R. Iezzi

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

ObjectivesTo 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.MethodsForty 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).ResultsTechnical 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.ConclusionsDSM-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

Radiofrequency thermal ablation of renal graft neoplasms: case series and literature review

PURPOSEnTo evaluate the feasibility, safety, and effectiveness of minimally invasive percutaneous radiofrequency thermal ablation (RFA) in renal graft neoplasms.nnnMETHODSnThree patients with transplanted kidney neoplasms were treated in our Centre with US-guided RFA; pre- and post-procedural serum creatinine levels were registered, as well as peri-procedural and long-term minor and major complications and deaths. Patients underwent laboratory and CT follow-up to the renal function and tumour response evaluation, respectively.nnnRESULTSnAll patients were successfully treated, with a complete necrosis of the target lesion, a low rate of complications, and no significative alterations in post-procedural serum creatinine levels. Two patients underwent a 1-year follow-up, with stable complete response.nnnCONCLUSIONSnRFA of renal graft neoplasms is a feasible, safe, and effective treatment. This procedure should be considered as a viable therapeutic option, granting good results, and preserving renal function. This article is protected by copyright. All rights reserved.

Transcatheter Arterial Embolization for Bleeding Peptic Ulcers: A Multicenter Study

PurposeTo investigate the outcomes of transcatheter arterial embolization (TAE) for the treatment of peptic ulcer bleeding (PUB).Materials and MethodsThis is a retrospective, multicenter study, which investigated all patients who underwent TAE for the treatment of severe upper gastrointestinal hemorrhage from peptic ulcers in five European centers, between January 1, 2012 and May 1, 2017. All patients had undergone failed endoscopic hemostasis. Forty-four patients (male; mean age 74.0u2009±u200911.1xa0years, range 49–94), with bleeding from duodenum (36/44; 81.8%) or gastric ulcer (8/44; 18.2%) were followed up to 3.5xa0years (range 2–1354xa0days). In 42/44 cases, bleeding was confirmed by pre-procedural CT angiography. In 50% of the cases, coils were deployed, while in the remaining glue, microparticles, gel foam and combinations of the above were used. The study’s outcome measures were 30-day survival technical success (occlusion of feeding vessel and/or no extravasation at completion DSA), overall survival, bleeding relapse and complication rates.ResultsThe technical success was 100%. The 30-day survival rate was 79.5% (35/44 cases). No patients died due to ongoing or recurrent hemorrhage. Re-bleeding occurred in 2/44 cases (4.5%) and was successfully managed with repeat TAE (one) or surgery (one). The rate of major complications was 4.5% (2/44; one acute pancreatitis and one partial pancreatic ischemia), successfully managed conservatively. According to Kaplan–Meier analysis survival was 71.9% at 3.5xa0years.ConclusionsTAE for the treatment of PUB was technically successful in all cases and resulted in high clinical success rate. Minimal re-bleeding rates further highlight the utility of TAE as the second line treatment of choice, after failed endoscopy.

DEBIRI plus capecitabine: a treatment option for refractory liver-dominant metastases from colorectal cancer

AIMnThis single institution Phase II study evaluated drug-eluting beads loaded with irinotecan (DEBIRI) plus capecitabine in pretreated patients with colorectal cancer liver metastases.nnnPATIENTS & METHODSnForty patients with liver-limited or liver-dominant disease, who have failed at least two previous lines of chemotherapy, underwent either four DEBIRI at 2-week interval or two DEBIRI every 4 weeks for bilobar or single-lobe metastases, respectively. Capecitabine was given at 1000 mg/m2 twice daily on days 1-14 every 3 weeks.nnnRESULTSnSeven partial responses and 12 stable diseases were observed, achieving a disease control rate of 47.5%. Median progression-free survival and overall survival resulted 4 and 8 months, respectively. Grade 3 adverse events occurred in 6/40 points (15%) of patients.nnnCONCLUSIONnDEBIRI plus capecitabine is a valid treatment option for heavily pretreated patients with colorectal cancer liver metastases.

