Accuray TomoTherapy® Helical Radiotherapy System Helps Preserve Breast Cancer Patients' Long-term Heart and Lung Functionality

- Phase III, randomized controlled trial results highlight patient reported outcomes at 10 years'follow-up

- TomoTherapy delivered hypofractionated radiotherapy was superior to conventional radiotherapy in maintaining patients' heart and lung functioning, enabling them to more easily perform daily and leisure time activities, and/or work

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Accuray Incorporated

Feb 10, 2022, 07:30 ET

SUNNYVALE, Calif., Feb. 10, 2022 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that data from a phase III, randomized controlled trial, TomoBreast, indicate post-surgery hypofractionated radiotherapy delivered with the TomoTherapy® System is superior to conventional radiotherapy in preserving long-term heart and lung functioning in women with early breast cancer. An analysis of patient reported outcomes showed 10-year survival free of heart and lung deterioration was 84.5% with TomoTherapy delivered radiotherapy - a significant improvement above the 66.9% achieved with conventional radiotherapy. The single-center trial results were published online in BMC Cancer.

"Our global team is committed to developing radiotherapy solutions that enable care teams to improve their patients' lives. The TomoBreast data show we are on the right path. This analysis of patient-driven, Real-World Evidence (RWE) is important because it suggests that patients treated with the TomoTherapy System are less likely than those receiving conventional radiotherapy to experience the debilitating heart and lung side effects that make breathing difficult and interfere with a person's ability to take part in even the most routine daily activities. Additionally, the overall course of treatment was significantly shorter for TomoTherapy treated patients enabling them to get back to living their lives, faster," said Philippe Degreze, Ph.D., vice president, downstream marketing & communications channels at Accuray.

The TomoTherapy platform, including the next-generation Radixact® System, is the first in the world capable of helical radiation delivery. Image-guided, intensity-modulated radiation therapy (IG-IMRT) is continuously delivered from multiple 360 degree rotations around the patient, providing greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue and sensitive organs. Previous reports of the TomoBreast trial showed treatment with the TomoTherapy System improved the uniformity of the dose delivered to the tumor, decreased the dose to the heart and lung, and reduced heart and lung related side effects, signifying that the system's unique architecture helps improve the accuracy of the treatment.

"This most recent TomoBreast trial analysis reinforces the outcomes seen in previous clinical evaluations and demonstrates the potential of the TomoTherapy System to make a meaningful difference in breast cancer patients' daily lives. The improvement in cardiorespiratory-related functioning experienced by patients treated with the system was remarkable considering a high proportion of them received concurrent medication and were current or ex-smokers receiving lymph node irradiation – both of which can increase the potential risk of side effects," said Prof Mark De Ridder, head of the radiotherapy department of UZ Brussel, Vrije Universiteit Brussel, Belgium.

About the Phase III Trial
TomoBreast is a single center phase III prospective, randomized controlled trial comparing accelerated adjuvant radiotherapy with the TomoTherapy® System (TT), versus conventional post-surgery radiotherapy (CR) for breast cancer designed to test the hypothesis that TT might reduce lung-heart toxicity. Patients receiving radiotherapy delivered with the TT underwent treatment five days per week for three weeks, while those receiving conventional radiotherapy had treatment five days per week for five weeks. Eligible patients were women ≥18 years old with histologically proven stage I or II (early) invasive breast cancer who had surgery (lumpectomy or mastectomy) with clear resection margins. 123 women participated, 64 were randomized to receive CR (control arm), 59 to receive treatment with TT (experimental arm). The trial was conducted from 2007–2011 at the Universitair Ziekenhuis Brussel (UZ Brussel), Belgium.

About Accuray
Accuray is committed to expanding the powerful potential of radiation therapy to improve as many lives as possible. We invent unique, market-changing solutions that are designed to deliver radiation treatments for even the most complex cases—while making commonly treatable cases even easier—to meet the full spectrum of patient needs. We are dedicated to continuous innovation in radiation therapy for oncology, neuro-radiosurgery, and beyond, as we partner with clinicians and administrators, empowering them to help patients get back to their lives, faster. Accuray is headquartered in Sunnyvale, California, with facilities worldwide. To learn more, 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 expectations related to the TomoTherapy platform, including related to treatment of breast cancer; clinical applications; clinical results; patient experiences and outcomes, and Accuray Incorporated'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 company's ability to achieve widespread market acceptance of its products, including new product offerings and improvements; the company's ability to develop new products or improve existing products to meet customers' needs; the company's limited long-term clinical data supporting the safety and efficacy of its products for certain users and such other risks identified under the heading "Risk Factors" in the company's quarterly report on Form 10-Q, filed with the Securities and Exchange Commission (the "SEC") on January 28, 2022, 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.