Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study.

BACKGROUND: Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM. METHODS: Eligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS). RESULTS: The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44-47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed. CONCLUSION: Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).

Trends in Percutaneous Embolization Procedures by Radiologists and Other Specialists.

PURPOSE: To evaluate utilization trends in percutaneous embolization among radiologists and nonradiologist providers. MATERIALS AND METHODS: The nationwide Medicare Part B fee-for-service databases for 2005-2016 were used to evaluate percutaneous embolization codes. Six codes describing embolization procedures were reviewed. Physician providers were grouped as radiologists, vascular surgeons, cardiologists, nephrologists, other surgeons, and all others. RESULTS: The total volume of Medicare percutaneous embolization procedures increased from 20,262 in 2005 to 45,478 in 2016 (+125%). Radiologists performed 13,872 procedures in 2005 (68% of total volume) and 33,254 in 2016 (73% of total volume), a 140% increase in volume. While other specialists also increased the number of cases performed from 2005 to 2016, radiologists strongly predominated, performing 87% of arterial and 30% of venous procedures in 2016, more than any other single specialty. In 2014 and 2015, a sharp increase in venous embolization cases performed by nonradiologists preceded a sharp decrease in 2016, likely the result of complicated billing codes for venous procedures. Radiologists maintained a steady upward trend in the number of cases they performed during those years. CONCLUSIONS: The volume of percutaneous embolization procedures performed in the Medicare population increased from 2005 to 2016, reflecting a trend toward minimally invasive intervention. In 2016, radiologists performed nearly 10 times more arterial embolization procedures than the second highest specialty and more venous embolization procedures than any other single specialty.

Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population.

OBJECTIVE. Although radiologists developed endovascular treatment of peripheral arterial disease (PAD) in the 1960s, vascular surgeons and cardiologists have become increasingly involved in its application. The purpose of this study was to examine utilization trends in endovascular and surgical treatment of PAD in recent years in the Medicare population. CONCLUSION. Surgical treatment of PAD has decreased each year from 2011 to 2016, whereas endovascular treatment has increased each year. By 2016, Medicare patients who needed revascularization for PAD were more than four times as likely to undergo endovascular as they were to undergo surgical treatment. Between 2011 and 2016, radiologists, vascular surgeons, and cardiologists all increased their endovascular volume, but by 2016, vascular surgeons and cardiologists performed three of every four endovascular procedures for the Medicare population. While only 12% of the total endovascular procedures for PAD were performed in 2016, radiology has grown its procedural volume each year from 2011 through 2016.

A Prospective Phase II Trial of Radioembolization for Treatment of Uveal Melanoma Hepatic Metastasis.

Background Overall survival (OS) for patients with uveal melanoma (UM) hepatic metastases is extremely poor. Therefore, stabilization of hepatic metastases is essential to prolonging OS. Purpose To assess the safety and effectiveness of radioembolization (RE) for treatment of UM hepatic metastases. Materials and Methods Enrollment for this prospective phase II trial began November 2011 and concluded January 2017. Treatment-naïve participants (group A) and participants who progressed after immunoembolization (group B) with hepatic tumor burden less than 50% underwent RE. Participants were followed for 1 month and every 3 months for acute and delayed toxicities, respectively. MRI, CT, and PET were performed every 3 months to evaluate for tumor response and extrahepatic disease. Participants were followed for at least 2 years or until death. Kaplan-Meier method and multivariable Cox proportional hazard models were used for data analysis. Results In group A, 24 participants (mean age ± standard deviation, 59 years ± 13; 13 men and 11 women) underwent unilobar (n = 7), fractionated whole-liver (n = 1), or sequential lobar (n = 16) RE. One participant was excluded from the trial. Complete response (n = 0), partial response (n = 9), or stable disease (n = 11) was achieved in 20 of 23 (87.0%; 95% confidence interval [CI]: 66.4%, 97.2%) participants. Median progression-free survival from liver metastasis was 8.1 months (95% CI: 6.4, 11.8; range, 3.3-33.7 months). Median OS was 18.5 months (95% CI: 11.3, 23.5; range, 6.5-73.7 months). In group B, 24 participants (mean age, 58 years ± 10; nine men and 15 women) underwent unilobar (n = 5) or sequential lobar (n = 19) RE. Complete response (n = 0), partial response (n = 8), or stable disease (n = 6) was achieved in 14 of 24 (58.3%; 95% CI: 36.3%, 77.9%) participants. Median progression-free survival from liver metastasis was 5.2 months (95% CI: 3.7, 9.8; range, 2.9-22.0 months). Median OS was 19.2 months (95% CI: 11.5, 24.0; range, 4.8-76.6 months). Grade 3 treatment-related toxicities included transient lymphopenia (group A, n = 1; group B, n = 1), pain (group A, n = 2) and nausea or vomiting (group A, n = 1). Conclusion Radioembolization is a promising treatment for patients with uveal melanoma hepatic metastases. © RSNA, 2019 Online supplemental material is available for this article.

