■Eribulin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),尤其是在后期化疗(ChT)治疗中。然而,在接受eribulin治疗的患者中,健康相关生活质量(HRQoL)和一线或二线治疗的疗效仍未知.与口服5-氟尿嘧啶衍生物S-1相比,在一线或二线使用艾瑞布林可能证明HRQoL的非劣效性,同时维护操作系统。
■这是随机的,控制,开放标签,在日本50家医院进行了III期试验.患者于2016年6月至2019年10月入选。HER2阴性MBC的患者曾低于或没有之前的ChT,被随机分配(1:1)接受eribulin或S-1。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)每六周评估一次,直到第24周,每9周评估一次,直到第42周。主要终点是定义为随机化后一年内QLQ-C30的一般健康评分恶化超过10分或死亡的恶化。次要端点包括OS。(试用ID:UMIN000021398)。
■纳入了三百零两名患者,152和148被分配到eribulin和S-1组,分别。问卷依从率为85.6%。与S-1组相比,eribulin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)。在eribulin和S-1组中,全球健康状况评分首次恶化的中位时间为5.64(95%CI:3.51-8.00)和5.28个月(95%CI:3.28-7.80),分别。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);eribulin和S-1组的中位无进展生存期为7.57和6.75个月,(HR:0.88,95%CI:0.67-1.16;P=0.35),分别。没有新的不良事件发生。
■两组之间首次临床恶化的时间相似,接受艾瑞布林治疗的患者的OS显着增加。
■本研究由CSPOR-BC和EisaiCO资助。,Ltd.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients.
UNASSIGNED: This study was funded by CSPOR-BC and Eisai CO., Ltd.