group and 51% of the anastrozole developed gynecomastia (P < 0.001); 6% of the tamoxifen group and 27% of the anastrozole group experienced mastodynia (P = 0.006). Arm B: control, 73% developed gynecomastia (P < 0.001) and 39% experienced mastodynia (P = 0.006). |
Arm A: 35.1%% of the tamoxifen group and 69.5% of the anastrozole group. Arm B: 37.5% |
| Ozen et al. [11] |
Randomized, multi-institutional trial |
Arm A: prophylactic RT resulted in 15.8% (P < 0.001) developing gynecomastia and 36.4% mastodynia. Arm B: control, 50.8% (P < 0.001) developed gynecomastia and 49.2% breast pain. |
Arm A: 11.3% (related to bicalutamide). Arm B: 11.1% (related to bicalutamide). |
| Van Poppel et al. [12] |
Open label, multicentre study |
Arm A: therapeutic RT resulted in 36.6% experienced improved or resolved gynecomastia and mastodynia; 22% had no change and 24.4% experienced worsening of symptoms. |
Arm A: 43.9%. All RT related side effects were transient. |
| Tyrrell et al. [13] |
Randomized, double-blind, multicentre trial |
Arm A: prophylactic RT resulted in an incidence of gynecomastia between 50% and 52% (OR 0.13, 95% CI 0.04, 0.38, P <0.001). Arm B: sham RT resulted in an incidence of gynecomastia between 81% and 85% (OR 0.13, 95% CI 0.04, 0.38, P <0.001). |
Arm A: 33% (RT related), all of which were short-lived. Arm B: 2% (RT related). |
| Widmark et al. [14] |
Randomized, Scandinavian trial |
Arm A: prophylactic RT resulted in an incidence of gynecomastia between 28% and 44%. Breast tenderness was reported in 43% of patients (P < 0.001). Arm B: control, incidence of gynecomastia between 71% and 78%. Breast tenderness reported in 75% of patients (P < 0.001). |
Some patients reported skin irritation |
| Perdonà et al. [15] Di Lorenzo et al. [16] |
Randomized, multicentre trial |
Arm A: prophylactic RT resulted in 34% developing gynecomastia (OR 0.51, P = 0.008) and 30% mastodynia (OR 0.43, P = 0.02). Arm B: tamoxifen daily resulted in 8% developing gynecomastia (OR 0.1, 95% CI, P = 0.0009) and 6–7% breast pain (OR 0.1, P = 0.009). Arm C: control, 67–70% developed gynecomastia and 57–58% mastodynia. Tamoxifen later significantly reduced gynecomastia and mastodynia in arm C (OR 0.2, P = 0.02) |
Arm A: highest number of side effects where 19–40% experienced short-lived skin irritations, rashes or nipple erythema. |