Inferior Vena Cava Filter Placement and Retrieval Rates among Radiologists and Nonradiologists.

PURPOSE: To evaluate inferior vena cava (IVC) filter placement and retrieval rates among radiologists, vascular surgeons, cardiologists, other surgeons, and all other health care providers for Medicare fee-for-service beneficiaries in the years 2012-2015. MATERIALS AND METHODS: The nationwide Medicare Physician/Supplier Procedure Summary Master Files were used to determine the volume and utilization rate of IVC filter placement, IVC filter repositioning, and IVC filter retrieval, which correspond to procedure codes 37191, 37192, and 37193, respectively. Procedural code 37193 was not available before 2012, so data were reviewed for the years 2012-2015. RESULTS: The total volume of Medicare IVC filter placement decreased from 57,785 in 2012 to 44,378 in 2015, with radiologists responsible for 60% of all filter placements. Volume of IVC filter placement declined across all specialties, including radiologists, who placed 33,744 in 2012 and 27,957 in 2015. In contrast, total retrieval of IVC filters increased from 4,060 removals in 2012 to 6,166 in 2015. Retrieval rate per 100,000 Medicare beneficiaries increased from 11 in 2012 to 16 in 2015. Radiologists removed the bulk of the filters: 64% in both 2012 and 2015. Vascular surgeons, cardiologists, and other surgeons retrieved, respectively, 20%, 10%, and 5% of all IVC filters in 2012 and 22%, 9%, and 5% in 2015. CONCLUSIONS: From 2012 to 2015, IVC filter placement steadily decreased across all specialties. Retrieval rate of IVC filters continued to rise over the same period. Radiologists were responsible for the majority of IVC filter placements and retrievals.

A Phantom Study and a Retrospective Clinical Analysis to Investigate the Impact of a New Image Processing Technology on Radiation Dose and Image Quality during Hepatic Embolization.

PURPOSE: To investigate changes in radiation dose and image quality using phantoms and hepatic embolization procedures performed with a new image processing technology (ClarityIQ) for a single-plane flat-detector-based interventional fluoroscopy system. MATERIALS AND METHODS: Phantom study was performed using acrylic sheets simulating different patient sizes. Air kerma rates (AKRs) were compared for different fluoroscopy modes and magnification modes without and with ClarityIQ. Repeat hepatic embolization procedures performed on the same lobe of the liver in the same patient by the same interventional radiologist between January 2013 and July 2014 without and with ClarityIQ were evaluated retrospectively. This included treatment of 33 hepatic lobes in 26 patients. Cumulative air kerma (CAK), kerma-area product (KAP), and factors affecting radiation dose were extracted from study metadata and compared. Blinded randomized image quality review was performed on arteriograms using a five-point scale. RESULTS: The phantom study revealed a significantly lower AKR (P < .005) with ClarityIQ. Repeated-measures analysis revealed a significant effect of ClarityIQ (P ≤ .001) on CAK and KAP, with reductions ranging between 9% and 85% (median, 67%) and between 5% and 89% (median, 75%), respectively, on a case-by-case basis. Mean reductions in CAK and KAP were 279 mGy and 134,030 mGy·cm(2), respectively. Image quality review scores were significantly lower (P ≤ .001) with ClarityIQ, effecting visualization of tumor vasculature and appearance of noise texture. CONCLUSIONS: ClarityIQ resulted in radiation dose reduction in the phantom study and in the hepatic embolization procedures, but with a decrease in subjective perceptions of image quality.

