National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Key Laboratory of Breast Cancer Prevention and Therapy, Tianjin Medical University, Ministry of Education, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
Int J Cancer. 2023 Nov 15;153(10):1809-1818. doi: 10.1002/ijc.34676. Epub 2023 Aug 6.
Pyrotinib, an irreversible pan-ErbB inhibitor, has been approved for treating HER2-positive advanced breast cancer in China. We conducted a nationwide, prospective observational study to examine the real-world data of pyrotinib-based therapy in this population. Patients from 61 sites across China were included. Pyrotinib-based regimens were prescribed at local physician's discretion. Demographics, treatment patterns, prognosis and safety were evaluated. The primary outcome was real-world progression-free survival (rwPFS). Of 1129 patients, pyrotinib-based therapy was prescribed as first-, second- and third- or later-line treatment in 437 (38.7%), 476 (42.2%) and 216 (19.1%) patients, respectively. Median rwPFS (mrwPFS) was 14.3 (95% CI, 13.3-15.2) months in the total population, with the longest mrwPFS of 17.8 (95% CI, 15.2-24.9) months in the first-line setting, followed by 14.4 (95% CI, 12.9-15.3) months in the second-line setting. Patients with third- or later-line treatment also achieved a mrwPFS of 9.3 (95% CI, 8.4-11.8) months. Patients with trastuzumab- or trastuzumab-pertuzumab-treated disease achieved a mrwPFS of 14.3 and 13.6 months, respectively. Dual HER2 blockade with pyrotinib plus trastuzumab showed a mrwPFS of 16.2 months in the total population, with data not mature in the first-line setting. For patients with baseline brain metastases, the mrwPFS was 11.7 months. The most common adverse event was diarrhea (any grade, 73.5%; grade ≥ 3, 15.3%). In real world, pyrotinib-based therapy shows promising effectiveness in the first-, as well as second- and later-line treatment, with acceptable tolerability. Further investigations regarding front-line use or novel combinations of pyrotinib might facilitate to maximize its anti-tumor potential.
吡咯替尼是一种不可逆的 pan-ErbB 抑制剂，已在中国获批用于治疗 HER2 阳性晚期乳腺癌。我们开展了一项全国性、前瞻性观察性研究，以评估该人群中吡咯替尼为基础的治疗的真实世界数据。来自中国 61 个地点的患者被纳入研究。吡咯替尼为基础的治疗方案由当地医生酌情开具。评估了患者的人口统计学特征、治疗模式、预后和安全性。主要结局为真实世界无进展生存期（rwPFS）。在 1129 例患者中，437 例（38.7%）、476 例（42.2%）和 216 例（19.1%）患者分别接受了一线、二线和三线或以上治疗。总体人群的中位 rwPFS（mrwPFS）为 14.3 个月（95%CI，13.3-15.2），一线治疗最长的 mrwPFS 为 17.8 个月（95%CI，15.2-24.9），二线治疗为 14.4 个月（95%CI，12.9-15.3）。三线或以上治疗的患者也获得了 9.3 个月的 mrwPFS（95%CI，8.4-11.8）。接受曲妥珠单抗或曲妥珠单抗-帕妥珠单抗治疗的患者的 mrwPFS 分别为 14.3 个月和 13.6 个月。在总体人群中，吡咯替尼联合曲妥珠单抗的双重 HER2 阻断显示出 16.2 个月的 mrwPFS，一线治疗的数据尚不成熟。对于基线时有脑转移的患者，mrwPFS 为 11.7 个月。最常见的不良反应是腹泻（任何级别，73.5%；≥3 级，15.3%）。在真实世界中，吡咯替尼为基础的治疗在一线以及二线和三线或以上治疗中显示出有前景的疗效，且具有可接受的耐受性。进一步研究吡咯替尼的一线应用或新的联合应用可能有助于最大限度地发挥其抗肿瘤潜力。
