Phase II Study of Hepatic Arterial Infusion Chemotherapy with Oxaliplatin and 5-Fluorouracil for Advanced Perihilar Cholangiocarcinoma.

Purpose To evaluate the efficacy and safety of hepatic arterial infusion (HAI) of oxaliplatin and 5-fluorouracil for advanced perihilar cholangiocarcinoma (PCC) in this prospective phase II study. Materials and Methods The protocol was approved by the local ethics committee, and all patients gave informed consent. Patients with nonresectable PCC were included in a prospective, open phase II study investigating HAI through interventionally implanted port catheters. HAI consisted of infusions of oxaliplatin 40 mg/m2 for 2 hours, followed by 5-fluorouracil 800 mg/m2 for 22 hours on days 1-3 every 3-4 weeks. A maximum of six cycles of HAI were applied for tumor control patients followed by maintenance with oral capecitabine until tumor progression. The primary end points were tumor response and progression-free survival (PFS). The secondary end points were local PFS, overall survival, and adverse events. Kaplan-Meier methodology and Cox regression analysis were used to evaluate the risk factors for survival. Results Between 2012 and 2015, 37 patients were enrolled. The overall response rate was 67.6% (25 of 37), and the disease control rate was 89.2% (33 of 37). Median PFS, local PFS, and overall survival were 12.2, 25.0, and 20.5 months, respectively. All three survival lengths in patients with periductal infiltrating pattern were found to be significantly longer than those in patients with mass-forming pattern (P < .001, hazard ratio < 0.2). Macroscopic growth patterns (P = .018) and number of HAI cycles (P < .001) were independent risk factors of survival. The most frequent adverse events were grades 1 and 2 gastrointestinal side effects and sensory neuropathy in 31 (83.8%) and 28 (75.7%) patients, respectively. Conclusion HAI with oxaliplatin and 5-fluorouracil may be an encouraging treatment choice for advanced PCC due to its high tumor control, survival benefit, and low toxicity, especially in patients with periductal infiltrating pattern. © RSNA, 2016.

Retrograde embolization technique of the right gastric artery during the implantation of port-catheter system for hepatic arterial infusion chemotherapy.

OBJECTIVE: This study aimed to introduce and evaluate a new embolization technique for the right gastric artery (RGA) during percutaneous implantation of a port-catheter system for hepatic arterial infusion chemotherapy (HAIC). METHODS: From January 2013 to January 2017, 159 patients with unresectable advanced liver cancer underwent percutaneous implantation of a port-catheter system. In 86 of these patients (56 men; aged 28-88 years; mean: 60.6 â€‹± â€‹12.0 years), in whom the RGA was obvious on arteriography, embolization of RGA was attempted using microcoils to protect the gastric mucosa during HAIC. In the first phase (first three years), antegrade embolization of the RGA using a 2.7 Fr microcatheter was performed in 55 patients. In the second phase (next two years), embolization of the RGA was attempted by combining antegrade embolization and retrograde embolization through the left gastric artery (LGA) in 31 patients. The success rates and the incidence of acute gastroduodenal mucosal toxicity (AGMT) in these two groups were compared. RESULTS: The total success rate of the RGA embolization was 70.9%. The success rate was 83.9% in 31 patients who underwent combined antegrade and retrograde embolization, which was significantly higher than that of antegrade embolization alone (63.6%) performed in 55 patients (p â€‹= â€‹0.047). No complications related to embolization of RGA were documented. The incidence of AGMT was 29.1% (16/55) in patients in the first phase, which was significantly higher than that in the patients in the second phase (9.7%, 3/31) (p â€‹= â€‹0.037). CONCLUSION: A combination of retrograde embolization via LGA could increase the success rates of RGA embolization and reduce the incidence of AGMT after HAIC.

Hepatic Arterial Infusion Chemotherapy Using Oxaliplatin Plus 5-Fluorouracil Versus Transarterial Chemoembolization/Embolization for the Treatment of Advanced Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.

PURPOSE: To compare the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) to transarterial chemoembolization/embolization (TACE/TAE) for the treatment of advanced hepatocellular carcinoma (HCC) with major portal vein tumor thrombosis (PVTT). MATERIALS AND METHODS: Forty-six patients with advanced HCC with major PVTT who underwent HAIC or TACE/TAE between April 2013 and April 2017 were included. In the HAIC group (n = 22), oxaliplatin (35-40 mg/m2 for 2 h) and 5-fluorouracil (600-800 mg/m2 for 22 h) on days 1-3 every 4 weeks were administered for a maximum of six serial courses. In the TACE/TAE group (n = 24), an emulsion of epirubicin (40-60 mg) and lipiodol was administered followed by particles (cTACE), or particles alone embolization (TAE). Overall survival (OS), tumor response according to mRECIST, progression-free survival (PFS), and adverse events were investigated. RESULTS: Median OS was 20.8 months in the HAIC group versus 4.0 months in the TACE/TAE group (P < 0.001; hazard ratio [HR], 0.17). The HAIC group showed higher tumor response rates than the TACE/TAE group (59.1% [13/22] vs. 22.7% [5/22]; P = 0.014) and a longer median PFS (9.6 vs. 1.5 months; P < 0.001; HR, 0.09). The Child-Pugh class (P = 0.007) and treatment method (P = 0.002) were independent risk factors of survival. The most frequent grade 3 or worse treatment-related adverse events were liver dysfunction (2 [9.1%] vs. 5 [20.8%]), hematological abnormalities (1 [4.5%] vs. 2 [8.3%]), and fever (1 [4.5%] vs. 4 [16.7%]). One treatment-related death due to acute liver failure occurred 3 days after TACE treatment. CONCLUSION: HAIC may significantly improve OS and provide better tumor control with mild side effects and preserved liver function in patients with advanced HCC with major PVTT compared to TACE/TAE treatment.

