Hasmukh J. Prajapati

Safety and Efficacy of Doxorubicin Drug-eluting Bead Transarterial Chemoembolization in Patients with Advanced Hepatocellular Carcinoma

PURPOSE To investigate the safety and efficacy of transarterial chemoembolization using doxorubicin drug-eluting beads (DEBs) in patients with Barcelona Clinic Liver Cancer (BCLC) C stage hepatocellular carcinoma (HCC). METHODS Consecutive patients with initial staging of BCLC C HCC who received DEB transarterial chemoembolization over the last 5 years were studied. The study included 121 patients (mean age, 61.2 years old). Adverse events (AEs) after DEB transarterial chemoembolization were studied in detail and were recorded as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 criteria. Survivals were analyzed according to parameters from the time of first DEB transarterial chemoembolization. Kaplan-Meier method by log-rank test and Cox proportional hazard model were used for survival analysis. RESULTS AEs occurred in 30.2% of patients. No AEs were greater than Common Terminology Criteria for Adverse Events grade III. Grade I and II AEs included nausea and vomiting in 7.8% of patients and abdominal pain in 23.8% of patients. Grade III AEs were noted in 1.06% of patients. There were no gastrointestinal or hepatic complications. There were no deaths within 30 days after DEB transarterial chemoembolization. The overall median survival was 13.5 months. Among the Child-Pugh class A patients, those without PVT and metastasis (28.9%) had better survival when treated with DEB transarterial chemoembolization than those with PVT and metastases (9.9%) (18.8 mo versus 4.4 mo, P = .001). Ascites, performance status, Okuda stage HCC, serum alpha fetoprotein levels, and etiologic factor for chronic liver disease predicted survival. CONCLUSIONS DEB transarterial chemoembolization appears to be a safe and effective treatment option for patients with BCLC C HCC. Patients with Child-Pugh class A without PVT and metastasis benefited most from DEB transarterial chemoembolization.

Modified Response Evaluation Criteria in Solid Tumors and European Association for the Study of the Liver Criteria Using Delayed-Phase Imaging at an Early Time Point Predict Survival in Patients with Unresectable Intrahepatic Cholangiocarcinoma following Yttrium-90 Radioembolization

PURPOSE To investigate early imaging prognostic factors in unresectable intrahepatic cholangiocarcinoma (ICC) refractory to standard chemotherapy after yttrium-90 ((90)Y) radioembolization therapy. MATERIALS AND METHODS In an institutional review board-approved prospective correlative study, 21 consecutive patients with ICC refractory to standard chemotherapy underwent (90)Y radioembolization therapy. Target and overall Response Evaluation Criteria In Solid Tumors (RECIST), modified RECIST (mRECIST), and European Association for the Study of the Liver (EASL) treatment responses were assessed. The mRECIST and EASL criteria were modified for application on delayed phases of dynamic contrast-enhanced cross-sectional imaging studies. Conventional definitions for complete and partial response were applied; these responses comprised objective response. Restaging imaging was obtained at 1- and 3-month intervals until patient death. Survival analyses by Kaplan-Meier and log-rank proportional models including application of the landmark method to avoid lead-time bias were performed from the day of treatment. Significance was set at P < .05. RESULTS Median overall survival (OS) from the time of (90)Y therapy was 16.3 months (95% confidence interval, 7.2-25.4 mo). Significant differences between mRECIST and EASL versus RECIST were found when categorizing patients into responders and nonresponders (P < .001). Significantly prolonged OS was observed for patients with targeted objective response based on modified mRECIST and EASL criteria (P = .005 and P = .001, respectively) at 3 months. RECIST was not found to correlate with survival at 1- or 3-month follow-up. CONCLUSIONS Modified target mRECIST and EASL criteria that employ delayed-phase contrast enhancement at 3 months after (90)Y radioembolization therapy for ICC predicted OS. RECIST did not correlate with survival.

Safety and Feasibility of Same-day Discharge of Patients with Unresectable Hepatocellular Carcinoma Treated with Doxorubicin Drug-eluting Bead Transcatheter Chemoembolization

PURPOSE The aim of this study was to investigate the safety and feasibility of same-day discharge of patients with unresectable hepatocellular carcinoma (HCC) after doxorubicin drug-eluting bead (DEB) transarterial chemoembolization and to elucidate the factors predisposing to overnight admission. MATERIALS AND METHODS Consecutive patients with unresectable HCC who underwent superselective 100-300 μm DEB transarterial chemoembolization were included. The parameters of same-day therapy (group A) were compared with those of patients admitted overnight (group B). A χ2 test and a t test were used to compare categorical and continuous variables accordingly. RESULTS Seventy-six patients (mean, 61 y) received 110 DEB transarterial chemoembolization treatments over an 8-month study period. In 84.5% (93/110) of DEB transarterial chemoembolization procedures, the patients were discharged on the same day (group A). The causes of hospitalization included the worsening of comorbidities in 41.1% (7/17), pain control in 29.4% (5/17), and groin and closure device-related complications in 29.4% (5/17) of patients. The mean Charlson comorbidity scores in groups A and B were 6.96 (standard deviation [SD] ± 1.98) and 8.47 (SD ± 2.18) (P = .0005), respectively. All of the patients in group B had Barcelona Clinic Liver Cancer (BCLC) stages C and D HCC (P = .024). There were no Common Terminology Criteria for Adverse Events (CTCAE) grade III or worse adverse events (AEs). There was no mortality or emergency visits within 30 days of discharge. CONCLUSIONS Same-day discharge after superselective DEB transarterial chemoembolization for unresectable HCC is safe and feasible. BCLC C or D stage of disease, a higher Charlson comorbidity score, and groin or closure device complications are correlated with a greater likelihood for overnight admission.

