Tag Archives: freezing

Freezing Breast Cancer to Death Avoids Surgery

In the United States, cryoablation or freezing tissue to death is a primary treatment option for a variety of cancers, including those originating in or spread to the bone, cervix, eye, kidney, liver, lung, pancreas, and prostate.

Cryoablation for prostate cancer, one of the most common cancers in men, was first approved in the 1990s.

But unlike in Europe, this nonsurgical approach is not approved for breast cancer in the US, one of the most common cancers in women.

So why is this approach still experimental for breast cancer?

“I don’t know,” answered cryoablation researcher Richard Fine, MD, West Cancer Center in Germantown, Tennessee, when asked by Medscape Medical News.

“It’s very interesting how slow the FDA is in approving devices for breast cancer [when compared with] other cancers,” he said.

New Clinical Data

Perhaps new clinical data will eventually lead to approval of this laparoscopic technique for use in low-risk breast cancer. However, the related trial had a controversial design that might discourage uptake by practitioners if it is approved, commented an expert not involved in the study.

Nevertheless, the new data show that cryoablation can be an effective treatment for small, low-risk, early-stage breast cancers in older patients.

The findings come from ICE-3, a multicenter single-arm study of cryoablation in 194 such patients with mean follow-up of roughly 3 years.

It used liquid nitrogen-based cryoablation technology from IceCure Medical Ltd, an Israeli company and the study sponsor.

The results show that 2.06% (n = 4) of patients had a recurrence in the same breast, which is “basically the same” as lumpectomy, the surgical standard for this patient group, said Fine, who is the lead investigator on the trial.

These are interim data, Fine noted, when presenting the findings recently at the American Society of Breast Surgeons annual meeting, held virtually because of the pandemic.

The primary outcome is the 5-year recurrence rate, and this is the first-ever cryoablation trial that does not involve follow-up surgery, he said.

Cryoablation, which delivers a gas to a tumor via a thin needle-like probe that is guided by ultrasound, has multiple advantages over surgery, Fine commented.

“The noninvasive procedure is fast, painless, and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring,” he said in a meeting press statement.

The potential market for cryoablation in breast cancer is large, as it is intended for tumors ≤1.5 cm, which comprise approximately 60%-70% of stage 1 breast cancers that are hormone receptor-positive (HR+), and HER2-negative (HER2–), Fine told Medscape Medical News.

Cryoablation is part of a logical, de-escalation of breast cancer care, he added. “We have moved from radical mastectomy to modified mastectomy to lumpectomy — so the next step in that evolution is ablative technology, which is ‘nonsurgical.’ ”

There are other experimental ablative treatments for breast cancer including high-frequency ultrasound and laser, but cryoablation is the furthest along in development.

Cryoablation as a primary cancer treatment was first approved for coverage by the US Centers for Medicare & Medicaid Services for localized prostate cancer in 1999.

But the concept extends back to 1845, when English physician James Arnott first used iced salt solutions (about –20 °C or – 4 °F) to induce tissue necrosis, reducing tumor size and ameliorating pain. Because the crude cryogen needed to be applied topically, the pioneering technique was limited to breast and cervical cancers because of their accessibility.

Not Likely to Show Superiority

The new study’s population was comprised of women aged 60 years or older (mean of 75 years) with unifocal invasive ductal cancers measuring ≤1.5 cm or less that were all low-grade, HR+, and HER2–, as noted above.

The liquid nitrogen-based cryoablation consisted of freeze-thaw-freeze cycle that totals 20-40 minutes, with freezing temperatures targeting the tumor area and turning it into an “ice ball.”

That ice ball eventually surrounds the tumor, creating a “lethal zone” and thus a margin in which no cancer exists, akin to surgery, said Fine.

There were no significant device-related adverse events or complications reported, say the investigators. Most of the adverse events were minor and included bruising, localized edema, minor skin freeze burn, rash, minor bleeding from needle insertion, minor local hematoma, skin induration, minor infection, and pruritis.