Single-step multimodal locoregional treatment for unresectable hepatocellular carcinoma: balloon-occluded percutaneous radiofrequency thermal ablation (BO-RFA) plus transcatheter arterial chemoembolization (TACE)@@@Terapia loco-regionale multimodale dell’epatocarcinoma non resecabile con approccio single-step: termoablazione a radiofrequenza durante occlusione temporanea dell’arteria epatica con catetere da PTA (BO-RFA) plus chemioembolizzazione arteriosa transcatetere (TACE)

PurposeThis study was undertaken to evaluate the feasibility, safety and efficacy of a new combined single-step therapy in patients with unresectable multinodular unilobar hepatocellular carcinoma (HCC), with at least one lesion >3 cm, with balloon-occluded radiofrequency ablation (BO-RFA) plus transcatheter arterial chemoembolization (TACE) of the main lesion and TACE of the other lesions. The second purpose of our study was to compare the initial effects in terms of tumour necrosis of this new combined therapy with those obtained in a matched population treated with TACE alone in a singlestep treatment in our centre in the previous year.Methods and materialsThis pilot study was approved by the institutional review board, and informed consent was obtained from all patients. Ten consecutive patients with multinodular (two to six nodules) unilobar unresectable HCC and with a main target lesion >3 cm (range, 3.5–6 cm) not suitable for curative therapy were enrolled in our single-centre multidisciplinary pilot study. The schedule consisted of percutaneous RFA (single 3-cm monopolar needle insertion) of the target lesion during occlusion of the hepatic artery supplying the tumour, followed by selective TACE, plus lobar TACE for other lesions (450-mg carboplatin and lipiodol plus temporary embolisation with SPONGOSTAN). Adverse events and intra- and periprocedural complications were clinically assessed. Early local efficacy was evaluated on 1-month follow-up multiphasic computed tomography (CT) on the basis of the Modified Response Evaluation Criteria in Solid Tumors (m-RECIST). A separate evaluation of target lesions in terms of enhancement, necrotic diameter and presence and distribution of lipiodol uptake was also performed.ResultsNo major complications occurred. Overall technical success, defined as complete devascularisation of all nodules during the arterial phase, was achieved in seven of 10 patients, with three cases of partial response (persistence of small hypervascular nodules). When considering only target lesions, technical success was obtained in all patients, with a nonenhancing area corresponding in shape to the previously identified HCC (necrotic diameter, 3.5–5 cm) and with circumferential peripheral lipiodol uptake (safety margin) of at least 0.5 cm (0.5–1.3cm).ConclusionsTACE and BO-RFA, plus TACE in a singlestep approach seems to be a safe and effective combined therapy for treating advanced, unresectable HCC lesions, allowing a high rate of complete local response to be achieved in large lesions also.RiassuntoObiettivoValutare nei pazienti affetti da epatocarcinoma multinodulare unilobare non resecabile, con almeno una lesione con diametro >3 cm, la fattibilità, la sicurezza e l’efficacia di una nuova terapia combinata con RFA durante occlusione arteriosa con catetere per PTA (BO-RFA) seguita da TACE della lesione principale e TACE delle restanti lesioni, in un’unica seduta. Endpoint secondario del nostro studio è stata la comparazione degli effetti iniziali in termini di necrosi tumorale delle lesioni trattate con questa nuova terapia combinata con quelli ottenuti in una popolazione di confronto trattata nel nostro centro nell’anno precedente con sola TACE.Materiali e metodiIl nostro studio pilota è stato approvato dal comitato etico e dall’autorità competente, e per tutti i pazienti è stato ottenuto un consenso informato scritto. Dieci pazienti consecutivi affetti da HCC multinodulare (2–6 noduli) unilobare, non resecabile e con una lesione target di diametro >3 cm di diametro (range 3,5–6 cm), non suscettibile di trattamenti di tipo curativo, sono stati arruolati nel nostro studio pilota monocentrico multidisciplinare. Il piano di trattamento è stato: RFA (ago con punta esposta da 3 cm) della lesione target durante occlusione endovascolare dell’arteria epatica afferente al tumore con catetere per PTA seguita da una TACE selettiva della stessa, più una TACE lobare per il trattamento delle altre lesioni (450 mg di carboplatino più lipiodol associato a embolizzazione temporanea con spongostan). Gli eventi avversi, cosÌ come le complicanze intra- e periprocedurali sono stati valutati clinicamente. L’efficacia locale in fase precoce è stata valutata mediante TC multifasica eseguita a un mese dalla procedura, sulla base dei criteri m-RECIST; separatamente è stata, inoltre, effettuata una valutazione delle lesioni target in termini di enhancement, diametro dell’area necrotica e presenza e distribuzione di lipiodol.RisultatiNon si sono verificate complicanze maggiori. Il successo tecnico complessivo, definito come la completa devascolarizzazione di tutti i noduli in fase arteriosa, è stato ottenuto in 7/10 pazienti con 3 risposte parziali (persistenza di piccoli noduli ipervascolarizzati). Considerando solo le lesioni target, il successo tecnico è stato raggiunto in tutti i pazienti, con la presenza di un’area priva di enhancement nella zona corrispondente al precedente nodulo di HCC (diametro necrotico 3,5–5 cm), con un accumulo periferico di lipiodol circonferenziale (margine di sicurezza), di almeno 0,5 cm (0,5–1,3 cm).ConclusioniIl trattamento combinato con BO-RFA seguita da TACE, in un approccio single-step, sembra essere una terapia sicura ed efficace per il trattamento dell’HCC avanzato non resecabile, permettendo di ottenere un alto tasso di risposta locale completa anche in lesioni di grandi dimensioni.

