Image-guided cryoablation without surgery can be an effective option for older women with early-stage, low-risk breast cancer, according to three-year results from a single-arm clinical trial. "The ICE3 trial is the largest liquid nitrogen cryoablation trial for breast cancer without surgical excision. The take-home is that it's a promising alternative to surgery for the appropriately selected patient (small tumors with favorable characteristics)," lead researcher Dr. Richard Fine of West Cancer Center and Research Institute, in Germantown, Tennessee, told Reuters Health by email. He added, however, that the treatment has not yet been approved by the U.S. Food and Drug Administration "for breast cancer specifically and should be utilized in a clinical trial or registry." Dr. Fine presented the latest data from the ICE3 trial at the American Society of Breast Surgeons (ASBrS) virtual annual meeting. The cohort included 194 women aged 60 and older with low-grade, hormone-receptor-positive, HER2-negative, unifocal invasive ductal cancers measuring 1.5 cm or less. Ultrasound-guided cryoablation is performed in the office under local anesthesia using the IceSense 3 system from IceCure Medical Ltd, which is funding the study. The procedure includes a freeze-thaw-freeze treatment cycle that takes 20 to 40 minutes, depending on lesion size. The decision to biopsy sentinel lymph nodes and the choice of appropriate adjuvant therapy was left to the treating physician; 27 patients received or are receiving adjuvant radiation, 148 with endocrine therapy and one with chemotherapy. All patients were followed at six month intervals. The primary outcome is breast-cancer recurrence in the same breast at five years after cryoablation as the primary trial outcome. After an average of nearly three years (35 months) of follow-up, only four patients had a recurrence, for a 2% overall recurrence rate. Ninety-five percent of patients and 98% of treating physicians reported satisfaction with the cosmetic results. No significant device-related adverse events were reported. One patient had breast-cancer-related positive sentinel lymph nodes at biopsy, but remains cancer-free at 60 months follow-up. "Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients, and at three years post-treatment, the ICE3 trial results are extremely positive," Dr. Fine said in a conference statement. "The non-invasive procedure is fast, painless and can be delivered under local anesthesia in a doctor's office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring. Now, this trial is underscoring the efficacy and safety of the procedure for this patient group," said Dr. Fine. Dr. Charles L. Shapiro, director of breast cancer translational research, Mount Sinai Health System, in New York City, told Reuters Health by email that "cryoablation of breast cancers is not new. It has long history but has never caught on." ICE3 was a trial of women with "most favorable subset of breast cancers. Unlike prior studies, they did not perform surgery after the cryoablation. The procedure was well-tolerated, and for both patient and surgeon satisfaction with the procedure was extremely high," said Dr. Shapiro, who was not involved in the study. He noted that "several points stand out. This a single-arm, non-randomized trial and the gold standard would be a randomized non-inferiority trial of cryoablation versus conventional breast surgery; if the results showed that cryoablation was non-inferior, that represents a 'de-escalation' of surgical treatment. However, it begs a question that has been raised by others; could we do without local therapy altogether in this favorable subset of breast cancers, and treat with just anti-estrogen therapy alone?" —Megan Brooks Source
