Derek M Biederman1, Raghuram Posham2, Raisa J Durrani3, Joseph J Titano4, Rahul S Patel5, Nora E Tabori6, Francis S Nowakowski7, Aaron M Fischman8, Robert A Lookstein9, Edward Kim10. 1. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: derek.biederman@mountsinai.org. 2. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: raghuram.posham@icahn.mssm.edu. 3. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: raisa.durrani@mountsinai.org. 4. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: joseph.titano@mountsinai.org. 5. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: rahul.patel@mountsinai.org. 6. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: nora.tabori@mountsinai.org. 7. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: Scott.nowakowski@mountsinai.org. 8. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: Aaron.Fischman@mountsinai.org. 9. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: Robert.Lookstein@mountsinai.org. 10. Icahn School of Medicine at Mount Sinai, Department of Vascular and Interventional Radiology, One Gustave Levy Place, New York, NY 10029-6574, USA. Electronic address: Edward.Kim@mountsinai.org.
Abstract
PURPOSE: To evaluate the outcomes of radioembolization (RE) as a therapy for unresectable hepatocellular carcinoma (HCC) in patients with marginal functional hepatic reserve. METHODS: A retrospective review of 471 patients (1/2010-7/2015) treated with RE (Therasphere, BTG, UK) was performed. A total of 36 patients (mean age: 66.1±9.3, male: 86.1%) underwent therapy for HCC with a MELD≥15 (median: 16, range: 15-22). Baseline demographics of the study cohort were as follows: etiology (HCV: 26, 72.2%), cirrhosis (n=32, 88.9%), ECOG 0 (n=16, 44.4%), Child-Pugh class (A=15, B=19, C=2), unilobar distribution (n=27, 75%), AFP>200 (n=11, 30.6%), portal vein thrombosis (PVT, n=7, 19.4%), metastasis (n=3, 8.3%). Outcomes analyzed included CTCAEv4.03 laboratory toxicities (120-day), imaging response (mRECIST), progression-free survival (PFS), and overall survival (OS). RESULTS: A total of 42 treatments were performed with mean dose of 2.02±1.23GBq. The cumulative grade 3/4 toxicity was 28% overall and 21% for bilirubin at 120-days. The objective response and disease control rates were 48.3% (14/29) and 69% (20/29) respectively. The median (95% CI) PFS was 5.9 (4.4-7.7) months. Ten (27.8%) patients received additional locoregional therapy at a median (IQR) of 138 (102-243) days post RE. The mean (95% CI) OS was 21.9 (14.8-29.0) months. The absence of PVT was associated with improved OS (p=0.005) Disease control at 90-days was also associated with an OS benefit (p=0.037). CONCLUSIONS: Patients with unresectable HCC and marginal functional hepatic reserve treated with RE had favorable objective response and disease control rates, both predictive of overall survival.
PURPOSE: To evaluate the outcomes of radioembolization (RE) as a therapy for unresectable hepatocellular carcinoma (HCC) in patients with marginal functional hepatic reserve. METHODS: A retrospective review of 471 patients (1/2010-7/2015) treated with RE (Therasphere, BTG, UK) was performed. A total of 36 patients (mean age: 66.1±9.3, male: 86.1%) underwent therapy for HCC with a MELD≥15 (median: 16, range: 15-22). Baseline demographics of the study cohort were as follows: etiology (HCV: 26, 72.2%), cirrhosis (n=32, 88.9%), ECOG 0 (n=16, 44.4%), Child-Pugh class (A=15, B=19, C=2), unilobar distribution (n=27, 75%), AFP>200 (n=11, 30.6%), portal vein thrombosis (PVT, n=7, 19.4%), metastasis (n=3, 8.3%). Outcomes analyzed included CTCAEv4.03 laboratory toxicities (120-day), imaging response (mRECIST), progression-free survival (PFS), and overall survival (OS). RESULTS: A total of 42 treatments were performed with mean dose of 2.02±1.23GBq. The cumulative grade 3/4 toxicity was 28% overall and 21% for bilirubin at 120-days. The objective response and disease control rates were 48.3% (14/29) and 69% (20/29) respectively. The median (95% CI) PFS was 5.9 (4.4-7.7) months. Ten (27.8%) patients received additional locoregional therapy at a median (IQR) of 138 (102-243) days post RE. The mean (95% CI) OS was 21.9 (14.8-29.0) months. The absence of PVT was associated with improved OS (p=0.005) Disease control at 90-days was also associated with an OS benefit (p=0.037). CONCLUSIONS:Patients with unresectable HCC and marginal functional hepatic reserve treated with RE had favorable objective response and disease control rates, both predictive of overall survival.