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Purpose <p>To investigate long-term outcomes for triple‑negative breast cancer (TNBC) patients enrolled in JBCRG-22.</p> Methods <p>TNBC (cT1c–T3, cN0–1, M0) patients were stratified by homologous recombination deficiency (HRD) and germline <i>BRCA</i> mutation (gBRCAm) status. Group A patients (aged &lt; 65&#xa0;years with HRD-positive tumors, or those with gBRCAm, if available) were randomized to receive 4 cycles of weekly paclitaxel (group A1) or eribulin (group A2), both with carboplatin, followed by 4 cycles of anthracycline. Group B patients (aged &lt; 65&#xa0;years with HRD-negative tumors or aged ≥ 65&#xa0;years) were randomized to receive 6 cycles of eribulin plus cyclophosphamide (group B1) or eribulin plus capecitabine (group B2). Five-year invasive disease-free survival (IDFS), distant disease-free survival (DDFS), and overall survival (OS) were assessed. Additionally, data were analyzed by biomarker levels including lymphocyte count (LC) and neutrophil-to-lymphocyte ratio (NLR).</p> Results <p>Ninety-nine patients were followed for a median of 5.6&#xa0;years. In patients who received eribulin-based therapy (groups A2 + B1 + B2), 5-year IDFS and OS rates, respectively, were 95% and 100% in patients who achieved pCR after neoadjuvant therapy (<i>n</i> = 20) and 71.4% and 80.2% in those who did not (<i>n</i> = 56), showing significantly better prognosis in the pCR cohort (<i>p</i> &lt; 0.05). OS tended to be better in patients with baseline LC ≥ 1500/mm<sup>3</sup> and NLR &lt; 3, particularly in eribulin-treated patients, although differences were non-significant.</p> Conclusions <p>These findings will help guide the development of eribulin-based neoadjuvant chemotherapy for selected TNBC patients. Our exploratory analysis of LC and NLR results may help inform clinical prediction models for eribulin-treated patients.</p> Trial registration <p>The study has been registered with the University Hospital Medical Information Network Clinical Trials Registry (<a href="https://www.umin.ac.jp/ctr/index-j.htm">https://www.umin.ac.jp/ctr/index-j.htm</a>) with unique trial number UMIN000023162. The Japan Breast Cancer Research Group trial number is JBCRG-22.</p>

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Long-term outcomes of eribulin‑based neoadjuvant chemotherapy for triple‑negative breast cancer patients stratified by homologous recombination deficiency status: results of the randomized JBCRG-22 study

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  • 发表日期：

    2026年3月19日

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  • Norikazu Masuda,
  • Hiroyuki Yasojima,
  • Hiroko Bando,
  • Takashi Yamanaka,
  • Hideo Shigematsu,
  • Masato Takahashi,
  • Shigenori E. Nagai,
  • Mitsuya Ito,
  • Tomoyuki Aruga,
  • Mariko Tokiwa,
  • Shigeru Imoto,
  • Rikiya Nakamura,
  • Hiroshi Ishiguro,
  • Hidetaka Kawabata,
  • Shigehira Saji,
  • Hironori Haga,
  • Satoshi Morita,
  • Masakazu Toi

摘要

Purpose

To investigate long-term outcomes for triple‑negative breast cancer (TNBC) patients enrolled in JBCRG-22.

Methods

TNBC (cT1c–T3, cN0–1, M0) patients were stratified by homologous recombination deficiency (HRD) and germline BRCA mutation (gBRCAm) status. Group A patients (aged < 65 years with HRD-positive tumors, or those with gBRCAm, if available) were randomized to receive 4 cycles of weekly paclitaxel (group A1) or eribulin (group A2), both with carboplatin, followed by 4 cycles of anthracycline. Group B patients (aged < 65 years with HRD-negative tumors or aged ≥ 65 years) were randomized to receive 6 cycles of eribulin plus cyclophosphamide (group B1) or eribulin plus capecitabine (group B2). Five-year invasive disease-free survival (IDFS), distant disease-free survival (DDFS), and overall survival (OS) were assessed. Additionally, data were analyzed by biomarker levels including lymphocyte count (LC) and neutrophil-to-lymphocyte ratio (NLR).

Results

Ninety-nine patients were followed for a median of 5.6 years. In patients who received eribulin-based therapy (groups A2 + B1 + B2), 5-year IDFS and OS rates, respectively, were 95% and 100% in patients who achieved pCR after neoadjuvant therapy (n = 20) and 71.4% and 80.2% in those who did not (n = 56), showing significantly better prognosis in the pCR cohort (p < 0.05). OS tended to be better in patients with baseline LC ≥ 1500/mm3 and NLR < 3, particularly in eribulin-treated patients, although differences were non-significant.

Conclusions

These findings will help guide the development of eribulin-based neoadjuvant chemotherapy for selected TNBC patients. Our exploratory analysis of LC and NLR results may help inform clinical prediction models for eribulin-treated patients.

Trial registration

The study has been registered with the University Hospital Medical Information Network Clinical Trials Registry (https://www.umin.ac.jp/ctr/index-j.htm) with unique trial number UMIN000023162. The Japan Breast Cancer Research Group trial number is JBCRG-22.