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Recent Clinical Publications Discussing Local Therapy Devices In The Treatment Of Liver Tumors Associated With Colorectal Cancer
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.
RITA Medical Systems, Inc
http://www.ritamedical.com
Clinice recente Publicatii Discutarea Local Tratamentul Dispozitive în tratamentul de ficat tumori asociate cu cancerul colorectal - Recent Clinical Publications Discussing Local Therapy Devices In The Treatment Of Liver Tumors Associated With Colorectal Cancer - articole medicale engleza - startsanatate