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F-37 Sorafenib versus 90Y-radioembolization: a preliminary study on tolerability and survival in patients with advanced mono-lobar hepatocellular carcinoma
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Abstracts of the 46th A.I.S.F. Annual Meeting 2013 / Digestive and Liver Disease 45S (2013), S1–S48
vs. G3); SSP-002021 increased inulin clearance (GFR) and natriuresis over the 13th–14th weeks of CCl4 (P<0.03 vs. G3). Reduction in catecholamines serum levels paralleled natriuretic responses in G4 and G5. Both α2 agonists blunted the hyper-reninism found in G2 and G3 over the 13th-14th weeks of CCl4 . α2 agonists reduce adrenergic function and secondary aldosteronism and improve natriuresis in cirrhotic refractory ascites. SSP-002021 prevents GFR from decaying in advanced liver cirrhosis.
F-36 Transarterial chemoembolization with drug-eluting beads (DEB TACE) for BCLC-A hepatocellular carcinoma (HCC): a radical option? M.A. Manini 1 , M. Iavarone 1 , L. Martinetti 2 , A. Sangiovanni 1 , R. Romeo 1 , E. Grassi 1 , S. Crespi 2 , M. Colombo 1 , A. Nicolini 2 1 1st
Division of Gastroenterology Fondazione IRCCS Cà Granda Maggiore Hospital, University of Milan, Milan, Italy; 2 Division of Radiology, Fondazione IRCCS Cà Granda Maggiore Hospital, University of Milan, Milan, Italy Background and aim: TACE is the recommended treatment strategy for patients with intermediate stage (BCLC B/Milan-out status) HCC. Its role in early HCC (BCLC A/Milan-in status) unsuitable for resection or locoregional ablation is partially known and particularly no data are available for TACE with drug-eluting beads (DEB TACE). We evaluated safety and rates of radiological response to DEB TACE in BCLC A patients. Methods: All consecutive patients with a first diagnosis of a BCLC A HCC unsuitable for resection or locoregional ablation, who underwent DEB TACE between October 2005 and January 2011, were evaluated. DEB TACE was carried out by an “on demand” protocol until complete tumor devascularization (mRecist). After a complete response (CR), CT scan was repeated every 3 months the first year after treatment and every 6 months thereafter for the next 2 years. Results: Forty-three patients (77% males, 64 years, 63% HCV, 65% ChildPugh A) with 59 HCC nodules (65% single, mean diameter 2.4 ranged 1.0–5.0 cm) underwent DEB TACE without any significant treatment-related adverse event. CR was obtained in 21 (49%) patients, maintained after 7 months in 11 (26%) and at the end of 21 months of median follow-up (range 12–60 months) in 10 (23%). The overall cumulative progression to Milan-out status rates at 6, 12, 18 and 24 months were 7%, 28%, 46% and 58%, respectively. Milan-in status was maintained for a median period of 20 months. Baseline AFP value >200 ng/mL and multifocal HCC were independent prognostic factors for the progression to Milan-out status (p=0.014 and p=0.017, respectively). Conclusion: DEB TACE is potentially a radical treatment modality for BCLC A patients competing for effective bridge therapy in the waiting list for liver transplantation. Patients with AFP value <200 ng/mL and/or with monofocal HCC are likely to benefit most of this therapy.
