Western Cancer Institute, Nantes, France.
Istituto Nazionale Tumori IRCCS "Fondazione Pascale", Naples, Italy.
Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. Epub 2022 Feb 25.
CompLEEment-1 (NCT02941926) is a single-arm, open-label, multicentre phase IIIb study investigating the safety and efficacy of ribociclib plus letrozole (RIB + LET) in a large, diverse cohort who have not received prior endocrine therapy (ET) for advanced disease. We present an exploratory analysis of male patients.
Eligible patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC), who had no prior ET and ≤ 1 line of prior chemotherapy for advanced disease, received RIB + LET. Male patients also received goserelin or leuprolide. Primary endpoint was safety and tolerability; efficacy was a secondary endpoint.
In total, 39/3246 patients were male. Baseline characteristics were similar to the overall population. Male patients experienced fewer treatment-related adverse events (AEs) and treatment-related serious AEs compared with the overall population; fewer male patients had treatment-related AEs leading to discontinuation, adjustment/interruption, or additional therapy. One male patient died as a result of a serious AE that was not considered to be treatment-related. The most common AE was neutropenia; the incidence of grade ≥ 3 neutropenia in males (41.0%) was lower than in the overall population (57.2%). Median follow-up was 25.4 months; median time to progression was not reached in males versus 27.1 months for the overall population.
The clinical benefit and overall response rates in males were consistent with the overall population. This analysis demonstrates the safety and efficacy of ribociclib in a close-to-real-world setting, supporting the use of RIB + LET in male patients with HR+, HER2- ABC.
NCT02941926 (Registered 2016).
CompLEEment-1（NCT02941926）是一项单臂、开放标签、多中心 IIIb 期研究，旨在评估利柏西利联合来曲唑（RIB+LET）在未接受过晚期疾病内分泌治疗（ET）的大型、多样化队列中的安全性和疗效。我们报告了一项男性患者的探索性分析。
符合条件的激素受体阳性（HR+）、人表皮生长因子受体 2 阴性（HER2-）晚期乳腺癌（ABC）患者，无既往 ET，且晚期疾病仅接受过≤1 线化疗，接受 RIB+LET 治疗。男性患者还接受了戈舍瑞林或亮丙瑞林。主要终点是安全性和耐受性；疗效是次要终点。
共有 39/3246 名患者为男性。基线特征与总体人群相似。与总体人群相比，男性患者的治疗相关不良事件（AE）和治疗相关严重 AE 更少；较少的男性患者因治疗相关 AE 而停药、调整/中断或额外治疗。1 名男性患者因非治疗相关的严重 AE 死亡。最常见的 AE 是中性粒细胞减少症；男性患者的中性粒细胞减少症发生率（41.0%）低于总体人群（57.2%）。中位随访时间为 25.4 个月；男性患者无进展中位时间未达到，而总体人群为 27.1 个月。
男性患者的临床获益和总缓解率与总体人群一致。这项分析证明了利柏西利在接近真实世界环境中的安全性和疗效，支持在 HR+、HER2- ABC 男性患者中使用 RIB+LET。
NCT02941926（2016 年注册）。
