Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Hepatol Commun. 2022 Sep;6(9):2565-2568. doi: 10.1002/hep4.2008. Epub 2022 Jun 10.
Tamoxifen is a commonly prescribed drug in both early and metastatic breast cancer. Prospective studies in Asian populations demonstrated that tamoxifen-related liver steatosis occurred in more than 30% of the patients within 2 years after start of treatment. No well-designed prospective studies on potential tamoxifen-related liver steatosis have been conducted in Caucasian patients so far. Therefore, our prospective study aimed to assess the incidence of tamoxifen-related liver steatosis for a period of 2 years in a population of Caucasian breast cancer patients treated with tamoxifen. Patients with an indication for adjuvant treatment with tamoxifen were included in this study. Data were collected at 3 months (T1) and at 2 years (T2) after start of tamoxifen treatment (follow-up period of 21 months). For the quantification of liver steatosis, patients underwent liver stiffness measurement by transient elastography with simultaneous controlled attenuation parameter (CAP) determination using the FibroScan. A total of 95 Caucasian breast cancer patients were included in this evaluation. Liver steatosis was observed in 46 of 95 (48%) and 48 of 95 (51%) of the patients at T1 and T2, respectively. No clinically relevant increase in liver steatosis was observed during the treatment period of 2 years with tamoxifen (median CAP = 243 ± 49 dB/m (T1) and 253 ± 55 dB/m (T2), respectively; p = 0.038). Conclusion: In this prospective longitudinal study in Caucasian breast cancer patients, no clinically relevant alterations in liver steatosis in terms of CAP values and liver/lipid parameters were observed after 2 years of tamoxifen treatment. This study therefore demonstrates an absence of tamoxifen-related adverse events such as steatosis and (early) development of fibrosis or cirrhosis during a treatment period of at least 2 years.
他莫昔芬是早期和转移性乳腺癌中常用的处方药物。在亚洲人群中的前瞻性研究表明，在开始治疗后 2 年内，超过 30%的患者出现了与他莫昔芬相关的肝脂肪变性。迄今为止，尚未在高加索患者中进行过关于潜在他莫昔芬相关肝脂肪变性的精心设计的前瞻性研究。因此，我们的前瞻性研究旨在评估接受他莫昔芬治疗的高加索乳腺癌患者在 2 年内发生与他莫昔芬相关的肝脂肪变性的发生率。本研究纳入了有接受他莫昔芬辅助治疗指征的患者。数据收集于开始他莫昔芬治疗后 3 个月（T1）和 2 年（T2）（随访期 21 个月）。为了定量肝脂肪变性，患者接受了瞬时弹性成像肝硬度测量，并同时使用 FibroScan 进行受控衰减参数（CAP）测定。本评估共纳入了 95 例高加索乳腺癌患者。在 T1 和 T2 时，分别有 46 例（48%）和 48 例（51%）患者观察到肝脂肪变性。在接受他莫昔芬治疗的 2 年期间，未观察到肝脂肪变性有临床相关的增加（中位 CAP 值分别为 T1 时 243±49 dB/m 和 T2 时 253±55 dB/m；p=0.038）。结论：在这项针对高加索乳腺癌患者的前瞻性纵向研究中，在接受他莫昔芬治疗 2 年后，根据 CAP 值和肝/脂参数，未观察到肝脂肪变性的临床相关变化。因此，本研究表明，在至少 2 年的治疗期间，他莫昔芬不会引起与药物相关的不良事件，如脂肪变性和（早期）纤维化或肝硬化的发生。
