SUNNYVALE, Calif., Feb. 16, 2017 /PRNewswire/ -- Accuray
Incorporated (NASDAQ: ARAY) announced today data from a
prospective, Phase II, 17-center study which showed that treatment
with the CyberKnife® System for low- and intermediate-risk prostate
cancer provides excellent long-term results. At five years,
the disease-free survival rate for low-risk prostate cancer
patients was 100 percent and for intermediate-risk patients was
88.5 percent. These results were maintained by patients followed
for seven years. The study was presented at the American Society of
Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in
Orlando, Florida, February 16 – 18, 2017.
A low prostate specific antigen (PSA) value is associated with a
reduced risk of cancer recurrence or metastases. The lower the PSA
value and the longer it continues to decline the greater the
patient's likelihood of achieving long-term disease free
survival1. According to the study, the five-year median
PSA was 0.1 ng/mL for low- and intermediate-risk prostate cancer
patients receiving stereotactic body radiation therapy (SBRT)
administered with the CyberKnife System. The median PSA value
subsequently decreased to 0.035 ng/mL at the seven-year mark for
patients followed to this time point.
Comparison to Other Prostate Cancer Studies
All patients participating in the study were treated with the
CyberKnife System. The study is unmatched in that:
- A highly effective pattern of radiation could be delivered
easily by any CyberKnife user as a routine part of their practice
-- such plans require steep dose fall-off from high-dose regions to
rectum, and would be difficult to deliver safely without continual
image-guidance and automatic correction of beam aim;
- Treatment resulted in among the lowest PSA levels reached after
radiation therapy (PSA nadirs); and
- The entire treatment was completed in four days.
The CyberKnife System was designed to deliver SBRT, a treatment
process enabling the delivery of radiation throughout the body with
an extremely high degree of precision. The system's unique ability
to continually track and automatically correct for movement of the
prostate in real-time throughout the entire treatment session
provides distinct advantages when treating a tumor which can move
as much as 10 mm in as little as 30
seconds2.
"Outcomes from this long-term, prospective study reinforce that
CyberKnife prostate SBRT is highly effective, with typically
minimal side effects and impact on quality of life during and after
treatment," said Donald B. Fuller,
MD, at Genesis Healthcare Partners in San
Diego, California and lead investigator of the study. "It is
important to note that nearly 90 percent of patients in the study
were treated at community facilities across the United States, which may provide
reassurance for men with localized prostate cancer that the results
are achievable in their community setting."
Additional Study Outcomes
The study, "Five-Year Outcomes from a Prospective
Multi-Institutional Trial of Heterogeneous Dosing Stereotactic Body
Radiotherapy (SBRT) for Low- and Intermediate-Risk Prostate
Cancer," evaluated a dosing regimen which emulated a high-dose
brachytherapy (HDR) plan. It demonstrated that:
- Patients experienced low toxicity rates despite the high SBRT
dosage and heterogeneous dose distribution specific to this study,
with higher dosage in the prostate peripheral zone;
- The 5-year local and distant failure-free remission rates (98.3
percent and 97.3 percent, respectively), for the entire patient
population, were achieved with the CyberKnife System alone. This
enables patients to avoid the unfortunate side effects associated
with the use of androgen deprivation therapy (aka "hormone
therapy") including loss of libido, hot flashes, bone fractures and
weight gain3; and
- The results were obtained without the need for invasive rectal
balloons or spacers to spare the rectal wall.
"This is the second large, prospective, multi-institutional
study to bring clinical evidence of the benefits of CyberKnife SBRT
for the treatment of patients with low- to intermediate-risk
prostate cancer. No other radiation therapy device for prostate
SBRT is supported by such a robust clinical database," said
Fabienne Hirigoyenberry-Lanson, PhD, vice president global clinical
development, at Accuray. "These data show why CyberKnife prostate
SBRT is increasingly being viewed as the treatment of choice by
clinicians and patients who want a non-invasive option that
provides excellent disease control with minimal side effects."
Details of a previously presented multi-institutional study
titled, "Prospective Evaluation of CyberKnife Stereotactic
Radiosurgery for Low- and Intermediate-Risk Prostate Cancer:
Homogenous Dose Distribution," which showed that five treatments
with the CyberKnife System provided excellent disease control for
prostate cancer patients, can be found at
http://www.accuray.com/pressroom/press-releases/prospective-multi-institutional-study-shows-five-treatments-cyberknife.
The study was presented at the American Society for Radiation
Oncology (ASTRO) 58th Annual Meeting and the 2016 Best of ASTRO
meeting.
About the Heterogeneous Dosing SBRT Study
Seventeen institutions analyzed 259 prostate cancer patients; 112
low-risk and 147 intermediate-risk. Patients received an HDR-like
heterogeneous dosing regimen of 38 Gy/four fractions delivered by
the CyberKnife System. The primary study objectives were to
determine biochemical disease free survival (bDFS) and measure the
rates of acute and late genitourinary and gastrointestinal
toxicities following treatment, and to compare the CyberKnife
System bDFS rates to published HDR brachytherapy bDFS rates
reported in the literature.
Important Safety Information
For Important Safety Information please refer to
http://www.accuray.com/safety-statement-radiation-treatment
About Accuray
Accuray Incorporated (NASDAQ: ARAY) is a radiation oncology company
that develops, manufactures and sells precise, innovative tumor
treatment solutions that set the standard of care with the aim of
helping patients live longer, better lives. The company's
leading-edge technologies deliver the full range of radiation
therapy and radiosurgery treatments. For more information, please
visit www.accuray.com.
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 clinical applications,
clinical results, patient outcomes, adoption of Accuray's
technologies and Accuray's leadership position in radiation
oncology innovation and technologies.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from expectations, including but not limited to the risks detailed
from time to time under the heading "Risk Factors" in the company's
report on Form 10-K, filed on August 24,
2016, the company's reports on Form 10-Q, filed on
November 1, 2016 and February 3, 2017, 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
Accuray 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.
Media:
Beth Kaplan
Public Relations Director, Accuray
+1 (408) 789-4426
bkaplan@accuray.com
Jane Hauser
MSLGROUP
+1 (781) 684-0770
accuray@mslgroup.com
1Anwar M, et al. Hypofractionated sbrt versus
conventionally fractionated ebrt for prostate cancer: Comparison of
psa slope and nadir. Radiation oncology 2014;9:42.
2Kupelian P, et al. Multi-Institutional Clinical
Experience with the Calypso System in Localization and Continuous,
Real-Time Monitoring of the Prostate Gland During External
Radiotherapy. Int J Radiat Oncol Biol Phys. 2007;
67(4):1088–1098.
3https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet#q6.
Accessed 2/15/2017.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/cyberknife-system-provides-long-term-disease-control-for-prostate-cancer-patients-300409107.html
SOURCE Accuray Incorporated