TACE with degradable starch microspheres (DSM-TACE) as second-line treatment in HCC patients dismissing or ineligible for sorafenib.

OBJECTIVES: To date, there is no approved second-line treatment for patients dismissing sorafenib or ineligible for this treatment, so it would be useful to find an effective alternative treatment option. The aim of our study was to evaluate safety, feasibility and effectiveness of transarterial chemoembolisation with degradable starch microspheres (DSM-TACE) in the treatment of patients with advanced hepatocellular carcinoma (HCC) dismissing or ineligible for multikinase-inhibitor chemotherapy administration (sorafenib) due to unbearable side effects or clinical contraindications. METHODS: Forty consecutive BCLC stage B or C patients (31 male; age, 70.6 ± 13.6 years), with intermediate or locally advanced HCC dismissing or ineligible for sorafenib administration, who underwent DSM-TACE treatment cycle via lobar approach were prospectively enrolled. Tumour response was evaluated on multidetector computed tomography based on mRECIST criteria. Primary endpoints were safety, tolerance and overall disease control (ODC); secondary endpoints were progression-free survival (PFS) and overall survival (OS). RESULTS: Technical success was achieved in all patients. No intra/peri-procedural death/major complications occurred. No signs of liver failure or systemic toxicity were detected. At 1-year follow-up, ODC of 52.5% was registered. PFS was 6.4 months with a median OS of 11.3 months. CONCLUSIONS: DSM-TACE is safe and effective as a second-line treatment in HCC patients dismissing or ineligible for sorafenib. KEY POINTS: • DSM-TACE is safe and effective as second-line treatment in HCC patients dismissing or ineligible for sorafenib • DSM-TACE allows the temporary occlusion of the smaller arterial vessels, improving overall therapeutic effectiveness by reducing the immediate wash-out of the cytostatic agent • DSM-TACE also decreases the risk of systemic toxicity and post-embolic syndrome.

Safety, Feasibility and Technical Considerations from a Prospective, Observational Study-CIREL: Irinotecan-TACE for CRLM in 152 Patients.

CIREL, a prospective, Europe-wide, observational study aimed to assess the real-world feasibility and tolerability of irinotecan-based transarterial chemoembolization (LP-irinotecan TACE) for unresectable colorectal cancer liver metastases with regard to the treatment plan and adverse events (AEs). CIREL enrolled 152 eligible patients (≥18 years) with liver-only or dominant metastases treated with LP-irinotecan TACE following a multidisciplinary tumor board decision. Data were prospectively collected for baseline, the number of planned and performed sessions, and technical information and safety according to CTCAE 4.03/5.0. Results from 351 analyzed treatment sessions showed technical success for 99% of sessions, and 121 patients (79%) completed all planned sessions. Further, 60% of sessions were performed using opioids, 4% intra-arterial anesthetics, and 25% both. Additionally, 60% of patients experienced at least one peri-interventional AE of any grade; 8% of grade 3−4. Occurrence of AEs was related to larger liver-involvement (p < 0.001), bi-lobar disease (p = 0.002), and larger beads (p < 0.001). Using corticosteroids together with antiemetics showed reduced and lower grade vomiting (p = 0.01). LP-irinotecan TACE was tolerated well and had a high proportion of completed treatment plans. This minimally invasive locoregional treatment can be used together with concomitant systemic therapy or ablation.

The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis.

