author_facet Vitale, Alessandro
Lombardi, Giuseppe
Ramirez Morales, Rafael
Lonardi, Sara
Zanus, Giacomo
Zagonel, Vittorina
Cillo, Umberto
Vitale, Alessandro
Lombardi, Giuseppe
Ramirez Morales, Rafael
Lonardi, Sara
Zanus, Giacomo
Zagonel, Vittorina
Cillo, Umberto
author Vitale, Alessandro
Lombardi, Giuseppe
Ramirez Morales, Rafael
Lonardi, Sara
Zanus, Giacomo
Zagonel, Vittorina
Cillo, Umberto
spellingShingle Vitale, Alessandro
Lombardi, Giuseppe
Ramirez Morales, Rafael
Lonardi, Sara
Zanus, Giacomo
Zagonel, Vittorina
Cillo, Umberto
Journal of Clinical Oncology
Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
Cancer Research
Oncology
author_sort vitale, alessandro
spelling Vitale, Alessandro Lombardi, Giuseppe Ramirez Morales, Rafael Lonardi, Sara Zanus, Giacomo Zagonel, Vittorina Cillo, Umberto 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14563 <jats:p> e14563 </jats:p><jats:p> Background: Patients with intermediate stage hepatocellular carcinoma (HCC) obtaining an unsatisfactory response after loco regional (LR) therapies are at high risk of drop-out from a new chance of LR treatment or progression to advanced-terminal stages of disease. We prospectively used Sorafenib in this particular category of patients as a bridge therapy. The aim was to decrease the risk of tumour progression and to make them again eligible for loco regional therapies. Methods: Primary endpoint: disease control (DC) with Sorafenib, defined as complete/partial response or stable disease as by the modified RECIST criteria, maintained for ≥ 28 days from the first indications of response. Secondary endpoints: proportion of patients progression free at 2 months; median overall and progression free survivals. Patients obtaining DC with Sorafenib were again considered eligible for LR therapy. Inclusion criteria: a) intermediate stage; b) Child Pugh class A; c) performance status 0; d) unsatisfactory response to LR therapies (resection, ablation, chemoembolization), defined as incomplete response after at least 2 LR therapies. Study period: 01/04/2008–31/10/2011. End of follow-up: 31/01/2012. Results: Forty one patients were enrolled according to the study design. Thirty seven patients (90%) were progression free at the 2 months evaluation. A persistent DC was obtained in 29 patients (71%). According to the study hypothesis these patients were considered again eligible for loco regional therapies: 19 patients (65%) had ablation ± chemoembolization; 6 had liver transplantation (22%); 3 had liver resection (13%); 1 had radioembolization. Median duration of therapy with Sorafenib was 5 months (1–22). Sixteen patients (55%) had Sorafenib therapy both before and after LR therapy. Fourteen patients (48%) had more than one LR procedure. Median survival was 21 months (range, 1–39) in the whole group, while it was 25 months (range, 2–39) in the DC subgroup (median time to progression = 21 months, range 2–39). Conclusions: Sorafenib achieves high DC rates in BCLC B HCC patients with unsatisfactory response to LR therapies making them again eligible for LR therapies. </jats:p> Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma. Journal of Clinical Oncology
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title Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_unstemmed Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_full Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_fullStr Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_full_unstemmed Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_short Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_sort sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
topic Cancer Research
Oncology
url http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14563
publishDate 2012
physical e14563-e14563
description <jats:p> e14563 </jats:p><jats:p> Background: Patients with intermediate stage hepatocellular carcinoma (HCC) obtaining an unsatisfactory response after loco regional (LR) therapies are at high risk of drop-out from a new chance of LR treatment or progression to advanced-terminal stages of disease. We prospectively used Sorafenib in this particular category of patients as a bridge therapy. The aim was to decrease the risk of tumour progression and to make them again eligible for loco regional therapies. Methods: Primary endpoint: disease control (DC) with Sorafenib, defined as complete/partial response or stable disease as by the modified RECIST criteria, maintained for ≥ 28 days from the first indications of response. Secondary endpoints: proportion of patients progression free at 2 months; median overall and progression free survivals. Patients obtaining DC with Sorafenib were again considered eligible for LR therapy. Inclusion criteria: a) intermediate stage; b) Child Pugh class A; c) performance status 0; d) unsatisfactory response to LR therapies (resection, ablation, chemoembolization), defined as incomplete response after at least 2 LR therapies. Study period: 01/04/2008–31/10/2011. End of follow-up: 31/01/2012. Results: Forty one patients were enrolled according to the study design. Thirty seven patients (90%) were progression free at the 2 months evaluation. A persistent DC was obtained in 29 patients (71%). According to the study hypothesis these patients were considered again eligible for loco regional therapies: 19 patients (65%) had ablation ± chemoembolization; 6 had liver transplantation (22%); 3 had liver resection (13%); 1 had radioembolization. Median duration of therapy with Sorafenib was 5 months (1–22). Sixteen patients (55%) had Sorafenib therapy both before and after LR therapy. Fourteen patients (48%) had more than one LR procedure. Median survival was 21 months (range, 1–39) in the whole group, while it was 25 months (range, 2–39) in the DC subgroup (median time to progression = 21 months, range 2–39). Conclusions: Sorafenib achieves high DC rates in BCLC B HCC patients with unsatisfactory response to LR therapies making them again eligible for LR therapies. </jats:p>
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author Vitale, Alessandro, Lombardi, Giuseppe, Ramirez Morales, Rafael, Lonardi, Sara, Zanus, Giacomo, Zagonel, Vittorina, Cillo, Umberto
