Healthcare Industry News: RITA Medical
News Release - July 14, 2008
Radiofrequency Ablation Yields High Proportions of Sustained Complete Responses in Patients with Lung CancerStudy Shows Confirmed, Complete Response in 88% of Patients After 1 Year
QUEENSBURY, N.Y.--(HSMN NewsFeed)--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.
- Correct placement of the ablation device into the target tumor with completion of the planned treatment protocol was feasible in 99% of patients.
- 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.
- 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.
- 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.
- Patients with stage I NSCLC (n=13) had a 2-year overall survival of 75% and a 2-year cancer-specific survival of 92%.
- Complications consisted of pneumothorax (n=27) or pleural effusion (n=4), which needed drainage. No significant worsening of pulmonary function was noted.
- No procedure-related deaths, defined as any death within 30 days after treatment, occurred following any of the 137 ablation procedures.
“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.”
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.
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.
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