New Data Show TomoTherapy® System Superior to RapidArc in Achieving Local Control of Head and Neck Cancers

Accuray Incorporated (NASDAQ: ARAY) announced today that a prospective study conducted at 14 French centers showed the clinical benefits of intensity-modulated radiation therapy (IMRT) delivered using the TomoTherapy® System over volumetric modulated arc therapy with RapidArc radiotherapy technology for patients with head and neck cancer. At 18 months, the local control rate and cancer-specific survival rate were significantly better in the TomoTherapy patient group than in the RapidArc group. The study, the first to prospectively compare clinical outcomes across radiation therapy platforms, was published online on June 26, 2017 in the peer-reviewed International Journal of Radiation Oncology - Biology - Physics .

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The TomoTherapy System is the only radiation system specifically designed for image-guided IMRT. Its TomoHelical™ Mode, used in this study, provides continuous delivery of radiation beams from 360 degrees around the patient, facilitating the treatment of the entire spectrum of head and neck tumors, regardless of shape or size or nodal involvement.

"This is the first study to assess whether the method of delivering IMRT impacts the results we are able to achieve. In previous studies, we showed that TomoHelical was able to deliver radiation dose distributions which precisely conformed to the shape of the tumor with steep radiation fall-off outside the target," said Jean-Emmanuel Bibault, MD, MSc, Department of Oncology and Radiotherapy, Georges-Pompidou European Hospital, Paris. "In this new study, we showed in a prospective, but not randomized manner, that this had a significant clinical impact. Precision and accuracy are especially important when treating head and neck tumors, where dose outside the desired target may result in damage to critical structures such as salivary glands, vocal cords, the spinal cord or brainstem. These results should be further explored in a randomized trial."

The study titled, "Clinical outcomes of several IMRT techniques for patients with head and neck cancer: A propensity score weighted analysis," provides results for 166 patients. It demonstrated:

• The TomoTherapy System's unique ring-gantry based architecture and fast multileaf collimator, combined with its daily 3D image guidance, enabled clinicians to deliver a highly conformal and more homogeneous dose, contributing to better local control and cancer-specific survival rates compared to RapidArc
  • Further analysis suggests an even greater benefit in the local control of larger tumors and those that have spread to a high number of lymph nodes
• Treatment with TomoHelical also enabled delivery of significantly reduced doses outside the tumor, leading to better acute salivary function than with RapidArc
  • Mouth dryness assessed by the treated patients was worse in the RapidArc group
  • Salivary disorders were more frequent in the RapidArc patient group

"This landmark study demonstrates that the technique used to deliver IMRT can have a major impact on patient outcomes. Two key measures - the local control rate and cancer-specific survival rate - reinforce the TomoTherapy® System's effectiveness in managing head and neck tumors, results we would also expect to see with the Radixact™ System, our next-generation TomoTherapy platform. And, importantly, salivary function was compromised after treatment in significantly fewer patients treated with TomoTherapy, even while they achieved better tumor control," said Fabienne Hirigoyenberry-Lanson, VP Global Medical and Scientific Affairs of Accuray.

About the Study 

Fourteen institutions evaluated 166 patients in this prospective comparative study; 74 were treated using the TomoTherapy® System and 92 using RapidArc. Randomization was not possible because of unavailability of equipment. Inverse probability of treatment weighting (IPTW) using the propensity score analysis was undertaken to adjust for potential bias due to non-randomization. Even before the adjustment the TomoTherapy platform results were better than RapidArc as measured by local control, cancer-specific survival and salivary function, even though significant differences in several pre-treatment characteristics may have placed the TomoTherapy group at a disadvantage. Loco-regional control, specific and overall survival assessed 18 months after treatment were evaluated, as well as long-term toxicity and salivary function.

About Accuray 

Accuray Incorporated (NASDAQ: 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 http://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 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 from time to time under the heading "Risk Factors" in the company's report on Form 10-K, filed on August 24, 2016, the company's reports on Form 10-Q, filed on November 1, 2016, February 3, 2017, and May 5, 2017, and as updated periodically with the company's other filings with the SEC.

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