Optimal patient selection for yttrium-90 glass plus chemotherapy in the treatment of colorectal liver metastases: additional quality of life, efficacy, and safety analyses from the EPOCH study.

BACKGROUND: Evaluating transarterial radioembolization (TARE) in patients with metastatic colorectal carcinoma of the liver who have progressed on first-line chemotherapy (EPOCH) demonstrated superior outcomes using yttrium-90 glass microspheres plus chemotherapy (TARE/Chemo) vs chemotherapy (Chemo) to treat colorectal liver metastases. Additional exploratory analyses were undertaken to assess the impact of TARE/Chemo on efficacy, safety, time to subsequent therapy, time to deterioration in quality of life (QoL), and identify criteria for improved patient selection. METHODS: Time to deterioration in QoL was analyzed for the primary study population. Subsequently, a post hoc analysis was undertaken to identify subgroups for which time to deterioration in QoL was improved with TARE/Chemo vs Chemo. Progression-free survival (PFS), hepatic (h)PFS, time to subsequent therapy, and safety outcomes were compared between treatments. RESULTS: The primary population showed no significant difference in time to deterioration in QoL between treatment arms; however, significance was seen in 2 identified subgroups, namely: Subgroup A (N = 303) which excluded patients with both Eastern Cooperative Oncology Group (ECOG) 1 and baseline CEA ≥ 35 ng/mL from both treatment arms; subgroup B (N = 168) additionally excluded patients with KRAS (Kirsten rat sarcoma) mutation. In subgroup A, TARE/Chemo patients (N = 143) demonstrated superior outcomes vs Chemo (N = 160): PFS (9.4 vs. 7.6 months, hazard ratio (HR): 0.64; 1-sided P = .0020), hPFS (10.8 vs. 7.6 months, HR: 0.53; 1-sided P < .0001), time to deterioration in QoL (5.7 vs. 3.9 months, HR: 0.65; 1-sided P = .0063), and time to subsequent therapy (21.2 vs. 10.5 months, HR: 0.52; 1-sided P < .0001). Subgroup B patients showed similar but larger significant differences between treatment arms. Median PFS, hPFS, and time to deterioration in QoL were numerically greater for TARE/Chemo in both subgroups vs the primary population, with the greatest magnitude of difference in subgroup B. Both subgroups exhibited higher percentage of CEA responders and improved ORR with TARE/Chemo vs chemo alone. Safety (reported as event rate/100 patient-years) was higher with Chemo in all populations. Additional efficacy analyses in the primary population are also reported. CONCLUSIONS: Careful patient selection, including consideration of the prognostic factors ECOG, baseline CEA, and KRAS status, sets outcome expectations in patients with colorectal liver metastases suitable for TARE/Chemo as second-line treatment (Trial Registry Number: NCT01483027).

Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization.

Genicular artery embolization (GAE) is an emerging, minimally invasive therapy to address the global burden of knee osteoarthritis (OA) and the unmet needs for medically refractory disease. Although total knee arthroplasty has been a standard intervention for severe cases, GAE is developing into a promising alternative, particularly for patients ineligible for or unwilling to undergo surgery. GAE targets the inflammatory cascade underlying OA pathophysiology by arresting neoangiogenesis and preventing pathological neoinnervation, offering potential pain relief. Although early studies have established safety and short-term effectiveness, ensuing studies are needed to validate long-term safety, durability, and comparative effectiveness and to optimize patient selection, embolic agent selection, and administration techniques. Standardized reporting guidelines are therefore essential to enhance transparency and reproducibility across clinical trials, facilitating data aggregation and comparison. This Society of Interventional Radiology (SIR)-endorsed reporting standards consensus document provides a framework to harmonize future research efforts and to improve the interpretation of outcomes.

Added Value of Cone-Beam CT to Identify Arterial Supply during Genicular Artery Embolization for Knee Osteoarthritis.

