Department of General Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Cancer Med. 2023 Jun;12(12):13193-13203. doi: 10.1002/cam4.6006. Epub 2023 May 10.
In monarchE and Postoperative Therapy with Endocrine and TS-1 (POTENT) trials, abemaciclib and S-1 have, respectively, shown to be effective as adjuvant therapies for luminal breast cancer (BC), although whether patients who meet the criteria are at high risk of recurrence compared to non-eligible patients is still unknown. Here, we investigated recurrence risk according to the criteria of each trial in Japanese patients.
We reviewed the records of 992 patients who received surgery at Chiba University Hospital for stage I-III BC from January 2017 to May 2022 and selected 553 analytic cohort patients and retrospectively analyzed the relapse-free survival of the patients as the primary endpoint. High-recurrence risk was defined according to monarchE trial and POTENT trial.
The 5-year RFS for monarchE cohort 1 and cohort 2 eligible patients were 77.78% and 89.33%, respectively, which were significantly lower than monarchE non-eligible patients (98.31%; p < 0.0001). However, the 5-year RFS rate for POTENT eligible patients (90.51%) was lower than for POTENT non-eligible patients (98.75%; p = 0.0001); excluding those who met the monarchE criteria, the prognosis of POTENT eligible patients had no significant differences from the prognosis of patients with POTENT non-eligible BC (p = 0.3100).
MonarchE criteria accurately identify patients who are prone to relapse. Moreover, although POTENT criteria also suggested a reasonable capacity for recurrence prediction, there was no significant difference in recurrence between POTENT non-eligible patients and the patients who were POTENT but not monarchE eligible. This might offer justification for reconsidering the use of S-1 in monarchE non-eligible patients.
在 monarchE 和术后内分泌治疗与 S-1(POTENT)试验中,阿贝西利和 S-1 分别被证明是治疗 luminal 型乳腺癌(BC)的有效辅助治疗药物,尽管符合标准的患者与不符合标准的患者相比是否具有更高的复发风险尚不清楚。在这里,我们根据每项试验的标准在日本患者中调查了复发风险。
我们回顾了 2017 年 1 月至 2022 年 5 月在千叶大学医院接受手术治疗的 I-III 期 BC 患者的病历,共 992 例,选择了 553 例分析队列患者,并对患者的无复发生存率进行了回顾性分析作为主要终点。高危复发风险的定义根据 monarchE 试验和 POTENT 试验确定。
monarchE 队列 1 和队列 2 符合条件的患者的 5 年 RFS 分别为 77.78%和 89.33%,显著低于 monarchE 不符合条件的患者(98.31%;p<0.0001)。然而,POTENT 符合条件的患者的 5 年 RFS 率(90.51%)低于 POTENT 不符合条件的患者(98.75%;p=0.0001);排除符合 monarchE 标准的患者后,POTENT 符合条件的患者的预后与 POTENT 不符合条件的 BC 患者的预后无显著差异(p=0.3100)。
monarchE 标准准确地识别了容易复发的患者。此外,尽管 POTENT 标准也提示了合理的复发预测能力,但 POTENT 不符合条件的患者与符合 POTENT 但不符合 monarchE 标准的患者之间的复发率无显著差异。这可能为重新考虑在 monarchE 不符合条件的患者中使用 S-1 提供了依据。