Pilot Study with Intraarterial Doxorubicin-Eluting Microspheres in Patients with Unresectable HCC

Abstract No:

419

Author:

IR Kamel, Johns Hopkins Hospital, Baltimore, MD, USA
DK Reyes, T Wahlin, K Hong, CS Georgiades, J-FH Geschwind

Presented:

Society of Interventional Radiology (SIR), March 2007

Purpose:

This pilot study under an investigator IDE was conducted to gather preliminary data using GelSphere (DC Bead) beads loaded with doxorubicin to treat patients with unresectable HCC. The endpoints measures were tumour response and adverse events.

Material & Methods:

Between 11/05 and 06/06, 10 patients (7 males and 3 females, man age, 64 years) were treated with 2 vials of GelSphere (DC Bead) beads (100-300 and/or 300/500microns), each loaded with 50mg of doxorubicin. Functional perfusion and diffusion MR imaging studies before and 12 month after single selective treatment were evaluated by consensus of 2 radiologists to assess treatment response. Tumour size, arterial and venous enhancement, and apparent diffusion coefficient (ADC) values were recorded before and after treatment. One targeted tumour in the treated lobe of the liver was included in each patient. Immediate adverse events, reported toxicities and serous adverse events at 1 month follow-up were recorded.

Results:

Mean tumour size was 8.7cm. Targeted tumours had mean decrease in arterial enhancement of 60% (p = 0.002), decrease in venous enhancement of 62% (p = 0.001), and increase in ADC of 38% (p = 0.0056). Targeted tumours had no change in size after treatment (p = 0.489). The ADC values for liver and spleen were unchanged (p = .398 and 0.401, respectively). The procedures were well tolerated without significant side effects. Toxicities reported 1 month following initial treatment were: fatigue (n = 6), abdominal pain (n = 3), decreased appetite (n = 3), decreased libido (n = 2), and 1 patient for each of the following (vomiting, chest pain, unilateral edema in leg, belching, fever, hypothermia, hypotension and insomnia). One patient died from progression of liver disease within 30 days of the procedure which was judged to be unrelated.

Conclusion:

This pilot study demonstrated that Gelsphere (DC Bead) beads mixed with doxorubicin result in significant reduction in arterial and venous enhancement of HCC, without a significant change in tumour size, at 1 month after therapy. Treated lesions have significant increase in ADC due to tumour
necrosis. Our data also suggest that this new drug-delivery device is effective and well tolerated.

 

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