Fedele Palma, Landriscina Matteo, Moraca Lucia, Cusmai Antonio, Gnoni Antonio, Licchetta Antonella, Guarini Chiara, Lanotte Laura, Pappagallo Maria Nicla, Melaccio Assunta, Giordano Guido, Maselli Felicia Maria, Pinto Antonello, Giuliani Francesco, Chiuri Vincenzo, Giotta Francesco, Gadaleta-Caldarola Gennaro
Oncology Unit, "Dario Camberlingo" Hospital, 72021 Francavilla Fontana, Italy.
U.O. Medical Oncology and Biomolecular Therapy, Department of Medical and Surgical Sciences, University of Foggia, 71100 Foggia, Italy.
Cancers (Basel). 2024 Oct 10;16(20):3442. doi: 10.3390/cancers16203442.
Metastatic HR+/HER2- breast cancer is commonly treated with CDK4/6 inhibitors in combination with endocrine therapy. However, the efficacy and safety of this approach in elderly patients (≥70 years) remain unclear, particularly in the context of real-world clinical practice. This study aims to evaluate the clinical outcomes and tolerability of CDK4/6 inhibitor treatments in this fragile population, which is often under-represented in randomized clinical trials.
This retrospective multicenter study included elderly patients with metastatic HR+/HER2-negative breast cancer receiving first-line CDK4/6 inhibitors. The primary endpoint was progression-free survival (PFS). The secondary endpoints focused on the overall survival (OS), safety, and tolerability, considering variables such as tumor subtype, age, comorbidities, and treatment specifics.
The median PFS and OS were slightly lower than those reported in clinical trials, reflecting the inclusion of a more fragile population. The luminal B subtype was linked to a poorer PFS, while other factors like age, BMI, and ECOG status did not significantly affect the outcomes. A safety analysis indicated a higher incidence of grade 3 or higher toxicities, especially in frail patients, leading to dose reductions. Despite these challenges, CDK4/6 inhibitors were generally well-tolerated, allowing most patients to continue therapy.
CDK4/6 inhibitors with endocrine therapy are effective in elderly patients with metastatic HR+/HER2- breast cancer, though careful management is crucial to balance efficacy and minimize adverse events.
转移性激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）乳腺癌通常采用细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂联合内分泌治疗。然而，这种治疗方法在老年患者（≥70岁）中的疗效和安全性仍不明确，尤其是在真实世界的临床实践中。本研究旨在评估CDK4/6抑制剂治疗在这一脆弱人群中的临床结局和耐受性，该人群在随机临床试验中往往代表性不足。
这项回顾性多中心研究纳入了接受一线CDK4/6抑制剂治疗的老年转移性HR+/HER2阴性乳腺癌患者。主要终点是无进展生存期（PFS）。次要终点侧重于总生存期（OS）、安全性和耐受性，同时考虑肿瘤亚型、年龄、合并症和治疗细节等变量。
中位PFS和OS略低于临床试验报告的结果，这反映了纳入了更脆弱的人群。管腔B亚型与较差的PFS相关，而年龄、体重指数和东部肿瘤协作组（ECOG）状态等其他因素对结局没有显著影响。安全性分析表明，3级或更高毒性的发生率较高，尤其是在体弱患者中，导致剂量减少。尽管存在这些挑战，但CDK4/6抑制剂总体耐受性良好，使大多数患者能够继续治疗。
CDK4/6抑制剂联合内分泌治疗对老年转移性HR+/HER2-乳腺癌患者有效，尽管谨慎管理对于平衡疗效和最小化不良事件至关重要。
