We'd like to acknowledge Dr. Gandhi as the Sanford Larson Award winner for his abstract. Congratulations. My name is Shashank Gandhi. I'm from Northwell Health. We'll be discussing kyphoplasty intraoperative radiation therapy as a new treatment paradigm for spinal metastatic disease and the Phase I, II clinical trial results that we have. Metastatic disease to the spinal column has been fairly well-described and very common, kind of for about 30% of all cancer patients. Twenty percent of these patients present with potentially unstable lesions that require surgery, followed by some sort of radiation. By the NOMS algorithm, these patients require multimodality treatment. Spinal column radiation is one of the mainstays of treatment. However, there are limitations to SBRT, some of which include pain improvement, which takes several weeks to months of onset, and vertebral column fractures, which have been reported up to 39%. With these fractures, there is a high likelihood of decreased quality of life and increased pain in these patients. And these patients with metastatic disease have their overall prognosis dictated by their systemic tumor burden. Therefore, pain and quality improvement of their life should be one of the mainstays of treatment of spinal metastatic disease. Vertebral compression fractures after radiation are associated with the presence of fractures before radiation, presence of a lytic tumor, and spinal deformity. These three factors make up three of the six factors of the SIN scores, suggesting that the SIN score may be of utility in identifying high-risk patients. Balloon kyphoplasty in patients with pathological fractures has been shown to improve pain and quality of life by the CAFE trial. So kyphoplasty intraoperative radiation combines both radiation and kyphoplasty in one setting. This is a brief schematic showing the actual procedure. The vertebral body where the tumor is embedded is accessed by a jamsheet needle. The radiation source is placed within the vertebral body, which is then radiated, and a kyphoplasty procedure is then conducted. This allows for immediate sterilization of the vertebral level with the tumor and also stabilization of the vertebral body. The intraoperative radiation technology that we used employs accelerator electrons. This allows us to radiate from within the vertebral body outwards as opposed to SRS, which you're essentially radiating from the outside inward from the body. This also allows us to deliver a highly focused radiation to the tumor bed. With a high drop-off of dose, we're able to reach higher doses of radiation to the actual tumor while still protecting the spinal cord and the spinal elements. Some intraoperative imaging pictures. We see that the vertebral body is cannulated. Intraoperative CAT scan is obtained, whereby localizing the radiation source, which is then merged with preoperative MRI and CAT scan. The radiation dose is then calculated. The radiation is then delivered, and kyphoplasty is then performed, and the patient goes to PACU and then home the same day. So the Phase I-II study was to assess for improvement in pain, quality of life, and the safety and tolerability of this kypho-IRT procedure. The secondary outcome measures were to assess for local control. Patient selection. We included all patients with a primary known histology, the presence of at least one to three lesions that were treated by this procedure and potentially unstable lesions in scores 7 through 12, and Bilski grades 0 to 1, essentially very little to no epidural involvement. And tumors located in sectors 1, 6, and 2, either the vertebral body or the bilateral pedicles. We followed the RTOG guidelines as far as radiating the full body and bilateral pedicles and limiting the radiation dose to one centimeter above and below the level. There was a maximum of 10 grays to the spinal cord itself. This is a breakdown of our patients. All patients were treated with at least 16 vertebral levels. The histologies that you see here, one patient experienced a recurrence. That was a patient with GI adenocarcinoma. One patient expired due to unrelated issues. We saw significant improvement in pain immediately one week, which was sustained out to 12 months. And our functional status, measured by the brief pain inventory, showed significant improvement in functional status from three months out to 12 months. When we compared our in-house SBRT data to a KIFO-IRT with SIN score 7 through 12, we see the trend toward better local control with KIFO-IRT 6% versus 17%. However, this did not reach statistical significance, likely due to underpowering of our study phase 1 and 2 trial. As far as vertebral body fractures are concerned, 12% with KIFO-IRT, 17% with SBRT. The two patients in KIFO-IRT that had progression of their vertebral body fractures had a preoperative fracture already, and their vertebral body posterior walls were destroyed by the tumor, which limited our ability to aggressively perform the kyphoplasty and inject significant amount of cement. In conclusion, KIFO-IRT is a safe procedure. It allows for stabilization of an unstable lesion, allows us to obtain local control at least comparable to that of SRS. We're able to obtain improvement of quality of life and pain control significantly out to 12 months. All of this can be done within one setting, one treatment setting in an ambulatory treatment center. Thank you. Applause.

kyphoplasty intraoperative radiation therapy

spinal metastatic disease

cancer patients

vertebral fractures

accelerator electrons