Double-blinded, randomized phase II study using embolization with or without granulocyte-macrophage colony-stimulating factor in uveal melanoma with hepatic metastases.

PURPOSE: To investigate the effects of immunoembolization with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with uveal melanoma (UM) with liver-only metastasis. MATERIALS AND METHODS: In this double-blind phase II clinical trial, patients were randomized to undergo immunoembolization or bland embolization (BE). Lobar treatment was performed with GM-CSF or normal saline solution mixed with ethiodized oil followed by embolization with gelatin sponge emulsified with iodinated contrast medium. Fifty-two patients (immunoembolization, n = 25; BE, n = 27) were enrolled. Response was assessed after every two treatments. The primary endpoint was overall response rate (ORR) of liver metastases. Progression-free survival (PFS), overall survival (OS), and immunologic responses were secondary endpoints. RESULTS: There were five partial responses in the immunoembolization group (ORR, 21.2%; 90% confidence interval [CI], 10.3%-30.5%) and three in the BE group (ORR, 16.7%; 90% CI, 6.3%-26.9%). Stable disease was seen in 12 patients in the immunoembolization group and 19 in the BE group. OS times were 21.5 months (95% CI, 18.5-24.8 mo) with immunoembolization and 17.2 months (95% CI, 11.9-22.4 mo) with BE. The degree of proinflammatory cytokine production was more robust after immunoembolization and correlated with time to "systemic" extrahepatic progression. In the immunoembolization group, interleukin (IL)-6 levels at 1 hour (P = .001) and IL-8 levels at 18 hours after the procedure (P < .001) were significant predictors of longer systemic PFS. Moreover, a dose-response pattern was evident between posttreatment serum cytokine concentrations and systemic PFS. CONCLUSIONS: Immunoembolization induced more robust inflammatory responses, which correlated with the delayed progression of extrahepatic systemic metastases.

Uveal Melanoma Metastatic to the Liver: Chemoembolization With 1,3-Bis-(2-Chloroethyl)-1-Nitrosourea.

OBJECTIVE: The purpose of this study is to evaluate whether chemoembolization with 1,3-bis-(2-chloroethyl)-1-nitrosourea (BCNU) is a safe and effective treatment for bulky uveal melanoma liver metastasis. MATERIALS AND METHODS: Over a 7-year period, 63 treatment-naïve patients presented with uveal melanoma metastasis replacing 50% or more of the normal liver parenchyma. Patients with Eastern Cooperative Oncology Group 0-2 performance status, no extensive extrahepatic metastases, and adequate liver and renal function were treated with BCNU (200 mg) chemoembolization. Pretreatment tumor burdens were classified by MRI as 50-75% and more than 75%. Lactate dehydrogenase (LDH) levels were divided into less than or equal to 500 and more than 500 IU/L (i.e., more than twice the normal level). Treatment toxicity was assessed using Common Terminology Criteria for Adverse Events (version 4.0). CT and MRI were used to determine best radiologic response (Response Evaluation Criteria in Solid Tumors). Overall survival (OS) and progression-free survival (PFS) were compared with tumor burden and LDH levels. RESULTS: Fifty patients (31 men; mean age, 59.1 years; range, 30-88 years) met the inclusion criteria. A total of 271 chemoembolization procedures were performed. Grade 3 thrombocytopenia occurred in two patients, grade 3 hyperbilirubinemia (n = 2) was attributed to disease progression, and asymptomatic grade 4 transaminitis occurred after 16 treatments. Best radiologic response was as follows: partial response, n = 3; stable disease, n = 33; and disease progression, n = 12 (no follow-up imaging, n = 2). The median OS was 7.1 months (range, 1.2-32.3 months), and the median PFS was 5.0 months (range, 1.1-32.3 months). Eleven patients (22%) survived longer than 12 months (range, 12.2-32.3) with one patient alive at follow-up. Tumor burden and LDH levels showed no statistically significant effect on OS (p = 0.20 and p = 0.14, respectively) or PFS (p = 0.10 and p = 0.34, respectively). CONCLUSION: BCNU chemoembolization should be considered as a treatment option for patients with bulky uveal melanoma hepatic metastases.