Selective internal yttrium-90 radioembolization therapy (90Y-SIRT) versus best supportive care in patients with unresectable metastatic melanoma to the liver refractory to systemic therapy: Safety and efficacy cohort study

Objectives: To investigate survival, efficacy, and safety of selective internal yttrium-90 radioembolization therapy (90Y-SIRT) in patients with unresectable metastatic melanoma (MM) to liver refractory to systemic therapy. Methods: An IRB-approved retrospective review of 58 patients diagnosed with unresectable MM to the liver, refractory to systemic therapy, between February 2003 and March 2012 was conducted. Of these, 28 received resin-based 90Y-SIRT (group A), and 30 patients received best supportive care (group B). Survival was calculated using the Kaplan-Meier method and Cox proportional hazard models. Results: Groups A and B were similar for the Child-Pugh class, ECOG scores, age, sex, and race. Median overall survival (OS) from diagnosis of primary melanoma in groups A and B were 119.9 and 26.1 months, respectively (P<0.001). Median OS from hepatic metastasis in groups A and B were 19.9 and 4.8 months, respectively (P<0.0001). In group A, median OS from hepatic metastasis in the Child-Pugh A, B, and C patients was 37.7, 4.2, and 3.6 months, respectively (P<0.001). In group B, median OS from hepatic metastasis in the Child-Pugh A, B, and C patients was 7.8, 4.2, and 1.9 months, respectively (P=0.04). Within group A, median OS from first 90Y-SIRT was 10.1 months; median OS of the Child-Pugh A, B, and C patients from first 90Y-SIRT was 10.3, 1.2, and 0.9 months, respectively (P=0.04). Median OS from first 90Y-SIRT was significantly greater in the absence of diffuse (>10) liver metastases (15.1 vs. 4.7 mo, P=0.02), and in the absence of extrahepatic metastases (21.3 vs. 8.6 mo, P<0.001). Common clinical toxicities following 90Y-SIRT included abdominal pain (17.9%), fatigue (14.3%), and self-limiting grade III bilirubin toxicity (10.7%). Conclusion: For patients with unresectable MM to the liver refractory to systemic therapy, resin-based 90Y was associated with longer survival from liver metastases than best supportive care. Child-Pugh A patients with <10 metastatic lesions and absence of extrahepatic metastases demonstrated greatest survival following 90Y-SIRT.

Survival, Efficacy, and Safety of Small Versus Large Doxorubicin Drug-Eluting Beads TACE Chemoembolization in Patients With Unresectable HCC

OBJECTIVE The purpose of this study was to investigate the overall survival, efficacy, and safety of small (100-300 µm) versus large (300-500 and 500-700 µm) doxorubicin drug-eluting beads transarterial chemoembolization (DEB TACE) in patients with unresectable hepatocellular carcinoma (HCC). MATERIALS AND METHODS Ninety-four consecutive patients with unresectable HCC who underwent 269 DEB TACE procedures in 48 months were studied. DEB TACE procedures were performed using different DEB sizes: 100-300 µm (Group A, 59 patients) and with mixed 300-500 and 500-700 µm DEB (Group B, 35 patients). Survival rates were compared between the groups. RESULTS The overall median survival in groups A and B were 15.1 and 11.1 months, respectively (p=0.005). Both groups were similar in demographics, tumor burden, and differential staging (p>0.5). Substratification of overall survival according to Child-Pugh class and Okuda, Cancer of the Liver Italian Program (CLIP), and Barcelona Clinic Liver Cancer (BCLC) staging were significantly higher in group A than in group B (p<0.05). Common terminology criteria for adverse events (CTCAE) grade III adverse events and 30-day mortality were significantly lower in group A than in group B (6.8% vs 20%; p=0.04, and 0% vs 14.3%; p=0.001, respectively). The particle size, Child-Pugh class, and serum α-fetoprotein level were significant prognostic indicators of survival on multivariate analysis. CONCLUSION TACE with 100-300 µm sized DEB is associated with significantly higher survival rate and lower complications than TACE with 300-500 and 500-700 µm sized DEB.

