RADIATION SEGMENTECTOMY. Robert J Lewandowski, MD

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1 RADIATION SEGMENTECTOMY Robert J Lewandowski, MD

2 Robert Lewandowski, M.D. Consultant/Advisory Board: Cook Medical, LLC, Arsenal, BTG International, Boston Scientific Corp., ABK Reference Unlabeled/Unapproved uses of drugs or products: In the US Radioembolization and drug-eluting embolic platforms are often used off-label

3 RADIATION SEGMENTECTOMY Apply ablative doses to HCC-bearing parenchyma Whole Liver Infusion Segmental Infusion Lobar Infusion Direct Infusion into Tumor Tumor Tissue not Infused Infused Tissue

4 Baseline Demographics (n=102): 33 patients had surgery 1. CP A (49%), CP B (51%) 2. Tumors in the hepatic dome (58%) 17/33 3. Median (52%) tumor size Complete 2.5 cm (2.1 pathologic 3.6 cm) necrosis 4. Median tumor volume 165 cc ( cc) 16/33 (48%) Pathologic necrosis > 90% 5. Median activity delivered 0.95 GBq ( GBq) 6. Median dose administered 242 Gy ( Gy) JHEP 2014

5 Pathologic Outcome by Radiation Dose More complete necrosis observed when irradiation dose > 190Gy, suggesting possibility of threshold dose needed to achieve CPN

6 57-YEAR-OLD FEMALE WITH HCV Arterial-Phase MRI Venous-Phase MRI

7 SEPARATE SEGMENT 4 ARTERY Celiac Angiogram Middle Hepatic Angiogram

8 SEGMENT 4 RADIOEMBOLIZATION MHA Cone-Beam CT

9 FOLLOW-UP Pre-Treatment 1-Month Post Y90 AFP

10 FOLLOW-UP Pre-Treatment 4-Months Post Y90

11 TRANSPLANT? TUMOR 5.4 CM; TBILI CHRONICALLY 3.5

12 DOWNSTAGING 1 month 36 9 months

13 Resection? 65 y/o Male with Hep C FLR 30%

14 Differential Dosing

15 1-month post Y90

16 Segmentectomy/Lobectomy FLR 30% FLR 61%

17 ABLATION? Arterial-Phase MRI Venous-Phase MRI

18 ANGIOGRAPHY Celiac Angiogram Selective Angiography

19 ANGIOGRAPHY Axial Cone Beam CT Coronal Cone Beam CT

20 FOLLOW-UP PRE-Y90 12-Month 1-Month 6-Month Follow-up

21 RADIATION SEGMENTECTOMY VS. RFA FOR SOLITARY HCC

22 NEEDLE TRACT SEEDING: 1. Llovet, J.M., Vilana, R., Brú, C. et al, Increased risk of tumor seeding after percutaneous radiofrequency ablation for single hepatocellular carcinoma. Hepatology. 2001;33: Imamura, J., Tateishi, R., Shiina, S. et al, Neoplastic seeding after radiofrequency ablation for hepatocellular carcinoma. Am J Gastroenterol. 2008;103: Chang, S., Kim, S.H., Lim, H.K. et al, Needle tract implantation after percutaneous interventional procedures in hepatocellular carcinomas: lessons learned from a 10-year experience. Korean J Radiol. 2008;9: Germani, G., Pleguezuelo, M., Stigliano, R., Burroughs, A.K. Risk of seeding is reduced by associating diagnostic biopsy with percutaneous ablation for hepatocellular carcinoma. Gut. 2009;58: Snoeren, N., Jansen, M.C., Rijken, A.M. et al, Assessment of viable tumour tissue attached to needle applicators after local ablation of liver tumours. Dig Surg. 2009;26: Yu JI, Liang P, Yu XL, Cheng ZG, Han ZY, Dong BW. Needle track seeding after percutaneous microwave ablation of malignant liver tumors under ultrasound guidance: analysis of 14-year experience with 1462 patients at a single center. Eur J Radiol Oct;81(10):

23 TACE? 57 y/o Woman with Hep C AFP 4,491.5

24 AFP 4,491.5 AFP 70.6

25 AFP 4,492 Pre-Y90 AFP 69 9 months post Y90

26 Prospective, randomized, phase 2 trial Clinical trial number: NCT met enrollment criteria 43 declined research despite tumor board recommendation 29 selected other clinical trials 49 requested Y90 13 requested ctace 45 treatment-naïve Barcelona Clinic Liver Cancer stage A/B patients randomly assigned to ctace or Y90 Imaging by 2 independent radiologists Primary outcome = time-to-progression (TTP) [intention-to-treat] Secondary outcomes = safety, RR, and OS Salem et al. Under Review

27 TIME TO PROGRESSION Significant difference in median TTP was observed ctace 6 4 months (CI: ) Y90: not reached (CI: 14.5-NC) p= [HR: 0.13 (CI: , p=0.009)]

28 TACE +/- ABLATION 4.4 cm HCC

29 TACE +/- ABLATION? 1-MONTH POST Y90

30 TACE +/- ABLATION? 4-MONTHS POST Y90

31 TACE +/- ABLATION? 11-MONTHS POST Y90

32 2 YEARS POST Y90

33 95 YEAR OLD WITH HCC Pre-Y90 16 months post y90 AFP

34 27 months post Y90 (now 98!)

35 SUMMARY SAFE Tumors in difficult locations Chronic hyperbilirubinemia EFFECTIVE Curative VERSATILE Downsizing to other therapies (surgery)

36 Question 1 The concept of Radiation Segmentectomy is to deliver the lowest radiation dose possible directly to the tumor: a) True b) False Answer B. Reference: Riaz A, Gates VL, Atassi B, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Baker T, Kulik L, Gupta R, Abecassis M, Benson AB 3 rd, Omary R, Millender L, Kennedy A, Salem R. Radiation Segmentectomy: A novel approach to increase safety and efficacy of radioembolization. Int J Radiat Oncol Biol Phys. 2011;79(1):

37 Question 2 For Radiation Segmentectomy, more complete pathologic necrosis is observed when irradiation dose exceeds: a) 130 Gray b) 160 Gray c) 190 Gray d) 220 Gray Answer C. Reference: Vouche M, Habib A, Ward TJ, Kim E, Kulik L, Ganger D, Mulcahy M, Baker T, Abecassis M, Sato KT, Caicedo JC, Fryer J, Hickey R, Hohlastos E, Lewandowski RJ, Salem R. Unresectable solitary hepatocellular carcinoma not amendable to radiofrequency ablation: multicenter radiology-pathology correlation and survival of radiation segmentectomy. Hepatology Jul;60(1):

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