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Wednesday, May 14, 2025

Breast-Conserving Treatment Outcomes Similar to Mastectomy in BRCA Variant Breast Cancer

 In a multicenter cohort study of 575 South Korean patients with BRCA1 or BRCA2 pathogenic variants, breast-conserving treatment demonstrated comparable oncologic outcomes to mastectomy over a median follow-up of 8.3 years. After propensity score matching, no significant differences between the two surgical approaches were found in terms of locoregional recurrence, distant recurrence, and overall survival.

METHODOLOGY:

  • Breast-conserving treatment has been established as a viable alternative to mastectomy for patients with sporadic breast cancer, showing comparable prognoses.
  • Current guidelines specify that patients with breast cancer with genetic predispositions, such as BRCA1 or BRCA2 pathogenic variants, may consider prophylactic bilateral mastectomy for risk reduction, though the suitability and safety of breast-conserving treatment in these patients remain relatively uncertain.
  • Researchers conducted a retrospective multicenter cohort study analyzing 575 female patients with BRCA1 or BRCA2 pathogenic variants who underwent either breast-conserving treatment (377 patients) or mastectomy (198 patients) at 13 institutions in South Korea from January 2008 through December 2015.
  • Analysis included propensity score matching with a 1:1 greedy nearest neighbor method to adjust for age, tumor size, lymph node metastasis, histologic grade, and tumor subtype, resulting in 159 matched pairs of patients.
  • Primary outcome measures encompassed locoregional recurrence–free survival, distant recurrence–free survival, and overall survival, with a median follow-up period of 8.3 years (interquartile range, 6.4-9.6 years).

TAKEAWAY:

  • Multivariate analysis revealed that breast-conserving treatment was not significantly associated with oncologic outcomes compared with mastectomy (hazard ratio [HR], 0.96 [95% CI, 0.36-2.59] for locoregional recurrence–free survival; 0.62 [95% CI, 0.28-1.38] for distant recurrence–free survival; and 0.82 [95% CI, 0.34-1.98] for overall survival).
  • Tumor size emerged as the sole factor significantly associated with distant recurrence–free survival (HR, 3.87; 95% CI, 1.51-9.94; P < .01), whereas lymph node metastasis significantly affected overall survival (HR, 3.78; 95% CI, 1.44-9.97; P < .01).
  • In subgroup analysis among matched patients based on BRCA1 or BRCA2 status, tumor size, lymph node metastasis, histologic grade, and subtype, breast-conserving treatment showed no significant association with risk for recurrence.

IN PRACTICE:

“The findings from this cohort study of patients with BRCA1 or BRCA2 pathogenic variants suggested that there were no significant differences in oncologic outcomes between patients who underwent [breast-conserving treatment] and those who underwent mastectomy. Therefore, breast conservation with close surveillance can be considered a viable treatment option for BRCA1 or BRCA2 pathogenic variant carriers,” wrote the authors of the study.

SOURCE:

The study was led by Janghee Lee, MD, PhD, Ewha Womans University Mokdong Hospital in Seoul, Republic of Korea. It was published online on May 14 in JAMA Network Open.

LIMITATIONS:

The study was retrospective, which introduces potential selection bias. The cohort did not clearly indicate whether BRCA pathogenic variant test results were available before surgery, which could have influenced surgical approach decisions. Additionally, the study was unable to include information on the precise site of BRCA1 or BRCA2 pathogenic variants and other pathogenic variants, such as TP53, which could impact recurrence and prognosis.

DISCLOSURES:

The study received support from the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group and the Korean Surgical Society. The funders had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data, preparation, review, or approval of the manuscript, and decision to submit the manuscript for publication.

https://www.medscape.com/viewarticle/breast-conserving-treatment-shows-similar-outcomes-2025a1000bqb

Can UnitedHealth turn it around?

 UnitedHealth Group's (NYSE:UNH) stock has plunged nearly 40% year-to-date as the healthcare company has grappled with crisis after crisis, including the aftermath of a massive cyberattack, the murder of a top executive, unexpectedly higher costs, and federal investigations into its business practices.

Shares of the managed care giant were battered yet again on Tuesday after the company withdrew its 2025 financial guidance and announced that CEO Andrew Witty had resigned. Witty will be succeeded by UnitedHealth Chairman Stephen Hemsley, who served as also CEO of the company from 2006 to 2017.

So, what's next for UnitedHealth (NYSE:UNH)? Can the healthcare juggernaut turn it around?

We asked Seeking Alpha analysts JR Research, Investing Group Leader for Ultimate Growth Investing, and Dr. Christopher Davis of Quad 7 Capital for their thoughts on what lies ahead.

JR Research: UnitedHealth (UNH) stunned investors by changing its CEO abruptly, although the transition is assessed to be "less disruptive" as new CEO Stephen Hemsley has proved himself as he previously led UNH between 2006 and 2017 and is also its current chair. During his tenure as CEO, Hemsley also helped shape UnitedHealth (UNH) into the monolith that we know today. 

