Minimally Invasive Radiofrequency Ablation Treatment of Metastatic Spinal Tumors

Transcription

1 Minimally Invasive Radiofrequency Ablation Treatment of Metastatic Spinal Tumors 1

2 Objectives Demographics of spinal tumors Treatment options and goals Adoption of RF ablation for pain palliation by NCCN Clinical Evidence 2

3 Overview of spine metastases 10 million Americans with cancer with 1.7 million dx/year 1 10% will develop symptomatic spine mets 2 Spinal SREs pain requiring palliative radiation therapy (RT) or surgical intervention pathologic vertebral compression fracture (VCF) metastatic epidural spinal cord compression (MESCC) hypercalcemia Surgical treatment of MESCC costs nearly $83,000 3 patients with MESCC are hospitalized twice as long during their last year of life compared with other cancer patients Fehlings MG, Spine 2014 Oct 15;39 (22 Suppl 1):S99-S Jayasekera J, Pharmacoeconomics 2014; 32 : Loblaw DA, Clin Onco (R Coll Radiol) 2003 ; 15 :

4 Bone Metastases: Large, Underserved Patient Group Metastatic Bone Disease Is Prevalent in Many Types of Cancer CANCER FIVE-YEAR WORLD PREVALENCE 1 INCIDENCE OF BONE METASTASES IN CANCERS 2 MEDIAN SURVIVAL (MONTHS) 2,3 Myeloma 144,000 70%-95% 6-54 Renal 480,000 20%-25% 6 Melanoma 533,000 14%-45% 6 Thyroid 475,000 60% 48 Lung 1,394,000 30%-40% 6 Breast 3,860,000 65%-75% Prostate 1,555,000 65%-75% Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan Int J Cancer Oct 15;94(2): Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 2001;27: Coleman RE. Skeletal complications of malignancy. Cancer 1997;80 (suppl):

5 Nature of Spinal Metastases Metastatic Spinal Metastases commonly osteolytic, affect multiple vertebrae and involve posterior vertebral body 1,2 600 cases of spinal metastases examined according to clinical characteristics, type of primary tumor, site of lesion, and survival 94/95 (99%) involved posterior vertebral body Batson plexus to basivertebral venous plexus 2 1. Constans, JP. et al. Spinal metastases with neurological manifestations. J. Neurosurg Algra et al. Do metastases in vertebrae begin in the body or the pedicles. AJR

6 Three primary pain generators in the spine Mechanical Pain Instability from pathologic microfractures Biological Pain Stretching/irritation of the periosteum: secondary to tumor growth Osteoclast mediated bone resorption and associated release of neuro-stimulating cytokines Radicular/myelopathic Canal or neuroforamenal involvement of tumor Severe compression fracture with narrowing of neuroforamen Rybak et al. Radiol Clin N Am 2009, Callstrom et al. Skeletal Radiol

7 Treatment Goal... Rapid & Lasting Pain Relief Debulk and Decompress tumor Stabilize Minimize active bone destruction Destroy nerve endings Decrease neuro-stimulating Cytokines Local Control Wallace et al. Oncologist 2015 v20 p

8 Focal Palliative Treatment of Bone Metastases Radiation Therapy EBRT: Standard of Care for bone met palliation - single versus multiple fraction regimen Rate and degree of pain relief is weeks to months Partial and complete palliation rates of 60% and 23%, respectively (Chow et al, Clin Oncol 2012). Requires Interruption of chemotherapy SBRT: Faster and more efficient pain relief Immobilization of painful patients for planning and treatment Associated with increased risk of fracture Boehling et al (20%) ; Rose et al (40%); Sahgal et al (14% median time to fracture 2.4 mos) Surgical intervention Neurologic deficit / instability requiring decompression, stabilization, corpectomy Invasive, risk/benefit Minimally Invasive Ablative Therapy Acute pain relief Does not require interruption of chemotherapy Complimentary to conventional radiotherapy 1. Chow et al. Clin Oncol (R Coll Radiol) 2012 Mar;24(2): Boehling et al. J Neurosurg Spine Apr;16(4): Rose PS et al. J Clin Oncol Oct 20;27(30): Sahgal A et al. J Clin Oncol Sep 20;31(27):

