韩国HR（+）、HER2（-）转移性乳腺癌患者中帕博西尼的全国真实世界实践模式和临床数据（KCSG BR21-15）

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

作者信息

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

机构信息

Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.

出版信息

Breast. 2025 May 12;82:104500. doi: 10.1016/j.breast.2025.104500.

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.

背景

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）的生存结局。尽管PALOMA-2试验达到了其主要终点，但与瑞博西尼和阿贝西利相比，总生存期（OS）相对较短。在韩国，绝经前女性使用哌柏西利+芳香化酶抑制剂（AI）+促性腺激素释放激素激动剂（GnRHa）的情况有限，治疗前需要进行双侧输卵管卵巢切除术（BSO）。我们分析了韩国来曲唑+哌柏西利的真实世界临床结局和患者特征。

方法

2016年8月至2022年12月期间，纳入了1017例接受一线来曲唑+哌柏西利治疗的HR+/HER2-绝经后女性。主要终点是总体人群的真实世界无进展生存期（rwPFS）以及根据绝经状态（自然绝经或通过BSO诱导绝经）的生存差异。

结果

患者的中位年龄为56岁（范围27-92岁）。中位rwPFS、真实世界总生存期（rwOS）分别为28.0个月（95%置信区间[CI]25.5-32.1）和61.8个月（95%CI57.7-70.5），中位随访时间为45.1个月（IQR，31.0-56.6）。BSO组的中位rwPFS与自然绝经组相似。辅助他莫昔芬±GnRHa是最常用的处方（73.3%）。原发性内分泌抵抗的mBC患者的中位rwPFS低于继发性抵抗的mBC患者（14.6个月对27.1个月，p=0.0063）。总体缓解率为47.5%，疾病控制率为89.6%。