艾日布林可延长人表皮生长因子受体 2 (HER2) 阴性转移性乳腺癌 (MBC) 患者的总生存期 (OS)，特别是在后期化疗 (ChT) 治疗中。然而，艾日布林治疗患者的健康相关生活质量 (HRQoL) 和一线或二线治疗的疗效仍不清楚。在一线或二线中使用艾日布林可以证明与 S-1（一种口服 5-氟尿嘧啶衍生物）相比，HRQoL 的非劣效性，同时维持 OS。这项随机、对照、开放标签的 III 期试验于日本50家医院。患者于 2016 年 6 月和 2019 年 10 月入组。曾经接受过 ChT 或既往未接受过 ChT 的 HER2 阴性 MBC 患者被随机分配 (1:1) 接受艾日布林或 S-1 治疗。 HRQoL 使用欧洲癌症研究与治疗组织 (EORTC) 生活质量问卷核心 30 (QLQ-C30) 进行评估，每六周直至第 24 周，每九周评估一次直至第 42 周。主要终点是恶化，定义为随机分组后一年内 QLQ-C30 总体健康评分恶化超过 10 分或死亡。次要终点包括 OS。 （试验 ID：UMIN000021398）。共招募了 302 名患者，其中 152 名患者和 148 名患者分别分配至艾日布林组和 S-1 组。问卷达标率为85.6%。与 S-1 组相比，艾日布林一年内全球健康状况恶化的风险差异为 -0.66%（95% CI：-12.47-11.16；非劣效性 P = 0.077）。艾日布林组和 S-1 组的全球健康状况评分首次恶化的中位时间分别为 5.64 个月（95% CI：3.51-8.00）和 5.28 个月（95% CI：3.28-7.80）。中位 OS 分别为 34.7 个月和 27.8 个月（HR：0.72，95% CI：0.54-0.96；P = 0.026）；艾日布林组和 S-1 组的中位无进展生存期分别为 7.57 个月和 6.75 个月（HR：0.88，95% CI：0.67-1.16；P = 0.35）。没有发生新的不良事件。两组之间首次临床恶化的时间相似，艾日布林治疗患者的 OS 显着增加。这项研究由 CSPOR-BC 和卫材有限公司资助。© 2024 作者。

Eribulin prolongs overall survival (OS) of patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC), particularly in later chemotherapy (ChT) treatment. However, the health-related quality of life (HRQoL) and efficacy of first or second-line therapy in eribulin-treated patients remain unknown. Using eribulin in the first- or second-line may demonstrate the non-inferiority of HRQoL compared to S-1, an oral 5-fluorouracil derivative, while maintaining OS.This randomised, controlled, open-label, phase III trial was conducted at 50 hospitals in Japan. Patients were enrolled from June 2016 and October 2019. Patients with HER2-negative MBC once under or no previous ChT were randomly assigned (1:1) to receive eribulin or S-1. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) every six weeks until week 24 and every nine weeks until week 42. The primary endpoint was the deterioration defined as more than 10 points worsening of the general health score of QLQ-C30 or death within one year after randomisation. The secondary endpoints included OS. (Trial ID: UMIN000021398).Three hundred and two patients were enrolled, with 152 and 148 assigned to the eribulin and S-1 groups, respectively. The questionnaire compliance rate was 85.6%. Risk difference of global health status deterioration through one year was -0.66% (95% CI: -12.47-11.16; non-inferiority P = 0.077) for eribulin compared to S-1 groups. Median time to first deterioration for global health status score was 5.64 (95% CI: 3.51-8.00) and 5.28 months (95% CI: 3.28-7.80) in the eribulin and S-1 groups, respectively. The median OS was 34.7 and 27.8 months, (HR: 0.72, 95% CI: 0.54-0.96; P = 0.026); the median progression-free survival was 7.57 and 6.75 months in the eribulin and S-1 groups, (HR: 0.88, 95% CI: 0.67-1.16; P = 0.35), respectively. No new adverse events occurred.The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients.This study was funded by CSPOR-BC and Eisai CO., Ltd.© 2024 The Authors.