Department of Oncology, Oncology Division, Yokohama City University Graduate School of Medicine, 3-9, Fuku-ura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Department of Radiation Oncology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Ann Nucl Med. 2021 Dec;35(12):1332-1341. doi: 10.1007/s12149-021-01674-9. Epub 2021 Sep 17.
Peptide receptor radionuclide therapy (PRRT) with Lu-DOTA-Tyr-octreotate (Lu-DOTATATE) is one of the most reliable treatments for unresectable, progressive neuroendocrine tumors (NETs) with somatostatin receptor expression. We have, for the first time, reported the results of the tolerability, safety, pharmacokinetics, dosimetry, and efficacy of this treatment for Japanese patients with NET.
Patients with unresectable, somatostatin receptor scintigraphy (SRS)-positive NETs were enrolled in this phase I clinical trial. They were treated with 29.6 GBq of Lu-DOTATATE (four doses of 7.4 GBq) combined with amino acid solution infusion plus octreotide long-acting release (LAR) 30 mg. The primary objective of this study was to evaluate the tolerability, safety, pharmacokinetics, and dosimetry of a single administration of this treatment in patients with SRS-positive NETs.
Six Japanese patients (three men and three women; mean age 61.5 years; range 50-70 years) with SRS-positive unresectable NETs were recruited. Lu-DOTATATE was eliminated from the blood in a two-phase manner. Cumulative urinary excretion of radioactivity was 60.1% (range 49.0%-69.8%) within the initial 6 h. The cumulative renal absorbed dose for 29.6 GBq of Lu-DOTATATE was 16.8 Gy (range 12.0-21.2 Gy), and the biological effective dose was 17.0 Gy (range 12.2-21.5 Gy). Administration of Lu-DOTATATE was well tolerated, with no dose-limiting toxicities. Grade 3 lymphopenia occurred in two (33.3%) cases, but there were no other severe toxicities. Four patients achieved partial response (objective response rate, 66.7%), one patient had stable disease, and one patient had progressive disease.
PRRT with Lu-DOTATATE was well-tolerated and showed good outcomes in Japanese patients with unresectable NETs. Peptide receptor radionuclide therapy, Lu-DOTA-Tyr-octreotate .
肽受体放射性核素治疗（PRRT）使用 Lu-DOTA-Tyr-octreotate（Lu-DOTATATE）是治疗具有生长抑素受体表达的不可切除、进行性神经内分泌肿瘤（NETs）的最可靠方法之一。我们首次报道了这种治疗方法在日本 NET 患者中的耐受性、安全性、药代动力学、剂量学和疗效。
本研究纳入了不可切除、生长抑素受体闪烁显像（SRS）阳性的 NET 患者，他们接受了 29.6GBq 的 Lu-DOTATATE（四剂 7.4GBq）联合氨基酸溶液输注和奥曲肽长效释放（LAR）30mg。本研究的主要目的是评估 SRS 阳性 NET 患者单次接受该治疗的耐受性、安全性、药代动力学和剂量学。
共纳入了 6 名日本 SRS 阳性不可切除 NET 患者（3 名男性，3 名女性；平均年龄 61.5 岁；年龄范围 50-70 岁）。Lu-DOTATATE 在血液中呈两相消除。初始 6 小时内放射性物质的累积尿排泄率为 60.1%（范围 49.0%-69.8%）。29.6GBq Lu-DOTATATE 的累积肾吸收剂量为 16.8Gy（范围 12.0-21.2Gy），生物有效剂量为 17.0Gy（范围 12.2-21.5Gy）。Lu-DOTATATE 给药耐受性良好，无剂量限制性毒性。2 例（33.3%）患者出现 3 级淋巴细胞减少症，但无其他严重毒性。4 例患者获得部分缓解（客观缓解率，66.7%），1 例患者病情稳定，1 例患者病情进展。
Lu-DOTATATE 的 PRRT 在日本不可切除 NET 患者中耐受性良好，疗效良好。肽受体放射性核素治疗，Lu-DOTA-Tyr-octreotate。
