Safety and efficacy of radioembolization with glass microspheres in hepatocellular carcinoma patients with elevated lung shunt fraction: analysis of a 103-patient cohort.

BACKGROUND: Technetium-99m macroaggregated albumin is used to estimate lung shunt fraction (LSF) prior to yttrium-90 (Y90). Studies have debated the safety and efficacy of Y90 in patients with LSF > 15%. We aimed to assess the role of Y90 in hepatocellular carcinoma (HCC) with LSF > 15%. METHODS: With IRB approval, we searched our prospectively acquired database of HCC patients with Y90 treated with LSF > 15%. Median LSF and liver and lung doses were calculated. The response was assessed using RECIST. Overall survival (OS) was calculated from date of first Y90. RESULTS: A total of 103 HCC patients underwent Y90. The median baseline LSF was 24.4% (IQR 18.1-28.8). Patients exhibited multifocal disease (59/103, 60%) and median tumor size of 7.85 cm (IQR 5.2, 10.57). BCLC class was A, B, C, and D in 7 (7%), 5 (5%), 85 (83%), and 6 (6%) patients, respectively. The median liver dose was 84.6 Gy (IQR 57.4, 107.55). The median lung dose per session and cumulatively was 22.9 Gy (IQR 15-28) and 29.5 Gy (IQR 20.5-44.3). Thirty-three patients (32%) demonstrated partial response, 57 stable disease, and 13 (13%) had progressive disease. The median OS was 7.3 months (95% CI 5.3, 11.47). Twenty patients (19%) had non-specific pulmonary symptoms (cough, shortness of breath, wheezing) in the 1-year post-Y90. The median time to the appearance of non-specific pulmonary symptoms was 63 days (range 7-224). Thoracic imaging demonstrated no pulmonary fibrosis/injury following treatment in any patient. CONCLUSION: Y90 can be performed in patients with LSF > 15%. The RECIST response was identified in 32% of the patients. In isolation, LSF > 15% should not deter from treatment with Y90.

Radioembolization for hepatocellular carcinoma: Statistical confirmation of improved survival in responders by landmark analyses.

Does imaging response predict survival in hepatocellular carcinoma (HCC)? We studied the ability of posttherapeutic imaging response to predict overall survival. Over 14 years, 948 patients with HCC were treated with radioembolization. Patients with baseline metastases, vascular invasion, multifocal disease, Child-Pugh > B7, and transplanted/resected were excluded. This created our homogeneous study cohort of 134 patients with Child-Pugh ≤ B7 and solitary HCC. Response (using European Association for Study of the Liver [EASL] and Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1] criteria) was associated with survival using Landmark and risk-of-death methodologies after reviewing 960 scans. In a subanalysis, survival times of responders were compared to those of patients with stable disease (SD) and progressive disease (PD). Uni/multivariate survival analyses were performed at each Landmark. At the 3-month Landmark, responders survived longer than nonresponders by EASL (hazard ratio [HR], 0.46; confidence interval [CI], 0.26-0.82; P = 0.002) but not RECIST 1.1 criteria (HR, 0.70; CI, 0.37-1.32; P = 0.32). At the 6-month Landmark, responders survived longer than nonresponders by EASL (HR, 0.32; CI, 0.15-0.77; P < 0.001) and RECIST 1.1 criteria (HR, 0.50; CI, 0.29-0.87; P = 0.021). At the 12-month Landmark, responders survived longer than nonresponders by EASL (HR, 0.34; CI, 0.15-0.77; P < 0.001) and RECIST 1.1 criteria (HR, 0.52; CI 0.27-0.98; P = 0.049). At 6 months, risk of death was lower for responders by EASL (P < 0.001) and RECIST 1.1 (P = 0.0445). In subanalyses, responders lived longer than patients with SD or PD. EASL response was a significant predictor of survival at 3-, 6-, and 12-month Landmarks on uni/multivariate analyses. CONCLUSION: Response to radioembolization in patients with solitary HCC can prognosticate improved survival. EASL necrosis criteria outperformed RECIST 1.1 size criteria in predicting survival. The therapeutic objective of radioembolization should be radiologic response and not solely to prevent progression. (Hepatology 2018;67:873-883).

