15/11/2025
Can Cryotherapy Replace Breast Cancer Surgery?
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the ProSense Cryoablation System as a non-invasive alternative to lumpectomy for a specific group of breast cancer patients. This authorization applies to women aged 70 and older with small (≤1.5 cm), low-risk, early-stage breast cancers (ER-positive, PR-positive, HER2-negative) who are also receiving adjuvant endocrine therapy.
The FDA's decision was based on the ICE3 trial, which showed a 5-year recurrence rate of 3.7%, comparable to traditional surgery. The procedure involves inserting a thin needle (cryoprobe) into the tumor under local anesthesia and ultrasound guidance, then freezing it with liquid nitrogen to destroy the cancer cells in place. Key advantages over lumpectomy, according to the manufacturer, include less pain, no scarring, a shorter recovery time, and a lower cost. As a condition of approval, the FDA is requiring a larger post-marketing study to confirm the long-term benefits. An estimated 46,000 women in the U.S. could be eligible for this treatment annually.
Ahmed Maamoun Nofal, MD, PhD
Faculty member and consultant for early diagnosis and treatment of breast, gynecologic, and solid tumors for adults at the Faculty of Medicine, Ain Shams University, and the International Medical Center - Cairo - Egypt. Certified member of the European Society of Oncology.
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