Nonsurgical breast cancer cryoablation, which destroys tumor cells by exposing them to subfreezing temperatures, is proving to be an effective alternative to surgery for small breast tumors with low-risk features in women older than age 60. These were the early findings from 3-year results of the ongoing ICE3 clinical trial, the first-ever cryoablation trial that does not involve follow-up surgery, presented at the American Society of Breast Surgeons (ASBrS) Annual Meeting by Richard E. Fine, MD, and colleagues (Abstract 243).
“Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients, and at 3 years posttreatment, the ICE3 trial results are extremely positive,” said Dr. Fine, of the West Cancer Center & Research Institute. “The noninvasive 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.”
In recent years, health care has been de-escalating breast cancer treatment, realizing that for some tumors, less aggressive therapies can be as effective and deliver greater patient satisfaction at a lower cost than traditional interventions. In keeping with that trend, cryoablation is a promising, high-value treatment for certain forms of less aggressive cancers.— Richard E. Fine, MD
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Dr. Fine noted that this clinical trial builds on others demonstrating that cryoablation of small, low-grade tumors is effective. The technique also is used routinely as therapy for other types of cancers.
ICE3 Details
Researchers studied 194 patients aged 60 or older with unifocal invasive ductal cancers measuring 1.5 cm or less. Tumors were all low-grade, hormone receptor–positive, and HER2-negative—consistent with a low-risk form of the disease. Women were treated with a cryoablation freeze-thaw-freeze cycle for 20 to 40 minutes. Treatment was delivered through a needle-like nitrogen-chilled probe inserted through the skin directly into the tumor. Freezing temperatures targeted a carefully controlled area; no surgical incision and related tissue damage and scarring were involved.
Along with cryoablation, at the discretion of their treating physician, 27 patients received or are receiving adjuvant radiation; 148 are receiving endocrine therapy; and 1 received chemotherapy. All patients were followed at 6-month intervals, with ipsilateral breast tumor recurrence at 5 years after cryoablation as the primary trial outcome.
Results
At a mean of 34.83 months from treatment, only 2.06% (n = 4) experienced disease recurrence. 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; that patient remains cancer-free at 60 months follow-up.
“Increasingly, precision medicine is helping physicians characterize breast cancer with tools like genomic profiling and hormone receptor status,” said Dr. Fine. “We also are picking up cancers at an earlier stage than ever before. In recent years, health care has been de-escalating breast cancer treatment, realizing that for some tumors, less aggressive therapies can be as effective and deliver greater patient satisfaction at a lower cost than traditional interventions. In keeping with that trend, cryoablation is a promising, high-value treatment for certain forms of less aggressive cancers.”
Disclosure: For full disclosures of the study authors, visit breastsurgeons.org.
