研究方案：钇 90（REMEMBR Y90）放射性栓塞术（REM）作为转移性乳腺癌（BR）肝转移的早期治疗方式（EM）的疗效和安全性。
Study Protocol: Efficacy and Safety of Radioembolization (REM) as an Early Modality (EM) Therapy for Metastatic Breast Cancer (BR) to the Liver with Y90 (REMEMBR Y90).
机构信息
School of Medicine, Emory University, Atlanta, GA, USA.
Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA.
出版信息
Cardiovasc Intervent Radiol. 2022 Nov;45(11):1725-1734. doi: 10.1007/s00270-022-03254-4. Epub 2022 Aug 25.
PURPOSE
The primary objective of the REMEMBR Y90 study is to evaluate the efficacy of Yttrium-90 (Y90) radioembolization in patients with breast cancer metastases to the liver as a 2nd or 3rd line treatment option with systemic therapy by assessing liver-specific and overall progression-free survival. Secondary objectives include quality of life, overall survival benefit, and toxicity in relation to patients' tumor biology.
MATERIALS AND METHODS
This trial is a multi-center, prospective, Phase 2, open-label, IRB-approved, randomized control trial in the final phases of activation. Eligible patients include those over 18 years of age with metastatic breast cancer to the liver with liver-only or liver-dominant disease, and history of tumor progression on 1-2 lines of chemotherapy. 60 patients will be randomized to radioembolization with chemotherapy versus chemotherapy alone. Permissible regimens include capecitabine, eribulin, vinorelbine, and gemcitabine within 2 weeks of enrollment for every patient. Patients receiving radioembolization will receive lobar or segmental treatment within 1-6 weeks of enrollment depending on their lesion. After final radioembolization, patients will receive clinical and imaging follow-up every 12-16 weeks for two years, including contrast-enhanced computed tomography or magnetic resonance imaging of the abdomen and whole-body positron emission tomography/computed tomography.
DISCUSSION
This study seeks to elucidate the clinical benefit and toxicity of Y90 in patients with metastatic breast cancer to the liver who are receiving minimal chemotherapy. Given previous data, it is anticipated that the use of Y90 and chemotherapy earlier in the metastatic disease course would improve survival outcomes and reduce toxicity.
LEVEL OF EVIDENCE
Level 1b, Randomized Controlled Trial.
TRIAL REGISTRATION NUMBER
NCT05315687 on clinicaltrials.gov.
目的
REMEMBR Y90 研究的主要目的是评估钇-90（Y90）放射性栓塞在转移性乳腺癌肝转移患者中的疗效，作为二线或三线治疗方案，联合系统治疗，评估肝脏特异性和总无进展生存期。次要目标包括与患者肿瘤生物学相关的生活质量、总生存获益和毒性。
材料和方法
这是一项多中心、前瞻性、二期、开放标签、IRB 批准、随机对照临床试验，处于激活的最后阶段。符合条件的患者包括年龄在 18 岁以上的转移性乳腺癌肝转移患者，且仅存在肝转移或肝优势转移，以及在 1-2 线化疗后肿瘤进展的病史。将 60 名患者随机分为化疗联合放射性栓塞组和单纯化疗组。每个患者在入组后 2 周内允许接受卡培他滨、艾瑞布林、长春瑞滨和吉西他滨的治疗方案。接受放射性栓塞的患者将在入组后 1-6 周内根据病变情况接受叶或节段治疗。最后一次放射性栓塞后，患者将在两年内每 12-16 周接受临床和影像学随访，包括腹部增强 CT 或磁共振成像以及全身正电子发射断层扫描/计算机断层扫描。
讨论
该研究旨在阐明在接受最小剂量化疗的转移性乳腺癌肝转移患者中 Y90 的临床获益和毒性。鉴于先前的数据，预计在转移性疾病过程中更早地使用 Y90 和化疗将改善生存结果并降低毒性。
证据水平
1b 级，随机对照试验。
试验注册号
NCT05315687，在 clinicaltrials.gov 上注册。
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