Toxicity and Tolerability of (177)Lu-DOTA-TATE PRRT with a Modified Administered Activity Protocol in NETs of Variable Origin - A Phase 2 Registry Study.
Toxicity and Tolerability of (177)Lu-DOTA-TATE PRRT with a Modified Administered Activity Protocol in NETs of Variable Origin - A Phase 2 Registry Study.
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DOI：
10.2174/1874471014666210810100435
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发表时间：
2022
影响因子：
2.3
通讯作者：
Laidley, David T.
中科院分区：
文献类型：
--
作者：
Khatami, Alireza;Sistani, Golmehr;Sutherland, Duncan E. K.;DeBrabandere, Sarah;Reid, Robert H.;Laidley, David T.
背景：肽受体放射性核素治疗（PRRT）最近已批准用于晚期，转移性或进行性神经内分泌肿瘤（NETS）。
目的：本研究报告了患者量化的管理活动观察到的不良事件（AE）。
方法：用177lu-二酸治疗52名幼体患者。使用患者的独特特征（年龄，症状，血液工作和生物标志物），管理的活动范围在2.78至5.55 GBQ/周期之间。
结果：该方案的耐受性很好，绝大多数参与者为46（88％），完成了所有4种诱导疗法周期。中位累积施用活性为19.6 GBQ（范围为3.8-22.3 GBQ）。总共42/52（81％）报告了至少一种症状，43/52（83％）的入学率有生化异常的证据，这些异常符合AES的1年级或2级标准。这些症状仅随着治疗而略有增加到50/52（96％）和51/52（98％）。最常见的症状是轻度疲劳（62％），呼吸急促（50％），恶心（44％），腹痛（38％）和肌肉骨骼疼痛（37％）。最常见的生物标志物异常是轻度贫血（81％），估计的肾小球过滤率（EGFR）降低（58％），碱性磷酸酶（ALP）（50％）和白细胞减少（37％）。至关重要的是，观察到177lu-二列酸盐相关的3或4级AE。
结论：针对各种蚊帐的患者量身定制177lu-二他的施用活性既安全且耐受性良好。没有患者出现严重的3级或4级AE。大多数患者在治疗前表现出症状或生化异常，诱导疗法后仅略有恶化。
Background: Peptide receptor radionuclide therapy (PRRT) has been recently approved for advanced, metastatic, or progressive neuroendocrine tumors (NETs). Objective: This study reports the adverse events (AEs) observed with patient-tailored administered activity. Methods: Fifty-two PRRT naive patients were treated with 177Lu-DOTATATE. The administered activity ranges between 2.78 and 5.55 GBq/cycle using the patient's unique characteristics (age, symptoms, blood work, and biomarkers). Results: The protocol was well tolerated with the overwhelming majority of participants being forty-six (88%), completing all 4 induction therapy cycles. The median cumulative administered activity was 19.6 GBq (ranged 3.8-22.3 GBq). A total of 42/52 (81%) reported at least one symptom, and 43/52 (83%) had evidence of biochemical abnormality at enrollment that would meet grade 1 or 2 criteria for AEs. These symptoms only slightly increase with treatment to 50/52 (96%) and 51/52 (98%), respectively. The most common symptoms were mild fatigue (62%), shortness of breath (50%), nausea (44%), abdominal pain (38%), and musculoskeletal pain (37%). The most common biomarker abnormalities were mild anemia (81%), reduced estimated glomerular filtration rate (eGFR) (58%), increased alkaline phosphatase (ALP) (50%), and leukopenia (37%). Of critical importance, no 177Lu-DOTATATE related grade 3 or 4 AEs were observed. Conclusion: Tailoring the administered activity of 177Lu-DOTATATE to the individual patient with a variety of NETs is both safe and well-tolerated. No patient developed severe grade 3 or 4 AEs. Most patients exhibit symptoms or biochemical abnormality before treatment and this only slightly worsens following induction therapy.
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DOI：
10.1007/s00259-018-3945-z
发表时间：
2018-06
影响因子：
9.1
作者：
Garske-Román U;Sandström M;Fröss Baron K;Lundin L;Hellman P;Welin S;Johansson S;Khan T;Lundqvist H;Eriksson B;Sundin A;Granberg D
通讯作者：
Granberg D
影响因子：
6.2
作者：
Modlin, IM;Lye, KD;Kidd, M
通讯作者：
Kidd, M
影响因子：
28.4
作者：
Dasari, Arvind;Shen, Chan;Yao, James C.
通讯作者：
Yao, James C.
影响因子：
5.6
作者：
Schmid, K;Birner, P;Geleff, S
通讯作者：
Geleff, S
影响因子：
45.3
作者：
Kwekkeboom, Dik J.;de Herder, Wouter W.;Krenning, Eric P.
通讯作者：
Krenning, Eric P.