F-37 Sorafenib versus 90 Y-radioembolization: a preliminary study on tolerability and survival in patients with advanced mono-lobar hepatocellular carcinoma S. Gaia 1 , M. Tabone 2 , A. Cantamessa 1 , D. Campion 1 , P. Carucci 1 , M. Grosso 3 , A. Risso 1 , P.R. Brunocilla 1 , A. Calvo 4 , F. Brunello 1 , M. Rizzetto 1 1 Department of Gastro-Hepatology, Molinette Hospital, University of Turin, Turin, Italy; 2 Department of Gastroenterology, Mauriziano Hospital of Turin, Turin, Italy; 3 Department of Radiology, S. Croce e Carle Hospital of Cuneo, Cuneo, Italy; 4 Department of Interventional Radiology, Mauriziano Hospital of Turin, Turin, Italy
Introduction: Sorafenib and 90 Y-radioembolization (TARE) are the optional therapies for advanced hepatocellular carcinoma (HCC). Aim: To evaluate survival and tolerability of sorafenib or TARE in patients with advanced HCC. Materials and methods: Data from our prospective database were analyzed. Inclusion criteria: Child-Pugh A liver cirrhosis with mono-lobar HCC; BCLC
stage B or C with or without portal thrombosis; M0, N0/N1; treatment with sorafenib for more than 60 days or with TARE (1–2 sessions); follow-up longer than 180 days. Liver-related complications, side effects and survival (Kaplan-Mayer curves) were analyzed. Results: Between January 2008 and November 2012, 137 patients received sorafenib and 30 were included: 26 male; median age: 69 years (range: 32–82); ECOG 0; median tolerated drug dose: 800 mg (200–800); median treatment time: 4.7 months (range: 2–23.4). Between May 2011 and November 2012, 29 patients underwent TARE and 19 were included: 19 male; median age: 69 years (range: 51–79); ECOG 0; treated with 1 (18/29) or 2 sessions. Among patients treated with sorafenib, 93% (28/30) complained of mild to moderate side effects (mostly asthenia, hand-foot skin syndrome, diarrhea, nausea). After TARE 21% (4/19) of patients experienced mild abdominal symptoms (nausea, vomiting). Liver function worsened (Child-Pugh ≥B) in 26% (8/30) of sorafenib and in 16% (3/19) of TARE group after 30–60 days from therapy. Overall 28 deaths occurred (22 sorafenib, 6 TARE). Median overall survival was 10.7 months (95% CI: 8.9–12.5) with sorafenib and 12.2 months (95% CI: 8.3–16) with TARE (p>0.05). Cumulative probability of survival at 6–12–16 months was 83.3–41.8–23.9% with sorafenib versus 94.6–39.1–39.1% with TARE (p=0.41). Conclusions: Patients treated with sorafenib had a higher rate of side effects comparing with TARE. Median overall survival in sorafenib group was comparable to the literature data and similar to those of TARE group. Further investigations are needed to evaluate clinical results and costs.
F-38 Chubby is beautiful: subcutaneous fat area as predictor of better survival in patients with HCC treated with sorafenib A. De Santis, C. Iegri, G. Gallusi, M. Di Martino, M. Lupo, C. Bassanelli, M. Forlino, C. Di Ciesco Gatroenterology Division, Department of Clinical Medicine, “La Sapienza” University of Rome, Rome, Italy Background: Sorafenib is a highly lipophilic molecule. So, we supposed that in well nourished pts, Sorafenib could be stored and then steadily released thus maintaining long-term higher plasma levels than in underweight pts. Aim: To evaluate a potential relationship between subcutaneous (SFA) and visceral fat area (VFA), and survival in pts with advanced HCC treated with Sorafenib. Method: SFA and VFA were retrospectively measured at the level of the umbilicus, as previously described, on baseline CT scan of 58 pts with HCC candidates to Sorafenib. Results: Given the absence of reference interval of SFA and VFA in literature, the values were dichotomized using the median of observed distribution as the cut-off (≤ or >14061 mm2 – SFA – and ≤ or >11534 mm2 – VFA). There were no differences in CP score, Meld score, BCLC and PS between pts with SFA and VFA values above the cut-off and pts under cut off. Time to progression (TTP) was longer in pts with higher SFA and VFA although not significantly. In pts with higher SFA mean survival was significantly longer (319.3±244.4 days vs. 194.3±224.4 d; p=0.04). Also in pts with higher VFA the mean survival was longer but not significantly. At multivariate analysis SFA was confirmed as the only independent predictive factors of better survival (Regression coefficient: –0.000059; CI: –0.000118–0; RR: 0.99; p=0.04). Conclusion: Our study suggests a role of SFA as a predictor of better survival in pts treated with Sorafenib. So, the maintenance of nutritional status during Sorafenib treatment seems to be an important goal. Would be very attractive studying the possible correlation between body fat content and the Sorafenib plasma levels.
