Department of Nuclear Medicine, Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
State Key Laboratory of Complex Severe and Rare Diseases, Beijing 100730, China.
Theranostics. 2022 Sep 6;12(15):6437-6445. doi: 10.7150/thno.77219. eCollection 2022.
This study aimed to assess the safety, efficacy, and survival of Lu-DOTA-EB-TATE in patients with metastatic neuroendocrine tumors (NETs) Thirty patients with metastatic NETs were prospectively enrolled and treated with Lu-DOTA-EB-TATE (3 intended cycles at 8 to 12-week intervals, 3.7 GBq/cycle). Treatment-related adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The treatment response was graded according to RECIST 1.1 and PERCIST 1.0 criteria. Kaplan-Meier analysis was performed to calculate progression-free survival (PFS) and overall survival (OS). Patients tolerated therapy well without acute adverse effects. During peptide receptor radionuclide therapy (PRRT), no grade 4 toxicity was observed in any of the patients; grade 3 hematotoxicity was recorded in 4 patients, including grade 3 thrombocytopenia in 4 patients (13.3%) and grade-3 anemia in 1 patient (3.3%); grade 3 hepatotoxicity was recorded in 1 (3.3%) patient, and no grade 2/3/4 nephrotoxicity was observed. On long-term follow-up, none of the patients developed grade 4 hematotoxicity or nephrotoxicity of any grade, reversible grade 3 hematotoxicity (thrombocytopenia) occurred in 1 patient. There was no incidence of leukemia or myelodysplastic syndrome for the duration of follow-up. Of 27 patients with RECIST-measurable disease, partial response and stable disease were seen in 9 and 14 patients, respectively, resulting in a response rate of 33.3% and disease control rate of 85.2%. Of 29 patients evaluable for response on Ga-DOTATATE PET/CT, 14 had partial response and 11 had stable disease, with a response rate of 48.3% and disease control rate of 86.2%. The follow-up period ranged from 5 to 57 months after the first Lu-DOTA-EB-TATE PRRT with a median follow-up of 46 months. The median PFS was 36 months, and the median OS was not reached. Ki-67 index of greater than 10% was associated with poorer PFS ( = 0.012). Our results suggest that PRRT with approximately 3.7 GBq Lu-DOTA-EB-TATE has acceptable toxicity profile and is effective in treating metastatic NET with high disease control rate. In addition, Lu-DOTA-EB-TATE achieved a favorable survival outcome with encouraging PFS.
本研究旨在评估 Lu-DOTA-EB-TATE 在转移性神经内分泌肿瘤（NETs）患者中的安全性、疗效和生存情况。
三十名转移性 NET 患者前瞻性入组并接受 Lu-DOTA-EB-TATE 治疗（3 个周期，每 8-12 周 1 个周期，每个周期 3.7GBq）。根据美国国立癌症研究所不良事件通用术语标准（CTCAE），版本 5.0 对治疗相关不良事件进行分级。根据 RECIST 1.1 和 PERCIST 1.0 标准对治疗反应进行分级。采用 Kaplan-Meier 分析计算无进展生存期（PFS）和总生存期（OS）。
患者对治疗耐受良好，无急性不良反应。在肽受体放射性核素治疗（PRRT）期间，无任何患者发生 4 级毒性；4 名患者出现 3 级血液学毒性，包括 4 名患者的 3 级血小板减少症（13.3%）和 1 名患者的 3 级贫血症（3.3%）；1 名患者出现 3 级肝毒性，无 2/3/4 级肾毒性。长期随访期间，无任何患者发生任何级别 4 级血液学毒性或肾毒性，1 名患者出现可逆性 3 级血液学毒性（血小板减少症）。随访期间无白血病或骨髓增生异常综合征发生。在可评估 RECIST 疾病的 27 名患者中，部分缓解和稳定疾病分别见于 9 名和 14 名患者，缓解率为 33.3%，疾病控制率为 85.2%。在 29 名可评估 Ga-DOTATATE PET/CT 反应的患者中，14 名患者部分缓解，11 名患者病情稳定，缓解率为 48.3%，疾病控制率为 86.2%。首次 Lu-DOTA-EB-TATE PRRT 后随访时间为 5-57 个月，中位随访时间为 46 个月。中位 PFS 为 36 个月，中位 OS 未达到。Ki-67 指数大于 10%与较差的 PFS 相关（=0.012）。
我们的结果表明，大约 3.7GBq 的 Lu-DOTA-EB-TATE 的 PRRT 具有可接受的毒性特征，并且在治疗转移性 NET 方面有效，疾病控制率较高。此外，Lu-DOTA-EB-TATE 实现了良好的生存结果，具有令人鼓舞的 PFS。
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