Radiation Segmentectomy: Potential Curative Therapy for Early Hepatocellular Carcinoma.

Purpose To report long-term outcomes of radiation segmentectomy (RS) for early hepatocellular carcinoma (HCC). The authors hypothesized that outcomes are comparable to curative treatments for patients with solitary HCC less than or equal to 5 cm and preserved liver function. Materials and Methods This retrospective study included 70 patients (median age, 71 years; range, 22-96 years) with solitary HCC less than or equal to 5 cm not amenable to percutaneous ablation who underwent RS (dose of >190 Gy) between 2003 and 2016. Patients who underwent subsequent curative liver transplantation were excluded to eliminate this confounding variable affecting survival. Radiologic response of time to progression and median overall survival were estimated by using the Kaplan-Meier method per the guidelines of the European Association for the Study of the Liver (EASL) and the World Health Organization (WHO). Results Seventy patients were treated with RS over 14 years. Sixty-three patients (90%) showed response by using EASL criteria, of which 41 (59%) showed complete response. Fifty patients (71%) achieved response by using WHO criteria, of which 11 (16%) achieved complete response. Response rates at 6 months were 86% and 49% by using EASL and WHO criteria, respectively. Median time to progression was 2.4 years (95% confidence interval: 2.1, 5.7), with 72% of patients having no target lesion progression at 5 years. Median overall survival was 6.7 years (95% confidence interval: 3.1, 6.7); survival probability at 1, 3, and 5 years was 98%, 66%, and 57%, respectively. Overall survival probability at 1, 3, and 5 years was 100%, 82%, and 75%, respectively, in patients with baseline tumor size less than or equal to 3 cm (n = 45) and was significantly longer than in patients with tumors greater than 3 cm (P = .026). Conclusion RS provides response rates, tumor control, and survival outcomes comparable to curative-intent treatments for selected patients with early-stage HCC who have preserved liver function. © RSNA, 2018 Online supplemental material is available for this article.

Clinical outcomes of Y90 radioembolization for recurrent hepatocellular carcinoma following curative resection.

PURPOSE: To assess safety/efficacy of yttrium-90 radioembolization (Y90) in patients with recurrent hepatocellular carcinoma (HCC) following curative surgical resection. METHODS: With IRB approval, we searched our prospectively acquired database for patients that were treated with Y90 for recurrent disease following resection. Baseline characteristics and bilirubin toxicities following Y90 were evaluated. Intention-to-treat overall survival (OS) and time-to-progression (TTP) from Y90 were assessed. RESULTS: Forty-one patients met study inclusion criteria. Twenty-six (63%) patients had undergone minor (≤3 hepatic segments) resection while 15 (37%) patients underwent major (>3 hepatic segments) resections. Two patients (5%) had biliary-enteric anastomoses created during surgical resection. The median time from HCC resection to the first radioembolization was 17 months (95% CI: 13-37). The median number of Y90 treatment sessions was 1 (range: 1-5). Ten patients received (entire remnant) lobar Y90 treatment while 31 patients received selective (≤2 hepatic segments) treatment. Grades 1/2/3/4 bilirubin toxicity were seen in nine (22%), four (10%), four (10%), and zero (0%) patients following Y90. No differences in bilirubin toxicities were identified when comparing lobar with selective approaches (P = 0.20). No post-Y90 infectious complications were identified. Median TTP and OS were 11.3 (CI: 6.5-15.5) and 22.1 months (CI: 10.3-31.3), respectively. CONCLUSIONS: Radioembolization is a safe and effective method for treating recurrent HCC following surgical resection, with prolonged TTP and promising survival outcomes.

Multiple comorbidities of 21 psychological disorders and relationships with psychosocial variables: a study of the online assessment and diagnostic system within a web-based population.

