AIM: To determine local response, its predictors and survival and complication rates after DC-Bead™-TACE in patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: DC-Beads™ are non-resorbable, polyvinyl-alcoholic hydrophilic microspheres. They release high amounts of chemotherapeutics directly into the tumour. Delivery is sustained over time, tumour feeders are embolised. We used beads from 100-300 to 500-700 μm loaded with Doxorubicin (max. 150 mg/4ml). Fifty patients (mean age: 68.5 ± 8.8 years) with HCC were analysed. DC-Bead™-TACE was performed once or repeated in two-month intervals. Imaging scans (CT or MRI) were done one-month following each procedure. To evaluate tumour response EASL and RECIST criteria was applied. If eligible, every patient received a non-selective TACE. RESULTS: 128 DC-Bead™ sessions were performed: 127 showed technical success, 120 successful stasis. Complications occurred in 7% (9/128): active bleeding into the tumour (n=1), liver failure (n=1), liver abscess (n=1) ascites (n=3), pleural effusion (n=1), false aneurysm (n=1) and hypoglycaemia (n=1). At imaging after the 1st, 2nd, 3rd and 4th-8th session, objective response (complete+partial) was 49%, 67%, 67% and 31%, progressive disease was seen in n=11/50. Baseline diameter and differentiation significantly impacted response. Median overall survival was 25.1 months (95% [CI]: 18.3-31.9) with an estimated cumulative survival rate at one and two-to-four years of 66.7% and 45.7%, respectively. CONCLUSION: DC-Beads™ can be safely and effectively control HCC. Survival and response rates are encouraging, complications are low. Many factors are involved in response to treatment like liver function or child state.
AIM: To determine local response, its predictors and survival and complication rates after DC-Bead™-TACE in patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: DC-Beads™ are non-resorbable, polyvinyl-alcoholic hydrophilic microspheres. They release high amounts of chemotherapeutics directly into the tumour. Delivery is sustained over time, tumour feeders are embolised. We used beads from 100-300 to 500-700 μm loaded with Doxorubicin (max. 150 mg/4ml). Fifty patients (mean age: 68.5 ± 8.8 years) with HCC were analysed. DC-Bead™-TACE was performed once or repeated in two-month intervals. Imaging scans (CT or MRI) were done one-month following each procedure. To evaluate tumour response EASL and RECIST criteria was applied. If eligible, every patient received a non-selective TACE. RESULTS: 128 DC-Bead™ sessions were performed: 127 showed technical success, 120 successful stasis. Complications occurred in 7% (9/128): active bleeding into the tumour (n=1), liver failure (n=1), liver abscess (n=1) ascites (n=3), pleural effusion (n=1), false aneurysm (n=1) and hypoglycaemia (n=1). At imaging after the 1st, 2nd, 3rd and 4th-8th session, objective response (complete+partial) was 49%, 67%, 67% and 31%, progressive disease was seen in n=11/50. Baseline diameter and differentiation significantly impacted response. Median overall survival was 25.1 months (95% [CI]: 18.3-31.9) with an estimated cumulative survival rate at one and two-to-four years of 66.7% and 45.7%, respectively. CONCLUSION: DC-Beads™ can be safely and effectively control HCC. Survival and response rates are encouraging, complications are low. Many factors are involved in response to treatment like liver function or child state.
Authors: Roman Kloeckner; Christian Ruckes; Kai Kronfeld; Marcus Alexander Wörns; Arndt Weinmann; Peter Robert Galle; Hauke Lang; Gerd Otto; Waltraud Eichhorn; Mathias Schreckenberger; Christoph Dueber; Michael Bernhard Pitton Journal: Trials Date: 2014-08-06 Impact factor: 2.279