Department of Surgery, Cheng Hsin General Hospital, Taipei, Taiwan, R.O.C.
Institute of Health Policy and Management, College of Public Health, National Taiwan University, Taipei, Taiwan, R.O.C.
PLoS One. 2024 Nov 27;19(11):e0313120. doi: 10.1371/journal.pone.0313120. eCollection 2024.
Numerous clinical trials have compared the efficacy of endocrine therapy in post-menopausal breast cancer patients. This study aims to explore whether there is a difference in recurrence rates between this population using tamoxifen and aromatase inhibitors (AIs) by analyzing real-world data.
This retrospective cohort study utilized the National Health Insurance (NHI) claims data and the Taiwan Cancer Registry (TCR). We identified 6,050 patients aged over 55 diagnosed with ER-positive, HER2-negative early breast cancer between 2012 and 2016 (4,451 on AIs alone and 1,599 on tamoxifen alone). Recurrence in both groups was assessed until the end of 2020. Hazards were measured based on age of diagnosis, cancer stage, adjuvant chemotherapy, radiation therapy, type of endocrine therapy used, and adherence. Recurrence‑free survival between the AIs and tamoxifen groups was evaluated using the Kaplan-Meier model.
The average age was 65.1 years, with a median follow-up time of 5.7 years and a median duration of endocrine therapy of 4.5 years. The recurrence rate was 2.2%. Using tamoxifen as endocrine therapy reduces the risk of recurrence compared to AIs (adjusted HR: 0.32, p < 0.0001). There was no statistical difference between the two drugs in stage 1 breast cancer. However, in stage 2, the risk of breast cancer recurrence decreased to 0.15 times with the use of tamoxifen compared to AIs (p = 0.0002). Stage 2 cancer, histological grade 3, and non-adherence increased recurrence risk in post-menopausal breast cancer patients.
Based on real-world data analysis, in ER-positive, HER2-negative post-menopausal women with early breast cancer in Taiwan, the use of tamoxifen compared to AIs is associated with a lower risk of recurrence. Improved adherence to medication can break the cycle of recurrence and improve health outcomes.
许多临床试验比较了绝经后乳腺癌患者使用内分泌治疗的疗效。本研究旨在通过分析真实世界的数据,探讨该人群使用他莫昔芬和芳香化酶抑制剂(AIs)的复发率是否存在差异。
本回顾性队列研究使用了全民健康保险(NHI)理赔数据和台湾癌症登记处(TCR)的数据。我们确定了 6050 名年龄在 55 岁以上的患者,这些患者在 2012 年至 2016 年间被诊断为 ER 阳性、HER2 阴性早期乳腺癌,其中 4451 名患者单独使用 AIs,1599 名患者单独使用他莫昔芬。两组患者的复发情况均评估至 2020 年底。风险根据诊断时的年龄、癌症分期、辅助化疗、放疗、使用的内分泌治疗类型和依从性进行测量。使用 Kaplan-Meier 模型评估 AIs 组和他莫昔芬组之间的无复发生存率。
平均年龄为 65.1 岁,中位随访时间为 5.7 年,内分泌治疗中位时间为 4.5 年。复发率为 2.2%。与 AIs 相比,使用他莫昔芬作为内分泌治疗可降低复发风险(调整后的 HR:0.32,p < 0.0001)。在 1 期乳腺癌中,两种药物之间无统计学差异。然而,在 2 期乳腺癌中,与 AIs 相比,使用他莫昔芬可将乳腺癌复发风险降低至 0.15 倍(p = 0.0002)。2 期癌症、组织学 3 级和不依从性增加了绝经后乳腺癌患者的复发风险。
基于真实世界数据分析,在台湾的 ER 阳性、HER2 阴性绝经后早期乳腺癌女性中,与 AIs 相比,使用他莫昔芬与复发风险降低相关。提高药物依从性可以打破复发循环,改善健康结局。