Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Japan.
Oncologist. 2023 Jun 2;28(6):551-e454. doi: 10.1093/oncolo/oyad013.
Ramucirumab plus docetaxel combination therapy (DOC/RAM) for advanced non-small cell lung cancer (NSCLC) achieves favorable outcomes; however, efficacy and safety for patients with brain metastases are still unclear.
Eligible patients included those with advanced NSCLC with measurable asymptomatic brain metastases that progressed after chemotherapy. Patients were intravenously administered ramucirumab (10 mg/kg) and docetaxel (60 mg/m2) every 21-day cycle.
Due to difficulties in accumulating the planned 65 participants, enrollment was terminated early when 25 patients were enrolled. Primary endpoint: Median progression-free survival (PFS) was 3.9 months (95% CI, 1.8-5.3). Secondary endpoints: Median intracranial progression-free survival was 4.6 months (95% CI, 2.5-5.9); median overall survival was 20.9 months (95% CI, 6.6-not possible to estimate); objective response rate was 20% (95% CI, 6.8-40.7); disease control rate was 68% (95% CI, 46.5-85.1). The most common grade 3 or higher toxicities were neutropenia in 10 patients (40%). Neither intracranial hemorrhage nor grade 5 adverse events were observed. Patients with higher serum soluble vascular endothelial growth factor receptor 2 concentrations at the start of treatment had slightly longer PFS.
No clinical concerns were identified with DOC/RAM for NSCLC with brain metastases in this study. Further investigation with a larger sample size is needed to determine the tolerability and safety of these populations (Trial Identifiers: University Hospital Medical Information Network in Japan [UMIN000024551] and Japan Registry of Clinical Trials [jRCTs071180048]).
雷莫芦单抗联合多西他赛（DOC/RAM）治疗晚期非小细胞肺癌（NSCLC）可获得良好的疗效；然而，对于有脑转移的患者，其疗效和安全性尚不清楚。
符合条件的患者包括那些患有晚期 NSCLC 且有可测量的无症状脑转移，且在化疗后进展的患者。患者每 21 天静脉注射雷莫芦单抗（10mg/kg）和多西他赛（60mg/m2）。
由于难以招募到计划的 65 名患者，当招募到 25 名患者时，提前终止了入组。主要终点：中位无进展生存期（PFS）为 3.9 个月（95%CI，1.8-5.3）。次要终点：中位颅内无进展生存期为 4.6 个月（95%CI，2.5-5.9）；中位总生存期为 20.9 个月（95%CI，6.6-无法估计）；客观缓解率为 20%（95%CI，6.8-40.7）；疾病控制率为 68%（95%CI，46.5-85.1）。最常见的 3 级或以上毒性反应是 10 名患者（40%）出现中性粒细胞减少症。未观察到颅内出血或 5 级不良事件。治疗开始时血清可溶性血管内皮生长因子受体 2 浓度较高的患者 PFS 略长。
在这项研究中，DOC/RAM 治疗 NSCLC 伴脑转移未发现临床相关问题。需要进一步扩大样本量进行研究，以确定这些人群的耐受性和安全性（试验识别号：日本大学医院医学信息网络[UMIN000024551]和日本临床试验注册[ jRCTs071180048]）。
