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