BACKGROUND: While research in the area of e-mental health has received considerable attention over the last decade, there are still many areas that have not been addressed. One such area is the comorbidity of psychological disorders in a Web-based sample using online assessment and diagnostic tools, and the relationships between comorbidities and psychosocial variables. OBJECTIVE: We aimed to identify comorbidities of psychological disorders of an online sample using an online diagnostic tool. Based on diagnoses made by an automated online assessment and diagnostic system administered to a large group of online participants, multiple comorbidities (co-occurrences) of 21 psychological disorders for males and females were identified. We examined the relationships between dyadic comorbidities of anxiety and depressive disorders and the psychosocial variables sex, age, suicidal ideation, social support, and quality of life. METHODS: An online complex algorithm based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision, was used to assign primary and secondary diagnoses of 21 psychological disorders to 12,665 online participants. The frequency of co-occurrences of psychological disorders for males and females were calculated for all disorders. A series of hierarchical loglinear analyses were performed to examine the relationships between the dyadic comorbidities of depression and various anxiety disorders and the variables suicidal ideation, social support, quality of life, sex, and age. RESULTS: A 21-by-21 frequency of co-occurrences of psychological disorders matrix revealed the presence of multiple significant dyadic comorbidities for males and females. Also, for those with some of the dyadic depression and the anxiety disorders, the odds for having suicidal ideation, reporting inadequate social support, and poorer quality of life increased for those with two-disorder comorbidity than for those with only one of the same two disorders. CONCLUSIONS: Comorbidities of several psychological disorders using an online assessment tool within a Web-based population were similar to those found in face-to-face clinics using traditional assessment tools. Results provided support for the transdiagnostic approaches and confirmed the positive relationship between comorbidity and suicidal ideation, the negative relationship between comorbidity and social support, and the negative relationship comorbidity and quality of life. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG).

Comorbidity structure of psychological disorders in the online e-PASS data as predictors of psychosocial adjustment measures: psychological distress, adequate social support, self-confidence, quality of life, and suicidal ideation.

BACKGROUND: A relative newcomer to the field of psychology, e-mental health has been gaining momentum and has been given considerable research attention. Although several aspects of e-mental health have been studied, 1 aspect has yet to receive attention: the structure of comorbidity of psychological disorders and their relationships with measures of psychosocial adjustment including suicidal ideation in online samples. OBJECTIVE: This exploratory study attempted to identify the structure of comorbidity of 21 psychological disorders assessed by an automated online electronic psychological assessment screening system (e-PASS). The resulting comorbidity factor scores were then used to assess the association between comorbidity factor scores and measures of psychosocial adjustments (ie, psychological distress, suicidal ideation, adequate social support, self-confidence in dealing with mental health issues, and quality of life). METHODS: A total of 13,414 participants were assessed using a complex online algorithm that resulted in primary and secondary Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) diagnoses for 21 psychological disorders on dimensional severity scales. The scores on these severity scales were used in a principal component analysis (PCA) and the resulting comorbidity factor scores were related to 4 measures of psychosocial adjustments. RESULTS: A PCA based on 17 of the 21 psychological disorders resulted in a 4-factor model of comorbidity: anxiety-depression consisting of all anxiety disorders, major depressive episode (MDE), and insomnia; substance abuse consisting of alcohol and drug abuse and dependency; body image-eating consisting of eating disorders, body dysmorphic disorder, and obsessive-compulsive disorders; depression-sleep problems consisting of MDE, insomnia, and hypersomnia. All comorbidity factor scores were significantly associated with psychosocial measures of adjustment (P<.001). They were positively related to psychological distress and suicidal ideation, but negatively related to adequate social support, self-confidence, and quality of life. CONCLUSIONS: This exploratory study identified 4 comorbidity factors in the e-PASS data and these factor scores significantly predicted 5 psychosocial adjustment measures. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG).

Posttreatment attrition and its predictors, attrition bias, and treatment efficacy of the anxiety online programs.

