Han Hao, Wang Congcong, Jiang Fenge, Sun Ping, Liu Jiannan
Hospital of Shandong Second Medical University, School of Clinical Medicine, Shandong Second Medical University, Weifang, 261053, People's Republic of China.
Department of Oncology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, 264000, People's Republic of China.
Drug Des Devel Ther. 2025 Apr 14;19:2885-2895. doi: 10.2147/DDDT.S516394. eCollection 2025.
HER2-positive advanced breast cancer poses significant treatment challenges. In China, T-DM1 and pyrotinib are key second-line therapies. A comprehensive evaluation of the comparative efficacy and safety profiles of these therapies is imperative for optimizing therapeutic strategies and enhancing patient outcomes. This study aims to compare the clinical efficacy and safety of T-DM1 against pyrotinib plus capecitabine.
Patients are females with HER2-positive, locally advanced, or metastatic breast cancer who at least 18 years old and have received anti-HER2 therapy in the past. This study included 148 patients who satisfied the inclusion criteria. Of these, 74 patients received intravenous T-DM1 (3.6 mg/kg) every 21 days, while the other 74 patients got oral pyrotinib (400 mg, once daily) plus capecitabine (1000 mg/m, twice daily on days 1-14 of each 21-day cycle). Progression-free survival (PFS) was the main outcome, while overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) were the secondary outcomes.
The median PFS was 12.2 months for the pyrotinib group vs 9.1 months for the T-DM1 group. The median follow-up was 12.7 months for pyrotinib and 9.3 months for T-DM1. The pyrotinib group had better DCR (56.8% vs 54.1%) and ORR (40.5% vs 29.7%). While adverse events were manageable, the most common severe AE in the pyrotinib group was diarrhea (24.3%), and in the T-DM1 group, it was thrombocytopenia (16.2%). However, by reducing the drug dosage or providing symptomatic treatment, most adverse events could be controlled at grades 1 to 2, indicating that the adverse events were manageable. Neither group recorded any adverse event-related deaths.
Pyrotinib plus capecitabine significantly improves median PFS compared to T-DM1 in patients with HER2-positive advanced breast cancer, demonstrating a favorable efficacy profile alongside manageable safety concerns.
人表皮生长因子受体2（HER2）阳性晚期乳腺癌带来了重大的治疗挑战。在中国，曲妥珠单抗-美坦新偶联物（T-DM1）和吡咯替尼是关键的二线治疗方案。全面评估这些疗法的疗效和安全性对比情况对于优化治疗策略和改善患者预后至关重要。本研究旨在比较T-DM1与吡咯替尼联合卡培他滨的临床疗效和安全性。
患者为年龄至少18岁、既往接受过抗HER2治疗的HER2阳性局部晚期或转移性乳腺癌女性。本研究纳入了148例符合纳入标准的患者。其中，74例患者每21天接受一次静脉注射T-DM1（3.6mg/kg），而另外74例患者接受口服吡咯替尼（400mg，每日一次）加卡培他滨（1000mg/m²，每21天周期的第1 - 14天每日两次）。无进展生存期（PFS）是主要观察指标，总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和不良事件（AE）为次要观察指标。
吡咯替尼组中位PFS为12.2个月，而T-DM1组为9.1个月。吡咯替尼组中位随访时间为12.7个月，T-DM1组为9.3个月。吡咯替尼组的DCR（56.8%对54.1%）和ORR（40.5%对29.7%）更高。虽然不良事件可控，但吡咯替尼组最常见的严重不良事件是腹泻（24.3%），T-DM1组是血小板减少（16.2%）。然而，通过减少药物剂量或进行对症治疗，大多数不良事件可控制在1至2级，表明不良事件是可控的。两组均未记录到任何与不良事件相关的死亡。
对于HER2阳性晚期乳腺癌患者，与T-DM1相比，吡咯替尼联合卡培他滨显著提高了中位PFS，显示出良好的疗效以及可控的安全性。
