By: Mike Basset
From: medpagetoday.com
The FDA granted marketing authorization for the ProSense Cryoablation Systemfor small, early-stage breast cancer in older women not suitable for surgery, maker IceCure announced.
A minimally invasive tool that destroys tumors by freezing them, the device is indicated for women 70 years and older who have biologically low-risk tumors, no larger than 1.5 cm, and who are being treated with adjuvant endocrine therapy.
Primary support for the cryoablation system came from the ICE3 study, a single-arm trial of more than 200 patients with early-stage breast cancer.
“The ICE3 study has proven that cryoablation with ProSense is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy, and has the benefit of being an office-based, nonsurgical treatment,” investigator Richard Fine, MD, of the West Cancer Center and Research Institute in Germantown, Tennessee, said in a statement.
During an FDA advisory committee meetingon the device last year, panel members were concerned that the evidence from ICE3 lacked certainty since the FDA and IceCure presented different efficacy results regarding the trial’s primary endpoint of ipsilateral breast tumor recurrence (IBTR). For the indicated population, the FDA’s assessed IBTR rate was 2.3% (95% CI 0.6-9.0) based on the 120 patients who also received adjuvant endocrine therapy in ICE3.
In addition, at least one panel member lamented the fact that ICE3 was a small, nonrandomized trial in a population where the risk of recurrence was low.
However, committee members ultimately said in a 9-5 vote that the benefits of the device when combined with adjuvant endocrine therapy outweigh the risks for older women with early-stage, low-risk breast cancer.
The FDA has asked the company to conduct a postmarket surveillance study that is expected to include about 400 patients at 30 sites, IceCure said.
“Further data coming out of the postmarket study should continue to support that cryoablation with ProSense is a successful option in the de-escalation of breast cancer care in appropriately selected patients,” said Fine.
According to IceCure, patients typically return to normal activity within 24 hours, with a median recovery time of 1 day (range of 0-8 days). Most of the adverse events besides breast cancer recurrence were edema, bruising, hematoma, skin burn, and postoperative pain. These were mild in severity and all of these events resolved without any permanent effect.
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