Healthcare Industry News: Stem Cell
News Release - November 2, 2015
New CyberKnife(R) and TomoTherapy(R) System Data Presented at Leading Scientific Industry MeetingExcellent Treatment Outcomes for a Wide Range of Tumor Types Demonstrated by Accuray CyberKnife and TomoTherapy Systems
SUNNYVALE, Calif., Nov. 2, 2015 -- (Healthcare Sales & Marketing Network) -- Accuray Incorporated (ARAY) announced today that studies on the clinical use of the leading-edge CyberKnife® and TomoTherapy® Systems continue to reinforce the devices' broad-based radiation treatment capabilities. More than 80 studies were presented during poster and oral sessions at the 57th Annual American Society for Radiation Oncology (ASTRO) Meeting in San Antonio, October 18 – 21, 2015. Some of the studies presented show long-term efficacy and safety with median follow-up exceeding five years.
For more information on the CyberKnife and TomoTherapy Systems, visit www.accuray.com.
Data from China and Japan show faster treatment times and efficacy with TomoEDGE™ Dynamic Jaws
A study compared the plan quality and delivery efficiency of TomoHelical™ using TomoEDGE™ dynamic jaws to TomoHelical fixed jaw delivery mode for nasopharyngeal carcinoma treatments. Results showed equivalent plan quality, with dynamic jaws mode providing a more efficient delivery and better sparing of the optic chiasm, pituitary and parotid glands when compared to fixed jaw delivery mode. Clinicians affiliated with the Hong Kong Sanatorium & Hospital conducted the study.
An evaluation of stereotactic radiation therapy (SBRT) for brain metastases using TomoHelical in dynamic jaws mode found treatment time was reduced by 75 percent using this modality compared to treatment with fixed jaw delivery mode, and at 12 months follow-up the local control rate was 100 percent. Research was conducted at five Japanese centers.
Long-Term data (5 plus years) show excellent efficacy with both the CyberKnife and TomoTherapy Systems
Five-year physician-reported toxicity, survival, and relapse free survival outcomes were reported for patients enrolled in a phase 2 prospective multicenter study evaluating SBRT for organ-confined prostate cancer using the CyberKnife System. The data indicate rates of serious adverse events have been minimal, with intermediate-risk patients experiencing high rates of overall and relapse-free survival. Physician-reported toxicities and relapse-free survival rates compared favorably to other radiation therapy modalities. Seven U.S. hospitals participated in the study, including Swedish Cancer Institute in Seattle, Washington and Beth Israel Deaconess Medical Center in Boston, Massachusetts.
An additional study of the CyberKnife System for low and intermediate organ-confined prostate cancer showed a high rate of biochemical progression free survival (95.8 percent and 90 percent for low- and intermediate-risk groups, respectively) with acceptable toxicity at a median follow-up of 84 months. Median PSA nadir was reached at four years and has remained unchanged for up to eight years, suggesting that the response is durable. Research was conducted at FROS Radiation Oncology and CyberKnife Center.
A study of patients with low, medium, or high-risk prostate cancer demonstrated that hypofractionated radiation therapy delivered using TomoHelical™ and simultaneous integrated boost (SIB) provides excellent results in terms of both efficacy and toxicity. Patients in all categories treated experienced a high rate of biochemical relapse-free survival and overall survival at five years follow-up, with low rates of acute and late toxicities. Research was conducted at San Raffaele Scientific Institute and Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, Italy.
Clinical innovation in breast cancer and total marrow irradiation
A study examined the safety and efficacy of an accelerated dose/fractionation schedule delivered using the CyberKnife System after lumpectomy for selected patients with early-stage breast cancer. With a median follow-up of 27 months all patients remained locally controlled with good to excellent cosmesis and no evidence of disease following treatment. Research was conducted at Winthrop University Hospital, Mineola, New York.
A phase 1-2 dose-escalation study evaluated the use of TomoHelical for total marrow irradiation (TMI) as the sole conditioning regimen for a second autologous Stem Cell transplant (ASCT) in recurrent leukemia patients. Full-body conformal radiation of the bone marrow enabled clinicians to successfully deliver a total dose of up to 1,800 cGy to the entire bony skeleton without dose-limiting toxicity. Median overall survival and progression-free survival were 3.8 years and 17.4 months, respectively. Research was conducted at the Ottawa Hospital Cancer Centre and the University of Ottawa, Ottawa, Ontario, Canada.
"Our ongoing commitment to product development and enabling our customers to optimize their use of our innovative technologies long-term is delivering meaningful clinical advances. It is great to see data supporting expanding access to the unique benefits of our leading-edge CyberKnife and TomoTherapy Systems," said Joshua H. Levine, president and chief executive officer of Accuray. "These data presented at the ASTRO meeting demonstrate that, with our devices, clinicians can expect good long-term results and innovative approaches to treatment that can drive better outcomes."
About the CyberKnife and TomoTherapy Systems
The Accuray CyberKnife M6™ Series and TomoTherapy H™ Series treatment solutions cover the entire spectrum of radiation therapy needs. The CyberKnife M6 Series enables precise, high-quality, dose distributions to be confidently delivered to the patient with extreme accuracy over a minimum number of treatments, reducing side effects and preserving patients' quality of life. The CyberKnife® System is the only robotic full-body radiosurgery system available today. The TomoTherapy H Series efficiently enables physicians to customize treatment plans for the entire range of radiation therapy patients and disease types. Its innovative design enables treatment plans to be delivered with integrated, daily CT image guidance, enhancing accuracy and delivering highly precise, intensity-modulated radiation for optimal sparing of healthy tissue and critical structures.
Accuray Incorporated (ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company's leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit www.accuray.com.
Safe Harbor Statement
Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to clinical applications, clinical results, patient outcomes, market adoption of the company's products and Accuray's leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed under the heading "Risk Factors" in the company's report on Form 10-K, filed on August 28, 2015 and the company's other filings with the SEC.
Forward-looking statements speak only as of the date the statements are made and are based on information available to the company at the time those statements are made and/or management's good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.
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