PURPOSE: Transarterial chemoembolisation (TACE) using irinotecan-eluting beads is an additional treatment option for colorectal cancer liver metastases (CRLM) patients that are not eligible for curative treatment approaches. This interim analysis focuses on feasibility of the planned statistical analysis regarding data distribution and completeness, treatment intention, safety and health-related quality of life (HRQOL) of the first 50 patients prospectively enrolled in the CIrse REgistry for LifePearl™ microspheres (CIREL), an observational multicentre study conducted across Europe. METHODS: In total, 50 patients ≥ 18 years diagnosed with CRLM and decided to be treated with irinotecan-eluting LifePearl™ microspheres TACE (LP-irinotecan TACE) by a multidisciplinary tumour board. There were no further inclusion or exclusion criteria. The primary endpoint is the categorisation of treatment intention, and secondary endpoints presented in this interim analysis are safety, treatment considerations and HRQOL. RESULTS: LP-irinotecan TACE was conducted in 42% of patients as salvage therapy, 20% as an intensification treatment, 16% as a first-line treatment, 14% a consolidation treatment and 8% combination treatment with ablation with curative intent. Grade 3 and 4 adverse events were reported by 4% of patients during procedure and by 10% within 30 days. While 38% reported a worse, 62% reported a stable or better global health score, and 54% of patients with worse global health score were treated as salvage therapy patients. CONCLUSION: This interim analysis confirms in a prospective analysis the feasibility of the study, with an acceptable toxicity profile. More patients reported a stable or improved HRQOL than deterioration. Deterioration of HRQOL was seen especially in salvage therapy patients. TRIAL REGISTRATION: NCT03086096.

Balloon-Occluded MWA (b-MWA) Followed by Balloon-Occluded TACE (b-TACE): Technical Note on a New Combined Single-Step Therapy for Single Large HCC.

Purpose To evaluate the feasibility, safety and efficacy of a combined single-step therapy in patients with unresectable single large (> 5 cm) hepatocellular carcinoma (HCC), with balloon-occluded microwave ablation (b-MWA) plus transcatheter arterial balloon-occluded chemoembolization (b-TACE). MATERIALS & METHODS: Five consecutive Child A patients (mean age: 71.4 ± 3.2 yo; range 68-76 yo) with an unresectable single large HCC (> 5 cm) (mean size: 5.7 ± 0.6 cm; range 5.1-6.5 cm) were enrolled in our pilot study. The schedule consisted of percutaneous microwave ablation of the lesion during balloon occlusion of the hepatic artery supplying the tumor (b-MWA), followed by TACE under the occlusion of feeding arteries by a microballoon catheter (b-TACE). Adverse events and intra- and peri-procedural complications were clinically assessed. Early local efficacy was evaluated on 1- and 6-month follow-up multiphasic computed tomography (CT) on the basis of m-RECIST criteria. RESULTS: Technical success was obtained in all procedures. No major complications occurred. A mean necrotic area of 6.8 ± 0.47 cm (range 6.3-7.4 cm) was obtained, with a complete response at 1-month follow-up obtained in 4 out of 5 lesions, with 1 partial response (less than 30% of residual tumor), successfully treated with a single TACE treatment. No residual tumor or local recurrence was registered at 6-month CT follow-up. CONCLUSIONS: Our preliminary experience seems to demonstrate that b-MWA plus b-TACE could be a safe and effective combined therapy for unresectable large HCC lesions, allowing a high rate of local response also in lesion exceeding 5 cm in size.

Multidetector-row CT imaging evaluation of superior and inferior vena cava normal anatomy and caval variants: Report of our cases and literature review with embryologic correlation.

OBJECTIVE: To assess the potential of multidetector-row computed tomography imaging and its reformations in the evaluation of the superior and inferior vena cava normal anatomy and their anatomical variants, and to make a brief review of caval embryogenesis and developmental errors. METHODS: We retrospectively reviewed a total of 1000 whole-body computed tomography scans performed between January 2010 and December 2016 to assess the normal superior and inferior vena cava anatomy and their variants. RESULTS: The normal superior and inferior vena cava anatomy was found in 88.9% of patients, whereas multiple variants were found, ranging from the superior or inferior vena cava duplication, to the azygos continuation of the inferior vena cava. CONCLUSIONS: Computed tomography is a powerful tool to analyse superior and inferior vena cava anatomical variants. The knowledge and assessment of normal caval anatomy and of its anatomical variants is mandatory in the correct pre-operative planning in surgical and radiological interventions. Knowledge of caval variants is helpful in the differential diagnosis of abdominal or mediastinal masses, to avoid misdiagnosis, as well as in the screening of associated congenital pathologic conditions.

