更新于：2024-11-01
Y-90 Resin Microspheres
更新于：2024-11-01
概要
基本信息
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
1
项与 Y-90 Resin Microspheres 相关的临床试验A Multinational, Double-blind, Placebo-Controlled, Parallel Randomized Arms, Phase II Trial to Compare Safety and Efficacy of Selective Internal Radiation Therapy (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab) Versus Selective Internal Radiation Therapy (SIRT-Y90) Followed by Placebo in Patients With Locally Advanced Hepatocellular Carcinoma (HCC)
100 项与 Y-90 Resin Microspheres 相关的临床结果
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100 项与 Y-90 Resin Microspheres 相关的转化医学
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100 项与 Y-90 Resin Microspheres 相关的专利（医药）
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556
项与 Y-90 Resin Microspheres 相关的文献（医药）2024-10-01EUROPEAN JOURNAL OF PEDIATRICS
Voxel-based tumor dose correlates to complete pathologic necrosis after transarterial radioembolization for hepatocellular carcinoma
Article
作者: Berman, Zachary T ; Minocha, Jeet ; Redmond, Jonas W ; Fowler, Kathryn J ; Barahman, Mark ; Rose, Steven C ; Schnickel, Gabriel T ; Pianka, Kurt T
PURPOSE:
The transarterial radioembolization (TARE) dose is traditionally calculated using the single-compartment Medical Internal Radiation Dose (MIRD) formula. This study utilized voxel-based dosimetry to correlate tumor dose with explant pathology in order to identify dose thresholds that predicted response.
METHODS:
All patients with HCC treated with TARE using yttrium-90 [90Y] glass microspheres at a single institution between January 2015 - June 2023 who underwent liver transplantation were eligible. The [90Y] distribution and dose-volume histograms were determined using Simplicity90 (Mirada Medical, Oxford UK) with a Bremsstrahlung SPECT/CT. A complete response was assigned if explant pathology showed complete necrosis and the patient had not undergone additional treatments to the same tumor after TARE. Logistic regression and receiver operator characteristic (ROC) curves were constructed to evaluate dose thresholds correlated with response.
RESULTS:
Forty-one patients were included. Twenty-six (63%) met criteria for complete response. Dose to 95% (D95), 70% (D70), and 50% (D50) of the tumor volume were associated with likelihood of complete response by logistic regression (all p < 0.05). For lesions with complete response versus without, the median D95 was 813 versus 232 Gy, D70 was 1052 versus 315 Gy, and D50 was 1181 versus 369 Gy (all p < 0.01). A D95 > 719 Gy had the highest accuracy at 68% (58% sensitivity, 87% specificity) for predicting complete response. Median percent of tumor volume receiving at least 100 Gy (V100), 200 Gy (V200), 300 Gy (V300), and 400 Gy (V400) also differed by pathologic response: the median V100, V200, V300, and V400 was 100% versus 99%, 100% versus 97%, 100% versus 74%, and 100% versus 43% in the complete response versus non-complete response groups, respectively (all p < 0.05).
CONCLUSION:
Voxel-based dosimetry was well-correlated with explant pathology. The D95 threshold had the highest accuracy, suggesting the D95 may be a relevant target for multi-compartment dosimetry.
2024-10-01CHEST
A 78-Year-Old Man With Shortness of Breath After Radioembolization of the Liver
Article
作者: Alwakeel, Amr ; Jamjoom, Mohammed ; Sagar, Ala-Eddin S ; Sagar, Ala-Eddin S.
CASE PRESENTATION:
A 78-year-old man with a history of GI stromal tumor (GIST) in the stomach with metastasis to the liver presented with progressive shortness of breath, dry cough, and subjective fever that started 1 week after radioembolization of liver metastatic lesions. His initial diagnosis of GIST was 10 years before, for which he underwent surgical resection; however, more recently he was noted to have hepatic lesions biopsy-proven to be metastatic GIST lesions. He stated that he did not have any respiratory symptoms before the radioembolization procedure and denied having a history of pulmonary disease. His medical history was otherwise notable for coronary artery disease post coronary artery bypass graft in 2002, heart failure with reduced ejection fraction, and atrioventricular block after pacemaker placement. After the diagnosis of liver metastasis, he began treatment with imatinib 6 months earlier and consequently received radioembolization with yttrium-90 (Y-90) microspheres.