Two of 15 patients who underwent sentinel lymph node biopsies had a positive sentinel node. At the discretion of their treating physician, 27 patients underwent adjuvant radiation, and 1 patient received chemotherapy and 148 began endocrine therapy. More than 95% of the patients and 98% of physicians reported satisfaction from the cosmetic results during follow-up visits.

Because not all patients underwent sentinel lymph node biopsy and adjuvant radiation, there is likely to be controversy about this approach, suggested Deanna Attai, MD, a breast surgeon at UCLA in Los Angeles and past president of the ASBrS, who was asked for comment.

“We have studies that [indicate that] these treatments don’t add significant benefit [in this patient population] but there still is this hesitation [to forgo them],” she told Medscape Medical News.

“The patients in this study were exceedingly low risk,” she emphasized.

“Is 5 years enough to assess recurrence rates? The answer is probably no. Recurrences or distant metastases are more likely to happen 10-20 years later.”

Thus, it will be difficult to show that cryoablation is superior to surgery, she said.

“You can show that cryoablation is not inferior to lumpectomy alone — which allows patients to avoid the operating room,” Attai summarized.

The Surgical Mindset and Breast Cancer

Attai, who was not involved in the current trial, was an investigator in an earlier single-arm cooperative group study of cryoablation for breast cancer, which had the rate of complete tumor ablation as the primary outcome. The study, known as the American College of Surgeons Oncology Group Z1072 trial, enrolled 99 patients, all of whom underwent ablation followed by surgery. The study reported results in 2014 but was very slow to develop, she observed.

“I did my first training in 2004 and I don’t think study opened for several years after that. I think there’s been a lot of hesitation to change the mindset that every cancer needs to be removed surgically,” Attai stated.

“When you put breast cancer in the context of the other organs, we are lagging behind a bit [with cryoablation],” she added.

“I don’t want to go there but…sometimes the innovation for male diseases and procedures sometimes surpasses that of women’s diseases,” she commented.

But the UCLA breast surgeon also defended her fellow practitioners. “There’s been tremendous changes in management over the 27 years I’ve been in practice,” she said, citing the movement from mastectomy to lumpectomy as one of multiple big changes.

There’s not a lot of vital structures inside the breast. Dr Richard Fine

The disparity between the development of cryoablation for breast and prostate cancer is a mystery when you contemplate the potential side effects, Fine observed. “There’s not a lot of vital structures inside the breast, so you don’t have risks that you have with the prostate, including urinary incontinence and impotence.”

As a next move, the ASBrS is planning to establish a cryoablation registry and aims to enroll 50 sites and 500 patients who are aged 55-85 years; for those aged 65-70, radiation therapy will be required, said Fine.

Currently, cryoablation for breast cancer is only allowed in a clinical trial, so a registry would expand usage considerably, he said.  

Attai hopes the field is ready for the nonsurgical approach.

“Halsted died in 1922 and the Halsted radical mastectomy really didn’t start to fall out of favor until the 1950s, 1960,” said Attai, referring to Dr William Halsted, who pioneered the procedure in the 1890s. “I would hope we are better at speeding up our progress. Changing the surgical mindset takes time,” she said.

Fine was an investigator in the ICE3 trial, which is funded by IceCure Medical. Attai has disclosed no relevant financial relationships.

American Society of Breast Surgeons 2021 Annual Meeting: Scientific Session Oral Presentation. Presented April 30, 2021.

Nick Mulcahy is an  award-winning  senior journalist for Medscape, focusing on oncology, and can be reached at  nmulcahy@medscape.net and on Twitter:   @MulcahyNick

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Laughing youths film themselves kicking pensioner, 74, into freezing cold river

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This post originally appeared on Daily Express :: UK Feed

In the footage, which we have chosen to show only in still images, a violent youth is seen moving his leg towards the victim. The brazen thug was filmed by his friends as he targeted the pensioner from behind in the “shocking and upsetting” attack.

