Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.
Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
J Geriatr Oncol. 2024 Jul;15(6):101813. doi: 10.1016/j.jgo.2024.101813. Epub 2024 Jun 8.
Palbociclib is a widely used treatment for advanced breast cancer in older adults. However, the existing evidence regarding its safety and tolerability in this age group is inconsistent and limited to retrospective subgroup or pooled analyses.
We conducted a prospective single-arm multicenter phase 2 study to evaluate the safety and tolerability of palbociclib in participants aged 70 years or older with advanced hormone receptor-positive breast cancer. Participants were given palbociclib in combination with their physician's choice of endocrine therapy (letrozole or fulvestrant). The primary endpoint was the incidence of grade 3+ adverse events (AEs) by six months. Secondary endpoints included AE-related dose delays, dose reductions, early discontinuations, and hospitalizations. Additionally, we compared these endpoints by age groups (70-74 and ≥ 75 years).
Of the 90 participants (median age 74 years [70-87]) enrolled, 75.6% (95% confidence interval [CI], 65.4-84.0) had grade 3+ AEs by six months. The most frequent grade 3+ AEs were neutropenia (61%), fatigue (4%), and nausea (3%). Febrile neutropenia was uncommon (1.1%). Due to AEs, 36% had dose delays, 34% had dose reductions, 10% had early discontinuations, and 10% had hospitalizations. Compared to those aged 70-74 years, participants aged ≥75 years had higher rates of early discontinuations (5.9% vs 15.9%, a difference of 9.5% [95% CI 3.5%-22.5%]).
Palbociclib has an overall favorable safety profile in adults aged ≥70 with advanced breast cancer. However, adults ≥75 years had a trend toward higher rates of AE-related early discontinuations compared to those 70-74 years. Further research is needed to evaluate tolerability and improve the delivery of palbociclib in older adults.
gov:NCT03633331.
帕博西尼是一种广泛用于治疗老年晚期乳腺癌的药物。然而，现有证据表明，它在这一年龄组中的安全性和耐受性并不一致，仅限于回顾性亚组或汇总分析。
我们进行了一项前瞻性、单臂、多中心的 2 期研究，评估了帕博西尼在 70 岁或以上、患有晚期激素受体阳性乳腺癌的患者中的安全性和耐受性。患者接受帕博西尼联合医生选择的内分泌治疗（来曲唑或氟维司群）。主要终点是 6 个月时 3+级不良事件（AE）的发生率。次要终点包括 AE 相关的剂量延迟、剂量减少、早期停药和住院。此外，我们还按年龄组（70-74 岁和≥75 岁）比较了这些终点。
90 名患者（中位年龄 74 岁[70-87]）入组，75.6%（95%置信区间[CI]，65.4-84.0）在 6 个月时出现 3+级 AE。最常见的 3+级 AE 是中性粒细胞减少症（61%）、疲劳（4%）和恶心（3%）。发热性中性粒细胞减少症少见（1.1%）。由于 AE，36%的患者出现剂量延迟，34%的患者出现剂量减少，10%的患者提前停药，10%的患者住院。与 70-74 岁的患者相比，≥75 岁的患者早期停药率更高（5.9%比 15.9%，差异为 9.5%[95%CI 3.5%-22.5%]）。
帕博西尼在 70 岁以上患有晚期乳腺癌的成年人中总体安全性良好。然而，与 70-74 岁的患者相比，≥75 岁的患者因 AE 相关的早期停药率有升高趋势。需要进一步研究来评估耐受性，并改善帕博西尼在老年人中的应用。
gov:NCT03633331。
