Klass Doxorubicin Dose Escalation Study Examines Dose & Delivery for the Treatment of HCC

The purpose of Dr. Darren Klass, et al’s study — “The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatocellular carcinoma: a dose escalation study” — was to investigate “the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma (HCC).”1  The study included 25 patients, randomly assigned and divided into 4 subgroups each receiving bland, 25 mg, 50 mg, 75 mg of doxorubicin-loaded HepaSphere™ Microspheres.

Klass and his colleagues published the following results:

  • 56% 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%).
  • 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).

The study concluded that “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.”

Merit Medical’s HepaSphere Microspheres are indicated for use in embolization of blood vessels with or without delivery of doxorubicin HCI for therapeutic or preoperative for the embolization of hepatocellular carcinoma and embolization of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

HepaSphere Microspheres offer targeted embolization that is flow directed due to their spherical shape, they rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI,* and compress in the vessel lumen, providing more surface contact with vessel intima. HepaSpheres expand up to four times the stated dry diameter when hydrated. For more information on HepaSphere Microspheres, go to the HepaSphere product page or contact us.

Antonio Rivera                                                                                                                                                                                                                                                                                                                                   Senior Product Manager

 

1 Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Research. 2014 Jul;34(7):3597-3606.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.