Early arterial stasis during resin-based yttrium-90 radioembolization: incidence and preliminary outcomes.

OBJECTIVES: This study was conducted to determine the incidence of early stasis in radioembolization using resin yttrium-90 (Y-90) microspheres, to evaluate potential contributing factors, and to review initial imaging outcomes. METHODS: Patients in whom early stasis occurred were compared with those in whom complete delivery was achieved for tumour type and vascularity, tumour : normal liver ratio (T : N ratio) at technetium-99m-macroaggregated albumin (Tc-99m-MAA) angiography, previous intra-arterial therapy, and infusion site (left, right or whole liver). Tumour response was evaluated at 3 months and defined according to whether a partial response and stable disease versus progressive disease were demonstrated. RESULTS: A total of 71 patients underwent 128 Y-90 infusions in which 26 (20.3%) stasis events occurred. Hypervascular and hypovascular tumours had similar rates of stasis (17.4% versus 27.8%; P = NS). The mean ± standard deviation T : N ratio was 3.03 ± 1.54 and 3.66 ± 2.79 in patients with and without stasis, respectively (P = NS). Stasis occurred in 14 of 81 (17.3%) and 12 of 47 (25.5%) infusions following previous intra-arterial therapy and in therapy-naïve territories, respectively (P = NS). Early stasis occurred in 15 of 41 (36.6%) left, 10 of 65 (15.4%) right and one of 22 (4.5%) whole liver infusions (P < 0.001). Rates of partial response and stable disease were similar in the stasis (88.3%) and non-stasis (76.0%) groups (P = NS). CONCLUSIONS: Early stasis occurred in approximately 20% of infusions with similar incidences in hyper- and hypovascular tumours. Whole-liver therapy reduced the incidence of stasis. Stasis did not appear to affect initial imaging outcomes.

Single-center comparison of three chemoembolization regimens for hepatocellular carcinoma.

PURPOSE: Transarterial chemoembolization regimens for hepatocellular carcinoma (HCC) vary, without a gold-standard method. The present study was performed to evaluate outcomes in patients with HCC treated with doxorubicin/ethiodized oil (DE), cisplatin/doxorubicin/mitomycin-c/ethiodized oil (CDM), or doxorubicin drug-eluting beads (DEBs). MATERIALS AND METHODS: Patients received the same regimen at all visits, without crossover. Groups were compared based on Child-Pugh disease status, tumor/node/metastasis stage, and Barcelona Clinic Liver Cancer stage. Imaging outcomes were assessed based on modified Response Evaluation Criteria in Solid Tumors to calculate tumor response (ie, sum of complete and partial response), progressive disease (PD), and time to progression (TTP). RESULTS: A total of 228 infusions were performed in 122 patients: 59 with DE, 30 with CDM, and 33 with DEBs. The groups had similar Child-Pugh status (P = .45), tumor/node/metastasis stages (P = .5), and Barcelona Clinic Liver Cancer scores (P = .22). Follow-up duration was similar among groups (P = .24). Patients treated with DE underwent significantly more treatments (2.3 ± 1.4) than those treated with CDM (1.6 ± 0.7; P = .004) or DEBs (1.4 ± 0.6; P<.0001). Compared with DE (51%), tumor response was significantly more common with CDM (84%; P = .003) or DEBs (82%; P = .004). PD was significantly more likely with DE (37%) than with CDM (13%; P = .02) or DEBs (9%; P = .004). TTP was similar between groups (P = .07). CDM and DEBs were similar in regard to disease progression (P = .6) and response (P = .83). CONCLUSIONS: During a similar follow-up period, patients treated with CDM or DEB chemoembolization showed a significantly higher response rate and a lower incidence of tumor progression, with fewer required treatment sessions, than those treated with DE chemoembolization.

Advances in the clinical management of uveal melanoma.

