Department of Radiation Therapy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Chinese Medicine Hospital of Gaomi, Gaomi, China.
Cancer Med. 2022 Feb;11(3):735-742. doi: 10.1002/cam4.4481. Epub 2021 Dec 27.
To investigate the efficacy and safety of pyrotinib in treating patients with human epidermal growth factor receptor type 2 (HER2)-positive breast cancers with brain metastasis.
This is a multicenter retrospective study, and the HER2-positive breast cancer patients with brain metastasis were studied. The enrolled patients were given pyrotinib 400 mg orally once per day for 21 days as one cycle, and evaluated every two cycles. All relevant data were detected for final assessments including medical history, clinical examination, histopathology, immunohistochemistry, radiographic imaging, treatment outcome, and adverse events.
Forty-two female patients in total were enrolled in this study. The objective response rate (ORR) and disease control rate (DCR) of central nervous system (CNS), were found in 20 of 42 (47.6%) and in 39 of 42 (92.8%), respectively, while for extra-CNS, the respective ORR and DCR were in 9 of 38 (23.6%) and in 36 of 38 (94.7%), respectively. The compounded ORR and DCR were seen in 17 of 42 (40.4%) and in 39 of 42 (92.8%), respectively. The improvement rate of craniocerebral symptoms after treatment was (19/19) 100% and the median duration was 15 months. The median effective time of brain metastases and other metastases was 43 and 50 days. The median follow-up time was 22 months (interquartile range, 16.0-24.3 months). The median time for progression in brain metastasis was 16.6 months. The median time to progress for our group patients was 11.1 months. Sixteen patients (36%) with adverse reactions were recorded in the study.
Pyrotinib combined with chemotherapy/radiotherapy or alone showed significantly greater local control rates and progression free survival (PFS), with manageable toxicity for patients with HER2-positive breast cancer with brain metastases, and further follow-up will provide an overall survival (OS) data.
研究吡咯替尼治疗人表皮生长因子受体 2（HER2）阳性乳腺癌伴脑转移患者的疗效和安全性。
这是一项多中心回顾性研究，纳入了 HER2 阳性乳腺癌伴脑转移患者。入组患者接受吡咯替尼 400mg 口服，每日 1 次，21 天为 1 个周期，每 2 个周期进行评估。所有相关数据均进行检测，最终评估包括病史、临床检查、组织病理学、免疫组织化学、影像学检查、治疗结果和不良事件。
本研究共纳入 42 例女性患者。中枢神经系统（CNS）的客观缓解率（ORR）和疾病控制率（DCR）分别为 20/42（47.6%）和 39/42（92.8%），而对于颅外转移灶，ORR 和 DCR 分别为 9/38（23.6%）和 36/38（94.7%）。复合 ORR 和 DCR 分别为 17/42（40.4%）和 39/42（92.8%）。治疗后颅脑部症状改善率为 19/19（100%），中位持续时间为 15 个月。脑转移和其他转移的中位有效时间分别为 43 和 50 天。中位随访时间为 22 个月（四分位距，16.0-24.3 个月）。脑转移进展的中位时间为 16.6 个月。本研究患者的中位无进展生存期为 11.1 个月。研究中记录了 16 例（36%）患者出现不良反应。
吡咯替尼联合化疗/放疗或单独使用，对 HER2 阳性乳腺癌伴脑转移患者的局部控制率和无进展生存期（PFS）有显著提高，且毒性可管理，进一步随访将提供总生存期（OS）数据。