Radiofrequency thermal ablation of renal graft neoplasms: A literature review.

Neoplasms occurring in renal grafts represent a relatively novel and rare condition, whose treatment has not been standardized yet. Radiofrequency thermal ablation (RFA) of renal graft neoplasms is a nephron-sparing treatment, reported to be safe and effective. However, even in the RFA field, there is no procedural standardization. In this review of the literature, mostly composed by case reports and case series, we aim to assess efficacy and complication rates of RFA in the treatment of kidney graft neoplasms, and summarize the various procedural protocols found in the literature, using an easy-to-read point format. We performed a literature search in PubMed/MEDLINE with an overall description of 66 renal graft lesion treated with RFA, with a mean follow-up of 16.3 months (range 3-54.3). Technical success was achieved in all cases, with only one recurrence reported (1/66; 1.5%), occurring at 6-months follow-up. Complications occurred in 11 (11/66; 16.7%) patients. Based on literature review, RFA of renal graft neoplasms seems to be a feasible, safe, and effective treatment.

Critical review of multidisciplinary non-surgical local interventional ablation techniques in primary or secondary liver malignancies.

Local non-surgical interventional percutaneous ablation represents nowadays an important part of the potential treatment strategies. Although surgical ablation represents the gold standard, in the past decade there was an expansion in the use of non-surgical ablative techniques: radiofrequency, microwave, laser, cryoablation, irreversible electroporation, and interventional radiotherapy (brachytherapy) in primary as well as secondary liver cancers. With the growing experience in the field, there was implemented a new pillar for cancer treatment, together with surgery, chemotherapy as well as radiotherapy, so-called interventional oncology (IO). To date, there are no published papers regarding a comparative interdisciplinary evaluation of all these non-surgical interventional local ablation therapies. Our paper offers a critical interdisciplinary overview of the treatments in both primary and secondary liver tumors, including from a cost-effective point of view. Furthermore, the present status of education in IO and a comparison of actual economic aspects of the treatments are also provided.

Interventional oncology treatments for unresectable early stage HCC in patients with a high risk for intraprocedural bleeding: Is a single-step combined therapy safe and feasible?

PURPOSE: This study was designed to assess the feasibility and safety of a single-step combined therapy using radiofrequency ablation and transarterial chemoembolization (RFA + TACE) in patients with hepatocellular carcinoma (HCC) and uncontrolled coagulopathy. The study also aimed to compare the effectiveness of this approach with TACE alone, performed in a control group. MATERIAL AND METHODS: One hundred and forty-three consecutive cirrhotic patients having a single HCC < 8 cm were enrolled in this observational prospective single-center study from January 2010 to June 2017 and were divided, according to coagulation tests, into three groups (A: low risk; B: intermediate risk and C: high risk of bleeding). The feasibility and safety of a single-step combined treatment (RFA followed by TACE) were evaluated in terms of technical success rate, periprocedural complications, and laboratory values variations. Tumor response obtained at 1-month CT follow-up for group C was compared with that of control group, composed by 16 matched patients with severe coagulopathy and single HCC < 8 cm, who underwent only TACE in a previous period, performed by the same operator. RESULTS: Technical success was achieved in all patients, without any major complications. Minor complications rate was significantly higher in group C after RFA; however, the patients were successfully treated with subsequent TACE therapy, without any differences between pre- and post-procedural laboratory values. One-month complete response rates were similar in all the three groups; however, the response rates of group C were significantly higher as compared to that of the control TACE Group (p < .001). CONCLUSION: The single-step RFA plus TACE therapy allows expansion of the indication for percutaneous thermal ablation, allowing to also include cases previously contraindicated due to the procedural high-risk of complications associated with bleeding, thus improving short-term patient outcome.