Melanomas arising in the uveal tract of the eye are a rare form of the disease with a biology and clinical phenotype distinct from their more common cutaneous counterparts. Treatment of primary uveal melanoma with radiotherapy, enucleation or other modalities achieves local control in more than 90% of patients, although 40% or more ultimately develop distant metastases, most commonly in the liver. Until January 2022, no systemic therapy had received regulatory approval for patients with metastatic uveal melanoma, and these patients have historically had a dismal prognosis owing to the limited efficacy of the available treatments. A series of seminal studies over the past two decades have identified highly prevalent early, tumour-initiating oncogenic genomic aberrations, later recurring prognostic alterations and immunological features that characterize uveal melanoma. These advances have driven the development of a number of novel emerging treatments, including tebentafusp, the first systemic therapy to achieve regulatory approval for this disease. In this Review, our multidisciplinary and international group of authors summarize the biology of uveal melanoma, management of primary disease and surveillance strategies to detect recurrent disease, and then focus on the current standard and emerging regional and systemic treatment approaches for metastatic uveal melanoma.

Radiation emission from patients treated with selective hepatic radioembolization using yttrium-90 microspheres: are contact restrictions necessary?

PURPOSE: To estimate the possible radiation dose to other individuals from patients treated with yttrium-90 ((90)Y). MATERIALS AND METHODS: Dosimetry data were analyzed after 143 consecutive administrations of (90)Y (124 resin, 19 glass) in 86 patients. External radiation exposure levels from patients were measured immediately after infusion. Total effective dose equivalent (TEDE) to maximally exposed individuals was calculated based on total body residence time and measured dose rate. These values were compared to Nuclear Regulatory Commission (NRC) regulations (maximum, 1 mSv) and other potential guidelines for caregivers, extensive caregivers, or pregnant contacts. RESULTS: Mean administered activity for resin microspheres was 0.71 GBq ± 0.35 (range, 0.07-1.6GBq). Mean TEDE dose to the maximally exposed contact was 0.03 mSv (range, 0.0005-0.16 mSv). For glass microspheres, mean administered activity was 2.8 GBq ± 1.5 (range, 0.37-5.14 GBq). Mean TEDE dose to the maximally exposed contact was 0.06 mSv (range, 0.0023-0.23 mSv). All (90)Y treatments were within current NRC regulations for release without instructions. One, three, and one infusion were beyond potential thresholds for caregivers, extensive caregivers, or pregnant contacts, respectively. For any contact scenario, release without instruction was appropriate when administered activity was less than 3 GBq. CONCLUSIONS: All patients treated with (90)Y hepatic radioembolization to a maximum administered activity of 5.14 GBq and maximum dose rate of 10 uSv/h were releasable without contact restrictions according to the NRC contact scenario. Patients who receive more than 3 GBq during infusion may require dose rate measurement if more restrictive contact scenarios are considered.

A Pilot Study of Hepatic Irradiation with Yttrium-90 Microspheres Followed by Immunotherapy with Ipilimumab and Nivolumab for Metastatic Uveal Melanoma.

Background: Liver metastases from uveal melanoma carry a very poor prognosis. Hepatic artery infusions with Yttrium-90 (90Y) resin microspheres have some activity in this disease, and radiation and immunotherapy may be synergistic. The primary objective of this study was to determine the safety and tolerability of sequential 90Y resin microspheres and immunotherapy with ipilimumab and nivolumab in metastatic uveal melanoma. Materials and Methods: Twenty-six patients with uveal melanoma with hepatic metastases were entered into a pilot study. Treatment consisted of two infusions of 90Y resin microspheres, one to each lobe of the liver, followed in 2-4 weeks by immunotherapy with ipilimumab and nivolumab every 3 weeks for four doses, then maintenance immunotherapy with nivolumab alone. Results: Initial dosing of both 90Y and immunotherapy resulted in excessive toxicity. With decreasing the dosage of 90Y to limit the normal liver dose to 35Gy and lowering the ipilimumab dose to 1 mg/kg, the toxicity was tolerable, with no apparent change in efficacy. There was one complete and four confirmed partial responses, for an objective response rate of 20% and a disease control rate of 68%. The median progression-free survival was 5.5 months (95% confidence interval [CI]: 1.3-9.7 months), with a median overall survival of 15 months (95% CI: 9.7-20.1 months). Conclusions: With dose reductions, sequential therapy with 90Y and immunotherapy with ipilimumab and nivolumab is safe and tolerable, and has activity in metastatic uveal melanoma. These results justify a controlled trial to demonstrate whether 90Y resin microspheres add to the utility of combination immunotherapy in this disease. Clinical Trial Registration number: NCT02913417.