author_facet Vitale, Alessandro, Lombardi, Giuseppe, Ramirez Morales, Rafael, Lonardi, Sara, Zanus, Giacomo, Zagonel, Vittorina, Cillo, Umberto, Vitale, Alessandro, Lombardi, Giuseppe, Ramirez Morales, Rafael, Lonardi, Sara, Zanus, Giacomo, Zagonel, Vittorina, Cillo, Umberto
author_sort vitale, alessandro
container_issue 15_suppl
container_start_page 0
container_title Journal of Clinical Oncology
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description <jats:p> e14563 </jats:p><jats:p> Background: Patients with intermediate stage hepatocellular carcinoma (HCC) obtaining an unsatisfactory response after loco regional (LR) therapies are at high risk of drop-out from a new chance of LR treatment or progression to advanced-terminal stages of disease. We prospectively used Sorafenib in this particular category of patients as a bridge therapy. The aim was to decrease the risk of tumour progression and to make them again eligible for loco regional therapies. Methods: Primary endpoint: disease control (DC) with Sorafenib, defined as complete/partial response or stable disease as by the modified RECIST criteria, maintained for ≥ 28 days from the first indications of response. Secondary endpoints: proportion of patients progression free at 2 months; median overall and progression free survivals. Patients obtaining DC with Sorafenib were again considered eligible for LR therapy. Inclusion criteria: a) intermediate stage; b) Child Pugh class A; c) performance status 0; d) unsatisfactory response to LR therapies (resection, ablation, chemoembolization), defined as incomplete response after at least 2 LR therapies. Study period: 01/04/2008–31/10/2011. End of follow-up: 31/01/2012. Results: Forty one patients were enrolled according to the study design. Thirty seven patients (90%) were progression free at the 2 months evaluation. A persistent DC was obtained in 29 patients (71%). According to the study hypothesis these patients were considered again eligible for loco regional therapies: 19 patients (65%) had ablation ± chemoembolization; 6 had liver transplantation (22%); 3 had liver resection (13%); 1 had radioembolization. Median duration of therapy with Sorafenib was 5 months (1–22). Sixteen patients (55%) had Sorafenib therapy both before and after LR therapy. Fourteen patients (48%) had more than one LR procedure. Median survival was 21 months (range, 1–39) in the whole group, while it was 25 months (range, 2–39) in the DC subgroup (median time to progression = 21 months, range 2–39). Conclusions: Sorafenib achieves high DC rates in BCLC B HCC patients with unsatisfactory response to LR therapies making them again eligible for LR therapies. </jats:p>
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spelling Vitale, Alessandro Lombardi, Giuseppe Ramirez Morales, Rafael Lonardi, Sara Zanus, Giacomo Zagonel, Vittorina Cillo, Umberto 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14563 <jats:p> e14563 </jats:p><jats:p> Background: Patients with intermediate stage hepatocellular carcinoma (HCC) obtaining an unsatisfactory response after loco regional (LR) therapies are at high risk of drop-out from a new chance of LR treatment or progression to advanced-terminal stages of disease. We prospectively used Sorafenib in this particular category of patients as a bridge therapy. The aim was to decrease the risk of tumour progression and to make them again eligible for loco regional therapies. Methods: Primary endpoint: disease control (DC) with Sorafenib, defined as complete/partial response or stable disease as by the modified RECIST criteria, maintained for ≥ 28 days from the first indications of response. Secondary endpoints: proportion of patients progression free at 2 months; median overall and progression free survivals. Patients obtaining DC with Sorafenib were again considered eligible for LR therapy. Inclusion criteria: a) intermediate stage; b) Child Pugh class A; c) performance status 0; d) unsatisfactory response to LR therapies (resection, ablation, chemoembolization), defined as incomplete response after at least 2 LR therapies. Study period: 01/04/2008–31/10/2011. End of follow-up: 31/01/2012. Results: Forty one patients were enrolled according to the study design. Thirty seven patients (90%) were progression free at the 2 months evaluation. A persistent DC was obtained in 29 patients (71%). According to the study hypothesis these patients were considered again eligible for loco regional therapies: 19 patients (65%) had ablation ± chemoembolization; 6 had liver transplantation (22%); 3 had liver resection (13%); 1 had radioembolization. Median duration of therapy with Sorafenib was 5 months (1–22). Sixteen patients (55%) had Sorafenib therapy both before and after LR therapy. Fourteen patients (48%) had more than one LR procedure. Median survival was 21 months (range, 1–39) in the whole group, while it was 25 months (range, 2–39) in the DC subgroup (median time to progression = 21 months, range 2–39). Conclusions: Sorafenib achieves high DC rates in BCLC B HCC patients with unsatisfactory response to LR therapies making them again eligible for LR therapies. </jats:p> Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma. Journal of Clinical Oncology
spellingShingle Vitale, Alessandro, Lombardi, Giuseppe, Ramirez Morales, Rafael, Lonardi, Sara, Zanus, Giacomo, Zagonel, Vittorina, Cillo, Umberto, Journal of Clinical Oncology, Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma., Cancer Research, Oncology
title Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_full Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_fullStr Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_full_unstemmed Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_short Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_sort sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
title_unstemmed Sorafenib as bridging therapy in patients with intermediate hepatocellular carcinoma.
topic Cancer Research, Oncology
url http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14563