Terapia loco-regionale multimodale dell'epatocarcinoma non resecabile con approccio single-step: termoablazione a radiofrequenza durante occlusione temporanea dell'arteria epatica con catetere da PTA (BO-RFA) plus chemioembolizzazione arteriosa transcatetere (TACE)

PurposeThis study was undertaken to evaluate the feasibility, safety and efficacy of a new combined single-step therapy in patients with unresectable multinodular unilobar hepatocellular carcinoma (HCC), with at least one lesion >3 cm, with balloon-occluded radiofrequency ablation (BO-RFA) plus transcatheter arterial chemoembolization (TACE) of the main lesion and TACE of the other lesions. The second purpose of our study was to compare the initial effects in terms of tumour necrosis of this new combined therapy with those obtained in a matched population treated with TACE alone in a singlestep treatment in our centre in the previous year.Methods and materialsThis pilot study was approved by the institutional review board, and informed consent was obtained from all patients. Ten consecutive patients with multinodular (two to six nodules) unilobar unresectable HCC and with a main target lesion >3 cm (range, 3.5–6 cm) not suitable for curative therapy were enrolled in our single-centre multidisciplinary pilot study. The schedule consisted of percutaneous RFA (single 3-cm monopolar needle insertion) of the target lesion during occlusion of the hepatic artery supplying the tumour, followed by selective TACE, plus lobar TACE for other lesions (450-mg carboplatin and lipiodol plus temporary embolisation with SPONGOSTAN). Adverse events and intra- and periprocedural complications were clinically assessed. Early local efficacy was evaluated on 1-month follow-up multiphasic computed tomography (CT) on the basis of the Modified Response Evaluation Criteria in Solid Tumors (m-RECIST). A separate evaluation of target lesions in terms of enhancement, necrotic diameter and presence and distribution of lipiodol uptake was also performed.ResultsNo major complications occurred. Overall technical success, defined as complete devascularisation of all nodules during the arterial phase, was achieved in seven of 10 patients, with three cases of partial response (persistence of small hypervascular nodules). When considering only target lesions, technical success was obtained in all patients, with a nonenhancing area corresponding in shape to the previously identified HCC (necrotic diameter, 3.5–5 cm) and with circumferential peripheral lipiodol uptake (safety margin) of at least 0.5 cm (0.5–1.3cm).ConclusionsTACE and BO-RFA, plus TACE in a singlestep approach seems to be a safe and effective combined therapy for treating advanced, unresectable HCC lesions, allowing a high rate of complete local response to be achieved in large lesions also.RiassuntoObiettivoValutare nei pazienti affetti da epatocarcinoma multinodulare unilobare non resecabile, con almeno una lesione con diametro >3 cm, la fattibilità, la sicurezza e l’efficacia di una nuova terapia combinata con RFA durante occlusione arteriosa con catetere per PTA (BO-RFA) seguita da TACE della lesione principale e TACE delle restanti lesioni, in un’unica seduta. Endpoint secondario del nostro studio è stata la comparazione degli effetti iniziali in termini di necrosi tumorale delle lesioni trattate con questa nuova terapia combinata con quelli ottenuti in una popolazione di confronto trattata nel nostro centro nell’anno precedente con sola TACE.Materiali e metodiIl nostro studio pilota è stato approvato dal comitato etico e dall’autorità competente, e per tutti i pazienti è stato ottenuto un consenso informato scritto. Dieci pazienti consecutivi affetti da HCC multinodulare (2–6 noduli) unilobare, non resecabile e con una lesione target di diametro >3 cm di diametro (range 3,5–6 cm), non suscettibile di trattamenti di tipo curativo, sono stati arruolati nel nostro studio pilota monocentrico multidisciplinare. Il piano di trattamento è stato: RFA (ago con punta esposta da 3 cm) della lesione target durante occlusione endovascolare dell’arteria epatica afferente al tumore con catetere per PTA seguita da una TACE selettiva della stessa, più una TACE lobare per il trattamento delle altre lesioni (450 mg di carboplatino più lipiodol associato a embolizzazione temporanea con spongostan). Gli eventi avversi, cosÌ come le complicanze intra- e periprocedurali sono stati valutati clinicamente. L’efficacia locale in fase precoce è stata valutata mediante TC multifasica eseguita a un mese dalla procedura, sulla base dei criteri m-RECIST; separatamente è stata, inoltre, effettuata una valutazione delle lesioni target in termini di enhancement, diametro dell’area necrotica e presenza e distribuzione di lipiodol.RisultatiNon si sono verificate complicanze maggiori. Il successo tecnico complessivo, definito come la completa devascolarizzazione di tutti i noduli in fase arteriosa, è stato ottenuto in 7/10 pazienti con 3 risposte parziali (persistenza di piccoli noduli ipervascolarizzati). Considerando solo le lesioni target, il successo tecnico è stato raggiunto in tutti i pazienti, con la presenza di un’area priva di enhancement nella zona corrispondente al precedente nodulo di HCC (diametro necrotico 3,5–5 cm), con un accumulo periferico di lipiodol circonferenziale (margine di sicurezza), di almeno 0,5 cm (0,5–1,3 cm).ConclusioniIl trattamento combinato con BO-RFA seguita da TACE, in un approccio single-step, sembra essere una terapia sicura ed efficace per il trattamento dell’HCC avanzato non resecabile, permettendo di ottenere un alto tasso di risposta locale completa anche in lesioni di grandi dimensioni.

