Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
Department of Internal Medicine, Kangbuk Samsung Hospital, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.
Breast Cancer Res Treat. 2022 Nov;196(1):121-128. doi: 10.1007/s10549-022-06566-8. Epub 2022 Sep 7.
Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor which shows promising effect in hormone receptor-positive breast cancer. The purpose of this study is to evaluate the real-world efficacy and toxicity of palbociclib plus endocrine therapy.
This is a retrospective study performed in two tertiary referral hospitals in Korea. Advanced breast cancer patients who were treated with 1st-line palbociclib plus endocrine therapy were enrolled.
A total of 216 patients were included between August 2016 and May 2019. Median age was 56 (29-89) years old and 75 patients (34.7%) were premenopausal. Median progression-free survival (PFS) was 33.0 months [95% confidence interval (CI) 24.7 to 41.3] and objective response rate was 59.3%. Luminal B patients had shorter PFS (33.0 months vs. Not reached, p = 0.019) and tendency of lower ORR (58.3 vs. 62.0%, p = 0.19) compared to luminal A patients. Multivariate analysis revealed luminal B (adjusted hazard ratio 1.90, p = 0.038) and germline BRCA mutation (adjusted hazard ratio 5.57, p = 0.002) as an independent poor prognostic factor for PFS. The most common grade 3 or 4 adverse event was neutropenia (86.7%).
The efficacy and toxicity of palbociclib in the real world were comparable to those of clinical trials. In addition, palbociclib with endocrine therapy was an effective treatment option for young patients. Luminal B and germline BRCA mutation were associated with inferior outcome.
帕博西尼是一种细胞周期蛋白依赖性激酶 4 和 6 抑制剂，在激素受体阳性乳腺癌中显示出良好的疗效。本研究旨在评估帕博西尼联合内分泌治疗的真实世界疗效和毒性。
这是一项在韩国两家三级转诊医院进行的回顾性研究。纳入接受一线帕博西尼联合内分泌治疗的晚期乳腺癌患者。
共有 216 例患者于 2016 年 8 月至 2019 年 5 月入组。中位年龄为 56 岁（29-89 岁），75 例（34.7%）为绝经前。中位无进展生存期（PFS）为 33.0 个月[95%置信区间（CI）24.7-41.3]，客观缓解率为 59.3%。与 luminal A 患者相比，luminal B 患者的 PFS 更短（33.0 个月 vs. 未达到，p=0.019），客观缓解率更低（58.3% vs. 62.0%，p=0.19）。多因素分析显示，luminal B（调整后的风险比 1.90，p=0.038）和种系 BRCA 突变（调整后的风险比 5.57，p=0.002）是 PFS 的独立不良预后因素。最常见的 3 级或 4 级不良事件是中性粒细胞减少症（86.7%）。
帕博西尼在真实世界中的疗效和毒性与临床试验相当。此外，帕博西尼联合内分泌治疗是年轻患者的有效治疗选择。Luminal B 和种系 BRCA 突变与预后不良相关。
