RT Journal Article SR Electronic T1 The Effect of Doxorubicin Loading on Response and Toxicity with Drug-eluting Embolization in Resectable Hepatoma: A Dose Escalation Study JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 3597 OP 3606 VO 34 IS 7 A1 DARREN KLASS A1 DAVID OWEN A1 ANDREZJ BUCZKOWSKI A1 STEPHEN W. CHUNG A1 CHARLES H. SCUDAMORE A1 ALAN A. WEISS A1 ERIC M. YOSHIDA A1 JO-ANN E. FORD A1 STEPHEN HO A1 DAVID M. LIU YR 2014 UL http://ar.iiarjournals.org/content/34/7/3597.abstract AB Aim: The dose–response relationship between doxorubicin and superabsorbent drug-eluting microspheres has not been established. In this study, we investigated the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma (HCC). Patients and Methods: Twenty-five patients with resectable HCC were randomly assigned and divided into four groups, each receiving either bland, 25 mg, 50 mg or 75 mg of doxorubicin loaded Super Absorbent Polymer microspheres, with 24 patients undergoing surgical resection. Response Evaluation and Criteria in Solid Tumors (RECIST) 1.0 and European Association for the Study of the Liver (EASL)-based volumetric response was performed at one month and surgical resection of the reference tumor was performed at two months. Adverse events were collected at regular intervals. Results: Fifty-six percent of patients demonstrated complete response according to EASL criteria as opposed to 0% according to RECIST (v1.0) criteria. Residual tumor was identified in all groups (0 mg: 35%±28.5%; 25 mg: 42%±30.4%; 50 mg: 3.6%±3.3%; and 75 mg: 49.29%±32.6%. A total of 112 adverse events of grades 1-3 occurred (average 5.1 per patient), with no grade 4 or 5. No difference was noted between bland embolic and drug-loaded groups. Subset analysis did demonstrate a significantly increased degree of necrosis in the 50 mg-loaded group (p=0.018). Strong correlation existed between arterial phase Computer Tomography EASL-based response and histopathology (r=0.81; p<0.0001). All groups had residual tumor. Conclusion: Histology correlates strongly with one-month post-procedural imaging and response optimized at 50 mg of loading per vial. Adverse events were a reflection of embolization, with no relationship between loading dose or administered dose of doxorubicin.