Cryoablation Therapy Freezes Breast Cancer Cells, Helps Patients Avoid Surgery

New clinical data from a study on cryoablation’s effects on small low-risk breast cancer tumors lend more support to the use of this minimally invasive treatment. Interim results from IceCure Medical LTD’s—developer of the cryoablation ProSense systems—ICE3 clinical trial were presented at the 22nd Annual Meeting of the American Society of Breast Surgeons. 

In the study conducted in 19 US hospitals and medical centers, 194 patients age 55 or older with low-risk, early stage breast cancer tumors measuring up to 1.5 cm were treated with IceCure’s ProSense Cryoablation System. After approximately 3 years post-treatment, 2.06%, or four patients, experienced cancer recurrence. 

According to the American Society of Breast Surgeons, “Treatment was delivered via a needle-like nitrogen-chilled probe inserted through the skin directly into the tumor. Freezing temperatures targeted a carefully controlled area, turning the tumor into an ice ball to destroy the diseased cells.”

“The procedure is office-based, under local anesthesia, requiring only a skin nick, as opposed to an incision and scar,” explains Richard E. Fine, MD, lead researcher and director of education and research for the West Cancer Center and Research Institute.

Common breast cancer treatment options include chemotherapy, radiation, hormone therapy, and surgical procedures. Patients often experience oral side effects from treatment, such as mouth and lip sores, xerostomia, and loss of taste. 

The ICE3 Trial commenced in 2014 and determined the treatment was well tolerated and resulted in no loss of breast tissue. Additionally, cryoablation was shown to deliver “excellent cosmetic outcomes and minimal adverse events, while showing a risk of recurrence comparable to breast conservation surgery.” 

The study also helped identify a subset of women with very favorable breast cancers that could undergo less aggressive treatment. Additionally, the findings will contribute to the US Food and Drug Administration’s (FDA) decision for clearance, Fine explains. 

Currently, cryoablation is approved by the FDA for other types of cancers, including kidney, liver, prostate, and cervical. The technology has not yet been extended to breast cancer treatment. 

“Increasingly, precision medicine is helping physicians characterize breast cancer with tools such as genomic profiling and hormone receptor status,” Fine said in a prepared statement. “We also are picking up cancers at an earlier stage than ever before. In recent years, healthcare has been deescalating breast cancer treatment, realizing that for some tumors less aggressive therapies can be as effective and deliver greater patient satisfaction at lower cost than traditional interventions. In keeping with that trend, cryoablation is a promising, high-value treatment for certain forms of less aggressive cancers.”

Results of the clinical trial will be reported 5 years post-treatment.