Accuray Incorporated announced on July 21 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-treatmentBack To Top
TomoTherapy provides favorable cosmetic outcomes without compromising efficacy in low-risk breast cancer patients . Appl Rad Oncol.