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Nonsurgical Treatment for Benign Breast Tumors wins FDA Approval

The FDA approved a treatment for benign breast tumors that uses a needle to freeze and destroy fibroadenomas, Reuters reports. Endocare's cryoablation technology [in which extremely cold temperatures guided by ultrasound destroy tissue or tumor cells] is already on the market as a treatment for prostate cancer, enlarged prostate, and cardiac arrhythmias. According to Endocare CEO Paul Mikus, the technology may help as many as 500,000 women diagnosed annually with benign breast tumors avoid surgery. He describes Endocare's technique as a "20-minute, office-based approach." The procedure reduces recovery time and complications, compared with surgery, and most patients can return to normal activities the day after treatment, Endocare asserts (Reuters/Washington Post, 10/17).

"The procedure leaves no apparent scar at three months of the initial 3mm skin nick that fades," says Karmanos Cancer Institute radiologist Peter Littrup, M.D. "It is virtually painless and has palpable improvement of the mass effect by six months.
"The 'painless' aspect led us to do the percutaneous cryosurgery of other sites including the liver, kidney, lung, and bone with no anesthesia. This is markedly different than radiofrequency (RF) ablation which requires full anesthesia but is commonly done around the country," says Littrup.

"It is also the proof-of-principle step to trying cryo-immunotherapy (cryotherapy plus immune stimulating drugs) under a soon to be launched protocol."
The Institute contributed more patients than all other U.S. centers combined for the clinical research study that led to the FDA's approval

 

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