Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Cancer Med. 2023 Sep;12(17):17718-17730. doi: 10.1002/cam4.6390. Epub 2023 Aug 1.
The role of endocrine therapy in the treatment of patients in a postmenopausal hormonal state and with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer (AMBC) is unclear.
We analyzed the data from 94 patients with ER-positive HER2-positive AMBC enrolled in the Safari study (UMIN000015168), a retrospective cohort study of 1072 ER-positive AMBC patients in a postmenopausal hormonal state who received fulvestrant 500 mg (F500): (1) to compare time to treatment failure (TTF) and overall survival (OS) by treatment group, and TTF by treatment line; (2) in patients who received endocrine therapy (including F500) or anti-HER2 therapy as initial systemic therapy before chemotherapy, to investigate relations between TTF for the first-line therapy or time to chemotherapy (TTC) and OS; (3) to investigate factors associated with OS.
The TTF was longer in the patients treated with F500 as first- or second-line therapy (n = 20) than in those who received later-line F500 therapy (n = 74) (6.6 vs. 3.7 months; HR, 1.98; p = 0.014). In the 59 patients who received endocrine therapy or anti-HER2 therapy as initial systemic therapy before chemotherapy, those with TTC ≥3 years had longer median OS than those with TTC <3 years (10.5 vs. 5.9 years; HR, 0.32; p = 0.001). Longer TTC was associated with prolonged OS.
In patients with ER-positive HER2-positive AMBC enrolled in the Safari study, TTF was longer in patients who received F500 as first- or second-line therapy. In patients who received chemotherapy-free initial systemic therapy, the prolonged OS in those with TTC ≥3 years suggests that this value may be a helpful cut-off for indicating clinical outcomes.
在绝经后激素状态且雌激素受体（ER）阳性、人表皮生长因子受体 2（HER2）阳性的晚期或转移性乳腺癌（AMBC）患者中，内分泌治疗的作用尚不清楚。
我们分析了 Safari 研究（UMIN000015168）中 94 例 ER 阳性 HER2 阳性 AMBC 患者的数据，这是一项对 1072 例绝经后激素状态的 ER 阳性 AMBC 患者的回顾性队列研究，这些患者接受氟维司群 500mg（F500）治疗：（1）根据治疗组比较治疗失败时间（TTF）和总生存期（OS），并根据治疗线比较 TTF；（2）在接受内分泌治疗（包括 F500）或抗 HER2 治疗作为化疗前初始全身治疗的患者中，调查一线治疗的 TTF 或化疗时间（TTC）与 OS 的关系；（3）探讨与 OS 相关的因素。
作为一线或二线治疗（n=20）接受 F500 治疗的患者的 TTF 长于接受后续线 F500 治疗的患者（n=74）（6.6 与 3.7 个月；HR，1.98；p=0.014）。在 59 例接受化疗前内分泌治疗或抗 HER2 治疗作为初始全身治疗的患者中，TTC≥3 年的患者中位 OS 长于 TTC<3 年的患者（10.5 与 5.9 年；HR，0.32；p=0.001）。较长的 TTC 与较长的 OS 相关。
在 Safari 研究中入组的 ER 阳性 HER2 阳性 AMBC 患者中，作为一线或二线治疗接受 F500 治疗的患者 TTF 较长。在接受无化疗初始全身治疗的患者中，TTC≥3 年的患者 OS 延长提示该值可能是提示临床结局的有用截止值。
