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比较吡咯替尼与曲妥珠单抗联合治疗、帕妥珠单抗与曲妥珠单抗联合治疗用于 HER2 阳性转移性乳腺癌:一项回顾性、多中心分析。

Comparing pyrotinib with trastuzumab and pertuzumab with trastuzumab for HER2-positive metastatic breast cancer: a retrospective, multicenter analysis.

机构信息

Department of Breast and Urological Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.

Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

出版信息

Front Endocrinol (Lausanne). 2023 Dec 11;14:1325540. doi: 10.3389/fendo.2023.1325540. eCollection 2023.

Abstract

OBJECTIVE

Pyrotinib and pertuzumab are effective treatment options for HER2-positive metastatic breast cancer (HER2+ MBC). Our study was to directly compare the efficacy and safety of pyrotinib plus trastuzumab (PyroH) and pertuzumab plus trastuzumab (HP) in patients with HER2+ MBC.

METHODS

We conducted a retrospective examination of HER2+ MBC patients who received PyroH plus chemotherapy or HP plus chemotherapy between 2017 and 2022 at five institutions in China. Our primary endpoint was progression-free survival (PFS).

RESULTS

This study involved 333 patients, among which 161 received PyroH and 172 received HP. The utilization of PyroH as a first-line therapy for MBC was more prevalent among older patients, those with a shorter duration of disease-free interval, or those who had previously been treated with trastuzumab. Although in the first-line advanced treatment HP cohort showed numerically longer PFS (median PFS: 14.46 vs. 22.90 months, =0.057), in the second-line or later treatments, there was no significant difference in PFS between the PyroH and HP groups (median PFS: 8.67 vs. 7.92 months, =0.286). Despite HP showing a longer PFS in the overall cohort (median PFS: 9.30 vs. 13.01 months, =0.005), it did not serve as an independent predictor of PFS in the multivariate analysis (HR 1.134, 95% CI 0.710-1.811, p=0.598). Without taxane, PyroH demonstrated a longer PFS than HP (median PFS: 10.12 vs. 8.15 months, =0.017). PyroH group displayed a numerically longer median PFS in patients with brain metastases compared to the HP group, though not statistically significant (median PFS: 9.03 vs. 8.15 months, =0.976). PyroH had higher incidence of grade 3/4 diarrhea (34.3% vs. 3.0%) but similar overall adverse events.

CONCLUSION

In conclusion, PyroH is comparable in second-line or later treatment and during brain metastasis, even having superior efficacy without taxane in real-world setting. Toxicities were tolerable in both groups. (ClinicalTrials.gov: NCT05572645).

摘要

目的

吡咯替尼和帕妥珠单抗是治疗人表皮生长因子受体 2 阳性转移性乳腺癌(HER2+MBC)的有效治疗选择。本研究旨在直接比较吡咯替尼联合曲妥珠单抗(PyroH)与帕妥珠单抗联合曲妥珠单抗(HP)在 HER2+MBC 患者中的疗效和安全性。

方法

我们对 2017 年至 2022 年在中国五家机构接受 PyroH 联合化疗或 HP 联合化疗的 HER2+MBC 患者进行了回顾性检查。我们的主要终点是无进展生存期(PFS)。

结果

本研究共纳入 333 例患者,其中 161 例接受 PyroH 治疗,172 例接受 HP 治疗。在 MBC 一线治疗中,使用 PyroH 的患者更倾向于老年患者、疾病无进展间隔时间较短的患者或先前接受过曲妥珠单抗治疗的患者。尽管在一线晚期治疗中,HP 组的 PFS 更长(中位 PFS:14.46 个月比 22.90 个月,=0.057),但在二线或以后的治疗中,PyroH 组和 HP 组的 PFS 无显著差异(中位 PFS:8.67 个月比 7.92 个月,=0.286)。尽管 HP 在总队列中表现出更长的 PFS(中位 PFS:9.30 个月比 13.01 个月,=0.005),但它在多变量分析中并不是 PFS 的独立预测因素(HR 1.134,95%CI 0.710-1.811,p=0.598)。无紫杉烷类药物时,PyroH 的 PFS 长于 HP(中位 PFS:10.12 个月比 8.15 个月,=0.017)。与 HP 组相比,PyroH 组脑转移患者的中位 PFS 更长,但无统计学意义(中位 PFS:9.03 个月比 8.15 个月,=0.976)。PyroH 组 3/4 级腹泻的发生率较高(34.3%比 3.0%),但总体不良事件相似。

结论

总之,在二线或以后的治疗和脑转移中,PyroH 与 HP 相当,即使在真实世界环境中无紫杉烷类药物时也具有更好的疗效。两组的毒性均可耐受。(临床试验:NCT05572645)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd4b/10750407/12c781d6036b/fendo-14-1325540-g001.jpg

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