Oncology Unit, ASST Bergamo Ovest, Treviglio, BG, Italy.
Oncology Unit, ASST Bergamo Ovest, Treviglio, BG, Italy.
Eur J Cancer. 2023 Nov;193:113322. doi: 10.1016/j.ejca.2023.113322. Epub 2023 Sep 6.
Adjuvant hormonal therapy, with or without prior chemotherapy, has been widely recognised as the preferred treatment strategy for resected breast cancer (BC) for a minimum duration of 5 years. If the effectiveness of therapy beyond a 5-year period has been established, there is still ongoing debate regarding the optimal duration for this prolonged period. A network meta-analysis (NMA) was conducted to ascertain the optimal duration of extended therapy for resected BC in postmenopausal women.
A comprehensive search was conducted on online databases, including MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, to identify all randomised trials on extended duration of endocrine therapy. The search was limited to trials that had been published before 30th April 2023. The study focused on evaluating disease-free survival (DFS) as the primary outcome, with overall survival (OS) as the secondary endpoint. Under the Bayesian framework, NMA was performed using the GeMTC package. The relative rankings of the treatments were determined by utilising surface under the cumulative ranking curve (SUCRA) p scores. A network meta-regression analysis was employed to ascertain the impact of the baseline characteristics of the disease and the initial treatments administered.
In the overall population, increasing the duration by 5 years did not result in a significantly better DFS compared to durations of 2-3 and 3-4 more years (hazard ratio [HR] = 0.97, 95% confidence interval [CI] [0.88-1.08] and HR = 0.87, 95% CI [0.72-1.06]). This effect was independent of adjuvant chemotherapy and nodal status. However, the effect of 5 more years of AI was significantly better in node-positive BC and in those who received some years of tamoxifen instead of aromatase inhibitors (AIs) as initial adjuvant therapy. OS was not affected by the administration of extended endocrine therapy.
We conclude that an extended course of AI lasting 2-3 years, following an initial 5-year treatment, may be considered an appropriate regimen for achieving DFS benefits. In node-positive BC cases, it has been observed that a duration of 10 years provides a greater advantage compared to shorter durations, especially when tamoxifen is administered initially. Therefore, it is suggested that a longer duration is a potential standard of care in these cases.
辅助激素治疗，无论是否联合化疗，已被广泛认为是切除乳腺癌（BC）的首选治疗策略，至少持续 5 年。如果治疗超过 5 年的有效性已经确定，那么对于这种延长的治疗时间，仍然存在着持续的争论。一项网络荟萃分析（NMA）旨在确定绝经后切除 BC 患者延长治疗的最佳持续时间。
对在线数据库（包括 MEDLINE、Embase 和 Cochrane 对照试验中心注册库）进行全面检索，以确定所有关于内分泌治疗延长持续时间的随机试验。检索范围仅限于 2023 年 4 月 30 日前发表的试验。该研究侧重于评估无病生存（DFS）作为主要结局，以总生存（OS）作为次要结局。在贝叶斯框架下，使用 GeMTC 包进行 NMA。通过累积排序曲线下面积（SUCRA）p 评分确定治疗方法的相对排名。采用网络荟萃回归分析确定疾病和初始治疗的基线特征对结果的影响。
在总体人群中，与 2-3 年和 3-4 年以上的持续时间相比，延长 5 年的治疗时间并没有显著改善 DFS（风险比[HR] = 0.97，95%置信区间[CI] [0.88-1.08]和 HR = 0.87，95% CI [0.72-1.06]）。这种效果独立于辅助化疗和淋巴结状态。然而，在淋巴结阳性 BC 和那些接受他莫昔芬而不是芳香化酶抑制剂（AIs）作为初始辅助治疗的患者中，5 年以上 AI 的效果明显更好。OS 不受延长内分泌治疗的影响。
我们得出结论，初始 5 年治疗后，2-3 年的延长 AI 治疗可能是一种实现 DFS 获益的适当方案。在淋巴结阳性 BC 病例中，与较短持续时间相比，10 年的持续时间提供了更大的优势，特别是当最初使用他莫昔芬时。因此，建议在这些情况下延长治疗时间是一种潜在的标准治疗方法。
