Proton beam therapy for liver tumors
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1 Proton beam therapy for liver tumors University of Tsukuba, Japan Hideyuki Sakurai, Toshiyuki Okumura, Nobuyoshi Fukumitsu, Hitoshi Ishikawa, Kayoko Ohnishi, Masashi Mizumoto, Keiko Murofushi, Haruko Numajiri, Hirokazu Makishima, Takeji Sakae, Koji Tsuboi
2 introduction
3 Neoplasms in the liver Classification of Liver Cancer Liver Cancer Study Group of Japan Primary liver cancer Hepatocellular Carcinoma (HCC) Intrahepatic Cholangiocarcinoma (CCC) Combined HCC & CCC Cystadenocarcinoma Hepatoblastoma Metastatic Liver cancer Colon, Rectum, Breast etc.
4 Regional variations in the mortality rates of HCC Age-adjusted mortality / 100,000 El-Serag HB, Gastroenterology 2007
5 Treatment options for HCC Surgical resection The mainstay Tx but majority are not eligible Liver transplantation Solitary, < 5cm or < 3 nodules, < 3cm Percutaneous ablation: RFA, PEI < 3 nodules, < 3 cm Transcatheter Arterial Chemoembolization Suitable for multiple, unresectable HCC Radiotherapy: particles, SBRT, Y90-IRT
6 Characteristics of HCC & requirements for the treatment Hepatitis virus related (cirrhosis) 90% of pts. with HCC have hepatitis C virus infection save functional liver volume Multicentric progression repeatable for new lesion Vascular invasion (portal v. & IVC) RT rather than operation
7 72.6GyE/22 fr. Before treatment normal liver enlargement (functional recovery) Tumor shrinkage (just like surgery) 4 years later
8 National Laboratory for High Energy Physics (KEK) Particle Radiation Medical Science Center (PARMS) Proton Medical Research Center (PMRC)
9 Mt.Tsukuba 筑波大学附属病院 University Hospital of Tsukuba 筑波大学附属病院 radiation examination In-pa Out-patient (450 cases/year) 陽子線医学利用研究センター Proton Medical Research Center
10 Patients in PMRC, Tsukuba Number of patients ( ) Practice 100 Bladder 2.8% Brain3.9% Pediatrics 5.1% H & N 5.8% Esophagus 6.1% Mets 10.2% Lung 11.4% 50 0 HCC 32.9% Trial Prostate 11.8% 原発性肝癌 1,257 前立腺癌 449 肺癌 435 転移性腫瘍 389 食道癌 231 頭頸部癌 220 小児癌 196 脳腫瘍 148 膀胱癌 108 膵臓癌 69 頭蓋底腫瘍 54 脳動静脈奇形等 45 直腸癌 22 縦隔 20 腎癌 その他 Total 3,
11 system
12 Proton Medical Research Center, Univ. of Tsukuba Binary Type First Scatterer High Precision Profile Monitor Synchrotron LINEAC Hydrogen Second Scatterer Sub Dose Monitor Ridge Filter Range Shifter Flatness Monitor Multileaf Collimator Bolus Main Dose Monitor Patient Collimator Iso-center Beam formation Rotating Gantry Treatment room
13 A fiducial marker is used to adjust the daily positioning platinum In-situ fiducial marker Deep seated Moving target digital radiography for tumor localization marker fiducial markers
14 Respiratory gated irradiation Laser Gauge Strain Gauge Patient laser gauge Respiratory wave Couch Trigger and pre-trigger Beam signal (Proton beams were released during the expiratory phases)
15 Protocols & results
16 Dose, Fractionations for PMRC Tsukuba 1) 66 GyE / 10 fraction (EQD 2 = 91.3GyE) peripheral tumor 2) 72.6GyE / 22 fractions (EQD 2 = 80.5GyE) central tumor close to porta hepatis (< 2cm) 3) 74.0 GyE / 37 fractions (EQD 2 = 74GyE) close to GI < 2cm RBE (relative biological effectiveness) = 1.1, 1 GyE = 1.1 Gy
17 Dose distribution for a peripheral type HCC (HCC 72 y.o.,lc (C), Pugh sc. 5, 7.5cm) 66GyE/ 10fr/ 15day white: GTV red: 100% dose blue: 10% dose
