Takada Masahiro, Imoto Shigeru, Ishida Takanori, Ito Yoshinori, Iwata Hiroji, Masuda Norikazu, Mukai Hirofumi, Saji Shigehira, Ikeda Takafumi, Haga Hironori, Saeki Toshiaki, Aogi Kenjiro, Sugie Tomoharu, Ueno Takayuki, Ohno Shinji, Ishiguro Hiroshi, Kanbayashi Chizuko, Miyamoto Takeshi, Hagiwara Yasuhiro, Toi Masakazu
Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Breast Surgery, Kyorin University School of Medicine, Mitaka, Japan.
Breast Cancer Res Treat. 2023 Dec;202(3):485-496. doi: 10.1007/s10549-023-07099-4. Epub 2023 Sep 7.
The Phase III POTENT trial demonstrated the efficacy of adding S-1 to adjuvant endocrine therapy for estrogen receptor-positive, HER2-negative early breast cancer. We investigated the efficacy of S-1 across different recurrence risk subgroups.
This was a post-hoc exploratory analysis of the POTENT trial. Patients in the endocrine-therapy-only arm were divided into three groups based on composite risk values calculated from multiple prognostic factors. The effects of S-1 were estimated using the Cox model in each risk group. The treatment effects of S-1 in patients meeting the eligibility criteria of the monarchE trial were also estimated.
A total of 1,897 patients were divided into three groups: group 1 (≤ lower quartile of the composite values) (N = 677), group 2 (interquartile range) (N = 767), and group 3 (> upper quartile) (N = 453). The addition of S-1 to endocrine therapy resulted in 49% (HR: 0.51, 95% CI: 0.33-0.78) and 29% (HR: 0.71, 95% CI 0.49-1.02) reductions in invasive disease-free survival (iDFS) events in groups 2 and 3, respectively. We could not identify any benefit from the addition of S-1 in group 1. The addition of S-1 showed an improvement in iDFS in patients with one to three positive nodes meeting the monarchE cohort 1 criteria (N = 290) (HR: 0.47, 95% CI: 0.29-0.74).
The benefit of adding adjuvant S-1 was particularly marked in group 2. Further investigations are warranted to explore the optimal usage of adjuvant S-1.
III期POTENT试验证明了在雌激素受体阳性、人表皮生长因子受体2阴性的早期乳腺癌辅助内分泌治疗中添加S-1的疗效。我们研究了S-1在不同复发风险亚组中的疗效。
这是对POTENT试验的事后探索性分析。仅接受内分泌治疗的患者根据多个预后因素计算出的综合风险值分为三组。使用Cox模型估计每组风险中S-1的效果。还估计了S-1在符合monarchE试验纳入标准的患者中的治疗效果。
总共1897名患者分为三组：第1组（≤综合值的下四分位数）（N = 677）、第2组（四分位间距）（N = 767）和第3组（>上四分位数）（N = 453）。在内分泌治疗中添加S-1分别使第2组和第3组的无侵袭性疾病生存期（iDFS）事件减少了49%（风险比：0.51，95%置信区间：0.33 - 0.78）和29%（风险比：0.71，95%置信区间0.49 - 1.02）。我们未发现第1组添加S-1有任何益处。对于符合monarchE队列1标准的1至3个阳性淋巴结患者（N = 290），添加S-1显示iDFS有所改善（风险比：0.47，95%置信区间：0.29 - 0.74）。
在第2组中添加辅助性S-1的益处尤为显著。有必要进一步研究以探索辅助性S-1的最佳使用方法。