Evaluation of percutaneous unilateral trans-femoral implantation of side-hole port-catheter system with coil only fixed-catheter-tip for hepatic arterial infusion chemotherapy.

BACKGROUND: The technique for arterial infusion chemotherapy (HAIC) is not standardized which limits its widely application. The aim of this study was to evaluate the long-term functionality and complications of port-catheter system using percutaneous unilateral trans-femoral implantation with coil only fixed-catheter-tip method. METHODS: From January 2013 to January 2017, 205 consecutive patients (138 men; aged 28-88 years; mean, 59.1 ± 11.2 years) with unresectable malignant liver tumors underwent percutaneous implantation of side-hole infusion port-catheter into hepatic artery using coil only fixed-catheter-tip method via the unilateral femoral artery. Technical success, procedure time, duration of port functionality, and complications of port dysfunction were investigated. RESULTS: Implantation technical success was 98.5% and the procedure time was 59.1 ± 10.2 min. Predictable functionality of the port-catheter system at 6-, 12-, and 24 months were 97.5, 89.9, 70.5%, respectively. Complications of port irreversible dysfunction were hepatic artery obstruction (4.0%), catheter occlusion (3.5%), and catheter dislocation (0.5%). Median 5 HAIC cycles (range: 1-14 cycles) were received via port. CONCLUSION: Percutaneous unilateral trans-femoral implantation of a side-hole port-catheter with coils only fixed-catheter-tip method is a simple and feasible interventional technique for HAIC which offers long-term functionality.

Dual phase cone-beam computed tomography in detecting <3 cm hepatocellular carcinomas during transarterial chemoembolization.

OBJECTIVE: The objective of this study was to evaluate the sensitivity of dual phase cone-beam computed tomography (CBCT) in detecting small (<3 cm in diameter) hepatocellular carcinoma (HCC) tumors during transarterial chemoembolization (TACE). MATERIALS AND METHODS: Twenty-two consecutive patients with unresectable small HCCs in whom TACE was performed were retrospectively evaluated. Contrast CT or contrast magnetic resonance imaging (MRI) was performed in all patients within 1 month prior to the procedure. Dual phase CBCT was performed prior to TACE and lipiodol-CBCT was performed after treatment. The sensitivity of dual phase CBCT in detecting small HCCs was compared to hepatic angiography, contrast enhanced CT and MRI. RESULTS: Seventy HCC tumors with sizes of P < 0.001). CONCLUSIONS: Dual phase CBCT is significantly more sensitive than hepatic angiography, contrast enhanced CT, and MRI in detecting smaller than 3 cm HCC tumors and can be a helpful modality in making accurate planning for treatment of HCC.

Lipiodol retention pattern assessed by cone beam computed tomography during conventional transarterial chemoembolization of hepatocellular carcinoma: accuracy and correlation with response.

BACKGROUND: To investigate accuracy of intraprocedural cone beam computed tomography (CBCT) compared to fluoroscopy for detection of lipiodol retention pattern during conventional transarterial chemoembolization (cTACE) of hepatocellular carcinoma (HCC) and its correlation with short-term response. METHODS: Between September 2013 and July 2014, 29 patients with HCC underwent chemoembolization of 51 tumors (mean diameter 28.1 mm, range 10.0-136.3 mm). Lipiodol retention pattern was assessed by CBCT at the endpoint of cTACE compared by fluoroscopy. Depending on the pattern of tumor covered by lipiodol three classes were defined: complete (more than 90 %, no peripheral defects), moderate (50-90 %, some with or without peripheral defects), and poor (less than 50 %). Tumor response was assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST) based on follow-up contrast enhanced (CE) computed tomography (CT) or magnetic resonance imaging (MRI) obtained 4-6 weeks post-cTACE. Correlations between lipiodol retention patterns on CBCT and fluoroscopy as well as tumor response were assessed using multivariate logistic regression. RESULTS: Of 51 hepatic tumors, 40 (78.4 %) had complete response (CR); 8 (15.7 %) had partial response (PR); 1 (2.0 %) had stable disease (SD); and 2 (3.9 %) had progressive disease (PD). The degree of lipiodol retention scored excellent, moderate, and poor, in fluoroscopic images vs CBCT images were 23 (45.1 %) vs 39 (76.5 %), 19 (37.3 %) vs 11 (21.6 %), and 9 (17.6 %) vs 1 (2.0 %), respectively. Lipiodol retention assessment with CBCT (Az = 0.75) is more accurate than fluoroscopy (Az = 0.54) in predicting target tumor response. Other than lipiodol retention pattern assessed with CBCT (p = 0.01), tumor size (p = 0.04) is an independent predictors of CR. CONCLUSION: CBCT is more accurate than fluoroscopy in classification of lipiodol retention pattern in HCC tumors at the time of cTACE. CBCT could be used as a reliable intra precedural monitoring modality of cTACE.