Breast Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione Pascale, Napoli, Italy.
Istituto Nazionale Tumori "Fondazione Pascale", Napoli, Italy.
Target Oncol. 2022 Nov;17(6):615-625. doi: 10.1007/s11523-022-00913-x. Epub 2022 Sep 24.
Ribociclib plus letrozole demonstrated manageable safety and efficacy profiles in hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) in the Phase 3b CompLEEment-1 trial.
To evaluate the safety and efficacy of ribociclib plus letrozole in the Italian subpopulation with HR+, HER2- ABC from the CompLEEment-1 trial.
Patients with HR+, HER2- ABC received ribociclib (600 mg/day, 3 weeks on/1 week off) plus letrozole (2.5 mg/day) while men and premenopausal women additionally received goserelin. Patients were allowed with ≤ 1 line of prior chemotherapy and an Eastern Cooperative Oncology Group performance status of ≤ 2. The primary outcome included safety and tolerability.
Of the 554 Italian patients, 246 (44.4 %) patients completed treatment. The reasons for treatment discontinuation included progressive disease (PD; 36.6 %), adverse events (AEs; 11.9 %), and death (1.6 %). All-grade AEs and grade ≥ 3 AEs occurred in 98.9 % and 77.8 % patients, respectively. The most common treatment-related AEs were neutropenia (73.6 %), followed by leukopenia (32.1 %), and nausea (25.3 %). The overall response rate was 28.2 % (95 % confidence interval [CI], 24.4-32.1); clinical benefit rate was 71.7 % (95 % CI, 67.7-75.4); and median time to progression was 26.7 months (95 % CI, 24.8-non-estimable). Health-related quality of life scores were maintained during treatment.
The safety and efficacy profiles of ribociclib plus letrozole in the Italian subpopulation was found to be consistent with the CompLEEment-1 global population result, MONALEESA-2, and MONALEESA-7 outcomes, which reaffirm ribociclib plus letrozole as the frontline treatment option in patients with HR+, HER2- ABC.
NCT02941926 (30 November 2016).
在 3b 期 CompLEEment-1 试验中，瑞博西利联合来曲唑在激素受体阳性（HR+）、人表皮生长因子受体 2 阴性（HER2-）晚期乳腺癌（ABC）患者中显示出可管理的安全性和疗效特征。
评估瑞博西利联合来曲唑在 CompLEEment-1 试验中的 HR+、HER2-ABC 意大利亚人群中的安全性和疗效。
HR+、HER2-ABC 患者接受瑞博西利（600mg/天，连用 3 周，停药 1 周）加来曲唑（2.5mg/天）治疗，男性和绝经前女性加用地戈辛。患者允许有≤1 线既往化疗和东部合作肿瘤学组表现状态≤2。主要结局包括安全性和耐受性。
在 554 例意大利患者中，246 例（44.4%）患者完成了治疗。治疗中断的原因包括疾病进展（PD；36.6%）、不良事件（AE；11.9%）和死亡（1.6%）。所有级别 AE 和≥3 级 AE 分别发生在 98.9%和 77.8%的患者中。最常见的治疗相关 AE 是中性粒细胞减少（73.6%），其次是白细胞减少（32.1%）和恶心（25.3%）。总缓解率为 28.2%（95%置信区间[CI]，24.4-32.1）；临床获益率为 71.7%（95%CI，67.7-75.4）；中位无进展生存期为 26.7 个月（95%CI，24.8-不可估计）。治疗期间维持了健康相关生活质量评分。
瑞博西利联合来曲唑在意大利亚人群中的安全性和疗效与 CompLEEment-1 全球人群结果、MONALEESA-2 和 MONALEESA-7 结果一致，这再次证实了瑞博西利联合来曲唑是 HR+、HER2-ABC 患者的一线治疗选择。
NCT02941926（2016 年 11 月 30 日）。
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