palbociclib在韩国HR（+）、HER2（−）转移性乳腺癌患者中的全国实践模式和临床数据（KCSG BR21-15）

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2025-05-12 DOI:10.1016/j.breast.2025.104500

Jieun Lee , Dae-Won Lee , Min Hwan Kim , Jee Hung Kim , Ju Won Kim , Jae-Ho Byun , Kyoung Eun Lee , Myoung Joo Kang , Su-Jin Koh , Soojung Hong , Hye Sung Won , Han Jo Kim , In Hae Park , Seong Hoon Shin , Sun Kyung Baek , Seul-Gi Kim , Sung Ae Koh , Joo Young Jung , Ji-Yeon Kim , Gun Min Kim , Yeon Hee Park

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引用次数: 0

摘要

细胞周期蛋白依赖性激酶（CDK） 4/6抑制剂显著改善了激素受体阳性(HR+)/人表皮生长因子-2阴性（HER2-）转移性乳腺癌（mBC）的生存结果。尽管PALOMA-2达到了主要终点，但与ribociclib和abemaciclib相比，总生存期（OS）相对较短。在韩国，绝经前妇女使用帕博西尼+芳香酶抑制剂(AI) +促性腺激素释放激素激动剂（GnRHa）是有限的，治疗前必须进行双侧输卵管卵巢切除术（BSO）。我们分析了韩国来曲唑+帕博西尼的真实临床结果和患者特征。方法2016年8月至2022年12月，1017名HR+/ her2绝经后妇女接受一线来曲唑+帕博西尼治疗。主要终点是总人口的真实无进展生存期（rwPFS）和绝经状态（通过BSO自然或诱导绝经）的生存差异。结果患者年龄中位数为56岁（27 ~ 92岁）。中位rwPFS和真实OS （rwOS）分别为28.0个月（95%置信区间[CI] 25.5-32.1）和61.8个月（95%置信区间[CI] 57.7-70.5），中位随访时间为45.1个月（IQR, 31.0-56.6）。与自然绝经组相比，BSO组的中位rwPFS相似。最常用的辅助用药是他莫昔芬±GnRHa（73.3%）。原发性内分泌抵抗性mBC患者的中位rwPFS低于继发性耐药mBC患者（14.6个月vs. 27.1个月，p = 0.0063）。总有效率为47.5%，疾病控制率为89.6%。这是亚洲最大的基于国家的帕博西尼+来曲唑的现实世界研究。帕博西尼的中位生存期超过60个月，与其他关键试验相当。

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Nationwide real-world practice pattern and clinical data of palbociclib in HR (+), HER2 (−) metastatic breast cancer patients in Korea (KCSG BR21-15)

Background

Cyclin-dependent kinase (CDK) 4/6 inhibitors have remarkably improved the survival outcome in hormone-receptor-positive (HR+)/human epidermal growth factor-2-negative (HER2-) metastatic breast cancer (mBC). Although PALOMA-2 has met its primary outcome, overall survival (OS) was relatively shorter compared to ribociclib and abemaciclib. In Korea, use of palbociclib + aromatase inhibitor (AI) + gonadotropin-releasing hormone agonist (GnRHa) in premenopausal women is limited, and bilateral salpingo-oophorectomy (BSO) is necessary before treatment. We analyzed the real-world clinical outcome and patient characteristics of letrozole + palbociclib in Korea.

Methods

Between August 2016 and December 2022, 1017 HR+/HER2-postmenopausal women treated with first-line letrozole + palbociclib were enrolled. Primary endpoints were real-world progression-free survival (rwPFS) in total population and survival differences according to menopausal status (natural or induced menopause via BSO).

Results

Patients’ median age was 56 (range 27–92) years. Median rwPFS, real-world OS (rwOS) were 28.0 months (95 % confidence interval [CI] 25.5–32.1) and 61.8 months (95 % CI 57.7–70.5), with a median follow-up of 45.1 (IQR, 31.0–56.6) months. BSO group demonstrated similar median rwPFS compared to natural menopause group. Adjuvant tamoxifen ± GnRHa was most frequently prescribed (73.3 %). Primary endocrine resistant mBC patients showed inferior median rwPFS compared to secondary resistant mBC (14.6 vs. 27.1 months, p = 0.0063). Overall response rate was 47.5 %, with a disease control rate of 89.6 %.

Conclusion

This is the largest country-based real-world study on palbociclib + letrozole in Asia. Palbociclib demonstrated median rwOS over 60 months, comparable to other pivotal trials.

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.