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Background <p>The Oncotype DX recurrence score (RS) is widely used to guide adjuvant chemotherapy decisions in hormone receptor–positive (HR-positive), HER2-negative early breast cancer. However, treatment decisions in real-world practice are rarely binary, and alternative strategies for treatment intensity modulation have emerged. In Japan, S-1-based endocrine therapy (ET + S-1), supported by the POTENT trial, represents one such option. How ET + S-1 is positioned in the context of RS-guided decision making remains unclear.</p> Methods <p>We retrospectively analyzed 290 patients with HR-positive/HER2-negative early breast cancer who underwent Oncotype DX testing between September 2023 and November 2025. Clinicopathological characteristics, recurrence score (RS) categories, use of intravenous (IV) chemotherapy, and use of adjuvant abemaciclib were evaluated. Among patients treated with ET + S-1 without IV chemotherapy, cases were classified as augmentation or substitution strategies according to documented treatment intent and multidisciplinary discussion records.</p> Results <p>ET + S-1 was selected in 58 patients (20.0%) and was more frequently used in patients with premenopausal status, larger tumor size, lymph node involvement, high Ki-67, higher histological grade, and higher RS categories, whereas the frequency of IV chemotherapy was similar between patients treated with and without ET + S-1. Among ET + S-1 patients without IV chemotherapy (<i>n</i> = 51), all substitution cases had RS ≥ 26, while 41 of 42 augmentation cases had RS &lt; 26. Clinical risk profiles were nevertheless not clearly separable, suggesting that treatment selection could not be explained solely by routinely collected clinicopathological variables. Among patients with RS ≥ 26 (<i>n</i> = 49), no single clinicopathological factor, including use of ET + S-1 or adjuvant abemaciclib, was significantly associated with IV chemotherapy use.</p> Conclusions <p>In this single-institution real-world cohort, ET + S-1 appeared to be used as part of individualized treatment intensity modulation rather than as a simple consequence of binary RS-based decision making. These findings should be interpreted as hypothesis-generating and suggest that RS may function as a component of integrated, patient-centered adjuvant treatment decision making.</p>

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Treatment intensity modulation using S-1-based endocrine therapy in the era of oncotype DX: a real-world study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月1日

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  • Haruhito Kinoshita,
  • Shinichiro Kashiwagi,
  • Mariko Nishikawa,
  • Asuka Kochi,
  • Chika Watanabe,
  • Koji Takada,
  • Yukie Tauchi,
  • Kana Ogisawa,
  • Masatsune Shibutani,
  • Tamami Morisaki

摘要

Background

The Oncotype DX recurrence score (RS) is widely used to guide adjuvant chemotherapy decisions in hormone receptor–positive (HR-positive), HER2-negative early breast cancer. However, treatment decisions in real-world practice are rarely binary, and alternative strategies for treatment intensity modulation have emerged. In Japan, S-1-based endocrine therapy (ET + S-1), supported by the POTENT trial, represents one such option. How ET + S-1 is positioned in the context of RS-guided decision making remains unclear.

Methods

We retrospectively analyzed 290 patients with HR-positive/HER2-negative early breast cancer who underwent Oncotype DX testing between September 2023 and November 2025. Clinicopathological characteristics, recurrence score (RS) categories, use of intravenous (IV) chemotherapy, and use of adjuvant abemaciclib were evaluated. Among patients treated with ET + S-1 without IV chemotherapy, cases were classified as augmentation or substitution strategies according to documented treatment intent and multidisciplinary discussion records.

Results

ET + S-1 was selected in 58 patients (20.0%) and was more frequently used in patients with premenopausal status, larger tumor size, lymph node involvement, high Ki-67, higher histological grade, and higher RS categories, whereas the frequency of IV chemotherapy was similar between patients treated with and without ET + S-1. Among ET + S-1 patients without IV chemotherapy (n = 51), all substitution cases had RS ≥ 26, while 41 of 42 augmentation cases had RS < 26. Clinical risk profiles were nevertheless not clearly separable, suggesting that treatment selection could not be explained solely by routinely collected clinicopathological variables. Among patients with RS ≥ 26 (n = 49), no single clinicopathological factor, including use of ET + S-1 or adjuvant abemaciclib, was significantly associated with IV chemotherapy use.

Conclusions

In this single-institution real-world cohort, ET + S-1 appeared to be used as part of individualized treatment intensity modulation rather than as a simple consequence of binary RS-based decision making. These findings should be interpreted as hypothesis-generating and suggest that RS may function as a component of integrated, patient-centered adjuvant treatment decision making.