Toxicities after radioembolization with yttrium-90 SIR-spheres: incidence and contributing risk factors at a single center.

PURPOSE: To report the incidence of liver function test (LFT) toxicities after radioembolization with yttrium-90 ((90)Y) SIR-Spheres and review potential risk factors. MATERIALS AND METHODS: Patients receiving (90)Y for radioembolization of primary or metastatic liver tumors had follow-up LFTs 29-571 days after treatment. The incidence and duration of bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) toxicities were documented using common terminology criteria. Factors that were assessed included previous intra-arterial (IA) therapy, systemic chemotherapy, low tumor-to-normal liver tissue ratio at mapping angiography, vascular stasis, and higher prescribed (90)Y doses. RESULTS: There were 81 patients who underwent 122 infusions and had follow-up LFTs. Of 122 infusions, 71 (58%) were associated with toxicity. One patient died with radiation-induced liver disease. Grade 3 or greater toxicities occurred in seven (7%) patients after nine procedures. The median durations of laboratory elevations for bilirubin, AST, and ALT were 29 days, 29 days, and 20 days. Toxicity developed after 51 (71%) of 72 infusions with previous IA therapy versus 20 (40%) of 50 infusions in treatment-naïve areas (P = .0006). Absence of previous systemic therapy was associated with greater risk of toxicity versus previous chemotherapy (47% vs 66%, P = .03). Other factors were not associated with increased toxicity. CONCLUSIONS: Mild hepatotoxicity developed frequently after infusion of SIR-Spheres using the body surface area method, with normalization of LFTs in most patients. Grade 3 or greater toxicities were seen in < 10% of infusions. Toxicity was strongly associated with previous IA therapy.

Moxifloxacin prophylaxis for chemoembolization or embolization in patients with previous biliary interventions: a pilot study.

OBJECTIVE: Abscess formation is a common serious adverse event after intraarterial therapy for hepatic malignancy in patients with colonized bile ducts. The combination of antibiotic prophylaxis and bowel preparation has been used to prevent hepatic abscess. We describe our outcomes with moxifloxacin prophylaxis alone without bowel preparation. CONCLUSION: Ten patients underwent 25 procedures and were followed for a median of 250 days. No abscesses developed. Our results suggest moxifloxacin alone may suffice for prophylaxis.

Radioembolization as salvage therapy for hepatic metastasis of uveal melanoma: a single-institution experience.

OBJECTIVE: The purpose of this study was to assess the safety and efficacy of radioembolization in the management of hepatic metastasis of uveal melanoma after failure of immunoembolization or chemoembolization. MATERIALS AND METHODS: From January 2007 through April 2009, 32 patients underwent radioembolization therapy for hepatic metastasis of uveal melanoma. Pretreatment tumor burdens were divided into three categories: less than 25% (n = 25), 25-50% (n = 5), and greater than 50% (n = 2). Toxicity, extrahepatic disease, and hepatic tumor response were assessed 1 month and then every 3 months after treatment. Best radiographic response of hepatic metastasis was determined with the Response Evaluation Criteria in Solid Tumors criteria. Overall survival and progression-free survival of hepatic metastasis were estimated by Kaplan-Meier analysis. Differences in survival between subgroups were evaluated by log-rank test in univariate analysis. RESULTS: The clinical follow-up period ranged from 1.0 to 29.0 months (median, 10.0 months). The median overall survival was 10.0 months, and the progression-free survival of hepatic metastasis, 4.7 months. Twenty-two patients died 1.0-29.0 months (median, 5.8 months) after treatment owing to progression of liver disease (n = 13), extrahepatic disease (n = 4), or both (n = 5). Patients who had a pretreatment tumor burden less than 25% had longer median overall survival (10.5 vs 3.9 months, p = 0.0003) and progression-free survival (6.4 vs 3.0 months, p = 0.03) than patients who had a pretreatment tumor burden of 25% or greater. Patients who had a complete response (n = 1), partial response (n = 1), or stable disease (n = 18) had longer median overall survival (14.7 vs 4.9 months, p = 0.0006) and progression-free survival of hepatic metastasis (7.9 vs 3.1 months, p < 0.0001) than patients with tumor progression (n = 12). Self-limiting grade 1-2 systemic toxicity included tiredness (n = 9), indigestion (n = 2), and abdominal discomfort (n = 5). Grade 3-4 hepatic toxicity was attributed to tumor progression. CONCLUSION: Radioembolization is safe and effective salvage therapy for limited metastasis of uveal melanoma.

