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多西他赛用于人表皮生长因子受体2阴性转移性乳腺癌的再激发治疗:一项针对既往因非疾病进展原因停药患者的真实世界研究

Docetaxel rechallenge in HER2-negative metastatic breast cancer: a real-world study of previously discontinued patients for non-progression reasons.

作者信息

Zeng Hui-Ai, Lv Hui-Min, Zhang Meng-Wei, Niu Li-Min, Wang Jing, Sun Hui-Hui, Liu Zhen-Zhen, Yan Min

机构信息

Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, No.127, Dongming Road, Zhengzhou, 450008, People's Republic of China.

出版信息

J Cancer Res Clin Oncol. 2025 Feb 21;151(2):89. doi: 10.1007/s00432-025-06133-w.

Abstract

PURPOSE

This study aimed to evaluate the efficacy and safety of docetaxel rechallenge in HER2-negative metastatic breast cancer (MBC) patients who discontinued docetaxel for reasons other than disease progression.

PATIENTS AND METHODS

We retrospectively analyzed HER2-negative MBC patients treated with docetaxel-based therapy (DBT) at our institution from 2010 to 2020. Objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were assessed. Multivariate Cox regression and propensity score matching analysis (PSMA) were used to minimize bias.

RESULTS

Among 600 patients, 369 only received docetaxel once (control group), while 231 (38.5%) received docetaxel rechallenge as second or later-line therapy (rechallenge group). In the second-line rechallenge subset (143 patients), ORR was 51.0%, and PFS was 6.7 months. Multivariate analysis showed that a response to initial DBT (stable disease [SD] vs. complete response/partial response [CR/PR]: odds ratio [OR] 2.615, 95% confidence interval [CI] 1.373-4.981; p = 0.03) independently predicted the ORR. Beyond second-line rechallenge, the ORR and PFS were 37.5% and 5.6 months, respectively. After PSMA, the rechallenge group demonstrated significantly improved OS compared to the control group: 50.5 months vs. 46.0 months (Hazard Ratio [HR] 0.632; 95% CI 0.455-0.878; p = 0.006). The toxicities reported were manageable, primarily hematologic, with grade 3-4 events occurring in 19.5% of cases.

CONCLUSION

This study suggests that docetaxel rechallenge may be an effective and tolerable later-line treatment option for patients with HER2-negative MBC, particularly those who responded to initial DBT. However, further prospective, randomized controlled research is needed to fully evaluate its impact on disease response in this patient population.

摘要

目的

本研究旨在评估多西他赛再次挑战疗法在因疾病进展以外的原因停用多西他赛的HER2阴性转移性乳腺癌(MBC)患者中的疗效和安全性。

患者和方法

我们回顾性分析了2010年至2020年在我院接受基于多西他赛的治疗(DBT)的HER2阴性MBC患者。评估了客观缓解率(ORR)、无进展生存期(PFS)、总生存期(OS)和不良事件(AE)。采用多变量Cox回归和倾向评分匹配分析(PSMA)以尽量减少偏差。

结果

在600例患者中,369例仅接受过一次多西他赛治疗(对照组),而231例(38.5%)接受了多西他赛再次挑战疗法作为二线或更后线治疗(再次挑战组)。在二线再次挑战亚组(143例患者)中,ORR为51.0%,PFS为6.7个月。多变量分析显示,对初始DBT有反应(疾病稳定[SD]与完全缓解/部分缓解[CR/PR]:优势比[OR]2.615,95%置信区间[CI]1.373 - 4.981;p = 0.03)可独立预测ORR。超过二线再次挑战时,ORR和PFS分别为37.5%和5.6个月。经过PSMA后,再次挑战组与对照组相比,OS显著改善:50.5个月对46.0个月(风险比[HR]0.632;95%CI 0.455 - 0.878;p = 0.006)。报告的毒性是可控的,主要是血液学毒性,3 - 4级事件发生率为19.5%。

结论

本研究表明,多西他赛再次挑战疗法可能是HER2阴性MBC患者有效的、可耐受的后线治疗选择,尤其是那些对初始DBT有反应的患者。然而,需要进一步进行前瞻性、随机对照研究,以全面评估其对该患者群体疾病反应的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e37d/11842397/8fa2bb7c47c5/432_2025_6133_Fig1_HTML.jpg

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