OBJECTIVES: To investigate the safety of transarterial chemoembolisation (TACE) in combination with sorafenib in patients with hepatocellular carcinoma (HCC). METHODS: Patients with Child-Pugh A/B liver function, ECOG performance status 0-2 and HCC treatable with TACE received continuous sorafenib 800 mg/day, and TACE with doxorubicin (75, 50 and 25 mg/m(2) according to serum bilirubin: <1.5, 1.5-3, and >3 mg/dL) and lipiodol 2 weeks after sorafenib initiation and repeated every 4 weeks. RESULTS: Fifteen patients were included (Child-Pugh A/B, n = 12/3; Barcelona Clinic Liver Cancer-A/B/C, n = 1/9/5; ECOG 0/2, n = 14/1). Median time on sorafenib was 5.2 months (2.6-7.4 months); median number of TACE sessions was 3. Common adverse events were abdominal pain (n = 14), weight loss (n = 13), alopecia (n = 12), fatigue (n = 12) and hyperbilirubinaemia (n = 11). There were 32 serious adverse events (grade ≥ 3); 9/10-unscheduled hospital admissions and 4/5 deaths were considered TACE-related. The study was stopped prematurely because of safety concerns. At 6 months, 2 and 5 patients had complete or partial responses; 1 had stable disease. Median overall survival was 10.6 months (95% CI: 5.2-16 months). CONCLUSION: These findings do not support use of an intensive, high-dose doxorubicin-based TACE regimen in combination with sorafenib in this study population. KEY POINTS: • Transarterial chemoembolisation (TACE) is widely used in patients with hepatocellular carcinoma (HCC) • Various antiangiogenic and other agents have been used to augment this treatment • We tested lipiodol-TACE with bilirubin-adjusted doxorubicin dosing in combination with sorafenib • This trial was stopped prematurely because of safety reasons • Our safety results do not support the combination of sorafenib with this TACE regimen.
OBJECTIVES: To investigate the safety of transarterial chemoembolisation (TACE) in combination with sorafenib in patients with hepatocellular carcinoma (HCC). METHODS: Patients with Child-Pugh A/B liver function, ECOG performance status 0-2 and HCC treatable with TACE received continuous sorafenib 800 mg/day, and TACE with doxorubicin (75, 50 and 25 mg/m(2) according to serum bilirubin: <1.5, 1.5-3, and >3 mg/dL) and lipiodol 2 weeks after sorafenib initiation and repeated every 4 weeks. RESULTS: Fifteen patients were included (Child-Pugh A/B, n = 12/3; Barcelona Clinic Liver Cancer-A/B/C, n = 1/9/5; ECOG 0/2, n = 14/1). Median time on sorafenib was 5.2 months (2.6-7.4 months); median number of TACE sessions was 3. Common adverse events were abdominal pain (n = 14), weight loss (n = 13), alopecia (n = 12), fatigue (n = 12) and hyperbilirubinaemia (n = 11). There were 32 serious adverse events (grade ≥ 3); 9/10-unscheduled hospital admissions and 4/5 deaths were considered TACE-related. The study was stopped prematurely because of safety concerns. At 6 months, 2 and 5 patients had complete or partial responses; 1 had stable disease. Median overall survival was 10.6 months (95% CI: 5.2-16 months). CONCLUSION: These findings do not support use of an intensive, high-dose doxorubicin-based TACE regimen in combination with sorafenib in this study population. KEY POINTS: • Transarterial chemoembolisation (TACE) is widely used in patients with hepatocellular carcinoma (HCC) • Various antiangiogenic and other agents have been used to augment this treatment • We tested lipiodol-TACE with bilirubin-adjusted doxorubicin dosing in combination with sorafenib • This trial was stopped prematurely because of safety reasons • Our safety results do not support the combination of sorafenib with this TACE regimen.
Authors: J-L Raoul; B Sangro; A Forner; V Mazzaferro; F Piscaglia; L Bolondi; R Lencioni Journal: Cancer Treat Rev Date: 2010-08-17 Impact factor: 12.111
Authors: F Farinati; N De Maria; C Marafin; L Herszènyi; S Del Prato; M Rinaldi; L Perini; R Cardin; R Naccarato Journal: Dig Dis Sci Date: 1996-12 Impact factor: 3.199
Authors: Ghassan K Abou-Alfa; Lawrence Schwartz; Sergio Ricci; Dino Amadori; Armando Santoro; Arie Figer; Jacques De Greve; Jean-Yves Douillard; Chetan Lathia; Brian Schwartz; Ian Taylor; Marius Moscovici; Leonard B Saltz Journal: J Clin Oncol Date: 2006-08-14 Impact factor: 44.544
Authors: Ghassan K Abou-Alfa; Philip Johnson; Jennifer J Knox; Marinela Capanu; Irina Davidenko; Juan Lacava; Thomas Leung; Bolorsukh Gansukh; Leonard B Saltz Journal: JAMA Date: 2010-11-17 Impact factor: 56.272
Authors: Victor Zaydfudim; Rory L Smoot; Clancy J Clark; Michael L Kendrick; Florencia G Que; Michael B Farnell; David M Nagorney Journal: J Gastrointest Surg Date: 2012-05-30 Impact factor: 3.452