PURPOSE: To evaluate if the addition of cone-beam computed tomography (CT) to digital subtraction angiography (DSA) improves the identification of the genicular arteries during genicular artery embolization (GAE) for knee pain secondary to osteoarthritis (OA). MATERIALS AND METHODS: This single-center study retrospectively analyzed 222 patients who underwent GAE for painful knee OA between May 2018 and April 2022. Intraprocedural cone-beam CT and DSA images were reviewed independently by 2 sets of interventional radiologists. DSA was performed for all patients. Technically adequate cone-beam CT was available for 205 patients (92.3%). The presence of the genicular arteries identified by cone-beam CT and DSA was compared using Φ coefficients. Embolization targets identified by both cone-beam CT and DSA were evaluated against those identified by DSA alone. RESULTS: Genicular arteries with the highest concordance between cone-beam CT and DSA were the inferior lateral (196 vs 198; Φ = 0.3530; P < .0001), superior lateral (197 vs 200; Φ = 0.3060; P < .0001), and superior medial genicular (186 vs 161; Φ = 0.2836; P < .0001) arteries. Cone-beam CT demonstrated higher rates of detection of the inferior medial (195 vs 178; Φ = 0.04573; P = .5150) and median genicular arteries (200 vs 192; Φ = 0.04573; P = .5150). Meanwhile, genicular arteries less frequently identified by cone-beam CT were the descending genicular (197 vs 200; Φ = -0.03186; P = .6502), superior patellar (175 vs 184; Φ = 0.1332; P = .0569), and recurrent anterior tibial (156 vs 186; Φ = 0.01809; P = .7969) arteries. Cone-beam CT in combination with DSA identified 13.4% (372 vs 328) more targets compared to DSA alone. CONCLUSIONS: Based on the results of the current study, cone-beam CT serves as a valuable adjunct for visualizing the genicular arteries during GAE, and together with DSA, it identifies more potential embolization targets.

Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography.

PURPOSE: Genicular artery embolization (GAE) is a new treatment option for symptomatic knee osteoarthritis. Genicular arterial anatomy is complex with limited published reports. This study describes the genicular artery anatomy utilizing intraprocedural cone-beam computed tomography (CBCT) during GAE. MATERIALS AND METHODS: This retrospective single-center study was approved by the institutional review board. All patients who underwent GAE between May 2018 and April 2022 were reviewed. Patients with a technically adequate CBCT were included in the analysis. CBCTs were analyzed to determine the presence, course, and branching patterns of the genicular arteries. RESULTS: A total of 222 patients underwent GAE and 205 (92%) were included for analysis. The descending genicular artery was present in 197 (96%) CBCTs with two branches in 152 (77%). The superior medial genicular artery (SMGA) was present in 186 (91%), superior lateral genicular artery (SLGA) in 203 (99%), inferior medial genicular artery (IMGA) in 195 (95%), inferior lateral genicular artery (ILGA) in 196 (95%), and median genicular artery (MGA) in 200 (97%). Four unique branching patterns were identified: common origin of SLGA and MGA (115, 56%), unique origins (45, 22%), trifurcation of SLGA, SMGA, and MGA (32, 15.5%), and common origin of SMGA and MGA (12, 6%). The recurrent ascending tibial was identified in 156 (76%) CBCTs and superior patellar artery in 175 (85%) CBCTs. CONCLUSION: Genicular artery anatomy is complex with numerous common variants. CBCT is a powerful adjunct in GAE to rapidly identify target vessels for embolization and potentially decrease the risk of nontarget embolization.

Elbow Artery Embolization for Lateral Epicondylitis.

Lateral epicondylitis, also known as tennis elbow, is characterized by a low-grade inflammatory process in the lateral aspect of the elbow. Symptoms are typically treated conservatively, and most patients show resolution or improvement of symptoms within a few months. For those with refractory symptoms, treatment options are limited with questionable benefit. Embolization of the arteries supplying the elbow decreases the neo-vascularity seen in epicondylitis. The procedure may result in marked improvement in pain and function, which has shown to be durable.

Clinical, dosimetric, and reporting considerations for Y-90 glass microspheres in hepatocellular carcinoma: updated 2022 recommendations from an international multidisciplinary working group.

PURPOSE: In light of recently published clinical reports and trials, the TheraSphere Global Dosimetry Steering Committee (DSC) reconvened to review new data and to update previously published clinical and dosimetric recommendations for the treatment of hepatocellular carcinoma (HCC). METHODS: The TheraSphere Global DSC is comprised of health care providers across multiple disciplines involved in the treatment of HCC with yttrium-90 (Y-90) glass microsphere-based transarterial radioembolization (TARE). Literature published between January 2019 and September 2021 was reviewed, discussed, and adjudicated by the Delphi method. Recommendations included in this updated document incorporate both the results of the literature review and the expert opinion and experience of members of the committee. RESULTS: Committee discussion and consensus led to the expansion of recommendations to apply to five common clinical scenarios in patients with HCC to support more individualized efficacious treatment with Y-90 glass microspheres. Existing clinical scenarios were updated to reflect recent developments in dosimetry approaches and broader treatment paradigms evolving for patients presenting with HCC. CONCLUSION: Updated consensus recommendations are provided to guide clinical and dosimetric approaches for the use of Y-90 glass microsphere TARE in HCC, accounting for disease presentation, tumor biology, and treatment intent.

