Overall survival and toxicity of hepatocellular carcinoma Barcelona Clinic Liver Cancer B patients receiving Y90 radioembolization: analysis of the radiation-emitting SIR-spheres in non-resectable liver tumor (RESiN) registry.

Background: To evaluate overall survival (OS), progression-free survival (PFS) and toxicity after resin Yttrium-90 (Y-90) radioembolization in Barcelona Clinic Liver Cancer B (BCLC B) hepatocellular carcinoma (HCC) patients using the Bolondi subgroup classification. Methods: A total of 144 BCLC B patients were treated between 2015-2020. Patients were broken into 4 subgroups by tumor burden/liver function tests with 54, 59, 8 and 23 in subgroups 1, 2, 3 and 4. OS and PFS were calculated with Kaplan-Meier analysis with 95% confidence intervals. Toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5. Results: Prior resection and chemoembolization were performed in 19 (13%) and 34 (24%) of patients. There were no deaths within 30 days. Median OS and PFS for the cohort were 21.5 and 12.4 months. Median OS was not reached for subgroup 1 at a mean 28.8 months, and was 24.9, 11.0 and 14.6 months for subgroups 2-4 (χ2=19.8, P=0.0002). PFS by BCLC B subgroup was 13.8, 12.4, 4.5, and 6.6 months (χ2=16.8, P=0.0008). The most common Grade 3 or 4 toxicities were elevated bilirubin (n=16, 13.3%) and decreased albumin (n=15, 12.5%). Grade 3 or greater bilirubin (32% vs. 10%, P=0.03) and albumin (26% vs. 10%, P=0.03) toxicity were more common in the subgroup 4 patients. Conclusions: The Bolondi subgroup classification stratifies OS, PFS and development of toxicity in patients treated with resin Y-90 microspheres. OS in subgroup 1 approaches 2.5 years and Grade 3 or greater hepatic toxicity profile in subgroups 1-3 is low.

Six-Year Evaluation of Same-Day Discharge following Conventional Transarterial Chemoembolization of Hepatocellular Carcinoma.

PURPOSE: To evaluate whether same-day discharge increased the incidence of 30-day readmission (30dR) after conventional transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) at a single institution. MATERIALS AND METHODS: In this retrospective study, 253 patients with HCC underwent 521 transarterial chemoembolization procedures between 2013 and 2020. TACE was performed with 50-mg doxorubicin/10-mg mitomycin C/5-10-mL ethiodized oil/particles. Patients not requiring intravenous pain medications were discharged after a 3-hour observation, and 30dR was tracked. The primary objective was to determine the incidence of 30dR in same-day discharge patients versus patients admitted for observation using the chi-square test. Secondary objectives assessed factors associated with overnight admission and factors predictive of 30dR using generalized estimated equation calculations and logistic regression. RESULTS: In the cohort, 24 readmissions occurred within 30 days (4.6%). Same-day discharge was completed after 331 TACE procedures with sixteen 30dRs (4.8%). Patients admitted overnight were readmitted 8 times after 190 TACE procedures (4.2%). This difference was not statistically significant (P = .4). Factors predicting overnight admission included female sex (58/190 [30.5%] vs 58/331 [17.5%], P < .001) and tumor size of ≥3.8 cm (104/190 [55%] vs 85/190 [45%]). Factors predicting 30dR included female sex (10/116 [8.6%] vs 14/405 [0.2%]) and younger age (median [interquartile range], 63 years [55-65 years] vs 65 years [59-71 years]). At regression, factors predictive of 30dR were Child-Pugh Class B/C (odds ratio [OR], 2.1; P = .04) and female sex (OR, 2.9; P = .004). CONCLUSIONS: Same-day discharge after conventional TACE is a safe and effective strategy with 30dR rate of <5%, similar to overnight observation.

Overall survival and toxicity of Y90 radioembolization for hepatocellular carcinoma patients in Barcelona Clinic Liver Cancer stage C (BCLC-C).