BACKGROUND: Although relatively new, the field of e-mental health is becoming more popular with more attention given to researching its various aspects. However, there are many areas that still need further research, especially identifying attrition predictors at various phases of assessment and treatment delivery. OBJECTIVE: The present study identified the predictors of posttreatment assessment completers based on 24 pre- and posttreatment demographic and personal variables and 1 treatment variable, their impact on attrition bias, and the efficacy of the 5 fully automated self-help anxiety treatment programs for generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder with or without agoraphobia (PD/A), obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). METHODS: A complex algorithm was used to diagnose participants' mental disorders based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision; DSM-IV-TR). Those who received a primary or secondary diagnosis of 1 of 5 anxiety disorders were offered an online 12-week disorder-specific treatment program. A total of 3199 individuals did not formally drop out of the 12-week treatment cycle, whereas 142 individuals formally dropped out. However, only 347 participants who completed their treatment cycle also completed the posttreatment assessment measures. Based on these measures, predictors of attrition were identified and attrition bias was examined. The efficacy of the 5 treatment programs was assessed based on anxiety-specific severity scores and 5 additional treatment outcome measures. RESULTS: On average, completers of posttreatment assessment measures were more likely to be seeking self-help online programs; have heard about the program from traditional media or from family and friends; were receiving mental health assistance; were more likely to learn best by reading, hearing and doing; had a lower pretreatment Kessler-6 total score; and were older in age. Predicted probabilities resulting from these attrition variables displayed no significant attrition bias using Heckman's method and thus allowing for the use of completer analysis. Six treatment outcome measures (Kessler-6 total score, number of diagnosed disorders, self-confidence in managing mental health issues, quality of life, and the corresponding pre- and posttreatment severity for each program-specific anxiety disorder and for major depressive episode) were used to assess the efficacy of the 5 anxiety treatment programs. Repeated measures MANOVA revealed a significant multivariate time effect for all treatment outcome measures for each treatment program. Follow-up repeated measures ANOVAs revealed significant improvements on all 6 treatment outcome measures for GAD and PTSD, 5 treatment outcome measures were significant for SAD and PD/A, and 4 treatment outcome measures were significant for OCD. CONCLUSIONS: Results identified predictors of posttreatment assessment completers and provided further support for the efficacy of self-help online treatment programs for the 5 anxiety disorders. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG).

Pretreatment attrition and formal withdrawal during treatment and their predictors: an exploratory study of the anxiety online data.

BACKGROUND: Although in its infancy, the field of e-mental health interventions has been gaining popularity and afforded considerable research attention. However, there are many gaps in the research. One such gap is in the area of attrition predictors at various stages of assessment and treatment delivery. OBJECTIVE: This exploratory study applied univariate and multivariate analysis to a large dataset provided by the Anxiety Online (now called Mental Health Online) system to identify predictors of attrition in treatment commencers and in those who formally withdrew during treatment based on 24 pretreatment demographic and personal variables and one clinical measure. METHODS: Participants were assessed using a complex online algorithm that resulted in primary and secondary diagnoses in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). Those who received a primary or secondary diagnosis of 1 of 5 anxiety disorders (generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and panic disorder) were offered an online 12-week disorder-specific treatment program. RESULTS: Of 9394 potential participants, a total of 3880 clients enrolled and 5514 did not enroll in one of the treatment programs following the completion of pretreatment assessment measures (pretreatment attrition rate: 58.70%). A total of 3199 individuals did not formally withdraw from the 12-week treatment cycle, whereas 142 individuals formally dropped out (formal withdrawal during treatment dropout rate of 4.25%). The treatment commencers differed significantly (P<.001-.03) from the noncommencers on several variables (reason for registering, mental health concerns, postsecondary education, where first heard about Anxiety Online, Kessler-6 score, stage of change, quality of life, relationship status, preferred method of learning, and smoking status). Those who formally withdrew during treatment differed significantly (P=.002-.03) from those who did not formally withdraw in that they were less likely to express concerns about anxiety, stress, and depression; to rate their quality of life as very poor, poor, or good; to report adequate level of social support; and to report readiness to make or were in the process of making changes. CONCLUSIONS: This exploratory study identified predictors of pretreatment attrition and formal withdrawal during treatment dropouts for the Anxiety Online program. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG).

Comparison Between Male and Female Survivors of Sexual Abuse and Assault in Relation to Age at Admission to Therapy, Age of Onset, and Age at Last Sexual Assault: Retrospective Observational Study.

