A phase II study of sunitinib in advanced hepatocellular carcinoma

Carlo Antonio Barone; Michele Basso; Marco Biolato; Maurizio Pompili; Vittoria Rufini; Luca Miele; Maria Basso; Anna Maria De Gaetano; Paola Castaldi; Alessandro Iaculli; Lucia Leccisotti; Laura Riccardi; Antonio Grieco

doi:10.1016/j.dld.2013.01.002

A phase II study of sunitinib in advanced hepatocellular carcinoma

Carlo Antonio Barone, Michele Basso, Marco Biolato, Maurizio Pompili, Vittoria Rufini, Luca Miele, Maria Basso, Anna Maria De Gaetano, Paola Castaldi, Alessandro Iaculli, Lucia Leccisotti, Laura Riccardi, Antonio Grieco

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Abstract

BACKGROUND: In 2007, sorafenib was the first drug able to improve overall survival in patients with advanced hepatocellular carcinoma. AIM: In 2005 we designed a phase II study to assess safety and efficacy of sunitinib. METHODS: This is a single arm, open-label, single-centre phase II trial. Eligibility criteria were advanced hepatocellular carcinoma; no prior chemotherapy, performance status 0-1; and Child≤B8. The treatment schedule was 50mg each day orally, 4 weeks on, 2 weeks off. RESULTS: Between 10/2007 and 10/2010, 34 patients were enrolled. A significant worsening of liver functional reserve after sunitinib was observed. Grade 3/4 adverse effects occurred in 80% of patients and included fatigue (47%), nausea (15%), liver failure (15%), encephalopathy (12%) and upper gastrointestinal bleeding (12%). Six patients (18%) died within 60 days of enrolment. A partial response was observed in 4 patients (12%). Median time to tumour progression was 2.8 months and median overall survival was 5.8 months. CONCLUSION: A dose of 50mg/d induces a high rate of severe adverse events. Toxicity remains a key concern also at the dose of 37.5mg/d. However, sunitinib is able to induce a prolonged response in some patients. Positron Emission Tomography/Computed Tomography scans may select good responders.

Original language	English
Pages (from-to)	692-698
Number of pages	7
Journal	Digestive and Liver Disease
Volume	45
DOIs	https://doi.org/10.1016/j.dld.2013.01.002
Publication status	Published - 2013

Keywords

Alpha-fetoprotein
Aminopyrine
Methacetin
PET

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10.1016/j.dld.2013.01.002

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title = "A phase II study of sunitinib in advanced hepatocellular carcinoma",

abstract = "BACKGROUND: In 2007, sorafenib was the first drug able to improve overall survival in patients with advanced hepatocellular carcinoma. AIM: In 2005 we designed a phase II study to assess safety and efficacy of sunitinib. METHODS: This is a single arm, open-label, single-centre phase II trial. Eligibility criteria were advanced hepatocellular carcinoma; no prior chemotherapy, performance status 0-1; and Child≤B8. The treatment schedule was 50mg each day orally, 4 weeks on, 2 weeks off. RESULTS: Between 10/2007 and 10/2010, 34 patients were enrolled. A significant worsening of liver functional reserve after sunitinib was observed. Grade 3/4 adverse effects occurred in 80% of patients and included fatigue (47%), nausea (15%), liver failure (15%), encephalopathy (12%) and upper gastrointestinal bleeding (12%). Six patients (18%) died within 60 days of enrolment. A partial response was observed in 4 patients (12%). Median time to tumour progression was 2.8 months and median overall survival was 5.8 months. CONCLUSION: A dose of 50mg/d induces a high rate of severe adverse events. Toxicity remains a key concern also at the dose of 37.5mg/d. However, sunitinib is able to induce a prolonged response in some patients. Positron Emission Tomography/Computed Tomography scans may select good responders.",

keywords = "Alpha-fetoprotein, Aminopyrine, Methacetin, PET, Alpha-fetoprotein, Aminopyrine, Methacetin, PET",

author = "Barone, {Carlo Antonio} and Michele Basso and Marco Biolato and Maurizio Pompili and Vittoria Rufini and Luca Miele and Maria Basso and {De Gaetano}, {Anna Maria} and Paola Castaldi and Alessandro Iaculli and Lucia Leccisotti and Laura Riccardi and Antonio Grieco",

year = "2013",

doi = "10.1016/j.dld.2013.01.002",

language = "English",

volume = "45",

pages = "692--698",

journal = "Digestive and Liver Disease",

issn = "1590-8658",

publisher = "-Roma: Editrice Gastroenterologica Italiana. -Ospedaletto Pisa: Pacini",

