Intra-hepatic lipiodol I 131 combined with oxaliplatin, infusional FUDR, leucovorin in hepatocarcinoma and hepatic metastasis

Abstract

4133 Background: We conducted a pilot study with L131 internal hepatic radiation combined with IA OHP, infusion FUDR and LV in 19 AHC and 20 HM pts, to assess feasibility, response rate, symptom relief, TTP and 1-year OS. Methods: Median age was 60 yo (20 - 76), 32 pts were male. All pts had predominant hepatic disease and symptomatic progression prior to inclusion. Portal vein thrombosis was documented in 3 pts. KPS was 70% in 4 pts and ≥ 80% in 35 pts. All HM and 10 out of 19 AHC pts have had prior treatment (range: 1–9). Out of 19 AHC pts, 12 were Child-Pugh A, 7 were B and 2 were C. Out of 20 HM, 14 were colorectal tumors. All pts were assigned to receive only one treatment. However, re-treatment was allowed after documented liver progression by CT or MRI in responders or to reach a tumor radiation dose ≥120 Gy. Therapy was a single L131 intra-hepatic infusion dose followed by OHP 100 mg/m2 IA over 2h on D1, and FUDR 60 mg/m2/d + LV 15 mg/m2/d IA by 96h infusion (D1–4). G-CSF SC was given from D5–15. The L131 dose was planned for each pt in order to deliver > 120 Gy to tumor mass and < 50 Gy to normal liver parenchyma. To date, 45 treatments were delivered (whole liver - 20; R lobe - 15; L lobe - 3). 6 pts got more than one treatment. The L131 median dose was 50 mCi (range: 25 - 80). Results: All pts developed severe fatigue post-procedure lasting 7 to 14 days. Other grade III/IV toxicity included thrombocytopenia (28%), elevation of liver enzymes (17%), neutropenia (15%), enteritis (11%), diarrhea (8%), hepatic encephalopathy (8%), mucositis (6%) and fever (4%). No clinical benefit was observed in Child B and C AHC pts. 2 AHC had treatment related death (liver failure and gastric bleeding). 3 other pts (1 HM, 1 Child B and 1 Child C AHC) died within 60 days of therapy due to PD. Conclusion: ICM is a feasible and active in refractory AHC and HM pts. An improved TTP trend was observed for AHC (p=0.057). A phase II study is ongoing for HM and AHC pts, restricted to Child-Pugh A. No significant financial relationships to disclose.