Seven-year Data Shows Accuray TomoTherapy® System Provides Excellent Long-Term Control of Low-Risk Breast Cancer

Rhea-AI Summary

Accuray Incorporated (NASDAQ: ARAY) announced promising results from a phase II trial involving 338 women with low-risk breast cancer. Seven years after receiving once-daily accelerated partial breast irradiation (APBI) with the TomoTherapy System, 98.8% achieved local disease control. The study, published in the International Journal of Radiation Oncology*Biology*Physics, found minimal acute and late toxicities. Key findings include 99.4% ipsilateral breast tumor recurrence-free control at 76 months and excellent patient-reported outcomes regarding breast appearance.

Positive

• 98.8% local disease control seven years post-APBI treatment.
• 99.4% ipsilateral breast tumor recurrence-free control at a median follow-up of 76 months.
• Very low incidence of acute and late toxicities, with no late toxicity cases reported.
• More than 95% of patients rated breast appearance as good/excellent at two years.

Negative

• None.

SUNNYVALE, Calif., Jan. 19, 2021 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that data from a prospective, phase II trial of 338 women with low-risk breast cancer showed 98.8 percent had local disease control seven years after receiving once-daily accelerated partial breast irradiation (APBI) delivered with the TomoTherapy^® System. The study, published online in the International Journal of Radiation Oncology*Biology*Physics, also reported that the once-daily schedule was associated with a very low incidence of acute and late toxicities.

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 delivering from a full 360 degrees around the patient as the treatment table also moves at a deliberate pace, providing greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue. This precision enables medical care teams to deliver hypofractionated treatment regimens - a higher dose per fraction in fewer fractions than conventional schedules - such as APBI, with increased confidence.

"Over the last 10 years, breast-conserving surgery and APBI have been widely used in clinical practice for the treatment of low-risk breast cancer. Our large phase 2 trial demonstrated that IG-IMRT delivered using the TomoTherapy System offers improvements over existing techniques and can provide better APBI outcomes in carefully selected patient populations. The system enabled our team to increase the conformality and homogeneity of the dose to the tumor bed and reduce the dose to surrounding healthy tissue, making APBI an effective and convenient option for our patients," said Prof. Ugo de Paula, Department of Radiation Oncology, San Giovanni-Addolorata Hospital, Rome, Italy.

Enhanced precision enables excellent long-term results: study highlights

Once-daily breast APBI delivered with the TomoTherapy System demonstrated the following:

• Ipsilateral breast tumor recurrence (IBTR) free control was 99.4% at a median follow-up of 76 months. This is important because patients with IBTR may be at high risk for subsequent distant metastasis;
• Locoregional control (no recurrence in ipsilateral breast as well as in regional nodes) was 98.8% at a median follow-up of 76 months;
• Progression-free survival was 98.4% and 92% at 5 and 10 years;
• Treatments were very well tolerated with minimal acute or late side effects. Importantly, there were no cases observed of late toxicity such as pneumonitis or rib fractures;
• More than 95 percent of patients and their physicians rated cosmesis -- preservation of the normal appearance of the breast -- as good/excellent at two years, the relevant timepoint for evaluation of cosmesis.

"This study builds on existing clinical evidence demonstrating the benefits of the TomoTherapy System in the treatment of breast cancer. Integrated image guidance and helical radiation delivery enables exceptional homogeneity in radiation dose delivery and superior treatments for patients. Dr. de Paula and his colleagues found that even those patients deemed cautionary or unsuitable for APBI by American Society of Radiation Oncology (ASTRO) criteria experienced a low rate of IBTR," said Fabienne Hirigoyenberry-Lanson, Ph.D., vice president global medical and scientific affairs, at Accuray.

About the Phase II Trial
In this trial, 338 women with low-risk breast cancer received a treatment dose of 3.85 Gray (Gy) delivered by the TomoTherapy^® System in 10 consecutive daily fractions, five days per week. Patients who had previously undergone breast-conserving surgery were enrolled in the study. The primary endpoints of this trial were breast tumor recurrence, and acute and late toxicity. Secondary outcomes were progression-free survival (PFS) and rates of adverse cosmesis. 

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 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.

Accuray
Beth Kaplan
Tel: +1 (408) 789-4426
E-mail: bkaplan@accuray.com

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SOURCE Accuray Incorporated

FAQ

What were the results of Accuray's phase II trial for breast cancer?

The trial showed 98.8% of women had local disease control seven years after treatment with the TomoTherapy System.

What is the significance of the 99.4% ipsilateral breast tumor recurrence-free control?

This indicates a high effectiveness of the TomoTherapy System in preventing recurrence in the treated breast at a median follow-up of 76 months.

How did patients tolerate the treatment using the TomoTherapy System?

Patients experienced minimal acute and late toxicities, with no cases of late toxicity reported.

What was the follow-up duration for the study on the TomoTherapy System?

The study had a median follow-up of 76 months, providing long-term data on treatment outcomes.

When was the trial data published?

The data was published on January 19, 2021.