Baek Sun Kyung, Jeong Jae-Ho, Jung KyungHae, Ahn Hee Kyung, Kim Min Hwan, Sohn Joohyuk, Park In Hae, Ahn Jin Seok, Lee Dae-Won, Im Seock-Ah, Sim Sung Hoon, Lee Keun Seok, Hyun Kim Jee, Shim Hyun-Jeong, Chae Yeesoo, Koh Su-Jin, Lee Hyorak, Lee Jieun, Byun Jae-Ho, Seol Youngmi, Lee Eun Mi, Jee Hee-Jung, An Hyonggin, Park Eun Byeol, Suh Young Ju, Lee Kyoung Eun, Park Yeon Hee
Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Ther Adv Med Oncol. 2024 Jan 28;16:17588359231225029. doi: 10.1177/17588359231225029. eCollection 2024.
This study aimed to investigate clinical practices and factors related to the outcomes of T-DM1 use in patients with HER2-positive metastatic breast cancer (mBC).
We included patients with HER2-positive mBC who received T-DM1 as a palliative therapy between August 2017 and December 2018. The safety and outcomes of T-DM1, including overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), were evaluated. A Cox proportional hazards model was used to estimate the hazard ratio and 95% confidence interval (CI) for mortality or progression to HER2-positive mBC.
In total, 824 patients were enrolled during the study period. The mean age of patients was 58 years, and 516 (62.6%) patients relapsed after curative treatment. Excluding a history of endocrine therapy, 341 (41.4%) patients previously received none or first-line chemotherapy, 179 (21.7%) received second-line therapy, and 303 (36.9%) received third-or later-line chemotherapy before T-DM1 therapy. During a median follow-up of 16.8 months, the ORR was 35%, the median PFS was 6.6 months, and the median OS was not reached. The clinical factors associated with the hazard of progression were age (<65 years), poor performance status (⩾2), advanced line of palliative chemotherapy (⩾2), prior pertuzumab use, and treatment duration of palliative trastuzumab (<10 months). Common grade 3-4 adverse events were thrombocytopenia ( = 107, 13.2%), neutropenia ( = 23, 2.8%), anemia ( = 21, 2.6%), and elevated liver enzyme ( = 20, 2.5%). Hypokalemia (⩽3.0 mmol/L) and any-grade bleeding events occurred in 25 (3.1%) and 94 (22.6%) patients, respectively.
This is the first nationwide real-world study of T-DM1 use in patients with HER2-positive mBC in Korea. The effectiveness and toxicity profiles of T-DM1 in real-world practice were comparable to those in randomized trials. Moreover, patient factors and previous anti-HER2 therapy could predict the outcomes of T-DM1 therapy.
本研究旨在调查HER2阳性转移性乳腺癌（mBC）患者使用曲妥珠单抗-美坦新偶联物（T-DM1）的临床实践及与治疗结果相关的因素。
我们纳入了2017年8月至2018年12月期间接受T-DM1作为姑息治疗的HER2阳性mBC患者。评估了T-DM1的安全性和治疗结果，包括总缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。采用Cox比例风险模型估计HER2阳性mBC死亡或进展的风险比及95%置信区间（CI）。
在研究期间共纳入824例患者。患者的平均年龄为58岁，516例（62.6%）患者在根治性治疗后复发。排除既往史，341例（41.4%）患者之前未接受过化疗或仅接受过一线化疗，179例（21.7%）接受过二线治疗，303例（36.9%）在接受T-DM1治疗前接受过三线或更晚线化疗。在中位随访16.8个月期间，ORR为35%，中位PFS为6.6个月，中位OS未达到。与疾病进展风险相关的临床因素包括年龄（<65岁）、体能状态差（⩾2）、姑息化疗线数高（⩾2）、既往使用过帕妥珠单抗以及姑息性曲妥珠单抗治疗时间（<10个月）。常见的3-4级不良事件为血小板减少（n = 107，13.2%）、中性粒细胞减少（n = 23，2.8%）、贫血（n = 21，2.6%）和肝酶升高（n = 20，2.5%）。低钾血症（⩽3.0 mmol/L）和任何级别的出血事件分别发生在25例（3.1%）和94例（22.6%）患者中。
这是韩国第一项关于HER2阳性mBC患者使用T-DM1的全国性真实世界研究。T-DM1在真实世界实践中的有效性和毒性特征与随机试验中的相当。此外，患者因素及既往抗HER2治疗可预测T-DM1治疗的结果。