Abstracts of the 46th A.I.S.F. Annual Meeting 2013 / Digestive and Liver Disease 45S (2013), S1–S48
vs. G3); SSP-002021 increased inulin clearance (GFR) and natriuresis over the 13th–14th weeks of CCl4 (P<0.03 vs. G3). Reduction in catecholamines serum levels paralleled natriuretic responses in G4 and G5. Both α2 agonists blunted the hyper-reninism found in G2 and G3 over the 13th-14th weeks of CCl4 . α2 agonists reduce adrenergic function and secondary aldosteronism and improve natriuresis in cirrhotic refractory ascites. SSP-002021 prevents GFR from decaying in advanced liver cirrhosis.
F-36 Transarterial chemoembolization with drug-eluting beads (DEB TACE) for BCLC-A hepatocellular carcinoma (HCC): a radical option? M.A. Manini 1 , M. Iavarone 1 , L. Martinetti 2 , A. Sangiovanni 1 , R. Romeo 1 , E. Grassi 1 , S. Crespi 2 , M. Colombo 1 , A. Nicolini 2 1 1st
Division of Gastroenterology Fondazione IRCCS Cà Granda Maggiore Hospital, University of Milan, Milan, Italy; 2 Division of Radiology, Fondazione IRCCS Cà Granda Maggiore Hospital, University of Milan, Milan, Italy Background and aim: TACE is the recommended treatment strategy for patients with intermediate stage (BCLC B/Milan-out status) HCC. Its role in early HCC (BCLC A/Milan-in status) unsuitable for resection or locoregional ablation is partially known and particularly no data are available for TACE with drug-eluting beads (DEB TACE). We evaluated safety and rates of radiological response to DEB TACE in BCLC A patients. Methods: All consecutive patients with a first diagnosis of a BCLC A HCC unsuitable for resection or locoregional ablation, who underwent DEB TACE between October 2005 and January 2011, were evaluated. DEB TACE was carried out by an “on demand” protocol until complete tumor devascularization (mRecist). After a complete response (CR), CT scan was repeated every 3 months the first year after treatment and every 6 months thereafter for the next 2 years. Results: Forty-three patients (77% males, 64 years, 63% HCV, 65% ChildPugh A) with 59 HCC nodules (65% single, mean diameter 2.4 ranged 1.0–5.0 cm) underwent DEB TACE without any significant treatment-related adverse event. CR was obtained in 21 (49%) patients, maintained after 7 months in 11 (26%) and at the end of 21 months of median follow-up (range 12–60 months) in 10 (23%). The overall cumulative progression to Milan-out status rates at 6, 12, 18 and 24 months were 7%, 28%, 46% and 58%, respectively. Milan-in status was maintained for a median period of 20 months. Baseline AFP value >200 ng/mL and multifocal HCC were independent prognostic factors for the progression to Milan-out status (p=0.014 and p=0.017, respectively). Conclusion: DEB TACE is potentially a radical treatment modality for BCLC A patients competing for effective bridge therapy in the waiting list for liver transplantation. Patients with AFP value <200 ng/mL and/or with monofocal HCC are likely to benefit most of this therapy.
