Data Published in The Lancet Oncology Suggest CyberKnife® Prostate Patients Experienced Lower Levels of Acute Genitourinary Toxicity (Grade 2 or Higher) Than Patients Treated on a Conventional Linear Accelerator

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Sep 17, 2019, 18:30 ET

SUNNYVALE, Calif., Sept. 17, 2019 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announces that The Lancet Oncology, a high impact and leading global peer-reviewed oncology journal, has published patient- and clinician-reported outcomes data from the PACE — Prostate Advances in Comparative Evidence — trial in its most recent issue. While further investigation is planned, data reported in the journal indicate that the level of grade 2 or higher acute genitourinary toxicity in the stereotactic body radiation therapy (SBRT) arm of the trial is lower for patients treated with the Accuray CyberKnife^® System than it is for patients treated on a conventional linear accelerator.

SBRT involves the delivery of very high doses of externally-administered radiation over a small number of treatment sessions, offering convenience for patients, compared to conventional radiation therapy which requires a substantially longer course of treatment. SBRT is cost-effective for healthcare providers and payers, and also increases patient satisfaction by reducing scheduling inconvenience versus conventional radiation treatments.

In the PACE trial, SBRT was delivered in five sessions while conventional radiation therapy was delivered in 20 or 39 sessions. Both the patient- and clinician-reported toxicity data demonstrate that despite the high dose delivered to the prostate, use of SBRT and conventional radiation therapy resulted in comparable rates of acute gastrointestinal and genitourinary toxicity.

Chief Investigator Dr Nicholas van As, Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, and Reader at The Institute of Cancer Research, London, said: "At The Royal Marsden and the ICR we are focused on developing smarter, better and kinder treatments for patients across the UK and internationally. Developments in radiotherapy such as SBRT mean we can target tumors much more effectively. It is reassuring to see from this trial that SBRT does not significantly impact patients' quality of life in the short term, compared with the current standard of care. Using SBRT to deliver this treatment would mean that patients could be spared numerous visits to hospital, allowing them to get back to their lives sooner."

The prostate gland can move unpredictably — as much as 10 mm in as little as 30 seconds — throughout the course of treatment because of normal patient bodily functions. This makes it critically important to be able to track, detect and correct for all types of motion. The CyberKnife Treatment Delivery System, designed to deliver SBRT, is the only radiotherapy device that can maintain sub-millimetric accuracy with continual imaging and automatic beam delivery corrections, including rotation, throughout treatment delivery, making it easier for clinicians to effectively treat patients while minimizing dose to healthy tissue.

"The patient-reported outcomes, when viewed alongside those of the participating clinicians, provide compelling rationale for treating prostate cancer patients with SBRT, an effective and much more convenient option for patients," said Birgit Fleurent, Chief Marketing Officer of Accuray. "With more than 15 years of expertise and more than 100 peer-reviewed articles, there is robust clinical data supporting the safety and efficacy of CyberKnife SBRT for the treatment of patients with low- and intermediate-risk prostate cancer. And now, with the Accuray Precision^® Treatment Planning System and the CyberKnife VOLO™ Optimizer, clinicians are able to significantly reduce both the time to create high quality treatment plans and the time to deliver patient treatments."

About the PACE-B Trial
PACE-B, an international phase 3 randomized controlled trial comparing stereotactic body radiotherapy to conventionally fractionated or moderately hypofractionated external beam radiotherapy (CFMHRT) for localized prostate cancer, represents one arm of a two-part trial. Further data on this arm, as well as the second arm comparing hypofractionated SBRT to prostatectomy, will be shared when available. Out of the 874 patients enrolled by 38 institutions, 845 patients were analyzed; 431 receiving SBRT and 414 CFMHRT. Men who were unsuitable for surgery or preferred treatment with external beam radiation therapy were eligible to participate. The trial evaluated the treatment regimens across multiple effectiveness and safety metrics.

About the CyberKnife^® System
The CyberKnife System is the only robotic radiosurgery system that offers highly precise, non-surgical treatment for tumors and lesions anywhere in the body—including the brain, breast, kidney, liver, lung, pancreas, prostate and spine. The CyberKnife System tracks and automatically adjusts for tumor or patient movement during treatment, delivering the radiation dose directly to the target with sub-millimeter precision. Synchrony^® motion tracking and correction technology expands on the CyberKnife System's unique motion synchronization capabilities to provide additional precision when treating tumors that move with respiration. The high level of accuracy in dose delivery made possible by the system gives clinical teams the confidence to deliver state-of-the-art treatments for a wide range of cancers and functional disorders, without sacrificing patients' quality of life.

About Accuray
Accuray Incorporated (Nasdaq: ARAY) develops, manufactures and sells radiotherapy systems that are intended to make cancer treatments shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Our radiation treatment delivery systems in combination with fully-integrated software solutions set the industry standard for precision and cover the full range of radiation therapy and radiosurgery procedures. For more information, please visit www.accuray.com or follow us on Facebook, LinkedIn, Twitter and YouTube.

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 the benefits of SBRT relative to conventional radiation treatments, clinical applications, clinical results, patient experiences and outcomes, and Accuray's leadership position in radiation oncology innovation and technologies. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of the company's assumptions prove incorrect, actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the absence of future articles or publications that diminish or questioning the efficacy and safety of SBRT, the company's ability to achieve widespread market acceptance of its products, including new product offerings, the company's ability to develop new products or enhance existing products to meet customers' needs, delays in the development or release of new offerings and such other risks identified under the heading "Risk Factors" in the company's annual report on Form 10-K, filed with the Securities and Exchange Commission (the "SEC") on August 23, 2019, and as updated periodically with 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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