Hepatic Arterial Infusion (Hai) Therapy In Patients With Unresectable Primary Liver Cancer: Use Of Dynamic Contrast Enhanced Mri To Evaluate Response.

4129 Background: This study reports preliminary results of the use of HAI of Floxuridine (FUDR) and Dexamethasone (Dex) in patients (pts) with unresectable cholangiocarcinoma (CC) or hepatocellular cancer (HCC), and investigates the use of dynamic contrast-enhanced MRI (DCE-MRI) to evaluate changes in tumor perfusion, and to correlate these findings with radiographic tumor response. Methods: Seventeen pts (15 CC, 2 HCC) deemed unresectable by experienced hepatobiliary surgeons were treated with HAI FUDR/Dex via arterial pump by continuous infusion over 14 days on a 4-week cycle. Imaging: MRI imaging was performed on a conventional 1.5 Tesla MRI scanner. DCE-MRI images were acquired with a temporal resolution of 1 second per image. Analysis was performed with a two compartment model, the slope of the initial contrast uptake, as well as transfer between lesion and plasma compartments were calculated. Results: Of 17 pts, 14 are presently evaluable, while 3 are too early to assess for response. One of 2 pts with HCC responded; 5 of 12 pts (42%) with CC had partial response, and 6 (50%) had stable disease. Median duration of response is 11.9 months (range 4.1 - 14.7). Median time to progression for all pts is 7.2 months. Seven have progressed: 4 (liver), 2 (lung), 1 (bone). Treatment has been well-tolerated: Gr 3 SGOT elevation was seen in 5 pts (29%), and Gr 3 alkaline phosphatase in 4 (23%). No pt had bilirubin elevation, diarrhea or neutropenia. Comparison of lesion size on DCE-MRI and conventional MRI showed that post-treatment changes in tumor perfusion (slope measurements) observed at 2 months predict treatment response earlier than bi-dimensional tumor measurements. Patients with rapid uptake of contrast (slope > 300% increase/min) all showed tumor response. Conclusions: Presently, HAI therapy with FUDR + Dex demonstrates a 43% response rate with an excellent toxicity profile. Changes in tumor perfusion and vascular permeability may predict treatment response earlier and correlate with probability of response in pts with CC or HCC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Johnson & Johnson Johnson & Johnson