INTRODUCTION: National Comprehensive Cancer Network HCC guidelines recommend Y90 to treat BCLC-C patients only in select cases given the development of systemic regimens. We sought to identify ideal candidates for Y90 by assessing survival and toxicities in this patient group. MATERIALS AND METHODS: The Radiation-Emitting Selective Internal radiation spheres in Non-resectable tumor registry is a prospective observational study (NCT: 02,685,631). Patients with advanced HCC were stratified into 3 groups based on tumor location, Eastern Cooperative Oncology Group (ECOG) performance status, and liver function. Group 1: liver isolated HCC, ECOG 0 and Child Pugh (CP) A (n = 12, 16%), Group 2: liver isolated HCC, ECOG ≥ 1 or CP B/C (n = 37, 49%), and Group 3: extrahepatic HCC with any ECOG or CP score (n = 26, 35%). Patients in any group could have macrovascular invasion. Overall survival (OS) and progression-free survival (PFS) with 95% confidence intervals (95% CI) were calculated. Grade 3 + toxicities were tracked using Common Terminology Criteria for Adverse Events v5. Cox proportional hazard model was performed to determine factors affecting OS. RESULTS: Seventy-five BCLC-C patients treated between 2015 and 2019 were reviewed. The groups were similar in age, sex, race, and ethnicity (all p > 0.05). Bilobar disease was least common in Group 1 (p < 0.001). Median OS of the entire cohort was 13.6 (95% CI 7.5-16.1) months. Median OS of Groups 1-3 were 21.8, 13.1 and 11.5 months respectively (p = 0.6). Median PFS for the cohort was 6.3 (4.8-14.7) months. Median PFS for group 1 was not reached. Mean PFS for Group 1 was 17.3 ± 4.8 months. Median PFS for Groups 2 and 3 was 6.8 and 5.9 months (X2 = 1.5, p = 0.5). Twenty-four Grade 3 or greater toxicities developed, most commonly hyperbilirubinemia (8/75, 11%) and thrombocytopenia (2/75, 3%). The incidence of toxicities between groups was similar (all p > 0.05). Cox Proportional Hazard analysis predicted shorter OS with CP class B/C (X2 = 6.7, p = 0.01), while macrovascular invasion (X2 = 0.5, p = 0.5) and ECOG score of ≥ 1 (X2 = 2.1, p = 0.3) was not associated with OS. CONCLUSIONS: OS of CPA patients with advanced HCC and performance status of 0 was 21.8 months following Y90. CP A cirrhosis is the best predictor of prolonged OS in advanced (BCLC-C) HCC.

Multicenter Evaluation of Survival and Toxicities of Hepatocellular Carcinoma following Radioembolization: Analysis of the RESiN Registry.

PURPOSE: To determine overall survival (OS), progression-free survival (PFS), and toxicity in patients with hepatocellular carcinoma (HCC) in a multicenter, real-world data registry using transarterial radioembolization (TARE) with resin microspheres. MATERIALS AND METHODS: A total of 448 patients with HCC were treated at 36 centers between 2015 and 2019. Treatment history, baseline laboratory and imaging, and treatment goal were assessed. OS and PFS were stratified using Barcelona Clinic Liver Cancer (BCLC) and Child-Pugh (CP) classifications. Kaplan-Meier analyses compared OS and PFS with 95% confidence intervals. Transplants were tracked. Toxicities were assessed using Common Terminology Criteria for Adverse Events v5. Cox proportional hazard of baseline demographics assessed factors affecting survival. RESULTS: Prior chemoembolization and systemic therapy were used in 107 (26%) and 68 (16%) patients, respectively. Using the BCLC staging system, 66 patients (19%) were BCLC A and 202, 51, and 26 were BCLC B, C, and D, respectively. Median OS for patients with BCLC A disease was not achieved at 30 months. Median OS for patients with BCLC B, C, and D disease were 19.5, 13.6, and 11.5 months, respectively (P = .0006). Median PFS for patients with BCLC A, B, C, and D were 19.8, 10.0, 6.3, and 5.9 months, respectively (P = .003). Twenty patients underwent transplantation, representing 14 of 43 (33%) and 6 of 28 (21%) patients who underwent bridging and downstaging therapy, respectively. Common Grade 3 toxicities were encephalopathy (11/448, 2.5%), hyperbilirubinemia (10/448, 2.2%), and ascites (9/448, 2.0%). Factors predicting longer survival included CP A (χ2 = 4.2, P = .04) and BCLC A (χ2 = 5.2, P = .02). CONCLUSIONS: In a frequently pretreated patient cohort with disease burden in 81% beyond the Milan criteria, TARE with resin microspheres provided OS comparable to other studies in this multicenter registry.

