Breast cancer research and treatment · 2026
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.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Masuda Norikazu, Yasojima Hiroyuki, Bando Hiroko, Yamanaka Takashi, Shigematsu Hideo, Takahashi Masato, Nagai Shigenori E, Ito Mitsuya, Aruga Tomoyuki, Tokiwa Mariko, Imoto Shigeru, Nakamura Rikiya, Ishiguro Hiroshi, Kawabata Hidetaka, Saji Shigehira, Haga Hironori, Morita Satoshi, Toi Masakazu
Аннотация
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.
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.