BACKGROUND:Transcatheter arterial chemoembolization (TACE) is the standard treatment in selected patients with unresectable hepatocellular carcinoma (HCC). Drug-eluting particles are developed to reduce side effects and improve efficacy. We present safety data of a prospective randomized phase II study with doxorubicin-eluting superabsorbent polymer (SAP) microspheres. MATERIAL AND METHODS: We prospectively included 30 HCC patients with different Barcelona Clinic Liver Cancer (BCLC) stages (A = 3, B = 19, C = 8) and randomly assigned them to receive conventional TACE (n = 14) (control group) or doxorubicin-eluting SAP microspheres (n = 16). The doxorubicin plasma level was assessed at different time points, biochemical analysis was performed, and side effects were reported following the Common Toxicity Criteria. Tumor response was assessed at 6 weeks according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RESULTS: There was a significantly lower plasma peak concentration (Cmax) of doxorubicin and smaller area under the curve (AUC) with SAP microspheres (mean Cmax 495 ± 293.9 ng/ml, mean AUC 69.7 ± 26.9 ng/ml min) compared to controls (mean Cmax 1,928 ± 560.8 ng/ml, mean AUC 165 ± 32.3 ng/ml/min; both p < 0.001). Furthermore, there were less grade 3 and no grade 4 adverse events in the SAP microsphere group. Tumor response was comparable between the groups. CONCLUSIONS:TACE with SAP microspheres leads to low plasma levels of the cytotoxic drug and therefore minimizes toxicity compared to conventional TACE.
RCT Entities:
BACKGROUND: Transcatheter arterial chemoembolization (TACE) is the standard treatment in selected patients with unresectable hepatocellular carcinoma (HCC). Drug-eluting particles are developed to reduce side effects and improve efficacy. We present safety data of a prospective randomized phase II study with doxorubicin-eluting superabsorbent polymer (SAP) microspheres. MATERIAL AND METHODS: We prospectively included 30 HCCpatients with different Barcelona Clinic Liver Cancer (BCLC) stages (A = 3, B = 19, C = 8) and randomly assigned them to receive conventional TACE (n = 14) (control group) or doxorubicin-eluting SAP microspheres (n = 16). The doxorubicin plasma level was assessed at different time points, biochemical analysis was performed, and side effects were reported following the Common Toxicity Criteria. Tumor response was assessed at 6 weeks according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RESULTS: There was a significantly lower plasma peak concentration (Cmax) of doxorubicin and smaller area under the curve (AUC) with SAP microspheres (mean Cmax 495 ± 293.9 ng/ml, mean AUC 69.7 ± 26.9 ng/ml min) compared to controls (mean Cmax 1,928 ± 560.8 ng/ml, mean AUC 165 ± 32.3 ng/ml/min; both p < 0.001). Furthermore, there were less grade 3 and no grade 4 adverse events in the SAP microsphere group. Tumor response was comparable between the groups. CONCLUSIONS:TACE with SAP microspheres leads to low plasma levels of the cytotoxic drug and therefore minimizes toxicity compared to conventional TACE.
Authors: Boris Gorodetski; Julius Chapiro; Ruediger Schernthaner; Rafael Duran; MingDe Lin; Howard Lee; David Lenis; Elizabeth A Stuart; Bareng Aletta Sanny Nonyane; Vasily Pekurovsky; Anobel Tamrazi; Bernhard Gebauer; Todd Schlachter; Timothy M Pawlik; Jean-Francois Geschwind Journal: Eur Radiol Date: 2016-06-08 Impact factor: 5.315
Authors: Jingjie Hu; Hassan Albadawi; Brian W Chong; Amy R Deipolyi; Rahul A Sheth; Ali Khademhosseini; Rahmi Oklu Journal: Adv Mater Date: 2019-06-06 Impact factor: 30.849
Authors: D Bossé; T Ng; C Ahmad; A Alfakeeh; I Alruzug; J Biagi; J Brierley; P Chaudhury; S Cleary; B Colwell; C Cripps; L A Dawson; M Dorreen; E Ferland; P Galiatsatos; S Girard; S Gray; F Halwani; N Kopek; A Mahmud; G Martel; L Robillard; B Samson; M Seal; J Siddiqui; L Sideris; S Snow; M Thirwell; M Vickers; R Goodwin; R Goel; T Hsu; E Tsvetkova; B Ward; T Asmis Journal: Curr Oncol Date: 2016-12-21 Impact factor: 3.677