Background:Breast cancer-related lymphedema (BCRL) remains a challenging complication for breast cancer survivors. Currently, there are no effective pharmacological options available to address this condition. Emerging research highlights the critical role of inflammation, lymphatic dysfunction, and T-cell activity in the development of BCRL. Tacrolimus, a calcineurin inhibitor, has demonstrated promising results in preclinical studies for reducing inflammation, enhancing lymphatic function, and modulating T-cell activity—key mechanisms implicated in BCRL pathogenesis. This study investigates whether topical tacrolimus ointment can reduce the incidence and severity of BCRL, providing a novel approach to mitigate this debilitating condition.Methods:A parallel, open-label non-randomized controlled multicenter clinical pilot trial was conducted from February 2020 to June 2022. Female participants undergoing axillary lymph node dissection (ALND) were recruited and divided into an intervention group (n = 22) receiving topical tacrolimus 0.1% ointment daily for 12 months and a control group (n = 39). Outcomes included lymphedema diagnosis (primary), arm volume, bioimpedance spectroscopy, quality of life (QOL) scores, and adverse events. Assessments were performed at baseline and at 3, 6, 9, and 12 months.Results:At 12 months, lymphedema was diagnosed in 3 of 18 patients (16.7%) in the intervention group and 4 of 37 patients (10.8%) in the control group (p> 0.05). Mean increase in at-risk arm volume was 80.7 mL in the intervention group versus 116.1 mL in the control group (p> 0.05). Disease-specific quality of life scores worsened in both groups, but scores returned to baseline at 12 months in the intervention group only. Adverse events were mild and manageable, with no serious events reported.Conclusions:While topical tacrolimus did not significantly reduce the incidence of lymphedema, exploratory patterns in symptom onset and quality-of-life measures indicate that further investigation in larger randomized trials may be warranted.
背景：乳腺癌相关淋巴水肿（BCRL）仍是乳腺癌幸存者面临的棘手并发症。目前尚无有效的药物治疗方案。新兴研究揭示了炎症、淋巴功能障碍和T细胞活性在BCRL发展中的关键作用。钙调神经磷酸酶抑制剂他克莫司在临床前研究中显示出通过减轻炎症、增强淋巴功能和调节T细胞活性（这些机制均与BCRL发病机制相关）的潜在疗效。本研究旨在探讨局部使用他克莫司软膏能否降低BCRL的发生率和严重程度，为缓解这一致残性疾病提供新思路。 方法：本研究于2020年2月至2022年6月开展平行、开放标签的非随机对照多中心临床预试验。招募接受腋窝淋巴结清扫术（ALND）的女性参与者，分为干预组（n=22）每日局部使用0.1%他克莫司软膏治疗12个月，对照组（n=39）不接受干预。主要结局指标为淋巴水肿诊断，次要指标包括患肢体积、生物电阻抗光谱、生活质量评分及不良事件。在基线期及第3、6、9、12个月进行评估。 结果：12个月时，干预组18例患者中3例（16.7%）确诊淋巴水肿，对照组37例患者中4例（10.8%）确诊（p>0.05）。干预组高危患肢平均体积增加80.7 mL，对照组增加116.1 mL（p>0.05）。两组疾病特异性生活质量评分均出现恶化，但仅干预组在12个月时恢复至基线水平。不良事件轻微可控，无严重不良事件报告。 结论：虽然他克莫司局部用药未能显著降低淋巴水肿发生率，但在症状发生模式和生活质量指标中发现的探索性趋势提示，有必要开展更大规模的随机试验进行深入研究。
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