Presentation on theme: "16001110 Overview of Cancer-Related Vertebral Compression Fractures."— Presentation transcript:
Overview of Cancer-Related Vertebral Compression Fractures
Objectives Describe Vertebral Compression Fractures (VCF) Describe the scope of the problem in patients with cancer Review evidence-based interventions
WedgeBiconcaveCrush 1. Genant HK et al. J Bone Miner Res. 1993;8:1137–1148. Vertebral Compression Fractures VCFs are fractures of the bones of the spinal column Occur when the vertebral body fractures or collapses because the bone is too weak Weakness can be caused by primary bone cancer, metastatic bone disease, and cancer- or chemotherapy- related osteoporosis
Cancer-Related VCFs An estimated 75K-100K cancer-induced VCFs occur annually in the U.S. Stage IV breast and lung cancers All stages of Multiple Myeloma Stages III and IV of prostate cancer Additional data calculations on file, Medtronic Spine LLC. Compiled from the following articles: 1.Hortobagy et al. NEJM. 1996;335: Berenson et al. NEJM. 1996;334: Brincker et al. Brit J Haematol. 1998;101: McCloskey et al. Brit J Haematol. 1998;100: Melton et al. J Bone Miner Res ;20: Djulbegovic et al. Cochrane Database Syst Rev. 2002; 4, CD003188: Berruti et al. J Urol. 2000; 164: Diamond et al. J Urol, 2004;172:
Metastatic Bone Disease
Regulation of Bone Metabolism 1.Roodman. NEJM. 2004;350: Images used with permission from NEJM.
Metastatic Bone Disease Epidemiology Definition: Tumors in bone arising from distant, non-bone sources. Most skeletal cancers are metastatic rather than primary % of the roughly 563,700 people who die annually of all cancers have bone metastasis. 1 Patients with cancer are at elevated risk for osteoporosis and fractures because of both disease and treatment 1 1.Coleman. Cancer Treat Rev. 2001;27:
Metastatic Bone Disease Lesion Types Osteoblastic Increased bone density Does not change bone strength but decrease bone stiffness Common in patients with prostate cancer 1.Lieberman et al. ClinOrthopaed Rel Res. 2003;415S:S Patel, DeGroot. Ortho J. 2001;24:612-7.
Metastatic Bone Disease Lesion Types Osteolytic Decrease both bone strength and density Common in patients with metastatic cancer and multiple myeloma 70% of multiple myeloma patients present with osteolytic involvement of the spine 1 Higher risk for fracture than blastic lesions 2 1. Lieberman et al. Clin Orthopaed Rel Res. 2003;415S:S Patel, DeGroot. Ortho J. 2001;24:
Metastatic Bone Disease Radiographic Appearance of Skeletal Metastases BreastUsually Osteolytic or Mixed ProstateUsually Osteoblastic LungUsually Osteolytic ThyroidUsually Osteolytic 1.Manoso, Healey. In: Cancer: Principles and Practice of Oncology. 7th ed. 2005:
Metastatic Bone Disease Prognosis Variable survival Many live for years with bony disease Patients live longer with bone metastases than with both bone metastases and pulmonary metastases 1 Potential for improved QoL Patients with longer median survival will typically require treatment for skeletal complications Disease Type Median Survival (months) Multiple Myeloma 2 36 – 60+ Breast 1 19* Lung 1 3* Thyroid 1 19* * After disease metastasizes to bone 1.Manoso, Healey. In: Cancer: Principles and Practice of Oncology. 7th ed. 2005: Ludwig et al. Blood Feb 11. [Epub ahead of print]
Metastatic Bone Disease Diagnostic Tools Imaging X-ray and/or skeletal survey Computed Tomography (CT) Bone Scan Positron Emission Tomography (PET) Magnetic Resonance Imaging (MRI) Blood Tests Calcium level, Alkaline Phosphatase, etc. Needle Bone Biopsy 1.Manoso, Healey. In: Cancer: Principles and Practice of Oncology. 7th ed. 2005:
Metastatic Bone Disease Treatment Goals Control pain and symptoms Eradicate or reduce tumor when primary tumors are involved Prevent neurologic complications Treat pathologic fractures and prevent recurrent fracture 1.American Cancer Society. How is Bone Metastasis Treated? Available at:
Surgery Open and minimally invasive Radiation therapy Radioisotopes Strontium Samarium Sm-153 lexidronam [ Quadramet ®, Cytogen ] Systemic treatment Supportive therapy Bisphosphonates Analgesics Metastatic Bone Disease Available Treatments 1,2 1.How is Bone Metastasis Treated? Available at: 2.Manoso, Healey. In: Cancer: Principles and Practice of Oncology. 7th ed. 2005:
