SELECTIVE INTERNAL RADIOTHERAPY Y90 RADIOEMBOLIZATION

Transcription

1 THE NEXT OIS FRONTIER? SELECTIVE INTERNAL RADIOTHERAPY Y90 RADIOEMBOLIZATION David Sperling, MD, FSIR Vice Chair, Strategy and Development Department of Radiology Columbia University Medical Center

2 David Sperling MD, FSIR - ColumbiaDoctors IntervenPonal Radiologist at Columbia University Medical Center Vice Chair, Strategy and Development for the Department of Radiology. Columbia Doctors has two separate Office Based IntervenPonal Suites (OBIS) for the Department of Radiology Our facilipes contain 3-C-Arm suites and perform all elements of outpapent IR, including consultapons and procedures Since our launch in 2008 our freestanding offices have: Treated over 13,000 papents Performed over 7,000 procedures Performed over 600 chemoembolizapons for liver tumors.

3 SIRT Selective Internal Radiation Therapy SIR-Spheres were approved by the FDA in March 2002 for Metastatic Colorectal Cancer Patients in combination with HAC Fudr Chemotherapy Treatment Goals: SelecPvely deliver a tumoricidal dose of beta radiapon to the liver tumor while maintaining a low radiapon dose to the normal liver Pssue

4 Y90 ParPcle DescripPon Resin microspheres charged with Y_rium microns in diameter Not biodegradable Y- 90 is a pure beta emi_er with a half life of 2.68 days Average radiapon range in Pssue is 2.5 mm with a maximum of 11 mm

5 Figure 1. Photomicrograph (original magnification, 200) shows glass microspheres. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

6 Figure 2. Photomicrograph (original magnification, 1000) shows resin microspheres. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

7 RaPonale for RadioembolizaPon Liver relapvely insensipve to radiapon HepaPc circulapon is uniquely organized with dual blood supply to the liver Almost exclusive arterial supply to the tumor

8 Y_rium 90 RadioembolizaPon Mechanism of Therapy Micro-catheter used to deliver Y90 microspheres to the tumor supplied by HA branches Lethal doses delivered to tumors ( Gy, 120 Gy tumoricidal) Low dose to normal liver Not an intenponal embolizapon Y90 is a micro-embolizapon or ischemia producing therapy

9 PaPent SelecPon PaPents with inoperable liver metastases, not surgical candidates with intent for cure Liver only or liver dominant disease Percent liver involvement < 60 ECOG 0-2 Life expectancy > 3 months Assessment of renal hepapc and pulmonary funcpon Patent Portal Vein Bilirubin <2.0 Lung Shunt <20%

10 METASTATIC OR PRIMARY LIVER TUMOR TYPES TREATED WITH Y90 COLORECTAL GIST NEUROENDOCRINE STOMACH HEPATOCELLULAR CARCINOMA SMALL BOWEL CHOLANGIOCARCINOMA UNKNOWN PRIMARY BREAST UROTHELIAL PANCREAS OVARY MELANOMA ESOPHAGUS LUNG RENAL SARCOMA

11 Y90 TREATMENT SCHEDULE Requires (2) outpapent procedures 1 st procedure is for pretreatment evaluapon/mapping Angiogram mapping and embolizapon Lung shunt study with MAA CT SPECT scan Base line PET or PET CT (opponal) Treatment planning and basic dosimetry 2 nd procedure is for the Y90 administrapon Repeat angiogram, possible embolizapon, administrapon/inserpon of SIR- Spheres with IR/AU Post-treatment Bremsstrahlung

12 Pre-treatment Mapping:EvaluaPon of Vasculature and ProphylacPc EmbolizaPon of Extra-HepaPc Vessels Angiographic evaluation of hepatic vasculature and identification of extra-hepatic vessels Prophylactic embolization of extra-hepatic vessels

13 Y90 SimulaPon With MAA MAA is similar in size to Y-90 microspheres but is bio-degradable Used as pre-treatment simulapon to select suitable papents for SIRT Determine extra-hepapc shunpng to the lungs and non-target organs MAA may show significant acpvity in areas beside tumor nodules? these papents may be at a higher risk for RILD* * Int J Radiation Onc Biol Phys 2006;66:3:

