Effectiveness & Testimonials

Studies have highlighted the following key findings:

• Efficacy for Small Tumors: Cryoablation is most effective for tumors 2 cm or smaller. The American College of Surgeons Oncology Group (ACOSOG) Z1072 trial reported a 100% success rate for tumors less than 1 cm and a 92% success rate for tumors up to 2 cm.
• Long-Term Success: A Japanese clinical trial involving 304 women with stage I invasive ductal carcinomas reported a 0.98% local recurrence rate over six years, demonstrating the long-term effectiveness of cryoablation when combined with anti-estrogen medications and radiation therapy.
• In April 2024, the 5-year follow-up results of the ICE3 trial were presented at the annual meeting of the American Society of Breast Surgeons in Orlando, Florida.  The ICE3 trial is multicenter, single-arm, non-randomized clinical trial that evaluated the role of cryoablation as an alternative to surgery. The trial enrolled 194 women  years of age (median 75 years) with unifocal, clinical stage I, histologic grade 1 or 2, estrogen receptor positive, progesterone receptor positive, HER2/neu negative invasive ductal carcinoma diagnosed by minimally invasive biopsy. The use of anti-estrogen therapy, radiation therapy, and sentinel node biopsy were not mandated by the trial. As such, nearly 80% of ICE3 trial participants utilized endocrine therapy but only 14% received adjuvant radiation therapy and only 8% of participants underwent a sentinel node biopsy. At 5 years of follow-up, there were 7 recurrences of cancer in the same breast yielding a local recurrence free survival rate of 96.7%, which is comparable to lumpectomy clinical trials in women over 60 years of age where radiation therapy was omitted.  The 5-year results will be published soon.

Cryoablation also offers theoretical benefits in stimulating an anti-cancer immune response, although this effect is not yet fully proven in humans. Proteins released from cryoablated tumors may help the immune system recognize and attack remaining cancer cells, potentially providing additional protection against recurrence.