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多西他赛与长春瑞滨联合曲妥珠单抗和帕妥珠单抗用于转移性 HER2 阳性乳腺癌一线治疗:一项回顾性的两中心研究。

Taxane versus vinorelbine in combination with trastuzumab and pertuzumab for first-line treatment of metastatic HER2-positive breast cancer: a retrospective two-center study.

机构信息

Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, 39 Jabotinsky St., Petach Tikva, 4941492, Israel.

Department of Oncology, Meir Medical Center, Kfar Saba, Israel.

出版信息

Breast Cancer Res Treat. 2021 Jul;188(2):379-387. doi: 10.1007/s10549-021-06198-4. Epub 2021 Mar 27.

Abstract

BACKGROUND

The combination of a taxane with trastuzumab and pertuzumab is standard of care for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The combination of vinorelbine with trastuzumab and pertuzumab showed anti-tumor activity in a phase 2 trial.

PATIENTS AND METHODS

The databases of two tertiary medical centers were retrospectively searched for patients with HER2-positive metastatic breast cancer who underwent first-line treatment in 2013-2019 with a taxane or vinorelbine in combination with trastuzumab and pertuzumab. Groups were compared for progression-free survival (PFS), overall survival (OS), and toxicity profile.

RESULTS

The study included 87 patients in the taxane group and 65 in the vinorelbine group. Overall median PFS was significantly longer in the taxane group [HR 0.56 (0.36-0.88), P = 0.01], but on multivariate analysis the difference was not statistically significant [HR 0.68 (0.4-1.1, P = 0.11)]. PFS was comparable in both groups of patients with recurrent disease [HR 0.94 (0.5-1.79), P = 0.85]. However, in patients with de novo metastatic disease, the difference in favor of the taxane group was pronounced [HR 0.4 (0.2-0.78), P = 0.007] and maintained significance on multivariate analysis [HR 0.46 (0.2-0.97, P = 0.04)]. There was no statistical significant difference in OS in the whole cohort [HR 0.69 (0.39-1.23)] or the subgroups.

CONCLUSIONS

Patients with HER2-positive metastatic breast cancer had similar survival with first-line treatment of taxane or vinorelbine combined with trastuzumab and pertuzumab. When the analysis was adjusted for prognostic factors, there was no PFS benefit for taxanes except in the subgroup with de novo disease.

摘要

背景

紫杉烷联合曲妥珠单抗和帕妥珠单抗是治疗人表皮生长因子受体 2(HER2)阳性转移性乳腺癌的一线治疗标准。长春瑞滨联合曲妥珠单抗和帕妥珠单抗的联合在 2 期试验中显示出抗肿瘤活性。

患者和方法

回顾性检索了两家三级医疗中心的数据库,以寻找 2013 年至 2019 年期间接受一线治疗的 HER2 阳性转移性乳腺癌患者的数据库,这些患者接受了紫杉烷或长春瑞滨联合曲妥珠单抗和帕妥珠单抗治疗。比较两组无进展生存期(PFS)、总生存期(OS)和毒性谱。

结果

该研究包括紫杉烷组 87 例和长春瑞滨组 65 例。紫杉烷组的总体中位 PFS 明显延长[风险比(HR)0.56(0.36-0.88),P=0.01],但多变量分析差异无统计学意义[HR 0.68(0.4-1.1,P=0.11)]。在复发性疾病患者中,两组患者的 PFS 无差异[HR 0.94(0.5-1.79),P=0.85]。然而,在新发转移性疾病患者中,紫杉烷组的优势明显[HR 0.4(0.2-0.78),P=0.007],多变量分析也有显著意义[HR 0.46(0.2-0.97,P=0.04)]。在整个队列中,OS 无统计学显著差异[HR 0.69(0.39-1.23)]或亚组。

结论

HER2 阳性转移性乳腺癌患者接受紫杉烷或长春瑞滨联合曲妥珠单抗和帕妥珠单抗一线治疗的生存相似。当对预后因素进行分析调整时,紫杉烷类药物除了在新发疾病亚组外,无 PFS 获益。

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