}

TY - JOUR

T1 - A phase II study of sunitinib in advanced hepatocellular carcinoma

AU - Barone, Carlo Antonio

AU - Basso, Michele

AU - Biolato, Marco

AU - Pompili, Maurizio

AU - Rufini, Vittoria

AU - Miele, Luca

AU - Basso, Maria

AU - De Gaetano, Anna Maria

AU - Castaldi, Paola

AU - Iaculli, Alessandro

AU - Leccisotti, Lucia

AU - Riccardi, Laura

AU - Grieco, Antonio

PY - 2013

Y1 - 2013

N2 - BACKGROUND: In 2007, sorafenib was the first drug able to improve overall survival in patients with advanced hepatocellular carcinoma. AIM: In 2005 we designed a phase II study to assess safety and efficacy of sunitinib. METHODS: This is a single arm, open-label, single-centre phase II trial. Eligibility criteria were advanced hepatocellular carcinoma; no prior chemotherapy, performance status 0-1; and Child≤B8. The treatment schedule was 50mg each day orally, 4 weeks on, 2 weeks off. RESULTS: Between 10/2007 and 10/2010, 34 patients were enrolled. A significant worsening of liver functional reserve after sunitinib was observed. Grade 3/4 adverse effects occurred in 80% of patients and included fatigue (47%), nausea (15%), liver failure (15%), encephalopathy (12%) and upper gastrointestinal bleeding (12%). Six patients (18%) died within 60 days of enrolment. A partial response was observed in 4 patients (12%). Median time to tumour progression was 2.8 months and median overall survival was 5.8 months. CONCLUSION: A dose of 50mg/d induces a high rate of severe adverse events. Toxicity remains a key concern also at the dose of 37.5mg/d. However, sunitinib is able to induce a prolonged response in some patients. Positron Emission Tomography/Computed Tomography scans may select good responders.

AB - BACKGROUND: In 2007, sorafenib was the first drug able to improve overall survival in patients with advanced hepatocellular carcinoma. AIM: In 2005 we designed a phase II study to assess safety and efficacy of sunitinib. METHODS: This is a single arm, open-label, single-centre phase II trial. Eligibility criteria were advanced hepatocellular carcinoma; no prior chemotherapy, performance status 0-1; and Child≤B8. The treatment schedule was 50mg each day orally, 4 weeks on, 2 weeks off. RESULTS: Between 10/2007 and 10/2010, 34 patients were enrolled. A significant worsening of liver functional reserve after sunitinib was observed. Grade 3/4 adverse effects occurred in 80% of patients and included fatigue (47%), nausea (15%), liver failure (15%), encephalopathy (12%) and upper gastrointestinal bleeding (12%). Six patients (18%) died within 60 days of enrolment. A partial response was observed in 4 patients (12%). Median time to tumour progression was 2.8 months and median overall survival was 5.8 months. CONCLUSION: A dose of 50mg/d induces a high rate of severe adverse events. Toxicity remains a key concern also at the dose of 37.5mg/d. However, sunitinib is able to induce a prolonged response in some patients. Positron Emission Tomography/Computed Tomography scans may select good responders.

KW - Alpha-fetoprotein

KW - Aminopyrine

KW - Methacetin

KW - PET

KW - Alpha-fetoprotein

KW - Aminopyrine

KW - Methacetin

KW - PET

UR - http://hdl.handle.net/10807/45591

U2 - 10.1016/j.dld.2013.01.002

DO - 10.1016/j.dld.2013.01.002

M3 - Article

SN - 1590-8658

VL - 45

SP - 692

EP - 698

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

ER -

A phase II study of sunitinib in advanced hepatocellular carcinoma

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Keywords

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