18 CT findings after proton therapy for HCC before 2 mo 4mo 28 mo 66GyE/ 10fr/ 15day
19 Central type HCC 81 yr., LC (C), Pugh score: 6, Vp4 axilal coronal 72.6GyE/ 22 fr.
20 Central type HCC 72.6 GyE/ 22fr. pre PBT 6 Mo. after
21 HCC close to the GI tract 74GyE / 37 fr. (77 GyE/ 35 fr)
22 Proton Beam Therapy for Hepatocellular Carcinoma: A Comparison of Three Treatment Protocols (2001 Jan Dec. n= 266 ) Local control rates 1yr : 98% 3yr : 87% 5yr : 81% Overall survival rates 1yr : 87% 3yr : 61% 5yr : 48% Grade 3 GI complication: 3 cases in protocol C IJROBP 2011;81:
23 HCC larger than 10cm Median target volume 567 cc ( cc) 72.6 GyE / 22 fractions ( GyE / fractions) 87% Local control (Sugahara S et al., Int J Radiat Oncol Biol Phys 76: , 2010)
24 PBT as an initial Tx for HCC
25 overall survival Survival after PBT in HCC (fresh case) Med. F/U Period: 37.3 Mon. ( ) Alive: 61,Dead 53 Overall survival(n=114) Data from JLCSG months from PBT treatment 1Y 2Y 3Y 4Y 5Y 6Y 7Y 8Y 9Y 10Y N all (%) 96,404 surgery ,062 RFA,PEI ,836 Proton JLCSG: Japan Liver Cancer Study Group, RFA: radiofrequency ablation, PEI: percutaneous Ethanol injection
26 overall survival OS according to liver function (Child-Pugh) all * p<0.001 * * months from PBT Child-Pugh 1Y 2Y 3Y 4Y 5Y 6Y 7Y 8Y 9Y 10Y N all (%) 114 C-P A C-P B C-P C
27 Toxicity Acute No patient discontinued treatment due to acute reactions. Gr. 3 hematologic toxicity: 4 (3.2%, PLT < 50000) Late GI Gr.3: 3 2.6% Biliary stenosis, biloma: 3 2.6% Rib fracture: 3 2.6%
28 Survival rate Liver function as most important risk factor 1.0 Child-Pugh score & OS (n = 250).8 Child A group(n=197); median 64 months 3y 70%, 5y 58% Child B/C group(n=53); median 20 months 3y 32%, 5y 18% Time (months)
29 Survival rate Liver function as most important risk factor ICG R15 & OS for only Child-Pugh A cases (n = 197) 1.0 ICG R15: ICG R15: ICG R15: ICG R15: ICG R15: >40 (n=18) 3y 38%, 5y 30% Time (months)
30 PVTT (Vp3-4) Strahlenther Onkol 2009;185: Cancer 2005;104:
31 Portal vein tumor thrombosis (PVTT) Case of 7 years survival with no evidence of disease progression pretreatment 1 mo after PBT 7 years after PBT
32 63 y.o. male 77.0GyE/35 fr Vp4 pretreatment 18 months after PBT Complete response Re-canalization
33 HCC with PVTT ( ) Local control Overall survival Main trunk or major branches of PV n = 35 2-year local control rate: 91% Median survival : 22mo 2-year overall survival : 48% RTOG with very mild side effects (Sugahara S et al., Strahlenther Onkol 185: 782-8, 2009)
34 Radiation therapy for HCC with PVTT Author No.Case PVTT treatment method RR* MST(Mo.) Tazawa J 24 Vp3,4 TACE+RT50Gy 50 CR,PR; NC,PD;3.8 Yamada K 8 Vp3 TACE+RT60Gy+TACE (+2) 2001 Ishikura S 20 Vp3 TACE+RT Nakagawa K 52 Vp2,3,4 3DCRT57Gy (39-60) 50 (25.3%;2YSR) 2005 Kim DY 59 Vp3,4 3DCRT30-54Gy 45.8 CR,PR; NC,PD;5.3 Lin CS 43 Vp3,4 RT45Gy/15fr: DCRT45Gy/25fr: Tsukuba 35 Vp3,4 PBT 72.6GyE (55-77) *RR: response rate
35 HCC with PVTT ( ,recent data) Survival of Data 1:Survival proportions Radical treatment: all GTV can be irradiated with intentional dose Percent survival MST: 6.33 p < MST: 26.9 radical palliative n month
36 CCC
37 Chemoproton therapy Proton beam therapy for Cholangiocellular carcinoma (CCC) Concurrent use of TS-1
38 3-year later Chemoproton therapy CCC 1-year later
39 CCC 73 yo female, ct3n0m0, 14x9 cm isodoses before Just after 8 mo 1 y 2 y 74GyE/ 37fr/ 58 days, combined TS-1
40 Overall survival rate OS in Proton for CCC(-2010, Tsukuba) Curative group (n=12) p=0.048 Local control 9/12 (curative group) MST > 2 years (curative group) Incurative group (n=8) cf MST by no surgery < 1 year MST by surgery = 2 years time(month)
41 Mets & others
42 Salvage RT Metastatic and/or recurrent tumors 60yo woman liver metastasis from colon cancer Obstruction of portal vein & bile duct Chemoresistant & inoperable PBT for central region Improvement of CT surgery for lateral lobe High control rate for micrometastasis Important to treat gross tumor with PBT 5 y NED normal liver function
43 PBT for liver metastasis (n=115) OS Dose:median 72.6 GyE(44-77 GyE) Concurrent Chemo.: 28 cases breast, [ 値 ] others [ 値 ] colon [ 値 ] 0.6 gastric, [ 値 ] panc, [ 値 ] 0.4 1Y: 68% 0.2 3Y: 43% 5Y: 31% months 3-y survivor = 17 solitary : 7 multiple
44 2 y.o.- girl, hepatoblastoma. Stage IVA initial Before PBT 61.6GyE/16fr 3fr/wks Change of AFP 16 years after (Oshiro Y. et al., Acta Oncol ISSN X print/issn X online 2013)
45 summary
46 PBT for HCC 90 % control with very less side effects Multimodality therapy RFA surgery TACE X-SRT PBT Inoperable Large volume PVTT IVCTT elder medical problem
47 RCT? HCC with cirrhosis, multicentric fashion Multimodality therapies based on tumor condition RFA Surgery TACE PBT for large HCC Proton PBT for PVTT Inoperable Poor function Large volume PVTT IVCTT elder medical problem potentially proposed RCTs PBT vs X-SRT vs RFA for 3cm HCC PBT vs surgery for more than 3cm HCC
48 A trial in Japan Non randomized controlled study comparing proton beam therapy and hepatectomy for resctable hepatocellular caricinoma Newly diagnosed solitary & nodular HCC 3 cm, 12 cm >, age y.o. Child-Pugh 5-7, PS 0-1 registration The treatments (S or P) can be chosen by patient surgery Proton 66Gy / 10 fr. 72.6Gy / 22 fr.
49 Acknowledgment Special thanks to all of the staffs who have been involved in PBT at University of Tsukuba
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