9 Patient Selection Symptoms Intensity Acuity Quality: Mechanical/ Neuropathic Patient Life expectancy Performance status (KPS, ECOG) Medical co-morbidities Urgency of systemic therapy / clinical trial entry Spine Epidural extension / cord compression Stability - SINS score? Treatment Chemo/biologic/hormone sensitivity of tumor. Radiosensitivity of tumor Prior therapy (surgery, radiation, ablation, vertebral augmentation) to spine segment(s) Spine Instability Neoplastic Score (SINS) Treatment Options Surgery Decompression Stabilization Corpectomy/GTR Radiation EBRT SRS/SBRT Unsealed sources Radiology Vertebral augmentation (vertebroplasty, kyphoplasty) Steroid/anesthetic injection (CE/TFE) Ablation (RFA, cryo, etc.) Medical Oncology Bisphosphonates Chemo Supportive care Total score: 0-6 stability 7-12 indeterminate stability instability Fourney DR et al. J Clin Oncol 2011;29:

10 NCCN Principles of Cancer Pain Management 1 Targeted tumor ablation supports NCCN Principles 2,3 There is increasing evidence in oncology that survival is linked to symptom reporting and control and that pain management contributes to broad quality-of-life improvement. To maximize patient outcomes, pain management is an essential part of oncologic management. Goals of pain management are to meet patient-specific goals for comfort, function, and safety. Prevention of expected analgesic side effects is key to effective pain treatment. t-rfa provides clinically significant pain relief to patients suffering from metastatic spinal lesions and improves quality of life. t-rfa is a safe and effective treatment option. Over 50% of those treated with t-rfa decreased usage of pain medications. 2 INTERVENTIONAL STRATEGIES recognized by NCCN for local bone pain include: vertebral augmentation and radiofrequency ablation 1. National Comprehensive Cancer Network. Adult Cancer Pain (Version ) 2. Anchala PR et al. Pain Physician 2014; 17: Bagla S et al. Cardiovasc Intervent Radiol 2016 v39 p

11 Treating Metastatic Vertebral Body Tumors through a minimally invasive RFA procedure Access & Navigation: Active steering capability reaches desired target location within the tumor via a unipedicular approach Controlled Energy Delivery: RF energy is delivered as the instrument actively monitors tumor temperatures and provides real-time feedback Tumor Debulking: Targeted tumor is destroyed while reducing risk of damage to adjacent neural tissues. Innovation: device purpose built for unique anatomy of the spine Clinical evidence: demonstrates pain palliation and improved QOL 11

12 Targeted Radiofrequency Ablation Navigational Bipolar Radiofrequency Ablation Device SpineSTAR Ablation Instrument Articulating electrode to optimize location Multiple thermocouples to confirm/quantify zone Bipolar design requires no grounding pads MetaSTAR RF Generator Active temperature measurements Displays critical real-time information 12

13 Controlled thermal distribution - predictable ablation zone Multiple thermocouples embedded along length of electrode Confirm and Quantify Ablation Zone intra-operatively Real time assessment of thermal spread of ablation zone Temperature monitored on Generator display 3:2 length to width ablation zone 20 mm Thermocouple Length of zone 10 mm 2.0 cm 15 mm 3.0 cm Anchala PR. et al. Pain Physician 2014 v17 RF ablation produced by altering the electric current at active electrode, causing local ionic agitation & subsequent frictional heat 13

14 CLINICAL DATA Is targeted RF ablation of spinal tumors effective in relief of pain? 14

15 Treatment of Spine Metastatic Lesions with a Navigational Bipolar Radiofrequency Ablation Device: Multicenter Retrospective 128 lesions ablated in 92 patients using STAR System 5 academic medical center multicenter study Immediate, significant and durable pain relief No reported complications or thermal injury Cement augmentation, when required, using same coaxial cannula > 50% of patients decreased pain medications Anchala et al. Pain Physician :

16 Treatment of Metastatic Posterior Vertebral Body Osseous Tumors by Using a Targeted Bipolar RFA Device 47 posterior VB tumors treated in 26 patients using the STAR System 9 patients (35%) had prior RT at same tumor Primary cancer types: breast, lung, prostate, renal cell carcinoma Pain decreased by 64% at one week > 50% of patients reduced pain medication usage No major complications Hillen et al. Radiology Oct;273(1):

17 Multicenter prospective series of RFA in painful spine metastatic lesions 69 lesions in 50 patients - Treated with STAR Tumor Ablation System Rapid onset, significant, durable pain reduction Decreased Disability - significantly improved at each follow up - categorical improvement: severe to moderate at 1 and 3 mos Improved Quality of Life - cancer specific FACT questionnaires (Functional Assessment of Cancer Treatment) NCCN Guidelines Version : Adult Cancer Pain Increasing evidence in oncology that survival is linked to symptom control and that pain management contributes to broad quality-of-life improvement. To maximize patient outcomes, pain management is an essential part of oncologic management. Baseline 3 Day 1 Mo 3 Mo Oswestry Disability * 40.0* 37.0* FACT-G * 15.8* 16.2* FACT-Bone Pain * 37.3* 38.9* * p<0.01 Bagla S et al. Cardiovasc Intervent Radiol 2016 v39 p

