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

National Multi-Center Trial of Cryoablation for Breast Cancers Shows Promise in Treatment of the Disease

MEMPHIS, Tenn., Oct. 26, 2015 /PRNewswire/ — Imagine.  A nick of the skin, a flash of cold and 25 minutes on an exam table. For thousands of women, this may soon replace surgery as a treatment for breast cancer.

Cryoablation, using extreme cold to destroy diseased cells, is potentially the first ever procedure to treat breast cancer tumors without the trauma of surgery.  Following numerous limited studies, a growing number of women are now being treated with the technique as part of a groundbreaking clinical trial involving leading breast cancer specialists across the country.  Utilizing IceCure Medical’s innovative IceSense3™ cryoablation system, the multi-center trial is examining cryoablation of certain types of breast cancer.    Potentially, it will usher in a new and gentler pathway for the treatment of a disease that affects one in every eight women annually.

The benefits of cryoablation over traditional breast cancer surgery are significant.  The procedure is typically performed in a physician’s office under ultrasound guidance in less than 30 minutes.  It involves a small incision and placement of an IceSense3™ nitrogen-cooled probe into the center of a tumor to freeze it from the inside out.  The diseased cells then crack open and die. Eventually they are absorbed by the immune system and new cells take their place.

By contrast, surgical cancer removal often means several hours in the operating room, complications of general anesthesia and weeks or months of recovery.  Surgery also typically involves significant breast tissue damage and disfigurement due to large incisions and removal of sizable breast mass.

Cryoablation, however, precisely targets the tumor site and involves insertion of only a slim probe. Therefore, it boasts fast recovery time, significantly improved cosmetic results and greater patient comfort overall.  In fact, most women are able to resume normal activities almost immediately following treatment.  They experience minimal scarring and excellent cosmetic results.

Physicians participating in the trial report that patients feel minimal discomfort and can watch the procedure on the ultrasound screen.  Most are extremely relieved to avoid painful, disfiguring surgery and long recovery times.

“For women with certain types of breast cancer, cryoablation is showing promise as an alternative to surgery, particularly for patients over age 65,” says Susan K. Boolbol, MD, Chief of the Appel-Venet Comprehensive Breast Service, Mount Sinai Beth Israel, who is participating in the trial.  “For older patients the risks associated with invasive procedures and general anesthesia as well as the discomfort of long recoveries also makes this procedure particularly desirable.  As our understanding of tumor biology grows, the ability to offer treatment options other than surgery is important.”

“There is growing awareness treatment should be based on individual tumor biology.  We are excited to be participating in this trial where some breast cancer patients can be treated without surgery,” adds Richard Fine, MD, The West Comprehensive Breast Center, Memphis, TN, another surgeon active in the cryoablation trial.  “Over the next 15 years, women 65 and older will make up one of the fastest growing populations diagnosed with breast cancer.  We are confident that the ICE3 trial can prove certain women can be successfully treated less aggressively than in the past.  The option of a non-surgical treatment has significant benefits for patients and the overall health care system.”

Cryoablation is well-established in the treatment of liver, kidney, prostate and other cancers. Its effectiveness in breast cancer has been proven in a number of smaller studies, including a recent American College of Surgeons Oncology Group (ACOSOG) trial and extensive long-term ongoing, unpublished studies in Japan.   The ICE3 trial, which began patient enrollment in October 2014, will significantly expand data on the technique as a treatment for breast cancer.  Patents will be followed for five years to ensure they remain cancer free.

Developed by IceCure Medical (Caesarea, Israel/Memphis, TN), specifically for breast applications, the IceSense3 Cryoablation System™, has a long history of successful treatment of benign breast fibroadenomas.  The ongoing refinement of the technology makes treatment more precise and extremely reliable.  The IceSense3™ device delivers a stable cycle of extremely cold temperatures and relies on a maneuverable, disposable probe and compact high tech console.  For the first time, these advances make precise targeting of tumors extremely reliable.

The ICE3 trial is recruiting and following women aged 65 years and older diagnosed with certain tumor sub-types and measuring less than 1.5 centimeters in diameter.  Developed by a diverse,  esteemed scientific advisory board, the trial is underway at 20 carefully selected sites throughout the United States.  As a market leader in cryoablation treatment of breast disease, IceCure will utilize its resources to provide clinical and technological support to sites in the cancer trial.

CONTACT:
William Irby
901-237-4630
wirby@icecure-medical.com

Photo – http://photos.prnewswire.com/prnh/20151026/280497

SOURCE IceCure Medical

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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