14 Tc-99m MAA Shunt Study Min lung shunt Mod lung shunt

15 Figure 8. Bremsstrahlung imaging helps confirm successful targeting of hepatic metastases from pancreatic islet cell tumor in a 54-year-old man. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

16 Dose and Dose ReducPons 1. DOSE CALCULATION Dose of SIR-Spheres (in GBq) = *BSA [% tumor volume ] volume of tumor + liver 2. DOSE REDUCTIONS i) PaPents with excessive lung shunpng reduce dose by: *BSA = body surface area in square Meters Note: EquaPon for whole liver,for bilobar Pmes equapon by lobe factor. ii) PaPents heavily pre-treated with chemotherapy reduce dose by 10-20% Sirtex Package Insert Int J Rad Oncol Biol Phys 2007;68:1: B J of Radiol 1997;70:823-8 Europ J of Nuc Med 1996;23:

17 Side Effects & ComplicaPons SIDE EFFECTS Nausea, abdominal pain and Predness seen in most papents laspng up to 6-8 weeks aser treatment COMPLICATIONS RILD = RadiaPon induced liver disease, occurs 4-8 weeks aser treatment rare Non-target embolizapon with duodenal / gastric ulcerapon ~ 5% Gallbladder disease < 1% RadiaPon pneumonips v. rare with pre-treatment lung shunt study JVIR 2005;16: JVIR 2006;17:

18 SIR-Spheres in Salvage Therapy of mcrc: Survival 100 PET Response Median Survival 80 responders: non-responders: 85% 15% 10.5 months 4.5 months P = Percent Survival Months Kennedy A, Coldwell D, Nutting C et al. Int J Radiation Oncology Biol Phys 2006; 65:

19 RESPONSE RATES Hepatocellular Carcinoma: WHO response rate 42%, EASL 57% (Salem et al 2010) Overall 3 yr survival rate = 75% (Kim et al 2015) Cholangiocarcinoma: Median OS range 11.7 months 22 months (mulpple studies: Camacho 2014, Filippi 2015, Haug 2011, Hoffman 2012) Breast Cancer: PR 48%, SD 39%, Median OS 12.2 months (Van Hazel 2009) PR 33%, SD 27% (Lim 2005) PancreaPc Cancer: PR 64.3%, Median OS 9 months (Michl 2013)

20 Figure 9a. Complete response to brachytherapy with use of the resin microsphere device as an adjunct to systemic chemotherapy. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

21 Figure 9b. Complete response to brachytherapy with use of the resin microsphere device as an adjunct to systemic chemotherapy. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

22 Figure 11a. Representative coronal images from two fluorine 18 fluorodeoxyglucose wholebody PET examinations performed 6 months apart in a 55-year-old man who was undergoing systemic chemotherapy for metastatic colorectal cancer. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

23 Figure 11b. Representative coronal images from two fluorine 18 fluorodeoxyglucose wholebody PET examinations performed 6 months apart in a 55-year-old man who was undergoing systemic chemotherapy for metastatic colorectal cancer. Murthy R et al. Radiographics 2005;25:S41-S by Radiological Society of North America

24 --59-year-old man with hepatocellular carcinoma treated with 90Y microspheres Keppke, A. L. et al. Am. J. Roentgenol. 2007;188: Copyright 2007 by the American Roentgen Ray Society

25 --59-year-old man with hepatocellular carcinoma treated with 90Y microspheres Keppke, A. L. et al. Am. J. Roentgenol. 2007;188: Copyright 2007 by the American Roentgen Ray Society

26 Figure 5c. Use of PET to measure treatment response. Atassi B et al. Radiographics 2008;28: by Radiological Society of North America

27 Figure 5d. Use of PET to measure treatment response. Atassi B et al. Radiographics 2008;28: by Radiological Society of North America

28 SO WHY IS Y90 THE NEXT OEIS FRONTIER? OUTPATIENT PROCEDURE INSURANCE WILL NOT EVEN CONSIDER PAYMENT AS AN INPATIENT WELL REIMBURSED WELL TOLERATED SAFE FATIGUE IS TYPICALLY THE ONLY MAIN SIDE EFFECT

29 CONSIDERATIONS Mapping and Dose Administration Dose Administration only Reimbursement

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31 Medicare CY 2018 Reimbursement for OBIS OBIS (1) Mapping with embolizapon $9, (1) Treatment Y-90 AdministraPon and Imaging $11, SIR-Spheres HCPCS Q3001 Invoice price $37, $16, $20, Global Payment

