Cyberknife Overview

CyberKnife® Overview

The CyberKnife® System treats cancerous and non-cancerous tumors in patients where radiation therapy is indicated, those seeking an alternative to surgery, or in patients with inoperable or surgically complex tumors. It precisely delivers high dose beams of radiation to treat tumors anywhere in the body.

The CyberKnife System is the only fully robotic radiation delivery system. This is critical in allowing the CyberKnife System to deliver uniquely angled radiation beams in many different directions. By precisely targeting the tumor, the CyberKnife System can deliver a maximum dose of radiation directly to the tumor with sub-millimeter precision, while minimizing radiation to nearby healthy organs and tissues.

· Most patients report minimal to no side effects following treatment with the CyberKnife System.

· The CyberKnife System is clinically proven to be effective, and in many cases improves the quality of life for patients.

· Treatments with the CyberKnife System are non-invasive and pain free.

· Treatment with the CyberKnife System is typically completed in 1 to 5 treatment sessions.

· Treatment times with the CyberKnife System vary depending upon the type of tumor being treated. Many treatments typically last 30 minutes.

· During and immediately following treatment with the CyberKnife System, most patients can continue their normal activities.

· In some cases, CyberKnife radiosurgery may be an alternative to traditional surgery. It does not typically require anesthesia or an overnight hospital stay, and eliminates the recovery time and risks associated with surgery.

· Due to its ability to precisely target tumors, the CyberKnife System may provide a safe radiation treatment option even for some previously irradiated patients.

· Discuss eligibility with your doctor. Side effects of CyberKnife treatment are usually mild and temporary, and may include nausea and fatigue. As with any radiation treatment, the side effects can also be severe in some patients and lead to permanent injury or even death. Talk to your doctor to determine if treatment with the CyberKnife System is right for you.

· The CyberKnife System is manufactured by Accuray. In a survey of radiation therapy medical professionals that use Accuray products, 84% were highly satisfied with the accuracy and precision of the Accuracy systems. Comparatively, with radiation therapy medical professionals that use the other radiation delivery systems available in the US, only 60 – 70% of them were highly satisfied with accuracy and precision of the systems manufactured by other companies.9

CyberKnife® for Prostate Cancer

· In most cases, radiosurgery with the CyberKnife® System for prostate cancer does not require a catheter. Traditional prostate cancer surgery requires the use of a catheter for help with urination, for up to 2 weeks post-procedure.

· With CyberKnife radiosurgery, the majority of patients can continue normal activity during and immediately following treatment. With traditional prostate cancer surgery patients must limit normal activity for 3-5 weeks.

· In a clinical study of 228 patients treated with CyberKnife radiosurgery for prostate cancer, 75% of patients maintained sexual function at the 5-year follow-up. The majority of these patients did not require the use of medication.1

· Patients treated with the CyberKnife System for prostate cancer reported a return to normal urinary and bowel function by 6 months post-procedure.4

· Treatment with the CyberKnife System is completed in 4-5 treatment sessions, over the course of a week. Conventional radiation therapy typically requires 30-40 treatment sessions, over the course of several weeks.

· The CyberKnife System delivers the required radiation dose to the prostate with sub-millimeter precision, thereby minimizing the radiation that is delivered to the bowel and urinary tract.

CyberKnife® for Brain Tumors

· The CyberKnife System is a leading technology in a targeted type of radiation delivery called stereotactic radiosurgery (SRS) or SBRT. SRS/SBRT is widely used for treatment of brain metastases, and other benign and malignant brain tumors.

· The CyberKnife System is a frameless radiation delivery system. With other technologies, immobilization devices such as a frame bolted to the patients’ skull are used to prevent movement. The CyberKnife System is designed to automatically adjust for movement and therefore does not require a frame.

· The CyberKnife System has been proven to deliver radiation to the skull with sub-millimeter precision, (to within <1.0mm of the target) 7, which means minimal radiation is delivered to the surrounding healthy brain tissue.

· In a clinical study of 133 patients, treated for tumor metastases to the brain presenting with clinical symptoms such as headaches and seizures, 90% of patients either stabilized or improved performance status following treatment with the CyberKnife System.8

· In a clinical study of 333 patients using the CyberKnife System to treat tumor metastases to the brain, >85% of evaluable patients achieved local tumor control at 2 years post treatment8. That is the tumor either decreased in size or stopped growing.

