Abstract
e15084 Background: SAP-MS have demonstrated utility in the treatment of hepatocellular carcinoma (HCC) as a bland embolic and have demonstrated the ability to load and release D in vivo. Little is known about its toxicity profile. We aimed to determine if the dose and maximum plasma concentration (Cmax) of D were correlated with occurrence of AE. Methods: A phase II dose-escalation study was performed to systematically evaluate AEs relating to outpatient-based D/ SAP-MS embolization in HCC using a D dose of 0-75 mg. D plasma levels were assessed at multiple time points (0.5, 2, 24 and 675h), in addition to standard analyses of liver and hematologic function. All AEs were reported following the Common Toxicity Criteria Version 3.0. A Pearson product-moment correlation was run to determine the relationship between Cmax and AE. Results: Of 25 patients enrolled, 24 were evaluable (6 = 0mg, 6 = 25mg, 6 = 50mg, 6 = 75mg). The side-effect profile was similar to other abdominal embolization procedures, with abdominal pain (62.5%), fatigue-like symptoms (41.7%), and nausea (41.7%) being the most common AE. There were no correlation between the administered doses of D and all grade AE (r = .209, p .328) or between Cmax's of D and all grade AE (r = .321, p .127). All patients were discharged on the same day. There were no grade 4 or 5 AE and no hepatic decompensation. One patient required hospitalization 7 days post-procedure for groin puncture related complication. Conclusions: In our phase II dose-escalation study, patients experienced minimal post-embolization syndrome, which was not correlated with the amount of doxorubicin administered. The toxicities relating to SAP-MS delivery likely result from the embolic effect as opposed to dose response relating to the use of doxorubicin and can be managed on an outpatient basis. Clinical trial information: NCT01116635.
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