尼拉帕利用于可切除的 HER2 阴性、BRCA 突变的乳腺癌患者的新辅助研究。
Neoadjuvant study of niraparib in patients with HER2-negative, BRCA-mutated, resectable breast cancer.
机构信息
Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Moffitt Cancer Center-McKinley Outpatient Clinic, Tampa, FL, USA.
出版信息
Nat Cancer. 2022 Aug;3(8):927-931. doi: 10.1038/s43018-022-00400-2. Epub 2022 Jul 4.
This single-arm pilot study (NCT03329937) evaluated neoadjuvant niraparib antitumor activity and safety in patients with localized HER2-negative, BRCA-mutated breast cancer. Twenty-one patients received niraparib 200 mg once daily in 28-day cycles. After 2 cycles, tumor response (≥30% reduction from baseline) by MRI was 90.5% and 40.0% (6 of 15) of patients who received only niraparib (2-6 cycles) had pathological complete response; no new safety signals were identified. High niraparib intratumoral concentration was observed.
这项单臂的初步研究（NCT03329937）评估了新辅助尼拉帕利（niraparib）在局部人表皮生长因子受体 2（HER2）阴性、BRCA 突变型乳腺癌患者中的抗肿瘤活性和安全性。21 名患者接受尼拉帕利 200mg 每日一次，28 天为一周期。经过 2 个周期后，MRI 评估的肿瘤缓解率（自基线降低≥30%）为 90.5%，仅接受尼拉帕利（2-6 个周期）的患者中有 40.0%（15 例中的 6 例）出现了病理完全缓解；未发现新的安全性信号。观察到尼拉帕利在肿瘤内的高浓度。
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