Multicenter Trial Shows Significant Pain Relief for Spine Cancer Patients Following Targeted Radiofrequency Ablation Treatment

July 22, 2014 06:00 AM Eastern Daylight Time -- SAN JOSE, Calif.--(BUSINESS WIRE) -- DFINE, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced the publication of a multicenter study in the July/August issue of Pain Physician Journal, the official peer-reviewed publication of the American Society of Interventional Pain Physicians (ASIPP). The study followed patients at 5 leading academic centers and found a significant decrease (P<.01) in pain scores after targeted radiofrequency ablation (t-RFA) with the STAR Tumor Ablation System.

“Our study showed significant and almost immediate reduction in pain and more than half of the patients also decreased their use of pain medication. The procedure also allowed us to treat tumors close to the spinal cord that we have not been able to treat in the past.”

The participating centers included Washington University School of Medicine, Moffitt Cancer Center, Montefiore Medical Center and the Albert Einstein College of Medicine, University of Louisville Hospital and the University of California, San Diego.

Physicians treated 128 lesions (metastatic tumors) in 92 patients. The average pain score before the procedure was 7.51 out of 10. Within 1 week post-procedure, the average pain score was reduced to just 1.73. Researchers also noted no patient complications or injuries.

“More than 40% of patients at the highest enrolling institution in this study had previous radiation treatment with little to no relief of symptoms,” said Jack W. Jennings, MD, PhD, Assistant Professor and Director of Musculoskeletal and Spine Interventions, Mallinckrodt Institute of Radiology, Washington University School of Medicine in St. Louis. “Our study showed significant and almost immediate reduction in pain and more than half of the patients also decreased their use of pain medication. The procedure also allowed us to treat tumors close to the spinal cord that we have not been able to treat in the past.”

The American Cancer Society estimates that in 2014 there will be more than 1.7 million new cancer cases diagnosed and 585,720 cancer deaths in the United States.¹ Metastatic lesions in bone are common and have been seen in up to 80% of patients with cancer at the time of death,² with spinal metastasis seen in approximately 50% of these patients.³

“For late-stage cancer patients, extreme back pain due to spinal tumors degrades quality of life; and until now, limited minimally invasive procedural options for immediate pain relief have been available,” said Nam D. Tran, MD, and PhD, neuro-oncology surgeon at Moffitt Cancer Center. “This multicenter study validates t-RFA as a treatment option that provides rapid, lasting pain relief without the need to interrupt the patient’s primary cancer therapy.”

About the STAR Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit https://www.dfineinc.com/Product-Risk---SpineSTAR.

1. Cancer Facts and Figures 2014, American Cancer Society, https://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf

2. van der Horst, Geertje, and Gabri van der Pluijm. Clinical and Preclinical Imaging in Osseous Metastatic Disease. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism, Eighth Edition (2013): 677-685.

3. Harel, Ran, and Lilyana Angelov. Spine metastases: current treatments and future directions. European Journal of Cancer. 2010;46(15):2696-2707.