Spagnolo Luca, Tienforti Daniele, Moretto Carolina, Tonni Camilla, Donatelli Vittoria, Ferranti Alessandro, Puocci Gennaro, Capuano Claudio, Barbonetti Arcangelo
Andrology Unit, Department of Clinical Medicine, Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Spinal Unit, San Raffaele Sulmona Institute, Sulmona, Italy.
J Endocrinol Invest. 2025 Apr 17. doi: 10.1007/s40618-025-02583-8.
This study aimed to quantitatively assess the effectiveness of tamoxifen, anastrozole, and radiotherapy in preventing bicalutamide-induced breast events-specifically gynecomastia and breast pain-in patients with prostate cancer.
A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted according to PRISMA-P guidelines. A comprehensive search was performed in PubMed, Scopus, and Web of Science for English-language studies without temporal restrictions. Studies were included if they involved prostate cancer patients treated with bicalutamide receiving preventive interventions (tamoxifen, anastrozole, or radiotherapy) compared to bicalutamide alone (or bicalutamide plus placebo/sham). Data extraction focused on the incidence of gynecomastia and breast pain, and study quality was assessed using the Jadad scale. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using fixed- or random-effects models, and heterogeneity was evaluated with the I² statistic. Publication bias was explored via funnel plots and the trim-and-fill method.
Nine RCTs met the inclusion criteria. Tamoxifen significantly reduced the risk of breast events by 82% (RR: 0.18, 95% CI: 0.08-0.38 for gynecomastia and RR: 0.18, 95% CI: 0.07-0.43 for breast pain). Radiotherapy reduced gynecomastia risk by 52% (RR: 0.48, 95% CI: 0.38-0.59) and breast pain by 34% (RR: 0.66, 95% CI: 0.48-0.90). Anastrozole did not show significant benefit.
Tamoxifen appears to be the most effective strategy for preventing bicalutamide-induced breast events, with radiotherapy serving as a viable alternative, and anastrozole offering no benefit. Further large-scale, high-quality studies are needed to confirm these findings and refine preventive treatment recommendations.
本研究旨在定量评估他莫昔芬、阿那曲唑和放射疗法在预防前列腺癌患者中比卡鲁胺引起的乳腺事件（特别是男性乳房发育和乳房疼痛）方面的有效性。
根据PRISMA-P指南进行随机对照试验（RCT）的系统评价和荟萃分析。在PubMed、Scopus和Web of Science中进行全面检索，以查找无时间限制的英文研究。如果研究涉及接受预防干预（他莫昔芬、阿那曲唑或放射疗法）的比卡鲁胺治疗的前列腺癌患者，并与单独使用比卡鲁胺（或比卡鲁胺加安慰剂/假治疗）进行比较，则纳入研究。数据提取重点关注男性乳房发育和乳房疼痛的发生率，并使用Jadad量表评估研究质量。使用固定效应或随机效应模型计算95%置信区间（CI）的风险比（RR），并使用I²统计量评估异质性。通过漏斗图和修剪填充法探索发表偏倚。
9项RCT符合纳入标准。他莫昔芬显著降低了乳腺事件的风险，男性乳房发育的风险降低了82%（RR：0.18，95%CI：0.08-0.38），乳房疼痛的风险降低了82%（RR：0.18，95%CI：0.07-0.43）。放射疗法使男性乳房发育风险降低了52%（RR：0.48，95%CI：0.38-0.59），乳房疼痛降低了34%（RR：0.66，95%CI：0.48-0.90）。阿那曲唑未显示出显著益处。
他莫昔芬似乎是预防比卡鲁胺引起的乳腺事件的最有效策略，放射疗法是一种可行的替代方法，而阿那曲唑没有益处。需要进一步的大规模、高质量研究来证实这些发现并完善预防性治疗建议。