F-37 Sorafenib versus 90 Y-radioembolization: a preliminary study on tolerability and survival in patients with advanced mono-lobar hepatocellular carcinoma S. Gaia 1 , M. Tabone 2 , A. Cantamessa 1 , D. Campion 1 , P. Carucci 1 , M. Grosso 3 , A. Risso 1 , P.R. Brunocilla 1 , A. Calvo 4 , F. Brunello 1 , M. Rizzetto 1 1 Department of Gastro-Hepatology, Molinette Hospital, University of Turin, Turin, Italy; 2 Department of Gastroenterology, Mauriziano Hospital of Turin, Turin, Italy; 3 Department of Radiology, S. Croce e Carle Hospital of Cuneo, Cuneo, Italy; 4 Department of Interventional Radiology, Mauriziano Hospital of Turin, Turin, Italy
Introduction: Sorafenib and 90 Y-radioembolization (TARE) are the optional therapies for advanced hepatocellular carcinoma (HCC). Aim: To evaluate survival and tolerability of sorafenib or TARE in patients with advanced HCC. Materials and methods: Data from our prospective database were analyzed. Inclusion criteria: Child-Pugh A liver cirrhosis with mono-lobar HCC; BCLC
stage B or C with or without portal thrombosis; M0, N0/N1; treatment with sorafenib for more than 60 days or with TARE (1–2 sessions); follow-up longer than 180 days. Liver-related complications, side effects and survival (Kaplan-Mayer curves) were analyzed. Results: Between January 2008 and November 2012, 137 patients received sorafenib and 30 were included: 26 male; median age: 69 years (range: 32–82); ECOG 0; median tolerated drug dose: 800 mg (200–800); median treatment time: 4.7 months (range: 2–23.4). Between May 2011 and November 2012, 29 patients underwent TARE and 19 were included: 19 male; median age: 69 years (range: 51–79); ECOG 0; treated with 1 (18/29) or 2 sessions. Among patients treated with sorafenib, 93% (28/30) complained of mild to moderate side effects (mostly asthenia, hand-foot skin syndrome, diarrhea, nausea). After TARE 21% (4/19) of patients experienced mild abdominal symptoms (nausea, vomiting). Liver function worsened (Child-Pugh ≥B) in 26% (8/30) of sorafenib and in 16% (3/19) of TARE group after 30–60 days from therapy. Overall 28 deaths occurred (22 sorafenib, 6 TARE). Median overall survival was 10.7 months (95% CI: 8.9–12.5) with sorafenib and 12.2 months (95% CI: 8.3–16) with TARE (p>0.05). Cumulative probability of survival at 6–12–16 months was 83.3–41.8–23.9% with sorafenib versus 94.6–39.1–39.1% with TARE (p=0.41). Conclusions: Patients treated with sorafenib had a higher rate of side effects comparing with TARE. Median overall survival in sorafenib group was comparable to the literature data and similar to those of TARE group. Further investigations are needed to evaluate clinical results and costs.
F-38 Chubby is beautiful: subcutaneous fat area as predictor of better survival in patients with HCC treated with sorafenib A. De Santis, C. Iegri, G. Gallusi, M. Di Martino, M. Lupo, C. Bassanelli, M. Forlino, C. Di Ciesco Gatroenterology Division, Department of Clinical Medicine, “La Sapienza” University of Rome, Rome, Italy Background: Sorafenib is a highly lipophilic molecule. So, we supposed that in well nourished pts, Sorafenib could be stored and then steadily released thus maintaining long-term higher plasma levels than in underweight pts. Aim: To evaluate a potential relationship between subcutaneous (SFA) and visceral fat area (VFA), and survival in pts with advanced HCC treated with Sorafenib. Method: SFA and VFA were retrospectively measured at the level of the umbilicus, as previously described, on baseline CT scan of 58 pts with HCC candidates to Sorafenib. Results: Given the absence of reference interval of SFA and VFA in literature, the values were dichotomized using the median of observed distribution as the cut-off (≤ or >14061 mm2 – SFA – and ≤ or >11534 mm2 – VFA). There were no differences in CP score, Meld score, BCLC and PS between pts with SFA and VFA values above the cut-off and pts under cut off. Time to progression (TTP) was longer in pts with higher SFA and VFA although not significantly. In pts with higher SFA mean survival was significantly longer (319.3±244.4 days vs. 194.3±224.4 d; p=0.04). Also in pts with higher VFA the mean survival was longer but not significantly. At multivariate analysis SFA was confirmed as the only independent predictive factors of better survival (Regression coefficient: –0.000059; CI: –0.000118–0; RR: 0.99; p=0.04). Conclusion: Our study suggests a role of SFA as a predictor of better survival in pts treated with Sorafenib. So, the maintenance of nutritional status during Sorafenib treatment seems to be an important goal. Would be very attractive studying the possible correlation between body fat content and the Sorafenib plasma levels.