Chao Ta-Chung, Gracia Deanna, Ho Chan-Heng, Chen Hao-Yang, Huang Chi-Cheng, Tseng Ling-Ming
Comprehensive Breast Health Center, Taipei Veterans General Hospital, Taipei, Taiwan.
Division of Cancer Prevention, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Discov Oncol. 2025 May 16;16(1):783. doi: 10.1007/s12672-025-02601-4.
Clinical trials have shown the efficacy of adding CDK4/6 inhibitors to standard endocrine therapy in hormone receptor (HR)-positive, human epidermal growth factor receptor II (HER2)-negative high-risk early breast cancer.
HR+ /HER2- early breast cancers were retrieved from cancer registry. The primary endpoints were overall survival (OS) and recurrence-free survival (RFS) among trial-defined high-risk patients, as well as the impact of adjuvant chemotherapy.
Among 2758 registered cases, 511 and 1207 patients met MonarchE (M) and NATALEE (N) high-risk criteria, respectively. OS was 94.8% for M-high/N-high, 96.8% for M-low/N-high, 90.7% for M-high/N-low, and 98.9% for M-low/N-low patients, with a hazard ratio (HR) of 2.3 and 2.8 for M-high and N-high, respectively. For RFS, chemotherapy reduced recurrence risk in M-high patients (HR: 0.24) but showed no benefit for N-high patients overall, except for stage III N-high cases (HR: 0.2).
Adjuvant chemotherapy significantly reduced recurrence risk in M-high patients with early breast cancer. Further stratification of M-low/N-high patients is needed to guide tailored chemotherapy approaches alongside CDK4/6 inhibition.
临床试验已表明，在激素受体（HR）阳性、人表皮生长因子受体II（HER2）阴性的高危早期乳腺癌中，在标准内分泌治疗基础上加用CDK4/6抑制剂具有疗效。
从癌症登记处检索HR+/HER2-早期乳腺癌病例。主要终点为试验定义的高危患者的总生存期（OS）和无复发生存期（RFS），以及辅助化疗的影响。
在2758例登记病例中，分别有511例和1207例患者符合MonarchE（M）和NATALEE（N）高危标准。M高/N高、M低/N高、M高/N低和M低/N低患者的OS分别为94.8%、96.8%、90.7%和98.9%，M高和N高患者的风险比（HR）分别为2.3和2.8。对于RFS，化疗降低了M高患者的复发风险（HR：0.24），但总体上对N高患者没有益处，但III期N高病例除外（HR：0.2）。
辅助化疗显著降低了早期乳腺癌M高患者的复发风险。需要对M低/N高患者进行进一步分层，以指导在CDK4/6抑制的同时采用个性化化疗方法。
