Let’s cool the hype about ‘ice’ treatment for breast cancer

Thousands of women with early-stage breast cancer may soon have a less invasive alternative to lumpectomy: freezing the tumor. Cryoablation - where a needle delivers liquid nitrogen into the breast to destroy cancer cells with ultra-cold temperatures - causes almost no pain or scarring, entails no recovery time, and costs less than removing cancer with surgery.

The manufacturer of this technology, IceCure Medical, touted the treatment in a news release as a "win-win scenario for patient, physician, health provider, and payor."

Some news coverage has already reflected this "rah-rah" attitude. Take this ABC-7 in Los Angeles story in which a patient raves that cryoablation is "better than a teeth cleaning."

Yet as cryoablation becomes more widely available, journalists should strive to temper such hype by cautioning the public that there's uncertainty about how effectively it works for breast cancer.

Weaknesses with the evidence

As a recent FDA advisory committee meeting indicates, older women with early-stage breast cancer may be forced to decide between cryoablation and lumpectomy with imperfect information.

The advisory panel voted 9-5 that the benefits of IceCure's ProSense cryoablation system with adjuvant endocrine therapy outweigh the risks for early-stage, low-risk breast cancer.

Panel members expressed concern about numerous weaknesses in the evidence that cryoablation prevents recurrence as effectively as lumpectomy, the gold standard treatment. Researchers didn't conduct a randomized trial, tested cryoablation on a relatively small sample of 206 women, and tracked recurrence for just five years.

In addition, FDA experts pointed out irregularities with the researchers' methods, such as excluding certain patients and not others in their analysis.

The sponsor calculated a recurrence rate of 4.3%, By comparison, the FDA estimated rates of 6.2% to 8.7%, in the upper range of recurrence rates in studies of similar women who had lumpectomy.

The medical publication MedPage Today quoted panel member Harold Burstein, M.D., Ph.D, of the Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston: "I'm not convinced there is sufficient safety data for a 61-year-old who may have a life expectancy of 28 years to consider this procedure as an alternative to a standard lumpectomy."

A big potential market

The FDA is expected to render a decision in early 2025. If the device is approved, insurers likely will pay for it, expanding access.

The potential market is large. In 2024, The American Cancer Society estimated that 310,720 U.S. women would be diagnosed with invasive breast cancer. Invasive ductal carcinoma, the ProSense target population, is the most common type, representing 70-80% of breast cancers, Steven Nagel, M.D., an FDA medical officer, said at the hearing.

One worry is that physicians will offer cryoablation to patients who are younger than the indicated minimum age of 60. Breast cancers tend to be more aggressive in younger women, who also have more years of remaining life during which cancer can recur.

Some panelists recommended that the company be required to keep a registry to measure recurrence longer than five years. Meanwhile, the National Center for Health Research, a not-for-profit think tank, asked the FDA to require that women receive "a short, simple patient checklist to maximize informed consent."

However, it's unusual for the FDA to add such extra requirements - known as special controls - for devices such as cryoablation that are deemed intermediate risk.

Enabling informed choice

For years patients have successfully pushed for less invasive breast cancer treatments that get similar good outcomes, Cindy Pearson, a non-voting consumer representative on the advisory panel, noted in an interview. Pearson served as executive director of the National Women's Health Network, an advocacy group, until retiring in 2021.

Whether cryoablation will be the next step in that progression is still unclear, Pearson said.

For now, journalists can convey essential information such as how many women were studied, how long the study lasted, what limitations exist with the data, and what the FDA's analysis found.

Pearson said patients should be informed that there's no evidence that cryoablation is safe for women outside of the study group of people ages 60 and older who appear to have slow-growing, non-aggressive tumors.

Women deserve to know that cryoablation "is not as well-proven as lumpectomy," she added, so they can weigh their own priorities for treatment.

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