P.04.15 NEW THERAPEUTIC PERSPECTIVES FOR MANAGEMENT OF ADVANCED HEPATOCELLULAR CARCINOMA WITH HEPATIC ARTERIOVENOUS FISTULA: BALLOON-OCCLUDED PERCUTANEOUS RADIO-FREQUENCY THERMAL ABLATION (RFA) PLUS TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE)

NEW THERAPEUTIC PERSPECTIVES FORMANAGEMENT OF ADVANCED HEPATOCELLULAR CARCINOMAWITH HEPATIC ARTERIOVENOUS FISTULA: BALLOON-OCCLUDED PERCUTANEOUS RADIO-FREQUENCY THERMAL ABLATION (RFA) PLUS TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) V. Cesario ∗ ,1, R. Iezzi 2, M.C. Campanale1 , E. Rinninella1 , F.R. Ponziani1, T.A. Di Rienzo1, F. Barbaro1 , B.E. Annicchiarico1 , M. Siciliano1 , M. Pompili 1, G.L. Rapaccini 1 , A. Grieco1, L. Miele1 , A. Milani 1 , L. Riccardi 1 , M.A. Zocco1, M. Santoro2, M. La Torre2, A.M. De Gaetano2 , G.B. Gasbarrini 3 , L. Bonomo2, A. Gasbarrini 1 1Medicina Interna, Ucsc, Policlinico Gemelli, Roma, Italy; 2Radiologia, Ucsc, Policlinico Gemelli, Roma, Italy; 3Fondazione Ricerca In Medicina, Bologna, Italy

634 BALLOON-OCCLUDED PERCUTANEOUS RADIO-FREQUENCY THERMAL ABLATION (RFA) PLUS TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE): A NEW COMBINED SINGLE-STEP THERAPY FOR TREATMENT OF MULTINODULAR UNRESECTABLE HEPATOCELLULAR CARCINOMA

Poster: ECR 2011 / C-1782 / Balloon-occluded percutaneous radio-frequency thermal ablation (RFA) plus transcatheter arterial chemoembolization (TACE): a new combined single-step therapy for treatment of unresectable hepatocellular carcinoma by: R. Iezzi, G. L. Rapaccini, A. M. De Gaetano, M. Pompili, A. Gasbarrini, L. Bonomo; Rome/IT