First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial
First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2-advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial
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DOI：
10.1007/s10549-017-4658-x
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发表时间：
2018-06-01
影响因子：
3.8
通讯作者：
Campone, Mario
中科院分区：
文献类型：
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作者：
Janni, Wolfgang;Alba, Emilio;Campone, Mario
3期MONALEESA-2研究表明，在来曲唑（LET）基础上添加ribociclib（RIB）可显著改善激素受体阳性（HR+）、HER 2阴性（HER 2-）晚期乳腺癌（ABC）患者的无进展生存期（PFS）。在这里，我们评估了缓解持续时间（DoR）、肿瘤缩小、无治疗间隔（TFI）的PFS以及健康相关的生活质量（HRQoL）。方法患有HR+、HER 2-ABC且既往未接受ABC全身治疗的绝经后女性（N = 668）随机接受RIB（600 mg/天;给药3周/停药1周）加LET（2.5 mg/天;连续）或安慰剂（PBO）加LET。主要终点为PFS; HRQoL为次要终点;结果在501例有可测量的疾病和确认的完全或部分缓解的患者中，中位DoR为26.7个月，（95% CI，24.0-NR），RIB组vs 18.6个月在第8周，RIB组（32%）比PBO组（17%）更多的患者经历>= 60%的最佳百分比变化。RIB组（26%）的平均疼痛减轻程度大于PBO组（15%）。结论RIB联合LET与PBO联合LET相比，前者肿瘤缓解更早、更持久，肿瘤缩小程度更大，疼痛减轻程度更轻，无进展生存率（PFS）与TFI无关。这些数据进一步支持RIB + LET作为HR+、HER 2-ABC绝经后女性的一线治疗选择。
Purpose The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Here, we evaluated duration of response (DoR), tumor shrinkage, PFS by treatment-free interval (TFI), and health-related quality of life (HRQoL).Methods Postmenopausal women (N = 668) with HR+, HER2-ABC and no prior systemic therapy for ABC were randomized to RIB (600 mg/day; 3 weeks on/1 week off) plus LET (2.5 mg/day; continuous) or placebo (PBO) plus LET. Primary end point was PFS; HRQoL was the secondary end point; DoR was exploratory end point and PFS by TFI was post hoc analysis.Results Of 501 pts with measurable disease and confirmed complete or partial response, median DoR was 26.7 months (95% CI, 24.0-NR) in the RIB arm versus 18.6 months (95% CI, 14.8-23.1) in the PBO arm. At 8 weeks, more pts in the RIB arm (32%) versus the PBO arm (17%) experienced best percentage change >= 60%. The average pain reduction was greater in the RIB arm (26%) versus the PBO arm (15%). PFS benefit was seen with RIB vs PBO, irrespective of TFI.Conclusion RIB plus LET versus PBO plus LET is associated with earlier and more durable tumor response, greater degree of tumor shrinkage and pain reduction, and PFS benefit irrespective of TFI. These data further support RIB plus LET as a first-line treatment option for postmenopausal women with HR+, HER2-ABC.