Cryoablation is emerging as a new alternative to surgical excision for smaller early-stage, low-risk breast cancers in appropriately selected patient populations, according to data presented during the 2021 American Society of Breast Surgeons Annual Meeting.1
Early 3-year results of the multicenter ICE3 trial—reportedly the first U.S. cryoablation trial of early-stage, low-risk breast cancer without subsequent tumor excision—demonstrated a local recurrence rate of 2.1% and a local failure–free probability of 99.2%. The study authors also reported no significant device-related adverse events or complications.
Richard E. Fine, MD, FACS
“Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients. At 3 years after treatment, the ICE3 trial results are extremely positive,” said lead study author, Richard E. Fine, MD, FACS, of West Cancer Center & Research Institute, Germantown, Tennessee. “The noninvasive procedure is relatively painless and can be delivered under local anesthesia in a doctor’s office.”
Dr. Fine continued: “Recovery time is minimal, and cosmetic outcomes are excellent, with little loss of breast tissue and no scarring. This trial is underscoring the efficacy and safety of the procedure for this patient group.”
Freezing Cancer
As Dr. Fine explained, the ICE3 trial was designed to evaluate the safety and efficacy of liquid nitrogen–based cryoablation. This procedure allows women aged 60 and older with early-stage, low-risk breast cancer to perhaps benefit from nonoperative treatment of their tumors.
The single-arm, nonrandomized trial included women with unifocal, ultrasound-visible invasive ductal carcinoma ≤ 1.5 cm in size, hormone receptor–positive, HER2-negative, and breast size allowing safe cryoablation. The choices of sentinel lymph node biopsy and adjuvant treatment were left to the discretion of the treating physician. Cryoablation was performed using an ultrasound-guided cryoprobe accurately placed in the center of the lesion.
“Freezing temperatures targeted a carefully controlled area, turning the tumor into an ice ball to destroy the diseased cells,” said Dr. Fine, who noted no surgical incision–related tissue damage and scarring were involved. “The procedure requires 20 to 40 minutes, depending on the lesion size, for a freeze-thaw-freeze treatment cycle.”
Patients were followed at 6 months and then annually out to 5 years, with clinical and imaging assessment and patient satisfaction. Investigators also administered the NCCN Distress Thermometer at baseline treatment and again at 6 months. The study’s primary outcome was ipsilateral breast tumor recurrence.
Results and Patient Satisfaction
As Dr. Fine reported, a total of 194 patients met eligibility criteria and underwent successful cryoablation. At the discretion of their treating physician, 27 patients received adjuvant radiation in addition to cryoablation, 148 patients received endocrine therapy, and 1 patient received chemotherapy.
The mean age of patients was 75.7 years, and there were no high-grade tumors. Of the 15 patients who underwent sentinel lymph node biopsies, 2 had a positive sentinel lymph node (1 with chronic lymphocytic leukemia and 1 with adenocarcinoma).
KEY POINTS
- In reportedly the largest controlled liquid nitrogen–based cryoablation trial of early-stage, low-risk breast cancer without subsequent tumor excision, 2.1% of patients experienced recurrence at 34.8 months.
- More than 95% of patients and 98% of treating physicians reported satisfaction with the cosmetic results.
- According to the lead author, further study within a clinical trial registry is needed to confirm cryoablation as a viable alternative to surgical excision in appropriately selected patients.
“With a mean of 34.8 months of follow-up, there were four treatment failures, putting the rate of ipsilateral breast tumor recurrence at 2.1%,” said Dr. Fine. He also reported no significant device-related adverse events or complications. Adverse events were minor, he said, and included bruising, localized edema, minor skin freeze, burns, rash, minor bleeding from needle insertion, minor local hematoma, skin induration, minor infection, and pruritus. .
Cautious Optimism Moving Forward
Despite the early data on this treatment, however, the researchers cautioned against performing cryoablation as standard of care based on just 34 months of follow-up data. As they await 5-year complete follow-up data from ICE3, Dr. Fine and colleagues are looking to start an American Society of Breast Surgeons cryoablation registry this summer to track a larger patient population.
“Further study within a clinical trial or registry is needed to confirm cryoablation as a viable alternative to surgical excision in appropriately selected patients,” said Dr. Fine. “I would not advise performing cryoablation on breast cancer outside of a clinical trial or participation in registry. This was the first study looking at follow-up of patients treated without excision, so I think we really need more data.”
DISCLOSURE: The trial was sponsored by IceCure Medical Ltd. Dr. Fine reported no conflicts of interest.
REFERENCE
1. Fine RE, Dietz JR, Boolbol SK, et al: Cryoablation without excision for early-stage breast cancer: ICE3 trial update on ipsilateral breast tumor recurrence. 2021 American Society of Breast Surgeons Annual Meeting. Abstract 243. Accessed May 14, 2021.
