Al Nouri Anwar, Al Terkait Faisal, El Saghir Nagi, Ghanem Hady, Kattan Joseph, Bishouti Cynthia, Dreyer Jade, Rai Soniya, Rosca Alexandru
Medical Oncology Department, Kuwait Cancer Control Center, Kuwait, Kuwait.
Division of Hematology/Oncology, American University of Beirut Medical Center (AUBMC), Beirut, Lebanon.
Front Oncol. 2025 Jun 17;15:1437380. doi: 10.3389/fonc.2025.1437380. eCollection 2025.
The burden of breast cancer is still growing in the Middle East and North Africa (MENA). BC patients typically present with more advanced stages than in Western countries. Limited information is available regarding the safety and efficacy of novel molecules for advanced BC in the Middle East region. The present real-world study evaluated the treatment patterns and survival outcomes of abemaciclib in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) locally advanced or metastatic BC (mBC) in Kuwait and Lebanon.
The TRACE study is an observational, retrospective, multicenter, single-arm cohort study. Medical records of HR+/HER2- locally advanced or mBC women were retrieved if they received abemaciclib as part of their treatment in Kuwait and Lebanon. Only patients who received abemaciclib monotherapy or in combination with other treatments for at least three months before data collection were included.
Eighty-five patients met the eligibility criteria (Kuwait =42 patients, Lebanon =43). Nearly 57% of the patients received abemaciclib in the first-line setting, 19.8% received it in the second-line, and 16.5% received it at third or later lines of treatment. Abemaciclib 150mg twice daily was administered in combination with other treatments, mainly endocrine therapy, in 95.3% of the patients. Overall, 18 patients (21.4%) had a dose reduction at the end of the third month of abemaciclib treatment. After three months of treatment, the rates of complete response (CR) and partial response (PR) as the best response were 6.9% and 63.8%, respectively, with an objective response rate (ORR) of 70.7%. The 12-month progression-free survival (PFS) was 33.3% in the monotherapy group and 79.6% in the combination group.
The present real-world evidence confirms the feasibility and effectiveness, in terms of response rate and PFS, of abemaciclib in patients with HR+/HER2- patients with locally advanced or mBC from Kuwait and Lebanon in the Middle East region.
中东和北非地区（MENA）乳腺癌负担仍在增长。与西方国家相比，乳腺癌患者就诊时分期往往更晚。关于中东地区新型分子治疗晚期乳腺癌的安全性和有效性的信息有限。本真实世界研究评估了阿贝西利在科威特和黎巴嫩激素受体阳性（HR +）/人表皮生长因子受体2阴性（HER2 -）局部晚期或转移性乳腺癌（mBC）患者中的治疗模式和生存结果。
TRACE研究是一项观察性、回顾性、多中心、单臂队列研究。检索科威特和黎巴嫩HR + /HER2 -局部晚期或mBC女性的医疗记录，前提是她们接受了阿贝西利作为治疗的一部分。仅纳入在数据收集前接受阿贝西利单药治疗或与其他治疗联合至少三个月的患者。
85例患者符合纳入标准（科威特42例，黎巴嫩43例）。近57%的患者在一线治疗时接受阿贝西利，19.8%在二线治疗时接受，16.5%在三线或更晚治疗时接受。95.3%的患者接受阿贝西利150mg每日两次与其他治疗联合使用，主要是内分泌治疗。总体而言，18例患者（21.4%）在阿贝西利治疗第三个月末出现剂量减少。治疗三个月后，作为最佳反应的完全缓解（CR）率和部分缓解（PR）率分别为6.9%和63.8%，客观缓解率（ORR）为70.7%。单药治疗组12个月无进展生存期（PFS）为33.3%，联合治疗组为79.6%。
本真实世界证据证实，就缓解率和无进展生存期而言，阿贝西利在中东地区科威特和黎巴嫩HR + /HER2 -局部晚期或mBC患者中具有可行性和有效性。
