RITA Medical Highlights Recent Clinical Publications Discussing Local Therapy Devices in the Treatment of Liver Tumors Associate
2006年10月3日 - 8:30PM
PRニュース・ワイアー (英語)
- Early Radiofrequency Ablation Treatment Demonstrates Encouraging
Impact on Survival FREMONT, Calif., Oct. 3 /PRNewswire-FirstCall/
-- RITA Medical Systems, Inc. (NASDAQ:RITA), a publicly-traded
medical device company focused solely on cancer therapies, today
announced three recent publications discussing radiofrequency
ablation (RFA) and embolization beads in the treatment of liver
metastases associated with colorectal cancer (CRC). In the first
American study to report 5-year survival data for patients with
unresectable CRC-related liver tumors treated with RFA, researchers
demonstrated positive long-term benefits of this treatment. In a
second study, conducted in Italy, encouraging preliminary reports
were released for patients with extensive liver tumors associated
with CRC and refractory after at least two prior chemotherapy
regimens who had been treated with Biocompatibles International plc
(LSE:BII) DC Bead(TM) embolization beads that had been "loaded"
with the chemotherapy drug irinotecan and injected directly into
tumor. The DC Bead is not cleared or approved in the U.S. for
chemoelution. Finally, independent researchers in the Netherlands
found favorable effectiveness (as measured by cancer recurrences at
the site of radiofrequency ablation) of RITA electrode devices
compared with those of two other manufacturers in the treatment of
CRC metastases. "Clinical studies continue to demonstrate the
important role of RITA's medical device oncology products in the
treatment of liver tumors related to colorectal cancers," said
Joseph DeVivo, president and chief executive officer RITA Medical
Systems. "These recent research publications are very encouraging
in terms of assessing the long-term potential to safely and
effectively improve the outcomes in patients with CRC liver
metastases. We are also very excited about the early results of the
Italian study using DC Bead to treat CRC liver metastases. Finally,
we were very pleased with the independently funded and run study
which found that RITA's expandable, deployable electrodes had a
lower recurrence rate for colorectal metastases tumors compared
with those of two of our competitors." About Colorectal Cancer
Colorectal cancer is one of the most common malignancies in the
U.S. and Europe with 500,000 new cases each year. In approximately
25% of patients, liver metastases are present at the time of
diagnosis and eventually over 70% of patients will develop liver
metastases. Only 20-30% of these patients are eligible for surgery
and there remains a large group of patients for whom new
treatments, such as local ablative techniques like RFA, are the
only feasible alternatives. Long-Term Outcome of RFA Treatment for
Unresectable Liver Metastases from CRC (Machi J et el., The Cancer
Journal 2006;12:318-326) In a paper titled, "Long-Term Outcome of
Radiofrequency Ablation for Unresectable Liver Metastases from
Colorectal Cancer: Evaluation of Prognostic Factors and
Effectiveness in First- and Second-Line Management", Junji Machi,
MD, PhD, and colleagues from the Department of Surgery and Internal
Medicine at the University of Hawaii and Kuakini Medical Center in
Hawaii conducted a long-term follow-up of patients with liver
tumors associated with CRC who received RFA treatment. The purpose
was to evaluate the long-term outcome of RFA in conjunction with
chemotherapy and to identify prognostic factors associated with
survival. RFA was performed for 100 patients in 146 procedures to
ablate 507 colorectal metastatic tumors. All patients were followed
up for at least 18 months up to 84 months or until death. The
overall median survival was 28 months, and 1-, 3- and 5-year
survival was 90.0%, 42.0% and 30.5%, respectively. This compares
favorably with survival rates reported from other studies, in which
patients who received chemotherapy treatment only, without
concurrent use of local intervention. The authors concluded that
RFA should be considered part of first-line management for
unresectable CRC-related liver metastases. Dr. Jelle W. Kylstra,
Vice President and Medical Director at RITA, commented: "While
numerous earlier studies had provided evidence of benefit of RFA in
the treatment of unresectable liver metastases, no prior study had
addressed the practical issue of timing of RFA in relationship to
other treatments received by most patients, in particular
chemotherapy. This study suggests that optimal cytoreduction
upfront with methods such as RFA, followed by modern systemic
chemotherapy, offers the best results. The results provide strong
support for this concept of "multi-modality treatment" of
metastatic colorectal cancer." Use of Irinotecan-Eluting Beads in
Treatment of Liver Metastases from CRC (Aliberti C et al.,
Anticancer Research 2006; 26:3779-82) In a paper titled,
"Trans-arterial Chemoembolization (TACE) of Liver Metastases from
Colorectal Cancer Using Irinotecan-Eluting Beads: Preliminary
Results," Camillo Aliberti, MD, Professor of Interventional
Radiology at Delta Hospital in Ferrara, Italy, presented the
preliminary results of a study to evaluate the feasibility of using
irinotecan drug-eluting beads (DC beads, Biocompatibles UK Ltd.)
administered intratumorally to patients with liver metastases from
CRC. Irinotecan is a systemically active drug in the first- and
second-line treatment of advanced CRC, and high-dose local
treatment may be beneficial to patients refractory after systemic
treatment. The objective of this study was to determine the safety,
feasibility, tolerance and tumor response of TACE using irinotecan
loaded DC beads for the treatment of unresectable liver metastasis
in CRC patients. Ten patients with liver metastases from CRC were
treated with irinotecan- eluting beads at a dose of 100 mg every
three weeks. Computed Tomography (CT) was performed 24 hours before
and after TACE. The findings showed that TACE with irinotecan
eluting beads was feasible and well tolerated. Right upper quadrant
pain lasting four days was felt by all patients. After 30 days, a
reduction of >50% of CEA levels (a marker used to diagnose or
indicate recurrence of cancer) and of the lesional contrast
enhancement was observed in all the patients. Factors Influencing
the Local Recurrence after RFA Treatment of CRC Liver Metastases.