Balloon-occluded middle adrenal artery embolization and percutaneous microwave ablation of a metastatic adrenal tumor from renal cell carcinoma.

Renal cell carcinomas present with locally advanced or metastatic disease in 25% of patients. Thermal ablation may be considered in selected patients with single-site or oligometastatic disease in selected patients. We describe single-session transarterial particle embolization with the assistance of a balloon-occlusion catheter and microwave ablation of a large hypervascular adrenal metastasis using cone beam CT and fluoroscopic XperGuide needle guidance.

Promoting Surgical Resection through Future Liver Remnant Hypertrophy.

An inadequate future liver remnant (FLR) can preclude curative-intent surgical resection for patients with primary or secondary hepatic malignancies. For patients with normal baseline liver function and without risk factors, an FLR of 20% is needed to maintain postsurgical hepatic function. However, the FLR requirement is higher for patients who are exposed to systemic chemotherapy (FLR, >30%) or have cirrhosis (FLR, >40%). Interventional radiologic and surgical methods to achieve FLR hypertrophy are evolving, including portal vein ligation, portal vein embolization, radiation lobectomy, hepatic venous deprivation, and associating liver partition and portal vein ligation for staged hepatectomy. Each technique offers particular advantages and disadvantages. Knowledge of these procedures can help clinicians to choose the suitable technique for each patient. The authors review the techniques used to develop FLR hypertrophy, focusing on technical considerations, outcomes, and the advantages and disadvantages of each approach. Online supplemental material is available for this article. ©RSNA, 2022.

Role of Radioembolization in Metastatic Neuroendocrine Tumors.

The liver is the most common site of metastasis for neuroendocrine tumors originating from the gastrointestinal tract. Neuroendocrine liver metastases (NELMs) portend a worsening clinical course, making local management important. Local treatment options include surgery, thermal ablation, and trans-catheter intra-arterial therapies, such as radioembolization. Radioembolization is generally preferred over other embolotherapies in patients with colonized biliary systems. Current best practice involves personalized treatment planning, optimizing tumor radiation absorbed dose and minimizing radiation to the normal hepatic parenchyma. As part of a multidisciplinary approach, radioembolization is a versatile embolotherapy offering neoadjuvant, palliative, and ablative treatment options for patients with NELMs.

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis.

Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA. METHODS: A prospective, single-center, open-label U.S. Food and Drug Administration-approved investigational device exemption study was conducted. Patients enrolled in the study were 40 to 80 years old, with moderate or severe knee OA (Kellgren-Lawrence grade 2, 3, or 4), who previously had failure of conservative therapy. Baseline pain (visual analog scale [VAS]) and symptom scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) were assessed. After femoral arterial access was achieved, GAE of 1, 2, or 3 genicular arteries supplying the location of the subject's pain, as determined by digital subtraction angiography and cone-beam computed tomography, was performed using 100-µm particles. Adverse events and symptoms scores were assessed at 1 week, 1 month, 3 months, 6 months, and 1 year after GAE. RESULTS: Over a 10-month period, 40 subjects were enrolled. The median age was 69 years (range, 49 to 80 years). The median body mass index was 29 kg/m2 (range, 19 to 44 kg/m2). Knee OA severity was grade 2 in 18% of the patients, grade 3 in 43%, and grade 4 in 40%. Technical success was achieved in 100% of the subjects. Transient skin discoloration and transient mild knee pain after the procedure were common and expected. Treatment-related adverse events included a groin hematoma requiring overnight observation in 1 subject, self-resolving focal skin ulceration in 7 subjects, and an asymptomatic small bone infarct on magnetic resonance imaging at 3 months in 2 subjects. The WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively. Twenty-seven patients (68%) had a reduction of ≥50% in both WOMAC total and VAS pain scores. CONCLUSIONS: This prospective trial demonstrates that GAE is effective and durable in reducing pain symptoms from moderate or severe knee OA that is refractory to other conservative therapy, with an acceptable safety profile. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial.

