SUNNYVALE, California, July 21, 2016 /PRNewswire/ --
Accuray Incorporated (NASDAQ: ARAY) announced today preliminary results from a prospective, phase II trial evaluating once-daily accelerated partial breast irradiation (APBI) in patients treated with the TomoTherapy® System. The study, published in the June issue of the peer-reviewed AntiCancer Research, International Journal of Cancer Research and Treatment, reported no recurrence of cancer in the treated breast at median follow-up of 34 months. Additionally, more than 95 percent of patients and their physicians rated cosmesis -- preservation of the normal appearance of the breast -- as good/excellent.
"The phase II trial results are very encouraging for a carefully selected patient population, and should be considered by all radiation oncologists when evaluating APBI treatments for their low-risk patients," said Prof. Ugo De Paula, Department of Radiation Oncology, San Giovanni-Addolorata Hospital, Rome-Italy. "In our experience we found there was extremely good patient compliance with their APBI treatment regimen because of a very short, 10-day schedule and well-tolerated treatments. We believe that using daily image guidance, which is unique to the TomoTherapy System, is essential for the precise identification of the tumor bed and reproducibility of treatment."
The study titled, "Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical TomoTherapy," provides results for 111 patients treated with APBI following lumpectomy. It also demonstrated that:
- Delivering the dose once a day over 10 days (others studies use 10 fractions twice-daily) could be a contributing factor to better cosmetic outcomes and lower toxicity. This is made possible because of the integrated image guidance of the TomoTherapy System and its excellent dose homogeneity;
- Patient compliance was remarkable as all patients completed the treatment without interruption;
- Treatments were very well tolerated with minimal acute or late side effects.
"The TomoTherapy System is proving itself to be an excellent breast radiotherapy device. In fact, some sites have purchased the system to use solely for breast radiotherapy," said Fabienne Hirigoyenberry-Lanson, PhD, vice president medical affairs, at Accuray. "Studies such as the one undertaken by Dr. de Paula and his colleagues reinforce the benefits which the TomoTherapy System can provide and highlight why customers worldwide rely on the system as their mainstream radiation treatment device."
The TomoTherapy System is the only radiation system specifically designed for image-guided intensity-modulated radiation therapy (IMRT). Leveraging a CT scanner-based platform, TomoHelical™ mode enables continuous delivery from 360 degrees around the patient with highly conformal and homogeneous dose to the tumor. A clinician can also choose to deliver treatment from specific fixed angles via TomoDirect™ mode. These unique features, combined with daily 3D image guidance, enable physicians to efficiently deliver highly accurate, individualized dose distributions which precisely conform to the shape of the patient's tumor while minimizing dose to normal, healthy tissue for a variety of cancer types, including breast cancer. This is especially important for women diagnosed with cancer in the left breast, where the tumor may be close to critical organs such as the heart.
For further information on the TomoTherapy System, visit http://www.accuray.com/solutions/treatment-delivery/tomotherapy-treatment-delivery/h-series
About the Phase II Trial
The study was designed to assess the role of once-daily accelerated partial breast irradiation in terms of cosmetic and local results. The primary endpoints of this trial were breast tumor recurrence and toxicity. Secondary outcomes were rates of adverse cosmesis, quality of life and compliance. Patients who had previously undergone breast-conserving surgery were enrolled in the study. Radiation treatments were administered in 10 daily fractions of 3.85 Gy.
Important Safety Information
For Important Safety Information please refer to http://www.accuray.com/safety-statement-radiation-treatment
Accuray Incorporated (Nasdaq: ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative 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 28, 2015, the company's reports on Form 10-Q, filed on November 5, 2015 and February 1, 2016 and April 29, 2016, 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.
SOURCE Accuray Incorporated