· Because treatments with the CyberKnife System can be spread out over more than 1 session, it can treat patients that could not be treated with frame-based systems such as the GammaKnife.9

· As compared with single session radiosurgery with the GammaKnife, treatment with the CyberKnife System can be spread out over 2-5 sessions, which may results in fewer side effects.11

CyberKnife® for Lung Tumors

The CyberKnife® System is the only radiation delivery system that incorporates Synchrony® technology and a flexible robotic arm.

The Synchrony Respiratory Management System is a sophisticated software system that automatically adjusts the aim of the radiation beam to account for tumor movement due to respiratory motion (i.e. breathing). When treating non-small cell lung cancer, standard radiation delivery systems usually result in over exposure of radiation to healthy lung tissue because a large area must be treated to account for movement of the tumor due to breathing.3 The CyberKnife System with Synchrony technology adjusts for movement of the tumor because of breathing, allowing for delivery of a maximum dose of radiation to the tumor, while minimizing the delivery of radiation to healthy tissue.

· The CyberKnife System allows patients to breath freely during lung cancer treatments. Other radiation delivery systems often require patients to hold their breath or use abdominal compression devices to limit breathing and therefore movement of the tumor during treatment.

· The CyberKnife System is a leading technology in SBRT (stereotactic body radiation therapy), a specialized type of radiation therapy, used to treat early stage inoperable non-small cell lung cancer while minimizing side effects.3

· In a clinical study of 55 patients, 3-year survival after SBRT was 55.8%. Reported results from conventional radiation therapy for similar patient groups show 2-year and 3-year survival rates between 20% - 35%.2

· In a clinical study of 31 patients with non-operable stage 1A or 1B non-small cell lung cancer that were treated with the CyberKnife System, overall survival at the 4.5 year follow-up was 83.5%.3

· In a clinical study of 118 patients with early stage non-small cell lung cancer treated with the CyberKnife System, less than 3% experienced chest wall pain.5, 6 Chest wall pain is a side effect that patients treated with SBRT for tumors close to the chest wall may experience. This is due to radiation delivery to the chest wall during treatment. With the CyberKnife System, radiation delivery to the chest wall is minimized.5,6

· In a clinical study using CyberKnife radiosurgery to treat 28 patients with early stage non-small cell lung tumors that were abutting the chest wall, no patients were found to have rib bone fractures in the follow-up monitoring.5 Broken ribs are a side effect that patients treated with radiation for tumors close to the chest wall may experience. This is due to radiation delivery to the ribs during treatment.

References:

1. Katz et al. Radiation Oncology 2013, 8:118. Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years.

2. Timmerman et al. Journal of the American Medical Association. 2010;303(11):1070-1076. Sterostatic Body Radiation Therapy for Inoperable Early Stage Lung Cancer.

3. Brown et al. Clinical Oncology 2009.06.006. Application of Robotic Stereotactic Radiotherapy to Peripheral Stage I Non-small Cell Lung Cancer with Curative Intent

4. King et al. International Journal of Radiation Oncology.2013. Health-Related Quality of Life After Sterostatic Body Radiation Therapy for Localized Prostate Cancer: Results from a Multi-institutional Consortium of Prospective Trials

5. Redjournal. Abstract 2876. Chest wall and rib Irradiation of Lung Cancer Patients Treated with Robotic Radiosurgery SBRT.

6. Redjournal. Abstract 3389. Stereotactic Body Radiation Therapy for Early Stage Lung Cancer: Quantifying the Effect of Tracking Respiratory Motion on Chest Wall Dosimetry.

7. Antypas et al. Physics in Medicine and Biology.53;(2008)4697-4718. Performance Evaluation of a CyberKnife® G4 image-guided robotic stereotactic radiosurgery system.

8. Muacevic et al. Journal of Neurooncology. October 2009. Feasibility, safety and outcome of frameless image-guided robotic radiosurgery for brain metastases.

9. Colombo et al. Neurosurgery. Volume 64 Number 2 February 2009 Supplement. CyberKnife Radiosurgery for Benign Meningiomas: Short-Term Results in 199 Patients

10. Hansasuta et al. Neurosurvery. Volume 69 Number 6 December 2011. Multisession Stereotactic Radiosurgery for Vestibular Schwannomas: Single-Institution Experience with 383 Cases.

11. Customer Loyalty Data. August 2012