2024-09-01JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY
Multidisciplinary Delphi Consensus on Safety of Combining Transarterial Radioembolization with Yttrium-90 Microspheres with Systemic Anticancer Agents for the Treatment of Liver Malignancy
Review
作者: Fakih, Marwan ; Van Cutsem, Eric ; Sharma, Navesh K ; Liu, David ; Wasan, Harpreet S ; Sangro, Bruno ; Kennedy, Andrew S ; Brown, Daniel B ; Sze, Daniel Y ; Jeyarajah, Rohan ; Jones, Suzanne ; Pinato, David J
PURPOSE:
To provide guidance, via multidisciplinary consensus statements, on the safety interactions between systemic anticancer agents (such as radiosensitizing chemotherapy, immunotherapy, targeted therapy, and peptide receptor radionuclide therapy) and transarterial radioembolization (TARE) with yttrium-90 (90Y)-labeled microspheres in the treatment of primary and metastatic liver malignancies.
MATERIALS AND METHODS:
A literature search identified 59 references that informed 26 statements on the safety of 90Y TARE combined with systemic therapies. Modified Delphi method was used to develop consensus on statements through online anonymous surveys of the 12 panel members representing the fields of interventional radiology, medical oncology, surgical oncology, hepatology, and pharmacy, focusing on hepatocellular carcinoma (HCC), metastatic colorectal cancer (mCRC), neuroendocrine tumors, metastatic breast cancer, and intrahepatic cholangiocarcinoma.
RESULTS:
High-level evidence was limited. Level 1 data in patients with mCRC suggest that some radiosensitizing chemotherapies (eg, oxaliplatin) require temporary dose reduction when used concomitantly with 90Y TARE, and some targeted therapies (eg, vascular endothelial growth factor inhibitors and antiangiogenic tyrosine kinase inhibitors) should be avoided for at least 4 weeks before 90Y TARE. In patients with HCC, the feasibility of 90Y TARE and immunotherapy has been demonstrated with Level 4 evidence. Data are more limited for other primary and secondary liver malignancies, and consensus statements were driven by expert opinion (Level 5).
CONCLUSIONS:
Given the absence of evidence-based guidelines on the safety of 90Y TARE in combination with systemic anticancer therapy, these consensus statements provide expert guidance on the potential risks when considering specific combinations.
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项与 Y-90 Resin Microspheres 相关的新闻（医药）
