Cryoablation for Early-Stage Breast Cancer a Safe Option in Older Women

ORLANDO — Cryoablation without excision for low-risk, early-stage breast cancer may be an option for women over 60, 5-year follow-up results from the ICE3 trial showed.

At a mean follow-up of 54.2 months, the ipsilateral breast tumor recurrence rate was 4.3%, the breast cancer survival rate was 96.7%, and the overall survival rate was 88.6% in the women who received cryoablation, reported Richard Fine, MD, of West Cancer Center and Research Institute in Germantown, Tennessee, at the American Society of Breast Surgeons annual meeting.

In his presentation, Fine said that the ipsilateral breast tumor recurrence rate dipped to 3.2% among the women in the study who were treated with adjuvant endocrine therapy following the cryoablation procedure. For the women who had adjuvant endocrine therapy with or without radiation therapy, this rate was 2.67%.

Two women in the study died of breast cancer, three died of unknown cancers, but were considered breast cancer deaths by the investigators, and 16 women died from cancers other than breast cancer.

No serious device-related adverse events or complications were reported. Minor adverse events were bruising, localized edema, skin freeze burn, rash, bleeding from needle insertion, local hematoma, skin induration, infection, and pruritus.

At 5-year clinical follow-up, 100% of patients and physicians reported satisfaction with the cosmetic results.

In response to questions from the audience, Fine said that this treatment has not been approved by the FDA for breast cancer, but is available for other cancers.

“Currently, this procedure should not be used outside a clinical trial, unless surgery is not an option for a patient,” he noted.

Catherine O’Connor, MD, a surgeon at Southern Illinois Healthcare in Carbondale, told MedPage Today that “a problem with cryoablation is that the ice ball can remain in the breast, and that may mean that in future mammograms, it may be hard to distinguish and may cause additional distress among patients and require additional imaging. A patient who had cryoablation may need to remain with the group that performed the treatment to avoid unnecessary imaging.”

A 3-year interim analysis of the ICE3 trial showed that the ipsilateral breast tumor recurrence rate was 2.06% at a mean follow-up of 34.8 months, with the researchers noting that these results showed cryoablation to be a promising alternative to surgery, while offering the benefits of a minimally invasive procedure with minimal risks.

The trial enrolled 194 women with sonographically visible, unifocal tumors ≤1.5 cm. Breast size had to be adequate to allow for safe cryoablation.

Median patient age was 74.9 years, and 85% were white. Mean tumor size was 7.4 mm transverse by 8.1 mm sagittal. All tumors were estrogen receptor positive, 93% were progesterone receptor positive, and 100% were HER2-negative. The Nottingham tumor score was low for 49% of participants, and moderate in 51%.

The office-based procedure performed with local anesthesia required about 20-40 minutes, depending on lesion size, Fine said. It was performed using the IceSense/ProSense System, which uses liquid nitrogen at a temperature of -180°C. The probe is inserted percutaneously and centered in the cancerous lesion using ultrasound guidance. The probe freezes the tumor and a 1-cm margin for 9 minutes, then the ice ball is allowed to thaw for 8 minutes, and then is refrozen for 9 minutes.

Choice of appropriate adjuvant treatment was left to the discretion of the treating physician. Fine said that 63.9% of the women received endocrine therapy and 77.3% received radiation therapy. Patients were followed at 6-month intervals and annually up to 5 years, with clinical and imaging assessment.

Fine noted that the study had limitations — it was single-arm and industry-sponsored — which could create bias.

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