Effectiveness of Deep Learning Algorithms to Determine Laterality in Radiographs.

Develop a highly accurate deep learning model to reliably classify radiographs by laterality. Digital Imaging and Communications in Medicine (DICOM) data for nine body parts was extracted retrospectively. Laterality was determined directly if encoded properly or inferred using other elements. Curation confirmed categorization and identified inaccurate labels due to human error. Augmentation enriched training data to semi-equilibrate classes. Classification and object detection models were developed on a dedicated workstation and tested on novel images. Receiver operating characteristic (ROC) curves, sensitivity, specificity, and accuracy were calculated. Study-level accuracy was determined and both were compared to human performance. An ensemble model was tested for the rigorous use-case of automatically classifying exams retrospectively. The final classification model identified novel images with an ROC area under the curve (AUC) of 0.999, improving on previous work and comparable to human performance. A similar ROC curve was observed for per-study analysis with AUC of 0.999. The object detection model classified images with accuracy of 99% or greater at both image and study level. Confidence scores allow adjustment of sensitivity and specificity as needed; the ensemble model designed for the highly specific use-case of automatically classifying exams was comparable and arguably better than human performance demonstrating 99% accuracy with 1% of exams unchanged and no incorrect classification. Deep learning models can classify radiographs by laterality with high accuracy and may be applied in a variety of settings that could improve patient safety and radiologist satisfaction. Rigorous use-cases requiring high specificity are achievable.

Radioembolization with Yttrium-90 Microspheres for the Treatment of Liver Metastases of Pancreatic Adenocarcinoma: A Multicenter Analysis.

PURPOSE: To retrospectively assess the efficacy and safety of radioembolization with yttrium-90 (90Y) resin microspheres as a second-line option in patients with liver metastases from pancreatic adenocarcinoma. MATERIALS AND METHODS: Thirty-three patients with metastatic pancreatic adenocarcinoma that progressed despite systemic chemotherapy and other treatments directed at primary tumors and metastases were treated with 90Y radioembolization at 1 of 3 institutions from 2011 through 2017. Data from laboratory and imaging studies at 2, 4, 8, and 12 weeks after treatment were analyzed. Tumor response was assessed with Response Evaluation Criteria In Solid Tumors version 1.1 and adverse events with Common Terminology Criteria for Adverse Events version 4.0. RESULTS: Imaging results showed partial response in 8 patients (42%), stable disease in 7 (37%), and progressive disease in 4 (21%). Median overall survival times after radioembolization and diagnosis of the primary tumor were 8.1 (95% CI, 4.8-12.5) and 20.8 (95% CI, 14.2-29.0) months, respectively. Radioembolization did not produce major hepatic toxicity, and changes in liver enzyme levels were rarely grade ≥ 3 during the 12-week follow-up. The exceptions were 3 patients with grade 3 increased alkaline phosphatase (week 2) and bilirubin levels (week 4), increased bilirubin level (week 12), and decreased albumin level (week 12), respectively. Most reported complications were grade ≤ 2, with 2 patients showing short-term radioembolization-related grade 3 abdominal distention, abdominal pain, fatigue, or ascites. CONCLUSIONS: Yttrium-90 radioembolization provided a meaningful survival benefit in patients with liver metastases from pancreatic adenocarcinoma that progressed despite previous therapies. Adverse events and liver toxicity were tolerable and only occasionally severe (grade ≥ 3).