Preservation of quality of life with doxorubicin drug‐eluting bead transarterial chemoembolization for unresectable hepatocellular carcinoma: Longitudinal prospective study

The study aims to determine the effects of doxorubicin drug‐eluting bead transarterial chemoembolization (DEB‐TACE) therapies on health‐related quality of life (HRQOL) in patients with unresectable hepatocellular carcinoma (HCC).

Percutaneous interventional management of biliary complications after pediatric liver transplantation: A 16-year single-institution experience.

The aim of the study was to investigate the BiCx after the pediatric OLT and to assess the efficacy of the fluoroscopic‐guided PBI in the patients with BiCx as compared to the SR. A total of 340 OLTs were performed in 302 patients over the last 16 years. The inclusion criteria were the presence of BS or BL as a complication after OLT. The management of the BiCx was studied. Graft revision, graft loss, and survival were evaluated following PBI and SR. BiCx occurred in 17.1% (58/339) of the transplants; 6.2% (21/339) of transplants demonstrated BL and 12.7% (43/339) of the transplants had BS. Overall graft survival rates at 1 and 3 years in OLT with BL treated with PBI were 75.0% and 68.8% as compared with 75% and 66.7% in OLT treated with SR (P>.05). Overall graft survival rates at 1 and 3 years in OLT with BS treated with PBI were 70.6% and 54.5% as compared with 71.4% and 50% in OLT with SR or ERCP, respectively (P>.05). Based on the results, we conclude that PBI is as effective as SR in patients with the BL and BS after OLT.

Treatment algorithm based on the multivariate survival analyses in patients with advanced hepatocellular carcinoma treated with trans-arterial chemoembolization

Purpose To develop the treatment algorithm from multivariate survival analyses (MVA) in patients with Barcelona clinic liver cancer (BCLC) C (advanced) Hepatocellular carcinoma (HCC) patients treated with Trans-arterial Chemoembolization (TACE). Methods Consecutive unresectable and non-tranplantable patients with advanced HCC, who received DEB TACE were studied. A total of 238 patients (mean age, 62.4yrs) was included in the study. Survivals were analyzed according to different parameters from the time of the 1st DEB TACE. Kaplan Meier and Cox Proportional Hazard model were used for survival analysis. The SS was constructed from MVA and named BCLC C HCC Prognostic (BCHP) staging system (SS). Results Overall median survival (OS) was 16.2 months. In HCC patients with venous thrombosis (VT) of large vein [main portal vein (PV), right or left PV, hepatic vein, inferior vena cava] (22.7%) versus small vein (segmental/subsegmental PV) (9.7%) versus no VT had OSs of 6.4 months versus 20 months versus 22.8 months respectively (p<0.001). On MVA, the significant independent prognostic factors (PFs) of survival were CP class, eastern cooperative oncology group (ECOG) performance status (PS), single HCC<5 cm, site of VT, metastases, serum creatinine and serum alpha-feto protein. Based on these PFs, the BCHP staging system was constructed. The OSs of stages I, II and III were 28.4 months, 11.8 months and 2.4 months accordingly (p<0.001). The treatment plan was proposed according to the different stages. Conclusion On MVA of patients with advanced HCC treated with TACE, significant independent prognostic factors (PFs) of survival were CP class, ECOG PS, single HCC<5 cm or others, site of VT, metastases, serum creatinine and serum alpha-feto protein. New BCHP SS was proposed based on MVA data to identify the suitable advanced HCC patients for TACE treatments.

Transcatheter arterial chemoembolization in recurrent unresectable hepatocellular carcinoma after orthotopic liver transplantation

1Division of Interventional Radiology, Department of Pediatric Radiology, The University of Tennessee Health Science Center, Memphis, TN 38103, USA. 2Division of Interventional Radiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO 63110, USA. 3Division of Interventional Radiology, Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, CT 06510, USA. 4Yale Cancer Center, Yale School of Medicine, New Haven, CT 06510, USA.

Survival in unresectable AJCC stage I and II HCC and the effect of DEB-TACE: SEER versus tertiary cancer center cohort study

AIM To evaluate overall survival (OS) in unresectable American Joint Committee on Cancer (AJCC) stage I/II hepatocellular carcinoma (HCC) treated with drug-eluting-bead transarterial chemoembolization (DEB-TACE) versus best supportive care. MATERIALS & METHODS OS in consecutive patients with AJCC stage I/II unresectable HCC diagnosed in 2005-2010 who underwent DEB-TACE and similar patients from SEER with no surgery/radiation recommended/performed was evaluated. RESULTS Median OS from HCC diagnosis was 28.9 months (DEB-TACE) versus 10.0 months (SEER), p < 0.0001. Median OS was 36.3 months (DEB-TACE) versus 12.0 months (SEER) in AJCC I, and 27.9 months (DEB-TACE) versus 10.0 months (SEER) in AJCC II, p < 0.0001. Significant independent prognostic factors for OS were single primary tumor, no vascular invasion, normal α-fetoprotein and DEB-TACE. CONCLUSION DEB-TACE in patients with unresectable AJCC stage I/II HCC was a significant independent prognostic factor for greater OS in a population-based study.