吡咯替尼联合长春瑞滨治疗HER2阳性转移性乳腺癌：一项多中心回顾性研究
Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study.
作者信息
Li Yi, Qiu Yixuan, Li Huihui, Luo Ting, Li Wei, Wang Hong, Shao Bin, Wang Biyun, Ge Rui
机构信息
Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
出版信息
Front Oncol. 2021 Apr 20;11:664429. doi: 10.3389/fonc.2021.664429. eCollection 2021.
INTRODUCTION
Pyrotinib plus capecitabine has been approved in China for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Meanwhile, vinorelbine is another important chemotherapy option for MBC available in oral and intravenous forms. Thus, pyrotinib plus vinorelbine may represent a new treatment option, particularly for patients with failed capecitabine treatment. This study reported the first real-world data for pyrotinib plus vinorelbine therapy in HER2+ MBC.
METHODS
HER2+ MBC patients (n = 97) treated with pyrotinib plus vinorelbine in six institutions across China from May 2018 to June 2020 were enrolled. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and toxicity profiles were determined.
RESULTS
Sixty-seven percent of patients received more than two lines of systematic therapy. Nearly all patients (97.9%) had received trastuzumab and 50.5% were administered lapatinib. When combined with pyrotinib, 74.2% received oral and 25.8% received intravenous vinorelbine. Median PFS (mPFS) was 7.8 (range, 4.7-10.8) months for all patients. The mPFS in patients administered pyrotinib as second-line therapy and third-or-higher-line therapy were 12.0 and 6.4 months, respectively. Patients who received pyrotinib plus oral or intravenous vinorelbine had similar mPFS (7.8 vs. 6.4 months, p = 0.871). The 23 patients with brain metastases had mPFS of 6.3 (range, 3.4-9.2) months. Lapatinib-naïve patients had significantly longer PFS than lapatinib-treated patients (10.8 months vs. 5.6 months, p = 0.020). Median OS was not achieved. The ORR for 96 patients was 34.3%. Common grade 3 and 4 adverse events were diarrhea (22.7%), neutropenia (7.2%), and leukopenia (4.1%).
CONCLUSIONS
Pyrotinib plus vinorelbine therapy demonstrated promising effects in HER2+ MBC with tolerable toxicity, particularly in patients with second-line treatment and without prior lapatinib treatment, as well as in patients with brain metastases. Oral vinorelbine is a useful alternative to the intravenous form when combined with pyrotinib.
CLINICAL TRIAL REGISTRATION
[ClinicalTrials.gov], identifier [NCT04517305].
引言
吡咯替尼联合卡培他滨已在中国获批用于治疗人表皮生长因子受体2（HER2）阳性转移性乳腺癌（MBC）。同时，长春瑞滨是MBC另一种重要的化疗选择，有口服和静脉注射两种剂型。因此，吡咯替尼联合长春瑞滨可能代表一种新的治疗选择，尤其适用于卡培他滨治疗失败的患者。本研究报告了吡咯替尼联合长春瑞滨治疗HER2阳性MBC的首个真实世界数据。
方法
纳入2018年5月至2020年6月在中国6家机构接受吡咯替尼联合长春瑞滨治疗的HER2阳性MBC患者（n = 97）。测定无进展生存期（PFS）、客观缓解率（ORR）、总生存期（OS）和毒性特征。
结果
67%的患者接受了超过两线的系统治疗。几乎所有患者（97.9%）接受过曲妥珠单抗治疗，50.5%接受过拉帕替尼治疗。与吡咯替尼联合使用时，74.2%的患者接受口服长春瑞滨，25.8%的患者接受静脉注射长春瑞滨。所有患者的中位PFS（mPFS）为7.8（范围4.7 - 10.8）个月。接受吡咯替尼作为二线治疗和三线及以上治疗的患者mPFS分别为12.0和6.4个月。接受吡咯替尼联合口服或静脉注射长春瑞滨的患者mPFS相似（7.8个月对6.4个月，p = 0.871）。23例脑转移患者的mPFS为6.3（范围3.4 - 9.2）个月。未接受过拉帕替尼治疗的患者PFS显著长于接受过拉帕替尼治疗的患者（10.8个月对5.6个月，p = 0.020）。未达到中位OS。96例患者的ORR为34.3%。常见的3级和4级不良事件为腹泻（22.7%）、中性粒细胞减少（7.2%）和白细胞减少（4.1%）。
结论
吡咯替尼联合长春瑞滨治疗在HER2阳性MBC中显示出有前景的疗效且毒性可耐受，尤其在二线治疗且未接受过拉帕替尼治疗的患者以及脑转移患者中。与吡咯替尼联合使用时，口服长春瑞滨是静脉注射剂型的一种有用替代方案。
临床试验注册
[ClinicalTrials.gov]，标识符[NCT04517305]
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