(van Duijnhoven et al., Annals of Surgical Oncology 2006;13:651-
658) In a paper titled, "Factors Influencing the Local Failure Rate
of Radiofrequency Ablation of Colorectal Liver Metastases",
researchers at four academic and four large community based
hospitals in the Netherlands presented results of a study designed
to provide a prospective evaluation of the risk factors for local
failure of RFA treatment of CRC liver metastases and to define
exclusion criteria for RFA treatment of these metastases. Devices
from three manufacturers were used in the study, including RITA
Medical Systems, Radionics Cool-tip and Radiotherapeutics (now
Boston Scientific). A total of 199 lesions in 87 patients were
ablated with 104 RFA treatments. These patients were not eligible
for hepatic resections as a result of the tumors' locations, the
number or size of the lesions or poor medical condition. Access was
percutaneous in 31 treatments and by laparotomy in 73 treatments.
RFA was combined with hepatic resection in 29 laparotomies.
Consistent with other studies, the research indicated that size and
access route are significant factors in RFA failure rates. The
study also suggests an influence of RFA electrode type on local
recurrence. The local rate of recurrence at similar average
original tumor sites for RITA devices was 26.8% as compared to
60.3% for the Radiotherapeutics (Boston Scientific) expandable
electrode and 42.9% for the Radionics Cool-tip clustered triple
electrode. Authors called the difference between the two types of
expandable electrodes (RITA and Radiotherapeutics-BSC) remarkable,
because >40 lesions of similar size were treated with each
system. The study was independently conducted and not sponsored by
RITA or any other RFA-systems manufacturer. About RITA Medical
Systems, Inc. RITA Medical Systems develops, manufactures and
markets innovative products for cancer patients including
radiofrequency ablation (RFA) systems and embolization products for
treating cancerous tumors as well as percutaneous vascular and
spinal access systems. The Company's oncology product lines include
implantable ports, some of which feature its proprietary Vortex(R)
technology; tunneled central venous catheters; and safety infusion
sets and peripherally inserted central catheters used primarily in
cancer treatment protocols. The radiofrequency product line also
includes the HABIB 4X resection device which coagulates a "surgical
resection plane" and is designed to facilitate a fast dissection in
order to minimize blood loss and blood transfusion during surgery.
The proprietary RITA RFA system uses radiofrequency energy to heat
tissue to a high enough temperature to ablate it or cause cell
death. In March 2000, RITA became the first RFA company to receive
specific FDA clearance for unresectable liver lesions in addition
to its previous general FDA clearance for the ablation of soft
tissue. In October 2002, RITA again became the first company to
receive specific FDA clearance, this time for the palliation of
pain associated with metastatic lesions involving bone. The Company
also distributes LC Bead embolic microspheres in the United States
and Canada. The LC Bead microspheres are injected into selected
vessels to block the blood flow feeding a tumor, causing it to
shrink over time, and are often used in combination with
radiofrequency ablation (RFA). The RITA Medical Systems website is
at http://www.ritamedical.com/. The statements in this news release
related to the number of patients in the United States and Europe
with colorectal cancer who may be candidates for local ablative
techniques, such as RFA; the safety and efficacy of RFA treatment;
the safety of treatment with embolic beads; survival rates
resulting from the use of RFA or the RITA System; the benefits of
RFA treatment for colorectal liver cancer; and the benefits of
embolic bead treatment for liver metastases are forward-looking
statements involving risks and uncertainties that could cause
actual results to differ materially from those in such
forward-looking statements. Such risks and uncertainties include
but are not limited to: the Company's ability to compete with
companies offering alternative therapies for solid cancerous and
benign tumors; the Company's lack of long-term data regarding the
safety and efficacy of its RF and embolization products; delay of
product introductions or modifications as a result of the FDA
regulatory process; the Company's limited experience as a
distributor of embolization beads; and the Company's success in its
physician training efforts. Information regarding these risks and
other risks and uncertainties is included in the Company's filings
with the Securities and Exchange Commission. DATASOURCE: RITA
Medical Systems, Inc. CONTACT: Investors, Doug Sherk, , or Jenifer
Kirtland, +1-415-896-6820, or Media, Steve DiMattia,
+1-646-277-8706, or , all of EVC Group, for RITA Medical Systems,
Inc.; Stephen Pedroff, VP Marketing Communications of RITA Medical
Systems, Inc., +1-510-771-0400, or Web site:
http://www.ritamedical.com/
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