PURPOSE: To study the impact of transarterial Yttrium-90 radioembolization (TARE) in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM). METHODS: In this international, multicenter, open-label phase III trial, patients with CLM who progressed on oxaliplatin- or irinotecan-based first-line therapy were randomly assigned 1:1 to receive second-line chemotherapy with or without TARE. The two primary end points were progression-free survival (PFS) and hepatic PFS (hPFS), assessed by blinded independent central review. Random assignment was performed using a web- or voice-based system stratified by unilobar or bilobar disease, oxaliplatin- or irinotecan-based first-line chemotherapy, and KRAS mutation status. RESULTS: Four hundred twenty-eight patients from 95 centers in North America, Europe, and Asia were randomly assigned to chemotherapy with or without TARE; this represents the intention-to-treat population and included 215 patients in the TARE plus chemotherapy group and 213 patients in the chemotherapy alone group. The hazard ratio (HR) for PFS was 0.69 (95% CI, 0.54 to 0.88; 1-sided P = .0013), with a median PFS of 8.0 (95% CI, 7.2 to 9.2) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. The HR for hPFS was 0.59 (95% CI, 0.46 to 0.77; 1-sided P < .0001), with a median hPFS of 9.1 (95% CI, 7.8 to 9.7) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. Objective response rates were 34.0% (95% CI, 28.0 to 40.5) and 21.1% (95% CI, 16.2 to 27.1; 1-sided P = .0019) for the TARE and chemotherapy groups, respectively. Median overall survival was 14.0 (95% CI, 11.8 to 15.5) and 14.4 months (95% CI, 12.8 to 16.4; 1-sided P = .7229) with a HR of 1.07 (95% CI, 0.86 to 1.32) for TARE and chemotherapy groups, respectively. Grade 3 adverse events were reported more frequently with TARE (68.4% v 49.3%). Both groups received full chemotherapy dose intensity. CONCLUSION: The addition of TARE to systemic therapy for second-line CLM led to longer PFS and hPFS. Further subset analyses are needed to better define the ideal patient population that would benefit from TARE.

Society of Interventional Radiology Multidisciplinary Position Statement on Percutaneous Ablation of Non-small Cell Lung Cancer and Metastatic Disease to the Lungs: Endorsed by the Canadian Association for Interventional Radiology, the Cardiovascular and Interventional Radiological Society of Europe, and the Society of Interventional Oncology.

PURPOSE: To state the Society of Interventional Radiology's position on the use of image-guided thermal ablation for the treatment of early stage non-small cell lung cancer, recurrent lung cancer, and metastatic disease to the lung. MATERIALS AND METHODS: A multidisciplinary writing group, with expertise in treating lung cancer, conducted a comprehensive literature search to identify studies on the topic of interest. Recommendations were drafted and graded according to the updated SIR evidence grading system. A modified Delphi technique was used to achieve consensus agreement on the recommendation statements. RESULTS: A total of 63 studies, including existing systematic reviews and meta-analysis, retrospective cohort studies, and single-arm trials were identified. The expert writing group developed and agreed on 7 recommendations on the use of image-guided thermal ablation in the lung. CONCLUSION: SIR considers image-guided thermal ablation to be an acceptable treatment option for patients with inoperable Stage I NSCLC, those with recurrent NSCLC, as well as patients with metastatic lung disease.

Survival Advantage of Yttrium-90 Radioembolization to Systemic Therapy in Patients with Hepatic Metastases from Colorectal Cancer in the Salvage Setting: Results of a Matched Pair Study.

RATIONALE AND OBJECTIVES: Patients with hepatic metastases from colorectal cancer have a poor prognosis in the salvage setting. This study assessed the survival benefit of adding transarterial 90Y radioembolization in the salvage setting to systemic therapy. MATERIALS AND METHODS: In this retrospective, matched-pair study, 21 patients who underwent radioembolization plus systemic therapy were matched with a cohort of 173 patients who received systemic chemotherapy alone in the salvage setting, defined as progression on at least two different regimens of systemic chemotherapy. Patients were matched one-to-one on Eastern Cooperative Oncology Group Performance Status, presence of extrahepatic disease, and presence of tumor KRAS mutation. Radioembolization patients underwent treatment using standard dosimetry to either a hepatic lobe or the whole liver. Survival data was analyzed using Kaplan-Meier analysis. RESULTS: Patients who underwent radioembolization plus systemic therapy vs. those who had systemic therapy alone had similar demographics and exposure to prior systemic chemotherapies. Median survival from the date of primary diagnosis was 38 (95% CI 26 to 50) v 25 (95% CI 15 to 35) months in radioembolization with systemic therapy vs. systemic therapy alone (p = 0.17). Median survival from the date of hepatic metastases was 31 (95% CI 23.8 to 38.2) v 20 months (95% CI 10.2 to 29.8) in radioembolization with systemic therapy vs. systemic therapy alone (p = 0.03). CONCLUSION: The addition of radioembolization to systemic therapy in patients with metastatic colorectal cancer to the liver may improve survival in the salvage setting.

