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Background <p>We previously reported the 21-gene Oncotype DX® assay results from TransNEOS in patients enrolled in the phase 3 NEOS trial. However, the association between assay results and long-term prognosis has remained unclear.</p> Methods <p>Of the 296 patients registered in TransNEOS, 226 patients were enrolled in this study. Multigene assay results were categorized into three groups based on Recurrence Score® (RS): RS low &lt; 11, RS intermediate 11–25, RS high &gt; 25. Kaplan–Meier methods evaluated the association between RS results and DDFS and OS across treatments and clinical response to neoadjuvant endocrine treatment (NET).</p> Results <p>The clinical efficacy of NET was judged as CR, PR, and SD in 4 (1.8%), 113 (50%), and 109 (48.2%) patients, respectively. In the RS low and intermediate groups, no statistically significant difference in DDFS or OS was observed between the endocrine therapy (ET) alone group and the chemoendocrine therapy (CT + ET) group. In the RS high group, OS was significantly lower in the ET group compared to the CT + ET group (p = 0.037). Among patients in the RS high group who achieved CR + PR response to NET, there was no significant difference in OS between the CT + ET group and the ET alone group (p = 0.25). However, the number of events was limited, and the study may have been underpowered to detect a meaningful difference.</p> Conclusions <p>The need for chemotherapy in postmenopausal HR + , HER2- breast cancer patients might be further informed by integrating the results of the Oncotype DX test with the response to NET.</p>

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Prognosis of ER-positive, HER2-negative postmenopausal early breast cancer patients based on response to neoadjuvant endocrine therapy and multigene assay results: findings from the NEOS trial

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  • 发表日期：

    2026年6月18日

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  • Hiroji Iwata,
  • Norikazu Masuda,
  • Yutaka Yamamoto,
  • Tomomi Fujisawa,
  • Tatsuya Toyama,
  • Masahiro Kashiwaba,
  • Shoichiro Ohtani,
  • Naruto Taira,
  • Takehiko Sakai,
  • Yoshie Hasegawa,
  • Rikiya Nakamura,
  • Takuhiro Yamaguchi,
  • Kentaro Sakamaki,
  • Christy A. Russell,
  • Naoko Sugiyama

摘要

Background

We previously reported the 21-gene Oncotype DX® assay results from TransNEOS in patients enrolled in the phase 3 NEOS trial. However, the association between assay results and long-term prognosis has remained unclear.

Methods

Of the 296 patients registered in TransNEOS, 226 patients were enrolled in this study. Multigene assay results were categorized into three groups based on Recurrence Score® (RS): RS low < 11, RS intermediate 11–25, RS high > 25. Kaplan–Meier methods evaluated the association between RS results and DDFS and OS across treatments and clinical response to neoadjuvant endocrine treatment (NET).

Results

The clinical efficacy of NET was judged as CR, PR, and SD in 4 (1.8%), 113 (50%), and 109 (48.2%) patients, respectively. In the RS low and intermediate groups, no statistically significant difference in DDFS or OS was observed between the endocrine therapy (ET) alone group and the chemoendocrine therapy (CT + ET) group. In the RS high group, OS was significantly lower in the ET group compared to the CT + ET group (p = 0.037). Among patients in the RS high group who achieved CR + PR response to NET, there was no significant difference in OS between the CT + ET group and the ET alone group (p = 0.25). However, the number of events was limited, and the study may have been underpowered to detect a meaningful difference.

Conclusions

The need for chemotherapy in postmenopausal HR + , HER2- breast cancer patients might be further informed by integrating the results of the Oncotype DX test with the response to NET.