Radiofrequency Ablation Yields High Proportions of Sustained Complete Responses in Patients with Lung Cancer
2008-07-14 05:30:00
Radiofrequency Ablation Yields High Proportions of Sustained Complete Responses in Patients with Lung Cancer
Study Shows Confirmed, Complete Response in 88% of Patients After 1
Year
QUEENSBURY, N.Y.–(EMWNews)–AngioDynamics (NASDAQ:ANGO) announced today results from its RAPTURE
study, which was conducted to identify the feasibility, efficacy and
safety of percutaneous radiofrequency ablation (RFA) of malignant lung
tumors. Published in The Lancet Oncology July 2008 issue,
the results show a high proportion of sustained, complete tumor response
after treatment with RFA.
This prospective, intention-to-treat clinical trial enrolled 106
patients with 183 lung tumors that were 3.5 cm in diameter or smaller
(mean 1.7 cm) at seven centers in the United States, Europe, and
Australia. Diagnoses included non-small-cell lung cancer (NSCLC) in 33
patients, metastasis from colorectal carcinoma in 53 patients, and
metastasis from other primary malignancies in 20 patients. Patients
underwent radiofrequency ablation in accordance with standard rules for
CT-guided lung biopsy and were then followed for a minimum of 2 years.
All patients were considered by their treating physician to be
unsuitable for surgery, radiotherapy or chemotherapy.
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Correct placement of the ablation device into the target tumor with
completion of the planned treatment protocol was feasible in 99% of
patients.
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A confirmed complete response of target tumors lasting at least 1 year
was shown in 75 (88%) of 85 assessable patients. No differences in
response were noted between patients with NSCLC or lung metastases.
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Cancer-specific survival was 92% at 1 year and 73% at 2 years in
patients with NSCLC, 91% at 1 year and 68% at 2 years in patients with
colorectal metastases, and 93% at 1 year and 67% at 2 years in
patients with other metastases.
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Overall survival was 70% at 1 year and 48% at 2 years in patients with
NSCLC, 89% at 1 year and 66% at 2 years in patients with colorectal
metastases, and 92% at 1 year and 64% at 2 years in patients with
other metastases.
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Patients with stage I NSCLC (n=13) had a 2-year overall survival of
75% and a 2-year cancer-specific survival of 92%.
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Complications consisted of pneumothorax (n=27) or pleural effusion
(n=4), which needed drainage. No significant worsening of pulmonary
function was noted.
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No procedure-related deaths, defined as any death within 30 days after
treatment, occurred following any of the 137 ablation procedures.
The study’s lead author was Prof. Riccardo
Lencioni of the Division of Diagnostic and Interventional Radiology,
Department of Oncology, Transplants, and Advanced Technologies in
Medicine, University of Pisa, Pisa, Italy. He was joined by authors from
the seven centers that participated in the trial. Their paper is also
available online at www.thelancet.com/journals/lanonc.
“In the RAPTURE study, we offered
radiofrequency ablation to patients who had no other chance of cure,”
said Prof. Lencioni. “Many of these patients
had very poor lung function or other diseases. As a result, several
patients died from causes unrelated to cancer, which accounts for the
significant difference between overall survival rates and
cancer-specific survival rates. Our complete cure rate of about 90%,
however, exceeded all of our expectations and appears to be better than
those reported for any other nonsurgical treatment option. With further
developments in the technique since the research began, RFA could become
a treatment option for all patients who cannot have standard surgery,
whether they have concomitant chemotherapy and radiotherapy or not.”
The procedures in this study were performed with a 150–200
watt AngioDynamics RITA Medical Systems Model 1500 and 1500X generators
with an expandable AngioDynamics RITA StarBurst™
XL radiofrequency ablation system.
“This is the first study that has aimed to
demonstrate the feasibility, effectiveness and safety of RFA in the
lung, and the results prove that RFA can treat patients with small,
non-resectable pulmonary tumors with a high rate of success,”
said Eamonn Hobbs, AngioDynamics President & CEO. “Lung
cancer is the single leading cause of cancer death, and as the leader in
RFA technology, we intend to advance the use of RFA as an important
treatment option for this dreadful disease. We join with the study’s
authors in their call for a randomized, controlled trial comparing
radiofrequency ablation versus standard treatment options to prove the
clinical benefit of this approach.”
About AngioDynamics
AngioDynamics, Inc. is a leading provider of innovative medical devices
used by interventional radiologists, surgeons, and other physicians for
the minimally invasive treatment of cancer and peripheral vascular
disease. The Company’s diverse product line includes market-leading
radiofrequency ablation systems, vascular access products, angiographic
products and accessories, dialysis products, angioplasty products,
drainage products, thrombolytic products, embolization products and
venous products.
Safe Harbor
The statements made in this document contain certain forward-looking
statements that involve a number of risks and uncertainties. Words such
as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,”
“estimates,” or variations of such words and similar expressions, are
intended to identify such forward-looking statements. Investors are
cautioned that actual events or results may differ from the Company’s
expectations. In addition to the matters described above, the ability of
the Company to develop its products, future actions by the FDA or other
regulatory agencies, results of pending or future clinical trials,
overall economic conditions, general market conditions, market
acceptance, foreign currency exchange rate fluctuations, the effects on
pricing from group purchasing organizations and competition, as well as
the risk factors listed from time to time in the SEC filings of
AngioDynamics, Inc., including but not limited to its Annual Report on
Form 10-K for the year ended June 2, 2007, may affect the actual results
achieved by the Company.
AngioDynamics, Inc. Gersuk, CFO, 800-772-6446 ext. 1608 Group, Inc. 415-896-6820 Takaya, 415-896-6820 DiMattia, 646-201-5445 Gale, 646-201-5445 |
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