100 项与 Y-90 Resin Microspheres 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期肝细胞癌 | 临床2期 | 新加坡 | 2022-10-26 | |
| 局部晚期肝细胞癌 | 临床2期 | 韩国 | 2022-10-26 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 肝细胞癌 新辅助 | 162 | 廠積淵憲顧憲積窪築網(廠蓋獵獵蓋鏇糧艱簾鬱) = 醖齋醖鬱齋鏇鑰餘構積 鑰艱廠簾齋鹽網製壓範 (範夢憲鏇鹽簾齋淵醖積, 64.9% ~ 78.5%) 更多 | 积极 | 2021-01-22 | ||
N/A | 晚期肝细胞癌 新辅助 | 162 | 蓋壓獵鑰遞範艱齋窪鹽(膚鑰網顧餘選蓋壓憲齋) = 鹽鏇襯淵選蓋窪淵鹽壓 醖製鹹淵醖齋遞醖鹽淵 (鬱鬱壓襯選艱廠構積鹽, 64.9% ~ 78.5%) 更多 | 积极 | 2020-09-17 | ||
临床2期 | - | Personalized dosimetry arm | 願餘遞鏇膚積餘窪願鏇(範鹹膚鹹顧夢積顧廠襯) = 淵淵膚選願淵壓顧壓鬱 廠構鬱顧鑰襯糧願獵壓 (鑰衊積鬱蓋醖淵淵憲憲 ) 更多 | 积极 | 2020-02-04 | ||
Standard dosimetry arm | 願餘遞鏇膚積餘窪願鏇(範鹹膚鹹顧夢積顧廠襯) = 廠鑰憲鹽選獵艱積鑰簾 廠構鬱顧鑰襯糧願獵壓 (鑰衊積鬱蓋醖淵淵憲憲 ) 更多 | ||||||
N/A | 1,243 | Selective Internal Radiation Therapy (SIRT) | (願鏇鹹餘觸鑰顧獵憲網) = Treatment-related AEs grades ≥3 were reported in 109/356 (30.6%) patients who received SIRT and 197/378 (52.1%) patients in the sorafenib arm (SIRveNIB and SARAH only, p = 0.0002) 構網願窪齋獵選鏇願網 (鑰膚憲遞網襯構夢範觸 ) 更多 | 积极 | 2019-05-26 | ||
N/A | 229 | 艱構積衊廠廠繭簾夢繭(簾鏇繭簾醖鏇窪鏇鏇簾) = 簾鹽齋簾齋淵糧蓋夢鏇 醖鏇鹽壓淵觸鹹膚蓋築 (網餘鬱網醖膚蓋簾窪構, 13.1 ~ â) | 积极 | 2019-04-12 | |||
N/A | 24 | 願夢繭蓋廠獵願鹽選網(鑰獵選構積願膚鹽鏇構) = Most AEs were grade 1 or 2. Three patients had grade 3 AEs (abdominal distension or pain, fatigue, ascites, odynophagia, oral sores, biliary duct dilation), and 4 had grade 3 laboratory values (white blood cells, bilirubin, alkaline phosphatase, albumin). Two patients experienced grade 4 AEs, 1 with peripheral neuropathy and 1 with elevated ALT & AST suggesting post-radioembolization hepatitis. 襯蓋選築觸齋觸選衊艱 (蓋鏇夢齋膚壓觸選鏇獵 ) | - | 2017-05-30 | |||
N/A | 结直肠癌肝转移 巩固 | 68 | SIRT after 1 line of chemotherapy | 簾壓蓋鹹範壓選繭壓膚(艱製製鏇憲衊艱積鑰鹹) = 餘積窪膚繭簾顧獵築繭 膚製夢繭憲獵繭遞獵鹽 (觸衊簾衊簾獵齋鏇醖艱 ) | 积极 | 2016-05-20 | |
SIRT after more than 2 lines of chemotherapy | 簾壓蓋鹹範壓選繭壓膚(艱製製鏇憲衊艱積鑰鹹) = 鑰齋夢顧蓋齋廠鏇膚鑰 膚製夢繭憲獵繭遞獵鹽 (觸衊簾衊簾獵齋鏇醖艱 ) | ||||||
N/A | 结直肠癌肝转移 巩固 | 64 | SIRT as consolidation treatment after 1st line CT | 壓廠鹹願獵艱衊網繭鹹(糧構築顧築廠齋壓襯顧) = 繭醖衊積鹹繭構憲鹽廠 壓壓襯襯鑰艱艱齋壓鬱 (積淵衊鏇構製膚鬱製襯, 3.1 ~ 7.2) 更多 | - | 2015-05-20 | |
SIRT as consolidation treatment after 2nd to 4th line CT | 壓廠鹹願獵艱衊網繭鹹(糧構築顧築廠齋壓襯顧) = 醖艱艱廠願鏇醖鹹蓋網 壓壓襯襯鑰艱艱齋壓鬱 (積淵衊鏇構製膚鬱製襯, 3.1 ~ 7.2) 更多 | ||||||
N/A | 114 | (Patients with albumin < 3) | 鹽淵網鹹顧網鏇憲憲襯(觸簾憲鑰醖夢衊餘願淵) = 襯艱壓範壓鹽鹽簾糧糧 網獵願顧淵膚製簾獵構 (遞襯窪膚蓋遞製繭醖觸 ) | - | 2015-01-20 | ||
N/A | 103 | (Yttrium-90 microspheres) | 獵鹽襯醖蓋網築鏇選膚(窪構遞窪範網糧築膚糧) = 構壓夢獵鑰遞艱積膚艱 簾鹹遞選壓網艱膚淵鏇 (艱顧蓋衊範鬱範願衊齋 ) 更多 | - | 2013-05-20 |
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