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Treatment with the TomoTherapy® System Concurrent with Systemic Medication Improves Progression-Free Survival in Patients with Solitary Plasmacytoma of the Bone

California (ots/PRNewswire)

Practice-Changing Study Presented at the 2016 Best of ASTRO Meeting

Accuray Incorporated (NASDAQ: ARAY) announced today new data showing that 80 percent of patients with solitary plasmacytoma of the bone (SPB) had excellent cancer control four years after receiving intensity-modulated radiation therapy (IMRT) delivered with the TomoTherapy® System, in addition to immunomodulatory drugs (IMiDs) or proteasome inhibitors (PI).[1] The concurrent treatments were well-tolerated and toxicity was manageable with standard approaches.[1] The study was presented on November 11, 2016 at the 2016 Best of ASTRO meeting, a two-day summary of the ASTRO Annual Meeting, at which the most relevant and practice-changing abstracts are presented.

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"For patients newly diagnosed with SPB, this study could change the game. We now have hope that the patients with SBP can live without disease and without major side effects after treatment with new targeted agents in addition to precise radiation treatments," said Youlia M. Kirova, MD, senior radiation oncologist at the Curie Institute in Paris and investigator of the study. "Tolerance was excellent because of the TomoTherapy System's highly conformal dose distribution which enabled clinicians to deliver optimal doses of radiation while sparing healthy tissue and also because of the less toxic new targeted treatments."

"This is a new approach enabling radiation oncologists, medical oncologists, and hematologists to give their patients prolonged progression-free survival (PFS)," Fabienne Hirigoyenberry-Lanson, PhD, vice president medical affairs, at Accuray. "These study results add to the evidence supporting the TomoTherapy System as an innovative and safe radiation therapy treatment for hemopathies such as hematological cancers.[1],[2]"

SPB is a rare disease with a high rate of progression to multiple myeloma (MM). The role of systemic treatments given concurrently with radiation therapy was uncertain in SPB and had never been evaluated

This study is the first to investigate whether patients who received a short course of IMiD or PI in addition to IMRT delivered with the TomoTherapy System had a longer progression free survival than patients treated only with IMRT. The study showed that:

- All patients (100 percent) in the study achieved local control of 
  the plasmacytoma and no local relapse was observed;
- Overall survival was more than 95 percent at four years;
- PFS rates at 48 months were significantly prolonged in patients 
  receiving the association (80.0 percent versus 50.3 percent).;
- Toxicity was mostly hematological, occurring in the patients 
  receiving the combined therapy, and was manageable with standard 
  approaches.

About the Study

The study titled "Intensity Modulated Radiation Therapy by Tomotherapy (IMRT) Concurrent With a Short Systemic Treatment for Solitary Plasmacytoma of the Bone (SPB) With Improvement of Progression-Free Survival" (1) is a retrospective analysis of the medical and dosimetry records of 28 consecutive patients treated for SPB in the Department of Radiation Oncology at the Curie Institute between 2004 and 2013. All patients had histologically proven plasmacytoma of the bone, without bone marrow involvement. Fifteen patients received the standard treatment, 40 Gy radiotherapy, and 13 patients received treatment with IMiDs or PIs, in addition to the 40 Gy radiotherapy delivered by IMRT.

Important Safety Information

For Important Safety Information please refer to http://www.accuray.com/safety-statement-radiationtreatment

About the TomoTherapy® System

The Accuray TomoTherapy H(TM) 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 more optimal sparing of healthy tissue and critical structures.

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 report on Form 10-Q, filed on November 1, 2016, 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 Accuray 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.

References

1. Le Ray E, et al. Intensity Modulated Radiation Therapy by 
   Tomotherapy (IMRT) Concurrent With a Short Systemic Treatment for 
   Solitary Plasmacytoma of the Bone (SPB) With Improvement of 
   Progression-Free Survival. Int J Radiat Oncol Biol Phys 2016; 
   96(2S):S22. 
   http://www.redjournal.org/article/S0360-3016(16)30392-3/abstract
2. Chargari C, et al. The role of helical tomotherapy in the 
   treatment of bone plasmacytoma. Med Dosim 2012 Spring; 
   37(1):26-30.

Contact:

s:
Sancie Nakarat, Accuray
Tel : +33-6-81-36-84-34
E-Mail : snakarat@accuray.com

Liliana Silva Fernandes, Elan Edelman
Tel : +33-1-86-21-50-37
E-Mail : liliana.silvafernandes@elanedelman.com

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