Metastatic Bone Disease Clinical Sequelae Bone damage leads to bone pain Pathologic fracture Vertebral compression fractures (VCFs) Long bones Spinal cord compression Hypercalcemia 1.Roodman. NEJM. 2004;350:
Vertebral Compression Fractures
Signs of Vertebral Compression Fractures Acute Event n Sudden onset of back pain with little or no trauma n Point tenderness n Girdle/belt/band-like pain n Muscle spasms Chronic Manifestation(s) n Loss of height n Spinal deformity - kyphosis n Protuberant abdomen Compiled from the following articles: 1. Coleman. Cancer. 1997;80: Lavelle et al. Med Clin N Am. 2007;91:
Biomechanics of VCF Knees bend, pelvis tilts forward to counteract forward bending Change in balance 1 Decrease in gait velocity 1 Increased muscle fatigue 1 Increased risk of falls and additional fractures 2,3 1.Gold, Lee, Tresolini. Working with patients to prevent, treat and manage osteoporosis, Ross et al. Annals Int Med, 1991; 114(11): Myers, Wilson. Spine. 1997;22(24 Suppl):25S-31S.
Compiled from the following articles: 1.Gold, Silverman The Downward Spiral of Vertebral Osteoporosis: Consequences. Designated by Cedar Sinai Medical Center Press, Podichetty. J Musculoskel Med. 2004;21: Radiculopathy Spinal cord compression Neurological Consequences Compression of the abdominal contents Early satiety, weight loss Kyphosis – curved back Decreased lung function Increased risk of death from lung disease Spinal instability Risk of more fractures Biomechanical Consequences Consequences of Untreated VCF
Consequences … Chronic pain Increased dependence Decreased ability for activities of daily living Partial to complete immobility Functional Consequences Depression or clinical anxiety or both Sleep disorder Psychological Consequences Compiled from the following articles: 1.Gold, Silverman. The Downward Spiral of Vertebral Osteoporosis: Consequences. Designated by Cedar Sinai Medical Center Press, Podichetty et al. J Musculoskel Med. 2004;21: Lavelle, Carl, Lavelle, Khaleel. Med Clin N Am. 2007:91: Gold. Rheum Dis Clin North Am. 2001; 27: Social Consequences 150,000 annual hospital admissions Higher medical costs
Future Fracture Risk After first VCF, risk of subsequent VCF is increased: 5-fold after first VCF 12-fold after 2 or more VCFs 75-fold after 2 or more VCFs and low bone mass (below the 33rd percentile) 1.Ross et al. Annals Int Med. 1991; 114(11):919-23
Tumor-Related VCFs Surgical Management Medical Management, Radiation to the tumor Open Surgical Procedures Vertebral column reconstruction Oncology patients are generally poor candidates for open surgery due to soft bone/tumor mass and co- morbidities Minimally Invasive Procedures Balloon kyphoplasty Vertebroplasty Compiled from the following articles: 1.Yeh, Berenson. Clin Cancer Res. 2006, 10: Lieberman, Reinhardt. Clin Orthop Relat Res. 2003;(415 Suppl):S Lavelle, Carl, Cavelle, Khaleel. Med Clin N Am. 2007;91: Pateder, Khanna, Lieberman. Orthop Clin N Am. 2007;38:
Percutaneous Vertebroplasty Augmentation of vertebral compression fractures with polymethylmethacrylate Uses pressure to introduce the material Used successfully to treat pain Does not attempt to restore the height of the collapsed vertebral body Cement leakage and extravasation can be problems Compiled from the following articles: 1.Lieberman, Reinhardt. Clin Orthop Relat Res. 2003;(415 Suppl):S Lavelle, Carl, Cavelle, Khaleel. Med Clin N Am. 2007;91: Pateder, Khanna, Lieberman. Orthop Clin N Am. 2007;38:
Tumor-Related VCFs Vertebroplasty vs. Balloon Kyphoplasty VertebroplastyBalloon Kyphoplasty Fracture Reduction Postural ReductionInflatable Bone Tamp (IBT) Cavity Creation --Inflatable Bone Tamp Cement Injection High-pressure injection into interstices Low-pressure fill into cavity created by IBT Compiled from the following articles: 1.Lieberman, Reinhardt. Clin Orthop Relat Res. 2003;(415 Suppl):S Lavelle, Carl, Cavelle, Khaleel. Med Clin N Am. 2007;91: Pateder, Khanna, Lieberman. Orthop Clin N Am. 2007;38:
Tumor-Related VCFs Balloon Kyphoplasty Aimed at Stabilizing the Fracture and Correcting Spinal Deformity caused by VCFs Indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. KYPHON ® HV-R™ Bone Cement. FDA Premarket Notification Summary. Available at:
Tumor-Related VCFs Balloon Kyphoplasty Procedure Minimally invasive Bilateral, 1 cm incisions Typically one hour per treated fracture General or local anesthesia (supplemented by conscious sedation) May require an overnight hospital stay Compiled from the following articles: 1.Lieberman, Reinhardt. Clin Orthop Relat Res. 2003;(415 Suppl):S Lavelle, Carl, Cavelle, Khaleel. Med Clin N Am. 2007;91: Pateder, Khanna, Lieberman. Orthop Clin N Am. 2007;38:
Vertebral Augmentation : Clinical Outcomes for Oncology Patients
Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures: A Comparative Systematic Review of Efficacy and Safety Taylor, Taylor, Fritzell. Spine. 2006;31:2747–2755
Meta-Analysis of Complications Total Procedure- Related Complications Cement-Related Complications Access-Related Complications Non-Device- Related Complications Balloon Kyphoplasty N = 1947 patients 14 (0.7%) 3 (0.2%) 4 (0.2%) 7 (0.4%) Vertebroplasty N = 6808 patients 199 (2.9%) 132 (1.9%) 28 (0.4%) 39 (0.6%) p-value *<0.0001* *Balloon kyphoplasty has statistically significant lower complication rates compared to vertebroplasty Data on file, Medtronic Spine LLC.
Taylor Study* Cement Leakage Results p < BK: 90/1111 = 8% VP: 614/1551 = 40% (p-value not reported) BK: 0/1094 = 0% VP: 8/275 = 3% Taylor, Taylor, Fritzell. Spine. 2006;31:2747–2755 – See Table 6. *Includes fracture of all etiologies. BK = balloon kyphoplasty. VP = vertebroplasty.
Patient Identification Patient cancer diagnosis Metastatic breast cancer, lung cancer, prostate cancer, and others Multiple myeloma Patient demographics Age, gender, type of cancer, comorbidities Patient self-report of symptoms Sudden pain in the back Persistent back pain with developing other signs Kyphosis, incontinence, respiratory difficulties, balance problems Identification of Fractures
Patient education Pain is NOT a necessary part of the cancer experience VCF treatment options, including balloon kyphoplasty Advocacy Awareness and referrals Where can the procedure be done? Who is qualified to perform it? Patient Education
Barriers to use Reimbursement What is your patient’s insurance coverage? Comfort level of spine physician/interventionalist Does the specialist have a full understanding of balloon kyphoplasty? Has he/she performed it multiple times? Can she/he refer the patient to a qualified practitioner? Barriers to Use
Monitoring post-procedure Immediate post-surgical monitoring usually done by surgical staff Longer term follow-up may be needed Monitor symptoms, status changes PCP be the first to note new symptoms, new fractures Considerations
Balloon Kyphoplasty Case Study Patient: 76 YO Female Diagnosis: Metastatic Lung Cancer Fracture Reduced: T8, 8 weeks old Courtesy of Henry Small, M.D., Houston, TX
Indications for Use Not Investigational – Indicated for Cancer-Related Fractures KYPHON ® HV-R ™ Bone Cement was originally cleared for marketing un the United States in 2004 for treatment of pathologic VCFs using a balloon kyphoplasty procedure Indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. KYPHON ® Inflatable Bone Tamps were originally cleared for marketing in the United States in 1998 Intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KYPHON ® HV-R ™ Bone Cement), hand, tibia, radius and calcaneus.
Risk Statement Although the complication rate with KYPHON® Balloon Kyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with the procedure, including serious complications. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use.
Summary VCFs can be significant problems for patients with cancer Pain Functional impairment Providers can identify and refer patients for appropriate therapy, including balloon kyphoplasty Balloon kyphoplasty can provide significant pain relief, restore vertebral body height, and improve function for many patients with cancer
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