Jose Urbano1, J Javier Echevarria-Uraga2, J Jose Ciampi-Dopazo3, Juan A Sánchez-Corral4, Jorge Cobos Alonso4, Ane Anton-Ladislao5, Borja Peña-Baranda6, Veronica Nacarino-Mejias7, Rocío González-Costero8, J Joaquín Muñoz Ruiz-Canela9, Julian Pérez-Cuesta10, Carlos Lanciego3, Miguel Angel de Gregorio11. 1. Vascular and InterventionalRadiology, Hospital Universitario Ramón y Cajal, M-607, km. 9, 100, 28034, Madrid, Spain; GITMI (Minimally Invasive Techniques Research Group), Zaragoza University, C/Miguel Servet 177, 50013, Zaragoza, Spain. Electronic address: jurbano@salud.madrid.org. 2. Head of Vascular and Interventional Radiology, Galdakao-Usansolo Hospital, Barrio Labeaga s/n, 48960, Galdakao, Vizcaya, Spain; Osakidetza Basque Health Service, Biocruces Bizkaia Health Research Institute, Cruces Plaza, 48903, Barakaldo, Vizcaya, Spain. 3. Vascular and Interventional Radiology, Complejo Hospitalario de Toledo, Av. de Barber, 30, 45004, Toledo, Spain. 4. Vascular and InterventionalRadiology, Hospital Universitario Ramón y Cajal, M-607, km. 9, 100, 28034, Madrid, Spain. 5. Galdakao-Usansolo Hospital, Research Unit, Barrio Labeaga s/n, 48960, Galdakao, Basque Country, Spain; Health Services Research on Chronic Diseases Network-REDISSEC, Osakidetza Basque Health Service, Bilbao, Spain. 6. Vascular and Interventional Radiology, Hospital Universitario de Basurto, C/Montevideo, 18, 48013, Bilbao, Spain. 7. Vascular and Interventional Radiology, Hospital Universitario Virgen del Rocío, Av. Manuel Siurot, s/n, 41013, Sevilla, Spain. 8. Vascular and Interventional Radiology, Hospital Universitario Puerta de Hierro, C/Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. 9. Head of Vascular and Interventional Radiology, Hospital Regional Universitario de Málaga, Av. de Carlos Haya, s/n, 29010, Málaga, Spain. 10. Vascular and Interventional Radiology, Hospital Universitario de la Princesa, C/de Diego de León, 62, 28006, Madrid, Spain. 11. GITMI (Minimally Invasive Techniques Research Group), Zaragoza University, C/Miguel Servet 177, 50013, Zaragoza, Spain; Head of Vascular and Interventional Radiology, Hospital Clínico de Zaragoza, Avda. San Juan Bosco, 15, 50009, Zaragoza, Spain; School of Medicine, Zaragoza University, Domingo Miral, s/n, 50009, Zaragoza, Spain.
Abstract
PURPOSE: To assess the safety and tolerability of transarterial drug-eluting bead chemoembolisation (DEB-TACE) using tightly calibrated 100-μm microspheres in hepatocellular carcinoma (HCC). METHOD: This multicentre prospective study included 131 patients with a 2-year follow-up. All patients had Child-Pugh scores ≤ B7, a good performance status, and Barcelona Clinic Liver Cancer stage A or B. Beads were loaded with 50 mg of doxorubicin per millilitre. Overall, 223 nodules were treated (mean size: 27.6 mm, average number of nodules per patient: 1.7). Toxicity was assessed using Common Terminology Criteria for Adverse Events 4.03 and response according to the modified Response Evaluation Criteria in Solid Tumours. The primary endpoint was safety. Secondary endpoints included technical success, post-embolisation syndrome (PES), local tumour response, and 2-year survival. RESULTS: A total of 214 DEB-TACE procedures were performed (mean per patient: 1.64), with a technical success rate of 97.6 % and a PES rate of 9.3 %. Major complications occurred in 6.8 % of patients and 4.1 % of procedures. There were no treatment-related deaths. Doxorubicin dose was an independent predictor of complications (p = 0.01). Four patients were lost to follow-up and 18 received liver transplants. Objective response rates were 74.6 %, 45.7 %, and 44.1 % at 6, 12, and 24 months, respectively. The cumulative 24-month overall survival rate was 55.96 %. Median survival was 22 months (interquartile range = 13-24). Co-morbidities and tumour response were independent predictors of survival (p = 0.0012 and 0.0052, respectively). Complications did not affect survival (p = 0.24). CONCLUSIONS: DEB-TACE with tightly calibrated 100-μm beads is safe and not associated with increases in biliary toxicity or complications. Tumour response and survival are in the expected range for chemoembolisation therapy. (Clinical trials ID: NCT02670122).
PURPOSE: To assess the safety and tolerability of transarterial drug-eluting bead chemoembolisation (DEB-TACE) using tightly calibrated 100-μm microspheres in hepatocellular carcinoma (HCC). METHOD: This multicentre prospective study included 131 patients with a 2-year follow-up. All patients had Child-Pugh scores ≤ B7, a good performance status, and Barcelona Clinic Liver Cancer stage A or B. Beads were loaded with 50 mg of doxorubicin per millilitre. Overall, 223 nodules were treated (mean size: 27.6 mm, average number of nodules per patient: 1.7). Toxicity was assessed using Common Terminology Criteria for Adverse Events 4.03 and response according to the modified Response Evaluation Criteria in Solid Tumours. The primary endpoint was safety. Secondary endpoints included technical success, post-embolisation syndrome (PES), local tumour response, and 2-year survival. RESULTS: A total of 214 DEB-TACE procedures were performed (mean per patient: 1.64), with a technical success rate of 97.6 % and a PES rate of 9.3 %. Major complications occurred in 6.8 % of patients and 4.1 % of procedures. There were no treatment-related deaths. Doxorubicin dose was an independent predictor of complications (p = 0.01). Four patients were lost to follow-up and 18 received liver transplants. Objective response rates were 74.6 %, 45.7 %, and 44.1 % at 6, 12, and 24 months, respectively. The cumulative 24-month overall survival rate was 55.96 %. Median survival was 22 months (interquartile range = 13-24). Co-morbidities and tumour response were independent predictors of survival (p = 0.0012 and 0.0052, respectively). Complications did not affect survival (p = 0.24). CONCLUSIONS:DEB-TACE with tightly calibrated 100-μm beads is safe and not associated with increases in biliary toxicity or complications. Tumour response and survival are in the expected range for chemoembolisation therapy. (Clinical trials ID: NCT02670122).