{"title":"Initial Findings on the Use of [<sup>225</sup>Ac]Ac-DOTATATE Therapy as a Theranostic Application in Patients with Neuroendocrine Tumors.","authors":"Emre Demirci, Nalan Alan Selçuk, Gamze Beydağı, Meltem Ocak, Türkay Toklu, Kaan Akçay, Levent Kabasakal","doi":"10.4274/mirt.galenos.2023.38258","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the stability, safety, and efficacy of alpha-targeted therapy with [<sup>225</sup>Ac]Ac-DOTATATE in patients with grade 1/2 metastatic neuroendocrine tumors (NETs).</p><p><strong>Methods: </strong>This retrospective cohort included patients (n=11) with metastatic NETs from different primary sites (bronchial, pancreatic, nonpancreatic gastroenteropancreatic NETs, paraganglioma, and unknown primary site) treated with [<sup>225</sup>Ac]Ac-DOTATATE with a mean activity of 8.2±0.6 MBq (range: 7.5-10.0 MBq) at our institution between November 2019 and March 2022. The <i>in vivo</i> and <i>in vitro</i> stability of [<sup>225</sup>Ac]Ac-DOTATATE was calculated. The safety profile was evaluated according to the CTCAE-v5.0. Treatment efficacy was evaluated according to [<sup>68</sup>Ga] Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) images and the RECIST 1.1 criteria.</p><p><strong>Results: </strong>Patients had 73% (n=8) lymph node metastases, 91% (n=10) liver metastases, 36% (n=4) lung metastases, and 73% (n=8) bone metastases. All but one patient was refractory to treatment with [<sup>177</sup>Lu]Lu-DOTATATE. [<sup>225</sup>Ac]Ac-DOTATATE was stable for at least 5 h in vitro (in saline) and 3 h <i>in vivo</i> (urine and blood samples). Grade 2 renal toxicity and grade 2 hematotoxicity were observed in one patient. No grade 3-4 toxicities were reported. According to post-treatment [<sup>68</sup>Ga]Ga-DOTATATE PET/CT (n=9), 11% (n=1) had progressive disease, 44.4% (n=4) had stable disease, and 44.4% (n=4) had a partial response. The disease control rate was 89% (n=8). The median progression-free survival estimated according to Kaplan-Meier analysis was 12 months.</p><p><strong>Conclusion: </strong>The preliminary results of this study suggest that [<sup>225</sup>Ac]Ac-DOTATATE is stable, safe, and effective for treating advanced and [<sup>177</sup>Lu] Lu-DOTATATE-refractory NETs. However, prospective studies are needed to determine the impact of treatment on overall survival and to uncover potential side effects.</p>","PeriodicalId":44681,"journal":{"name":"Molecular Imaging and Radionuclide Therapy","volume":null,"pages":null},"PeriodicalIF":0.9000,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fe/5c/MIRT-32-226.PMC10600558.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Molecular Imaging and Radionuclide Therapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4274/mirt.galenos.2023.38258","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
引用次数: 0
Abstract
Objectives: This study aimed to evaluate the stability, safety, and efficacy of alpha-targeted therapy with [225Ac]Ac-DOTATATE in patients with grade 1/2 metastatic neuroendocrine tumors (NETs).
Methods: This retrospective cohort included patients (n=11) with metastatic NETs from different primary sites (bronchial, pancreatic, nonpancreatic gastroenteropancreatic NETs, paraganglioma, and unknown primary site) treated with [225Ac]Ac-DOTATATE with a mean activity of 8.2±0.6 MBq (range: 7.5-10.0 MBq) at our institution between November 2019 and March 2022. The in vivo and in vitro stability of [225Ac]Ac-DOTATATE was calculated. The safety profile was evaluated according to the CTCAE-v5.0. Treatment efficacy was evaluated according to [68Ga] Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) images and the RECIST 1.1 criteria.
Results: Patients had 73% (n=8) lymph node metastases, 91% (n=10) liver metastases, 36% (n=4) lung metastases, and 73% (n=8) bone metastases. All but one patient was refractory to treatment with [177Lu]Lu-DOTATATE. [225Ac]Ac-DOTATATE was stable for at least 5 h in vitro (in saline) and 3 h in vivo (urine and blood samples). Grade 2 renal toxicity and grade 2 hematotoxicity were observed in one patient. No grade 3-4 toxicities were reported. According to post-treatment [68Ga]Ga-DOTATATE PET/CT (n=9), 11% (n=1) had progressive disease, 44.4% (n=4) had stable disease, and 44.4% (n=4) had a partial response. The disease control rate was 89% (n=8). The median progression-free survival estimated according to Kaplan-Meier analysis was 12 months.
Conclusion: The preliminary results of this study suggest that [225Ac]Ac-DOTATATE is stable, safe, and effective for treating advanced and [177Lu] Lu-DOTATATE-refractory NETs. However, prospective studies are needed to determine the impact of treatment on overall survival and to uncover potential side effects.
期刊介绍：
Molecular Imaging and Radionuclide Therapy (Mol Imaging Radionucl Ther, MIRT) is publishes original research articles, invited reviews, editorials, short communications, letters, consensus statements, guidelines and case reports with a literature review on the topic, in the field of molecular imaging, multimodality imaging, nuclear medicine, radionuclide therapy, radiopharmacy, medical physics, dosimetry and radiobiology.
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