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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.

  • 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.

The studys 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 150200

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 studys

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.
D. Joseph

Gersuk, CFO, 800-772-6446 ext. 1608
[email protected]
or
EVC

Group, Inc.
Investor Relations:
Doug Sherk,

415-896-6820
[email protected]
Don

Takaya, 415-896-6820
[email protected]
Media:
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DiMattia, 646-201-5445
[email protected]
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Gale, 646-201-5445
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