Side-branch embolization before 90Y radioembolization: rate of recanalization and new collateral development.

OBJECTIVE: The purpose of this study was to assess the rate of recanalization and collateral vessel formation after side-branch embolization during mapping angiography for planned (90)Y radioembolization. MATERIALS AND METHODS: Patients who underwent side-branch embolization at mapping angiography before (90)Y administration were included. Embolized vessels included the gastroduodenal artery, right gastric artery, and accessory arteries. Four interventional radiologists reviewed follow-up angiograms to assess recanalization and new collateral formation of embolized vessels. The time to recanalization or new collateral formation was tracked within 60 days and after the final arteriographic study. Differences in outcome among patients who had and those who had not undergone previous arterial directed therapy were reviewed. RESULTS: Fifty-six patients underwent side-branch embolization and follow-up arteriography; 124 treatments were performed after side-branch embolization (median, 2; range, 1-7), and the median follow-up period was 134 days (range, 7-684 days). Recanalization or new collateral vessel formation was found in 6 of 56 patients (10.7%) and in 8 of 56 patients (14.3%) 60 days after treatment or at final angiography, respectively. Embolization of 110 arteries was accomplished (42 gastroduodenal arteries, 46 right gastric arteries, and 22 accessory arteries). Two of 110 arteries (1.8%) recanalized, and four of 110 (3.6%) had new collateral vessels within 60 days. At final evaluation, 2 of 110 arteries (1.8%) had recanalized and 7 of 110 (6.4%) had new collaterals. Previous liver-directed therapy did not affect outcome (p > 0.05). No patient had symptomatic gastrointestinal ulceration. CONCLUSION: In more than 89% of patients, side-branch embolization provides durable occlusion for (90)Y radioembolization without collateral development or recanalization for a bilobar cycle of therapy. Further recanalization and collateral development at longer-term follow-up are minimal.

Investigation of Radiation Dose Estimates and Image Quality Between Commercially Available Interventional Fluoroscopy Systems for Fluoroscopically Guided Interventional Procedures.

RATIONALE AND OBJECTIVES: To investigate differences in radiation dose and image quality for single-plane flat-panel-detector based interventional fluoroscopy systems from two vendors using phantom study and clinical procedures. MATERIALS AND METHODS: AlluraClarityIQ (Philips) and Artis Q (Siemens-Healthineers) interventional fluoroscopy systems were evaluated. Phantom study included comparison of system-reported air-kerma rates (AKR) for clinical protocols with simulated patient thicknesses (20-40 cm). Differences in system-reported radiation dose estimates, cumulative-air-kerma (CAK) and kerma-area-product (KAP), for different clinical procedures were investigated. Subset analysis investigated differences in CAK, KAP and other factors affecting radiation dose when the same patients underwent repeat embolization procedures performed by the same physician on the two different fluoroscopy systems. Two blinded interventional radiologists reviewed image-quality for these procedures using a five-point scale (1-5; 5-best) for five parameters. RESULTS: Phantom study revealed that air-kerma rates was significantly higher for Artis Q system for 30-40cm of simulated patient thicknesses (p < 0.05). Overall data analysis from 4381 clinical cases revealed significant differences in CAK and KAP for certain procedures (p < 0.05); with significantly lower values for AlluraClarityIQ systems (median CAK lower by: 29%-58%). Subset analysis with 40 patients undergoing repeat embolization procedures on both systems revealed that median CAK and KAP were significantly lower for AlluraClarityIQ systems (p < 0.02) by 45% and 31%, respectively. Image quality scores for AlluraClarityIQ systems were significantly greater (mean difference range for five parameters: 1.3-1.6; p < 0.005). CONCLUSION: Radiation dose and image quality differences were observed between AlluraClarityIQ and Artis Q systems. AlluraClarityIQ systems showed lower radiation utilization and an increase in subjective perception of image quality.