18 Palliative Radiation Therapy: Opportunities to improve the gold standard Meta-analysis of 11 individual prospective trials comparing effectiveness of palliative single and multi-fraction RT 3,435 patients treating 3,487 painful sites Most common primary cancers: prostate, breast, and lung Single Fraction Multi-fraction Overall response 60% 59% Complete pain relief 34% 32% Retreatment needs 21.5% 7.4% Conclusions: Single and Multi-fraction EBRT are similar in terms of resulting pain relief 40% of patients receive no pain relief after RT 65% have persistent pain after RT Sze WM., et al. Cochrane Review (2011): Issue 5 18

19 RFA + RT adjuvant: An enabling technology Patients with solitary bone metastases and a VAS pain score 5 n=15 RFA+RT (20 Gy delivered in 5 fractions of 4 Gy over 1 week) n=30 treated with RT (matched group) RT only RFA+RT P-value Overall response 60% 93% <.05 Complete pain relief 17% 53% <.05 Time to Pain Relief 9 wks 3 wks <.01 Recurrent pain Retreatment need 26.6% 6.7% NS Authors Conclusions: Feasibility study demonstrated RFA+RT may be more effective than EBRT alone. Addition of RFA may improve degree, rate, and duration of pain relief Limitations: small study cohort, interpret comparative effectiveness with caution Di Staso M. et al. Eur Radiol (2011) 21:

20 Combined t-rfa and radiation therapy of spinal metastases Retrospective 21 patients 36 spinal metastases (STAR System) - Concurrent ablation (21/22RFA; 1/22 Cryo) + RT within 4 wks - RT: 63% Conventional fractionated, 27% SBRT; 9% unknown - Lung (38%); renal cell (24%); breast (14%); rectal (9%) - 7 (33%) radio-resistant tumors (renal cell, sarcoma, melanoma) Pre-treatment 1 week 1 month Pain (Change in score) 1 week (n=21) 1 month (n=19) Partial 2 16 (76%) 13 (68%) Imaging demonstrated stable treated disease in: - 12/13 at 3 mos - 10/10 at 6 mos Complete 5 (24%) 9 (47%)** Nonresponders < 2 5 (24%) 6 (32%) ** Di Staso et al RFA+RT 53% complete pain response Greenwood TJ, Wallace A, Friedman MV, Hillen TJ, Robinson CG, Jennings JW. Pain Physician 2015;18:

21 t-rfa in radiation resistant lesion post t-rfa L2/L3 6 mos post t-rfa of L2-L3 pre t-rfa T11-T12 3 mos post t-rfa of T11-T12 Metastatic renal cell post EBRT: L2/L3 vertebral lesions ablated and augmentation T11/T12 small enhancing lesions 6 months post ablation: L2/L3 no further tumor progression T11/T12 marked increased in size 3 months post ablation at T11-12 retraction of previously seen epidural tumor Anchala et al. Pain Physician: July/August (4) Wallace et al. Oncologist 2015 v20 p

22 Clinical experience/evidence suggest patients with focalized pain from metastatic spinal tumor who may benefit from RFA with radio-resistant tumors (e.g. - RCC, melanoma, sarcoma) with persistent and/or recurrent pain after radiation therapy with posteriorly positioned metastatic tumors who have reached their maximum radiation dose limit with focalized pain and symptoms that are preventing palliative radiation who cannot undergo other palliative treatments due to concurrent systemic treatments in which myelosuppression is of concern 22

23 Summary Percutaneous spine ablation is becoming more integrated into the multidisciplinary algorithm for treatment of metastatic spine disease, especially in patients who have failed RT or in which it is not a clinical option Patient selection is paramount, should be done in a multi-disciplinary fashion RFA is most published modality for spine ablation with proven pain palliation Prospective clinical evidence important to drive adoption extensive clinical evidence in spine on STAR Ablation System 23

24 STAR Tumor Ablation System Indications for Use The STAR Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body Risks and Contraindications As with most surgical procedures, there are risks associated with the STAR procedure, including serious complications. For complete information regarding risks, contraindications, warnings, precautions and adverse events please review the System s Instruction for Use 24

25 Thank You /001 25