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Cryoablation could be cool for breast tumors, but we still want data

New Non-Surgical Treatment Freezes Breast Cancer in its Tracks

Our Review Summary

iStock_000061208998_MediumThis news release plays up a liquid nitrogen-based procedure for treating breast cancer, called IceSense3 (ICE3). The probe is inserted into the breast via a small incision, guided into the middle of a tumor, and pumped with liquid nitrogen to freeze and kill the cancerous lesion from the inside out. This allows the body to naturally dismantle and get rid of the dead tissue — no major surgery required and it lasts less than 30 minutes, we’re told. And it’s stated (over and over again) how “minimal” the procedure is, plus the “excellent cosmetic results” it has, since it can get rid of cancers that would otherwise call for disfiguring breast surgeries and mastectomies. The technology is described as a new-and-improved version of a cryoablation method used to treat “liver, kidney, prostate and other cancers.” But the release offers no hard numbers of efficacy of those treatments, nor does it make any meaningful comparison as to how good they are compared to surgery. Unless the reader is a clinician or very well-informed patient, ICE3 could come off sounding like a magical cure-all. The reality is that no treatment is foolproof, and there are also other uncomfortable treatments that precede and/or follow surgery — radiation therapy and chemotherapy being the two principles ones. At its core, the release is a sales pitch intended to recruit women recently diagnosed with breast cancer into a clinical trial for ICE3, since how well the procedure treats breast cancer is an unknown. But the pitch falls short. Describing the efficacy of cryoablation compared to surgery, even with other types of cancers, would have made this a much stronger, more balanced, and more convincing release. So would have describing typical follow-up radiation and chemotherapy treatments.

 

Why This Matters

Bowing to cosmetic appeal doesn’t necessarily save lives when it comes to breast cancer, but it matters a great deal to women diagnosed with the disease. They want to come out of their treatment feeling as whole and like themselves as possible. So, any effective and minimally invasive procedure that lowers the need for breast surgery is welcome in the suite of tools to treat breast cancer. But for better or for worse, it takes brave volunteers to prove the efficacy of such treatments.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There isn’t a dollar sign anywhere in this release, but other cryoablative therapies cost about $11,000 to $12,000 per session and multiple sessions are sometimes necessary.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release says that “the benefits of cryoablation over traditional breast cancer surgery are significant.” And it lists many purported benefits including greater convenience, cosmetic advantages, and fewer complications. But we’re not given any hard numbers on recurrence or spread of breast cancer following an ICE3 procedure — arguably the most important outcomes. This would be difficult to report on, since the procedure is currently undergoing clinical trials to assess just that. But not including a sentence that concisely explains this is a pretty glaring omission. ICE3 is also compared to cryoablation therapy for other cancers (e.g. liver, prostate, kidney). Numbers here comparing those treatments to traditional surgery would have helped us grasp how effective the procedure might be.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The most we get is that patients felt “minimal discomfort.” But could ICE3 leave cancerous tissue behind without a clinician knowing? And are there any other side effects? We aren’t told, and this seems strange given that the “cosmetic” benefits are so well-known and touted so frequently in the text. The National Cancer Institute does describe a few potential harms of cryoablation (which they classify as a type of cryosurgery), including hemorrhaging and bad interactions with chemotherapy. These probably should be mentioned in the release.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release claims ICE3 could help “thousands of women” and that the clinical trial being conducted is limited to patients with a breast tumor that’s 1.5 cm wide or smaller. But it offers no other details about the nature of the trial being conducted, nor does it discuss the evidence from other studies of this approach, whether in breast cancer or in other cancers. It would have been nice, for example, to see some discussion of the difficulties in doing a randomized clinical trial of this surgical procedure. There is such a high likelihood of bias in trials of surgery that there should be something about how they would avoid that in the current (undocumented) trial. Similarly, a few words about the strength of the evidence from other trials would’ve helped ground the discussion.

Does the news release commit disease-mongering?

Satisfactory

There’s some strong language describing the pain and lengthy recovery of surgery, and the suffering that many women experience following surgery. But that’s not disease-mongering per se — it’s more of a way for the release to pump up the advantages of the new approach.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

IceCure Medical, the manufacturer of ICE3, is named as the source of the release.

Does the news release compare the new approach with existing alternatives?

Satisfactory

ICE3 is compared extensively to surgery, which is the leading treatment for breast cancer. However, it would have helped to put the treatment into context with preceding and follow-up treatments, including radiation and chemotherapy.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

We’re told ICE3 is currently in clinical trials for treating breast cancer and is only available at 20 US sites, at least two of which are named in the release.

Does the news release establish the true novelty of the approach?

Satisfactory

Breast cancer isn’t normally treated with cryoablation, and the release makes this clear. We’re also told the improvements built into ICE3 makes treating cancer with it “more precise” and reliable.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The introduction is pretty dramatic — “Imagine. A nick of the skin, a flash of cold…” — but the release crosses the line with its language about the disfiguring nature of surgery. It says women achieve “excellent cosmetic results” with cryoablation and that they are “extremely relieved to avoid painful, disfiguring surgery and long recovery times.” According to the release, it seems that the only alternative to cryoablation is disfiguring mastectomy, but there are other intermediate surgical options (lumpectomy) that minimize scarring and post-mastectomy reconstruction is available. The release should have been more tempered in its description of surgical outcomes.

Total Score: 5 of 10 Satisfactory

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