Accuracy and Safety of 1,055 Transjugular Liver Biopsies in Postliver Transplant Patients.

INTRODUCTION: The purpose of this study was to investigate the rates of complications and diagnostic yield of transjugular liver biopsy (TJLB) in deceased donor liver transplant (DDLT) recipients. METHODS: From January 2009 to December 2019, 1,055 TJLBs were performed in 603 adult DDLT recipients with a mean age of 54 (±12 years). Data were retrospectively reviewed to determine the diagnostic efficacy and incidence of major and minor complications in the 3-day and 1-month period after TJLB. In addition, data were stratified according to platelet count and international normalized ratio to determine the safety of TJLB in patients with varying degrees of coagulopathy. RESULTS: TJLB yielded diagnostic rate of 98.1% (1,035/1,055), with an overall complication rate of 8.3% (88/1,055). Major complications accounted for 0.85% (9/1,055), and minor complications occurred in 7.48% (79/1,055). When patients were stratified by platelet count (0-50, 51-100, 101-200, 201-300, and >300 × 103 platelets/µL), no significant difference was noted in complication rates (9.5%, 8.6%, 7.6%, 8.5%, and 10.7%, respectively). When grouped by international normalized ratio (0-1, 1.1-2.0, 2.1-3.0, and >3.0), there was no statistical difference in complication rates (8.3%, 8.5%, 7.7%, and 0%, respectively). DISCUSSION: TJLB is a safe, adequate, and effective method to investigate hepatic disorders in DDLT recipients with severe coagulopathy.

Society of Interventional Radiology Quality Improvement Standards on Percutaneous Ablation of Non-Small Cell Lung Cancer and Metastatic Disease to the Lungs.

PURPOSE: To provide guidance on quality improvement thresholds for outcomes and complications of image-guided thermal ablation for the treatment of early stage non-small cell lung cancer, recurrent lung cancer, and metastatic disease. MATERIALS AND METHODS: A multidisciplinary writing group conducted a comprehensive literature search to identify studies on the topic of interest. Data were extracted from relevant studies and thresholds were derived from a calculation of 2 standard deviations from the weighted mean of each outcome. A modified Delphi technique was used to achieve consensus agreement on the thresholds. RESULTS: Data from 29 studies, including systematic reviews and meta-analyses, retrospective cohort studies, and single-arm trials were extracted for calculation of the thresholds. The expert writing group agreed on thresholds for local control, overall survival and adverse events associated with image-guided thermal ablation. CONCLUSION: SIR recommends utilizing the indicator thresholds to review and assess the efficacy of ongoing quality improvement programs. When performance falls above or below specific thresholds, consideration of a review of policies and procedures to assess for potential causes, and to implement changes in practices, may be warranted.

ACR-ABS-ACNM-ASTRO-SIR-SNMMI practice parameter for selective internal radiation therapy or radioembolization for treatment of liver malignancies.

PURPOSE: The American College of Radiology (ACR), American Brachytherapy Society (ABS), American College of Nuclear Medicine (ACNM), American Society for Radiation Oncology (ASTRO), Society of Interventional Radiology (SIR), and Society of Nuclear Medicine and Molecular Imaging (SNMMI) have jointly developed a practice parameter on selective internal radiation therapy (SIRT) or radioembolization for treatment of liver malignancies. Radioembolization is the embolization of the hepatic arterial supply of hepatic primary tumors or metastases with a microsphere yttrium-90 brachytherapy device. MATERIALS AND METHODS: The ACR -ABS -ACNM -ASTRO -SIR -SNMMI practice parameter for SIRT or radioembolization for treatment of liver malignancies was revised in accordance with the process described on the ACR website (https://www.acr.org/ClinicalResources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters-Interventional and Cardiovascular Radiology of the ACR Commission on Interventional and Cardiovascular, Committee on Practice Parameters and Technical Standards-Nuclear Medicine and Molecular Imaging of the ACR Commission on Nuclear Medicine and Molecular Imaging and the Committee on Practice Parameters-Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with ABS, ACNM, ASTRO, SIR, and SNMMI. RESULTS: This practice parameter is developed to serve as a tool in the appropriate application of radioembolization in the care of patients with conditions where indicated. It addresses clinical implementation of radioembolization including personnel qualifications, quality assurance standards, indications, and suggested documentation. CONCLUSIONS: This practice parameter is a tool to guide clinical use of radioembolization. It focuses on the best practices and principles to consider when using radioemboliozation effectively. The clinical benefit and medical necessity of the treatment should be tailored to each individual patient.