دورية أكاديمية
188Re-SSS Lipiodol Radioembolization in HCC Patients: Results of a Phase 1 Trial (Lip-Re-01 Study)
| العنوان: | 188Re-SSS Lipiodol Radioembolization in HCC Patients: Results of a Phase 1 Trial (Lip-Re-01 Study) |
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| المؤلفون: | Etienne Garin, Xavier Palard, Yan Rolland, Samuel Le Sourd, Nicolas Lepareur, Valérie Ardisson, Christelle Bouvry, Sophie Laffont, Boris Campillo-Gimenez, Eric Bellissant, Julien Edeline |
| المصدر: | Cancers, Vol 15, Iss 8, p 2245 (2023) |
| بيانات النشر: | MDPI AG, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| مصطلحات موضوعية: | 90Y-loaded microspheres, 188Re-SSS lipiodol, radioembolization, hepatocellular carcinoma (HCC), radiation therapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: | Background: Despite the wide development of 90Y-loaded microspheres, 188Re-labeled lipiodol is still being used for radioembolization of hepatocellular carcinoma (HCC). However, the use of this latter compound is limited by in vivo instability. This study sought to evaluate the safety, bio-distribution, and response to 188Re-SSS lipiodol, a new and more stable compound. Method: Lip-Re-01 was an activity-escalation Phase 1 study involving HCC patients progressing after sorafenib. The primary endpoint was safety based on Common Terminology Criteria for Adverse Events (AEs) of Grade ≥3 within 2 months. Secondary endpoints included bio-distribution assessed by scintigraphy quantification from 1 to 72 h, tumor to non-tumor uptake ratio (T/NT), as well as blood, urine and feces collection over 72 h, dosimetry, and response evaluation (mRECIST). Results: Overall, 14 heavily pre-treated HCC patients were treated using a whole liver approach. The mean injected activity was 1.5 ± 0.4 GBq for activity Level 1 (n = 6), 3.6 ± 0.3 GBq for Level 2 (n = 6), and 5.0 ± 0.4 GBq for Level 3 (n = 2). Safety was acceptable with only 1/6 of Level 1 and 1/6 of Level 2 patients experiencing limiting toxicity (one liver failure; one lung disease). The study was prematurely discontinued unrelated to clinical outcomes. Uptake occurred in the tumor, liver, and lungs, and only sometimes in the bladder. The T/NT ratio was high with a mean of 24.9 ± 23.4. Cumulative urinary elimination and fecal eliminations at 72 h were very low, 4.8 ± 3.2% and 0.7 ± 0.8%, respectively. Partial response occurred in 21% of patients (0% in the first activity level; 37.5% in the others). Conclusion: The high in vivo stability of 188Re-SSS lipiodol was confirmed, resulting in encouraging responses for a Phase 1 study. As the 3.6 GBq activity proved to be safe, it will be used in a future Phase 2 study. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 15082245 2072-6694 |
| Relation: | https://www.mdpi.com/2072-6694/15/8/2245; https://doaj.org/toc/2072-6694 |
| DOI: | 10.3390/cancers15082245 |
| URL الوصول: | https://doaj.org/article/bce2c448b9504a6ba9da6abed5b43a93 |
| رقم الأكسشن: | edsdoj.bce2c448b9504a6ba9da6abed5b43a93 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 15082245 20726694 |
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| DOI: | 10.3390/cancers15082245 |