The victim fell headfirst into the River Mersey in Warrington, Liverpool Echo reports. He suffered a cut to his face after banging his head.

Two women passing by rushed to the pensioner’s aid on Sunday afternoon, reports Cheshire Live.

But the pensioner was left shaken following the ordeal and police are desperate to trace the young thugs.

Facebook users vented their fury at the sickening offence.

One wrote: “Sadly today the punishment does not fit the crime, probably a slap on the wrist and told not to do it again.”

Another added: “Something needs to be done about these unruly youths of today, it’s because they know they get away with things too easily, they do things all the more, do what’s right and throw the book at them.

“This guy is someone’s dad, grandad, if he was a member of my family I’d be guns blazing, they are no less than sick in the head if they think pushing an elderly man into the water is funny! Hope the man in question makes a speedy recovery.”

One user commented: “He’s lucky he wasn’t knocked unconscious when he banged his head!

“Being he walked home, he probably didn’t want any fuss made when the women helped him, are they able to give a description of the youths.”

Another wrote: “Unfortunately I believe things like this will become more and more common.

“The law, society and parents are becoming so mamby pamby and therefore children/youths have no respect for their own parents let alone anyone else.

“I really hope they catch them but I doubt it unfortunately. Parents out there, it’s someone’s child, if you live in the area maybe question them about this incident. Youths talk and Snapchat everything.”

Sergeant Mark Spaven, of Warrington Local Policing Unit, said: “This was a shocking and upsetting incident which has understandably left the gentleman shaken.

“He returned home freezing cold and had sustained a cut to his face due to banging his head as he fell into the water.

“We are determined to find those responsible and I am urging anyone who has any information or believes they know who did this to come forward.

“I also want to appeal to the two women who thankfully came to his rescue to please get in touch with us as you could have information which could help our investigation.”

The horror happened in the centre of Warrington between 2.30pm and 3pm, and police believe there will have been several witnesses.

It happened near a popular retail park and a McDonald’s.

Anyone who can assist police with their enquiries should contact 101 quoting IML 973152 or Crimestoppers anonymously on 0800 555 111.

N-ice! New Russian passenger jet passes tests in freezing conditions (VIDEO)

Russia has tested its first post-Soviet large domestic airliner, the MC-21-300, in freezing conditions to see how it performs when covered with ice. Hours of tests have proven the jet can safely fly in harsh conditions.

The aircraft successfully completed certification tests under natural icing conditions in northern Russia, its manufacturer Irkut Corporation, part of United Aircraft Corporation (UAC), revealed earlier this week. 

It made some 14 flights lasting from three to five hours over the coast of the White Sea, part of the Barents Sea and the Subpolar Urals area. The routes were specifically picked because of the high humidity and low temperatures found there, which lead to ice formation on aircraft surfaces.

https://cdnv.rt.com/files/2021.04/606db5f8203027277242fe6d.mp4

The certification flights were conducted in several steps. First, the crew looked for clouds that would create the required conditions. Special equipment installed on the plane, including 12 cameras, then allowed them to control how much of the aircraft’s surface was covered with ice and record how it was functioning. After the ice layer was thick enough, the airliner gained altitude to check its performance under those conditions. 

Ice thickness was increased with each test flight, finally reaching eight centimeters – more than enough to say that the plane successfully passed the test. According to Russian and European standards, an aircraft shouldn’t lose its designed characteristics while covered a layer of ice 7.6 cm thick.
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After completing the certification flights, the MC-21-300 returned from Arkhangelsk to the Zhukovsky airport near Moscow on Wednesday.

Irkut has been successfully flying the MC-21 for more than three years, but US sanctions forced the corporation to think of ways to develop the aircraft using more domestic components. A variant of the MC-21, known as MC-21-310 aircraft, equipped with two Russian PD-14 engines made its maiden flight at the end of last year.

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