BACKGROUND: Sexual abuse and sexual assault are complex phenomena that involve many factors (or correlates) and have many health and financial implications for individuals, families, and society. Every correlate needs to be studied in detail, individually and in relation to other correlates. Only with a thorough understanding of these correlates can more efficient and targeted prevention and intervention programs be designed. OBJECTIVE: The purpose of this study was to examine the differences between male and female survivors of sexual abuse and sexual assault regarding the correlates of the survivors' age of onset of assault, age at the last assault, and age at which they entered therapy. METHODS: Therapists at eight sexual assault centers in the province of Alberta, Canada, completed a questionnaire on each of their clients over a period of 7 years. A total of 3302 participants, of whom 2901 (87.86%) were female and 401 (12.1%) were male survivors of sexual abuse and assault, were included in this study. Mostly descriptive analyses were carried out on the 4 variables of concern in this study. RESULTS: Regarding the number of survivors who sought therapy, female survivors outnumbered male survivors by a ratio of 7:1, with different ratios for different age groups. As children age, their risk of being sexually assaulted for the first time decreases. Male children are more likely to be sexually abused at a younger age, whereas female children are more vulnerable to being assaulted at all ages, particularly in adolescence. The mean age of onset of sexual abuse was found to be 6.71 (SD 2.86) years, and the odds of experiencing the first sexual assault during childhood, as opposed to adolescence, were 4:1 for females and 9:1 for males. Male survivors were two times more likely than female survivors to experience their first sexual assault in childhood. The vast majority of survivors sought help many years after being sexually assaulted, and male survivors waited an average of 3 years longer from the last sexual assault before seeking therapy. CONCLUSIONS: The majority of survivors of sexual abuse and sexual assault live with the consequences for many years before they seek help, and a large proportion of male survivors are not likely to seek help.

Analysis of adjuvant chemotherapy in patients undergoing curative-intent resection of localized adrenocortical carcinoma.

BACKGROUND: Studies evaluating the role of adjuvant chemotherapy (ACT) in Adrenocortical Carcinoma (ACC) are limited due to its rarity. The objective of this study was to evaluate if ACT provides a survival benefit in patients who underwent curative-intent resection of localized ACC and to determine factors associated with receipt of ACT. METHODS: The National Cancer Data Base was queried to identify patients (2010-2016) with curative-intent resection of localized ACC (T1-T3, N0, M0). RESULTS: Of 577 patients with adrenalectomy, 389 (67%) had adrenalectomy alone, and 188 (33%) received ACT. Private insurance, lymphovascular invasion, stage II, and radiotherapy were predictors of ACT (P < 0.05). Advanced (T3) stage lymphovascular invasion, and being uninsured were associated with decreased OS (P < 0.05). There was no association between ACT and OS. CONCLUSIONS: For patient who underwent curative-intent resection of localized ACC, there was no association between ACT and OS. Private insurance, lymphovascular invasion, stage II disease, and radiotherapy were associated with receipt of ACT.

Post-embolization outcomes of splenic artery pseudoaneurysms: A single-center experience.

PURPOSE: Splenic artery pseudoaneurysms (PSA) are relatively rare but associated with high mortality/morbidity when presenting acutely. Embolization has emerged as the treatment of choice. We aim to evaluate the outcomes of embolization for the treatment of splenic artery PSAs. METHODS: From 2007 to 2019, all patients that underwent embolization for splenic artery PSAs were included in this IRB-approved review. Evaluated outcomes included complications, morbidity/mortality rates, and 30-day white blood cell count. Student t-tests were performed to compare laboratory values before and after embolization. 5-year survival rates were estimated using Kaplan Meier methodology. RESULTS: A retrospective analysis of 24 patients (14 males, mean age 51 ± 19 years) who underwent splenic artery PSA embolization was performed. Fifteen PSA embolizations were performed in an emergent setting. There was technical success in 23/24 patients. Etiologies included trauma (10), pancreatitis (9), post-surgical (3), and malignancy (2). Post-embolization patients had a mean length of stay of 19 days and within 30 days, 9 patients developed leukocytosis (median of 14,800/µl). The 5-year survival rate of these patients was 89% [95% CI 75% - 100%]. Post-procedure, 4 patients developed grade 2 complications. Grade 3 complications were observed in 5 patients. One (4.2%) splenic abscess was identified. Of the 19 patients with follow-up imaging, 14 patients had splenic infarcts (5 infarcts were >50% of splenic volume). CONCLUSIONS: Splenic artery PSAs are encountered in the emergent setting and are most frequently secondary to trauma or pancreatitis. Embolization can be life-saving in these critically ill patients.

