2014

CyberKnife Radiosurgery for Early-Stage Breast Cancer May Offer Reduced Infection Risk and Improve Cosmetic Results

SUNNYVALE, Calif., Oct. 31 /PRNewswire/ -- Accuray Incorporated, (Nasdaq:  ARAY), a global leader in the field of radiosurgery, announced today studies underway at two leading academic institutions using CyberKnife radiosurgery in breast cancer treatment. These two studies, from the University of Texas Southwestern and Fox Chase Cancer Center, will be presented at the 52nd Annual Meeting of the American Society for Radiation Oncology (ASTRO) in San Diego from October 31 to November 4.

According to the American Cancer Society, breast cancer is the most frequently diagnosed cancer among women and the second leading cause of cancer death. Typically, women with early stage, localized breast cancer are treated with a lumpectomy, also known as breast conserving surgery, followed by radiation to ensure any remaining microscopic cancer cells are treated. It has been shown that women receiving radiation following surgery have more than a 15 percent reduction in recurrence rates as compared to women who did not receive radiation after their tumors were surgically removed(1).

Initially clinicians delivered radiation to the whole breast following surgery, but over the last decade a more limited radiation approach has gained interest among clinicians and patients. This approach, called partial breast irradiation, can be as effective as whole breast irradiation and is less likely to damage to the heart, lungs, and skin, leading to improved cosmetic outcomes and reduced toxicities.(2)

Partial breast irradiation can be delivered in a number of ways, including invasive options, such as MammoSite, which involves surgical implantation of a catheter in the breast to deliver interstitial brachytherapy, or non-invasive radiation therapy options such as 3D conformal or intensity modulated radiation therapy (IMRT).

Each technique has its advantages and drawbacks: For example, invasive brachytherapy can cause infection, hematoma or abscess(3-4). While non-invasive radiation therapy approaches minimize such risks, studies have demonstrated that the larger margins required to compensate for treatment inaccuracies, such as those caused by the movement of the breast with respiration, result in a higher risk for overdosing the skin and nearby critical structures such as the heart and lungs(5-7). One recent study investigating IMRT for partial breast irradiation found 7 out of 32 evaluated patients developed unacceptable cosmesis, leading to premature closure of the study(5).

Because of the non-invasive delivery and high precision that the CyberKnife System offers in treating tumors throughout the body, clinicians see a role for it in breast cancer treatment. The CyberKnife System has the unique ability to not only track tumor movement during respiration, but to also lock onto the tumor as it moves delivering radiation directly to the tumor and avoiding damage to surrounding critical structures. The CyberKnife System's extreme precision enables clinicians to reduce the treatment margins that are often added with conventional IMRT Systems. For this reason, clinicians believe partial breast irradiation using the CyberKnife System holds the potential to improve toxicity and associated side effects for patients.

"We think that the real-time tracking and high conformality made possible with the CyberKnife System could result in reduced toxicity by reducing the dose to the surrounding breast tissue, skin, chest wall, lung or heart," said Charlie Ma, Ph.D., Professor and Vice-Chairman, Department of Radiation Oncology, Fox Chase Cancer Center.

University of Texas Southwestern recently launched a multi-center early stage breast cancer protocol, which is currently accruing patients. UTSW was one of the first five CyberKnife sites in the world and has remained on the forefront of clinical research.

Physicians at UTSW intend to demonstrate equivalent local control rates or to improve those seen in current treatment for early-stage disease while attempting to increase convenience, limit invasiveness, decrease toxicity and improve cosmesis compared to other methods of radiation treatment. The treatment regimen using the CyberKnife System would be five days compared to 25-30 days typically associated with conventional radiation therapy.

"In particular, we believe a very abbreviated, non-invasive, outpatient treatment would be considered a favorable option to underserved populations of women living in more remote areas for whom longer courses of treatment pose a barrier," said Robert Timmerman, M.D., professor of Radiation Oncology at UTSW and lead author of the ongoing study.

(1). Fisher B, Anderson S, Bryant J, Margolese R, Deutsch M, Fisher E, Jeong J-H, Wolmark N.  Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer.  New England Journal of Medicine 2002; 347:1233-1241.

(2). Wadasadawala T, Sarin R, Budrukker A et al. Accelerated partial-breast irradiation vs conventional whole-breast radiotherapy in early breast cancer: A case-control study of disease control, cosmesis, and complications.  Journal of Cancer Research & Therapy 2009: 5:2 93-101.

(3).  Watkins JM, Harper JL, Dragun AE, Ashenafi MS, Sinha D, Li J, Cole DJ, Jenrette JM 3rd. Incidence and prognostic factors for seroma development after MammoSite breast brachytherapy. Brachytherapy. 2008;7:305-9.

(4).  Evans SB, Kaufman SA, Price LL, Cardarelli G, Dipetrillo TA, Wazer DE. Persistent seroma after intraoperative placement of MammoSite for accelerated partial breast irradiation: incidence, pathologic anatomy, and contributing factors. Int J Radiat Oncol Biol Phys. 2006;65:333-9.

(5).  Jagsi R, Ben-David MA, Moran JM, Marsh RB, Griffith KA, Hayman JA, Pierce LJ.  Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation.  Int J Radiat Oncol Biol Phys. 2010;76:71-8.

(6).  Vicini FA, Chen P, Wallace M, Mitchell C, Hasan Y, Grills I, Kestin L, Schell S, Goldstein NS, Kunzman J, Gilbert S, Martinez A.  Interim cosmetic results and toxicity using 3D conformal external beam radiotherapy to deliver accelerated partial breast irradiation in patients with early-stage breast cancer treated with breast-conserving therapy.  Int J Radiat Oncol Biol Phys. 2007;69:1124-30.

(7).  Livi L, Buonamici FB, Simontacchi G, Scotti V, Fambrini M, Compagnucci A, Paiar F, Scoccianti S, Pallotta S, Detti B, Agresti B, Talamonti C, Mangoni M, Bianchi S, Cataliotti L, Marrazzo L, Bucciolini M, Biti G. Accelerated partial breast irradiation with IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial. Int J Radiat Oncol Biol Phys. 2010;77:509-15.

About the CyberKnife® Robotic Radiosurgery System

The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system designed to treat tumors anywhere in the body non-invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife System to deliver high-dose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a non-surgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more 100,000 patients worldwide and more than 206 systems have been installed in leading hospitals in the Americas, Europe and Asia. For more information, please visit www.accuray.com

Safe Harbor Statement

The foregoing may contain certain forward-looking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release, including statements relating to clinical evidence and clinical results are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: clinical applications, clinical outcomes, potential results of clinical studies, competing products, the combination of our products with complementary technology; and other risks detailed from time to time under the heading "Risk Factors" in our report on Form 10-K for the 2010 fiscal year which has been filed with the Securities and Exchange Commission, filed on August 31, 2010. The Company's actual results of operations may differ significantly from those contemplated by such forward-looking statements as a result of these and other factors. We assume 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.

SOURCE Accuray Incorporated



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