Dana-Farber Cancer Institute, Dana-Farber/Brigham & Women's Cancer Center, 450 Brookline Avenue, Boston, MA, 02215, USA.
Department of Diagnostic Physics, Oslo University Hospital, Oslo, Norway.
Breast Cancer Res. 2020 Nov 30;22(1):131. doi: 10.1186/s13058-020-01372-w.
We aimed to examine the safety and efficacy of bevacizumab and carboplatin in patients with breast cancer brain metastases.
We enrolled patients with breast cancer and > 1 measurable new or progressive brain metastasis. Patients received bevacizumab 15 mg/kg intravenously (IV) on cycle 1 day 1 and carboplatin IV AUC = 5 on cycle 1 day 8. Patients with HER2-positive disease also received trastuzumab. In subsequent cycles, all drugs were administered on day 1 of each cycle. Contrast-enhanced brain MRI was performed at baseline, 24-96 h after the first bevacizumab dose (day + 1), and every 2 cycles. The primary endpoint was objective response rate in the central nervous system (CNS ORR) by composite criteria. Associations between germline VEGF single nucleotide polymorphisms (rs699947, rs2019063, rs1570360, rs833061) and progression-free survival (PFS) and overall survival (OS) were explored, as were associations between early (day + 1) MRI changes and outcomes.
Thirty-eight patients were enrolled (29 HER2-positive, 9 HER2-negative); all were evaluable for response. The CNS ORR was 63% (95% CI, 46-78). Median PFS was 5.62 months and median OS was 14.10 months. As compared with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, patients with ECOG PS 1-2 had significantly worse PFS and OS (all P < 0.01). No significant associations between VEGF genotypes or early MRI changes and clinical outcomes were observed.
The combination of bevacizumab and carboplatin results in a high rate of durable objective response in patients with brain metastases from breast cancer. This regimen warrants further investigation.
NCT01004172 . Registered 28 October 2009.
我们旨在研究贝伐珠单抗联合卡铂治疗乳腺癌脑转移患者的安全性和有效性。
我们纳入了患有乳腺癌且>1 个可测量的新发或进展性脑转移病灶的患者。患者在第 1 周期第 1 天接受贝伐珠单抗 15mg/kg 静脉输注（IV），第 1 周期第 8 天接受卡铂 IV AUC=5。HER2 阳性疾病患者还接受曲妥珠单抗治疗。在后续周期中，所有药物均在每个周期的第 1 天给药。基线时、首次贝伐珠单抗给药后 24-96 小时（第+1 天）以及每 2 个周期进行增强对比脑 MRI 检查。主要终点为中枢神经系统（CNS）复合标准的客观缓解率（CNS ORR）。还探讨了种系 VEGF 单核苷酸多态性（rs699947、rs2019063、rs1570360、rs833061）与无进展生存期（PFS）和总生存期（OS）之间的关系，以及早期（第+1 天）MRI 变化与结局之间的关系。
共纳入 38 例患者（29 例 HER2 阳性，9 例 HER2 阴性）；所有患者均可评价疗效。CNS ORR 为 63%（95%CI，46-78）。中位 PFS 为 5.62 个月，中位 OS 为 14.10 个月。与 ECOG PS 0 相比，ECOG PS 1-2 的患者 PFS 和 OS 显著更差（均 P<0.01）。未观察到 VEGF 基因型或早期 MRI 变化与临床结局之间存在显著相关性。
贝伐珠单抗联合卡铂治疗乳腺癌脑转移患者可获得持久的客观缓解率较高。该方案值得进一步研究。
NCT01004172。于 2009 年 10 月 28 日注册。
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