Technical Aspects and Practical Approach Toward Same-Day Y90 Radioembolization in the Management of Hepatocellular Carcinoma.

Radioembolization with Yttrium-90 (Y90) has been proven safe and effective for the treatment of primary and secondary hepatic malignancies. Standard protocols have necessitated planning angiography with Technetium-99m macroaggregated albumin (Tc99m MAA) administration/scan typically 1-2 weeks prior to the radioembolization therapy. The intent of this practice is to ensure appropriate patient selection and treatment candidacy while also confirming best dosimetry approaches. At our center, we started performing "same-day Y90" in 2008; in a subset of international patients with travel hardship, we performed the planning and treatment procedures consecutively on the same day. In this article, we reveal our practical approach to treating patients on the same day as planning angiography. With more than 160 same-day procedures completed between 2008 and 2017, the safety and efficacy of such a paradigm has been established at our center. This approach is appealing to patients, their families, and referring physicians. Appropriate patient selection and proper preprocedure planning based on baseline imaging are key elements in successful same-day radioembolization treatments.

Prognosticating Survival in Hepatocellular Carcinoma with Elevated Baseline Alpha-fetoprotein Treated with Radioembolization Using a Novel Laboratory Scoring System: Initial Development and Validation.

AIMS: To investigate laboratory parameters as predictors of overall survival (OS) for hepatocellular carcinoma (HCC) treated with radioembolization and develop/validate a scoring system. METHODS: With IRB approval, we included all patients with baseline alpha-fetoprotein (AFP) > 100 ng/dL from our prospectively acquired HCC radioembolization database. Neutrophil-lymphocyte ratio, albumin-bilirubin (ALBI), and AFP were measured at baseline and at 1-, 3-, and 6-month post-radioembolization Landmarks. OS was assessed from these Landmarks. Univariate/multivariate analyses were performed to evaluate OS predictability of these parameters. Baseline Imaging, Laboratory, and Combination scoring systems were developed. Developing/validating groups were created to investigate/validate the score's OS predictability. Time-dependent receiver operating characteristics (ROC) were evaluated. Patients were stratified into groups I, II, and III by using 25th and 75th percentile cutoffs according to change in Laboratory Score from baseline. RESULTS: 345/401 (86%), 238/401 (59%), and 167/401 (42%) patients had laboratory parameters available at the 1-, 3-, and 6-month Landmarks, respectively. ALBI and AFP were significant OS prognosticators at all Landmarks. The Laboratory Score [ALBI + (0.3 × LnAFP)] was developed/internally validated to predict OS from these Landmarks. Areas under the curve of time-dependent ROCs of the Baseline Imaging vs. Laboratory scores in predicting patient OS post 3 and 6 months Landmarks were 0.56 versus 0.82 and 0.57 versus 0.77, respectively. OS differences in groups I, II, and III according to change in Laboratory Score from baseline were significant (p < 0.001). CONCLUSIONS: Post-radioembolization AFP and ALBI scores were significant OS prognosticators. A decrease in post-therapeutic Laboratory Score, which combines AFP and ALBI, correlates with an improved OS.

Survival Analysis of Advanced HCC Treated with Radioembolization: Comparing Impact of Clinical Performance Status Versus Vascular Invasion/Metastases.