32 2018 non-facility Payment: One Treatment (NaPonal Average: physician non-facility payments) Procedure CPT QuanFty Reimbursement Arterial EmbolizaPon day of treatment $9,900 SelecPve catheter Operator determined (pretreatment & day of treatment) $921 Treatment Planning per treatment (prior to Y-90 treatment) Basic Dosimetry per treatment $69 $171 Y-90 AdministraPon AU $117 Total 11,378 HCPCS Q3001 Brachytherapy Elements Add to line 19 on 1500 Q day of treatment $16,500

33 Medicare: SIR-Spheres Reimbursement in the OBIS Q3001 Medicare only Q3001, C2616, & S2065 Private Payer Contracts vary Important to understand your commercial payer contracts and reimbursement in the OBIS setting Key codes: CPT codes 75726, 37242, and HCPCS codes Q3001, C2616 or S2095

34 C-Arm vs. Ceiling/Floor Mounted Unit? IMAGING CONSIDERATIONS

35 Mobile C-Arm vs. Fixed Lab

36 Mobile C-Arm vs. Fixed Lab

37 Lung Shunt Imaging NUCLEAR MEDICINE! Facility based Capital Investment for Gamma Camera ROI Possible Certification Need (CON) Staffing Space Requirements! Offsite Facility Proximity to Facility <30min Political Considerations Hospital Owned? Scheduling Flexibility Relationship with OP Facility

38 Dose PreparaPon and Storage! Onsite Hot Lab Capital Investment Space Certification Ongoing Maintenance and Licensing Find out your state or city regulations; some require a hot lab, others do not!! 3 rd Party Vendor Unit Dose delivery No capital investment No ongoing maintenance and certification Additional Procedural costs

39 RADIOACTIVE MATERIALS LICENSING AND RADIATION SAFETY COMPLIANCE What is a RadioacPve Materials License? Possession and medical use of radioacpve material Safety Security This is not your x-ray registrapon Inspectors will inspect once a year

40 RadioacPve Materials License ApplicaPon New RAM License? ExisPng RAM License? License Amendment only

41 Authorized User* What Staff Do You Need? Responsible for medical use of radioactive materials on license - SIR-Spheres Y-90 resin microspheres - Tc-99m Radiation Safety Officer* Responsible for safety and security of radioactive materials onsite - SIR-Spheres Y-90 resin microspheres - Tc-99m Consultant Technologist Responsible for dose draw and pre-/post-administration measurements

42 Radiation Safety Compliance Do you know how to do a contamination survey? Does your technician know how to do a contamination survey? Who collects your written directives? Who will store your records?

43 Offsite PaPent Workflow 8:00AM Marks PaPent Arrival and Confirms PaPent Appointment with Radiology Center for 12pm 9:00AM PATIENT BROUGHT INTO SUITE AND PRE-OPERATIVE WORKUP PERFORMED INCLUDING RADIAL BARBEUAX OR ALLENS 10:00AM PROCEDURE PERFORMED AND POSITIONING FOR MAA DELIVERY CONFIRMED 10:30AM MAA INJECTION AND RADIAL BAND APPLIED 11:30AM RADIAL BAND AND PATIENT DISCHARGED FROM FACILITY 12:00PM PATIENT COMPLETES LUNG SHUNT STUDY AT OP RADIOLOGY FACILITY

44 Two vendors for Y90: Sirtex BTG (BiocompaPbles) Both will be very willing partners to assist in starpng up your office based Y90 pracpce!

45 Summary Y90 is an effective procedure to treat liver malignancies Safe Designed to be an outpatient procedure Well reimbursed Treats an underserved, ever increasing population Can be performed from femoral or radial approach Treatment day = less than 30 minutes of room time Discharge home in under 2 hours (start to finish) if radial

46 Summary Option to perform both mapping/dose or dose only in the OBIS. Medicare coverage generally provided in OBIS setting. Imaging Limitations and Considerations. Pathway to licensure for your center. Logistical considerations for nuclear medicine studies. Third-Party relationships can eliminate need for hot labs. Regulatory guidance and suggestions.

47 THANK YOU!