Background <p>Patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer remain at risk of recurrence even beyond 5&#xa0;years post-surgery. The monarchE and the POTENT trials have demonstrated the efficacy of adding abemaciclib and S-1, respectively, to adjuvant endocrine therapy for patients with intermediate to high-risk luminal breast cancer. Given the broad eligibility criteria of the POTENT trial, this study aimed to determine the optimal selection criteria for adjuvant S-1 therapy in HR-positive/HER2-negative early breast cancer.</p> Methods <p>We analyzed the prognosis of POTENT-eligible patients with HR-positive/HER2-negative early breast cancer who underwent surgery at our institute from 1981 to 2023. Kaplan–Meier curves were established, and differences were assessed using the log-rank test.</p> Results <p>The analysis included 2099 patients. Among lymph node-negative patients eligible for the POTENT trial, those with grade 2 tumors &lt; 3&#xa0;cm demonstrated significantly better disease-free survival (DFS) than those with tumors ≥ 3&#xa0;cm, while patients with grade 3 tumors &lt; 2&#xa0;cm demonstrated significantly improved DFS compared with those with tumors ≥ 2&#xa0;cm. Lymph node-negative patients with “grade 2 &amp; ≥ 2&#xa0;cm, &lt; 3&#xa0;cm” and “grade 3 &amp; &lt; 2&#xa0;cm” disease had significantly better DFS compared with the “remaining POTENT eligible” patients (p = 0.009).</p> Conclusions <p>The results of this study showed that the prognosis for lymph node-negative early breast cancer patients classified as “grade 2 &amp; ≥ 2&#xa0;cm, &lt; 3&#xa0;cm” and “grade 3 &amp; &lt; 2&#xa0;cm” was favorable. The benefit of adding S-1 to endocrine therapy to these groups may be marginal.</p>

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Optimal patient population for adjuvant S-1 therapy in hormone receptor-positive, HER2-negative early breast cancer

  • Ayaka Isogai,
  • Mitsuo Terada,
  • Yumi Wanifuchi-Endo,
  • Takashi Fujita,
  • Tomoko Asano,
  • Makiko Mori,
  • Kazuki Nozawa,
  • Nana Matsumoto,
  • Yuka Niwa,
  • Yuya Tanaka,
  • Hiroyuki Kato,
  • Masayuki Komura,
  • Tatsuya Toyama

摘要

Background

Patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer remain at risk of recurrence even beyond 5 years post-surgery. The monarchE and the POTENT trials have demonstrated the efficacy of adding abemaciclib and S-1, respectively, to adjuvant endocrine therapy for patients with intermediate to high-risk luminal breast cancer. Given the broad eligibility criteria of the POTENT trial, this study aimed to determine the optimal selection criteria for adjuvant S-1 therapy in HR-positive/HER2-negative early breast cancer.

Methods

We analyzed the prognosis of POTENT-eligible patients with HR-positive/HER2-negative early breast cancer who underwent surgery at our institute from 1981 to 2023. Kaplan–Meier curves were established, and differences were assessed using the log-rank test.

Results

The analysis included 2099 patients. Among lymph node-negative patients eligible for the POTENT trial, those with grade 2 tumors < 3 cm demonstrated significantly better disease-free survival (DFS) than those with tumors ≥ 3 cm, while patients with grade 3 tumors < 2 cm demonstrated significantly improved DFS compared with those with tumors ≥ 2 cm. Lymph node-negative patients with “grade 2 & ≥ 2 cm, < 3 cm” and “grade 3 & < 2 cm” disease had significantly better DFS compared with the “remaining POTENT eligible” patients (p = 0.009).

Conclusions

The results of this study showed that the prognosis for lymph node-negative early breast cancer patients classified as “grade 2 & ≥ 2 cm, < 3 cm” and “grade 3 & < 2 cm” was favorable. The benefit of adding S-1 to endocrine therapy to these groups may be marginal.