PURPOSE: In this study, we aim to compare the effects of prognostic indicators on survival analysis for Barcelona Clinic Liver Cancer (BCLC) C patients undergoing yttrium-90 radioembolization (Y-90). METHODS: A prospectively acquired database (2003-2017) for BCLC C hepatocellular carcinoma (HCC) patients that underwent radioembolization with Y-90 was searched. The criteria for BCLC C status (Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1 or 2, metastases, and/or portal vein thrombosis (PVT)) were recorded. Kaplan-Meier survival analyses were performed from the date of the first radioembolization with Y-90, censored to curative treatment, to determine median overall survival (OS). Cox regression hazards model was used for multivariate analyses. Significance was set at P < 0.05. RESULTS: 547 BCLC C patients treated with radioembolization with Y-90 had a median OS of 10.7 months (range: 9.5-12.9). 43% (233 of 547) patients classified as BCLC C solely by their ECOG PS had a median OS of 19.4 months (14.7-23.7); 57% (314 of 547) patients with PVT/metastases had a median OS of 7.7 months (6.7-8.7). On multivariate analysis, ECOG PS was not found to be a statistically significant prognostic indicator of OS in BCLC C whereas metastases and PVT exhibited hazards ratios (95%CI) of 0.51 (0.38-0.69) and 0.49 (0.38-0.63), respectively (P < 0.0001). CONCLUSION: Patients classified as BCLC C due to ECOG PS 1 demonstrated longer survival when compared to those presenting with PVT, metastases and/or ECOG PS 2. Hence, ECOG PS 1, as an isolated variable, may not be a true indicator of advanced disease.

90Y Radioembolization for Locally Advanced Hepatocellular Carcinoma with Portal Vein Thrombosis: Long-Term Outcomes in a 185-Patient Cohort.

We report survival outcomes for patients with advanced-stage hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT) treated with 90Y radioembolization. Methods: With institutional review board approval, we searched our prospectively acquired database for 90Y patients treated between 2003 and 2017. Inclusion criteria were patients who had HCC with tumor PVT. Patients with metastases were excluded. Laboratory data were collected at baseline and 1 mo after 90Y radioembolization. Toxicity grades were reported according to the Common Terminology Criteria for Adverse Events, version 4.0, and long-term survival outcomes were reported and stratified by Child-Pugh class (CP). Overall survival was calculated using the Kaplan-Meier method. Multivariate analysis was performed using Cox proportional hazards regression. A subanalysis for patients with a high level of α-fetoprotein (AFP) (>100 ng/dL) was conducted. Results: In total, 185 patients with HCC PVT underwent 90Y radioembolization. Seventy-four (40%) were CP-A, 51 (28%) were CP-B7, and 60 (32%) were ≥CP-B8. New albumin, bilirubin, and alkaline phosphatase grade 3/4 toxicities were, respectively, 3%, 10%, and 0% for CP-A; 14%, 12%, and 6% for CP-B7; and 23%, 32%, and 3% for ≥CP-B8. Median overall survival for CP-A patients was 13.3 mo (95% confidence interval [CI], 8.7-15.7 mo). CP-B7 and ≥CP-B8 patients exhibited median overall survival of 6.9 mo (95% CI, 5.3-10.1 mo) and 3.9 mo (95% CI, 2.9-5.0 mo), respectively. Significant overall survival prognosticators on univariate analysis were albumin, bilirubin, ascites, tumor size 5 cm or smaller, focality, distribution, infiltration, Eastern Cooperative Oncology Group status, AFP level, and PVT extent. Multivariate analysis showed the prognosticators of overall survival to be bilirubin, no ascites, tumor size 5 cm or smaller, solitary lesion, baseline AFP level lower than 100 ng/dL, and Eastern Cooperative Oncology Group status. Of 123 patients with a high AFP level (>100 ng/dL), 12 patients achieved restored normal AFP levels (<13 ng/dL) and exhibited median overall survival of 23.9 mo (95% CI, 20.1-124.1 mo). AFP responders at 1 mo had better overall survival than nonresponders, at 8.5 mo versus 4.8 mo (P = 0.018); AFP responders at 3 mo had overall survival of 13.3 mo, versus 6.9 mo for nonresponders (P = 0.021). Conclusion:90Y radioembolization can serve as a safe and effective treatment for advanced-stage HCC patients with tumor PVT. Overall survival outcomes are affected by baseline liver function, tumor size, and AFP level.