Short-term imaging response after drug-eluting embolic trans-arterial chemoembolization delivered with the Surefire Infusion System® for the treatment of hepatocellular carcinoma.

PURPOSE: To review the initial imaging responses after drug-eluting embolic trans-arterial chemoembolization (DEE-TACE) delivered with the Surefire Infusion System ® for the treatment of hepatocellular carcinoma (HCC). METHODS: Single center retrospective evaluation of patients who underwent DEE-TACE for HCC, delivered with SIS. Information was gathered from available medical records. Treatment response rates were assessed using the modified Response Evaluation Criteria in Solid Tumors criteria. Assessment of adverse events was categorized per Common Terminology Criteria for Adverse Events version 4.03. RESULTS: Twenty-two patients with 39 hepatocellular carcinoma lesions were treated with the surefire infusion system. Complete response was demonstrated in 32% of patients and 54% of lesions after a single treatment session. Overall disease response was demonstrated in 91% of patients and 85% of lesions after a single treatment. No grade 3 or higher elevations in liver function tests were demonstrated in the short-term. CONCLUSION: SIS delivered DEE-TACE leads to a higher than expected initial response in patients with HCC.

Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study.

BACKGROUND: Acellular dermal matrix has enjoyed extensive use in primary and secondary alloplastic breast aesthetic and reconstructive surgery. The objective of this study was to examine clinical outcomes between available acellular dermal matrix products: DermACELL (LifeNet Health, Virginia Beach, Va.) and AlloDerm Ready To Use (LifeCell Corp., Branchburg, N.J.). METHODS: A retrospective chart review was performed on 58 consecutive patients (100 breasts) reconstructed with either DermACELL (n = 30 patients; 50 breasts) or AlloDerm Ready To Use (n = 28 patients; 50 breasts). The mastectomies were performed by three different breast surgeons. All reconstructions were performed by the same plastic surgeon (T.A.P.). Statistical analysis was performed by means of Fisher's exact test. RESULTS: Differences in the average age, body mass index, percentage having neoadjuvant/adjuvant chemotherapy or breast irradiation, and numbers of therapeutic and prophylactic mastectomies between the two groups were not statistically significant (p < 0.05). Complications in both cohorts of patients were clinically recorded for 90 days after immediate reconstruction. When comparing outcomes, patients in the DermACELL group had a significantly lower incidence of "red breast syndrome" (0 percent versus 26 percent; p = 0.0001) and fewer days before drain removal (15.8 days versus 20.6 days; p = 0.017). No significant differences were seen in terms of seroma, hematoma, delayed healing, infection, flap necrosis, or explantation. CONCLUSION: Patients reconstructed with DermACELL as compared with AlloDerm Ready To Use have significantly decreased number of days to drain removal and red breast syndrome and equivalent rates of other complications, including seroma, infection, flap necrosis, and explantation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Do we know when our clients get worse? an investigation of therapists' ability to detect negative client change.

Routine clinical judgment is often relied upon to detect client deterioration. How reliable are therapists' judgments of deterioration? Two related studies were conducted to investigate therapist detection of client deterioration and therapist treatment decisions in situations of deterioration. The first study examined therapists' ability to detect client deterioration through the review of therapy progress notes. Therapist treatment decisions in cases of client deterioration were also explored. Therapists had considerable difficulty recognizing client deterioration, challenging the assumption that routine clinical judgment is sufficient when attempting to detect client deterioration. A second study was a survey of therapists asking how they detect client deterioration and what treatment decisions they make in response. Symptom worsening was the most commonly stated cue of deterioration.