It remains to be seen, however, whether Hemsley's return can reinvigorate a remarkable turnaround amidst the current regulatory headwinds, pricing and utilization challenges emanating from its aggressive enrollment growth. With management maintaining its confidence of returning UNH to its long-term growth trajectory of between 13% to 16%, I believe the UNH story isn't dead yet, suggesting investors must focus on execution over the next two to three quarters to assess the plausible turnaround opportunity further. 

Quad 7 Capital: After this last kitchen sink flush, we highlighted that UNH was in chaos, but presented a potential generational entry opportunity into a world class, blue chip stock. 

Look, a surprise overnight CEO exit and uncertainty around WHY the company is experiencing high costs, on top of its Q1 report and guidance cut, deserved a selloff. But the stock is incredibly cheap historically. Bringing back a tremendous leader in Stephen Hemsley is bullish. He will right the ship. 

We are not saying this stock returns to $500-$600 in a few weeks. But we do think the stock finds a base at around $300. We suggested readers consider buying in $15 drops on the day of the flush. We think that while catching the bottom is improbable, it is possible; this is the type of selloff you have to take advantage of. 

We expect as early as the Q2 earnings we will get some sort of guidance. If not, then in Q3. We will get more clarity on the costs and the plan to address it. For traders with a medium-term horizon, look for a mean reversion trade back over $350-$360 later this year, provided the outlook does not change to project no growth in 2026. 

https://www.msn.com/en-us/money/markets/sa-asks-can-unitedhealth-turn-it-around/ar-AA1EMtD7

AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis

 After flexing its antibody-drug conjugate bona fides at last year’s American Society of Clinical Oncology (ASCO) conference, AbbVie is advancing its solid tumor ambitions with a new FDA green light.

The FDA on Wednesday granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis, also known as telisotuzumab vedotin, as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who’ve previously received systemic therapy. The drug is cleared in patients whose tumors exhibit high overexpression of the c-Met protein.

The c-Met protein is overexpressed in around 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, and roughly half of those patients have high c-Met overexpression, AbbVie explained in a press release.

As a member of the ADC class of drugs, which joins targeted antibodies with potent chemical payloads, Emrelis can home in on c-Met-expressing cancer cells for a precision strike.

Given the nature of the FDA’s accelerated approval pathway, AbbVie may have to leverage data from a confirmatory trial to keep hold of its approval in the long run. The FDA signed off on the therapy after reviewing data from the phase 2 Luminosity study, in which Emrelis charted a 35% overall response rate (ORR) and a median duration of response (DOR) of 7.2 months in c-Met-high patients.

AbbVie is leveraging the ongoing Luminosity trial to pinpoint c-Met overexpressing NSCLC patient populations best suited for telisotuzumab as a second- or third-line monotherapy. Once those groups are selected, AbbVie aims to further gauge efficacy across metrics like ORR and DOR, as well as disease control rate, progression-free survival and overall survival.

AbbVie is already running a phase 3 confirmatory study on Emrelis in c-Met-overexpressing NSCLC dubbed TeliMET NSCLC-01, which pits the ADC against the chemotherapy docetaxel.

Emrelis represents AbbVie’s first internally developed solid tumor drug and its first solid tumor drug to win FDA approval in lung cancer, Roopal Thakkar, M.D., the company’s chief scientific officer, said in a statement.

The regulatory win comes after AbbVie executives stressed their commitment to the ADC field in an interview with Fierce Biotech at last year’s ASCO conference in Chicago.

“You look back five years ago, ADCs were primarily in the hematology space,” Daejin Abidoye, M.D., head of solid tumors, oncology development at AbbVie, said at the time. “Now you're seeing ADCs playing a significant role in solid tumors.”

“We want to be part of that wave,” Pedro Valencia, Ph.D., AbbVie’s vice president of solid tumor pipeline strategy and execution, added during the joint interview.

Although Emrelis marks AbbVie’s first internal ADC win, the company already has a separate commercial treatment in the ovarian cancer ADC Elahere, which it picked up through its $10.1 billion acquisition of ImmunoGen in early 2024.

At the time the deal was announced, former AbbVie CEO Richard Gonzalez noted that establishing a foothold in solid tumors was a major priority for the company.

AbbVie also has several other internal candidates working their way through the clinic, such as the SEZ6-directed ADC ABBV-706 in small cell lung cancer and another c-Met-directed ADC coded ABBV-400, which is being evaluated in colorectal cancer.

As for Emrelis itself, the drug is likely to receive a positive reception among doctors if the results of a ZoomRx survey from last summer ring true.

In the poll, which ZoomRx conducted last June, 55% of oncologists said they were aware of AbbVie’s drug, and nearly one-quarter of those surveyed named telisotuzumab as one of the three most exciting cancer prospects in development at the time. Those results were strong enough to make Emrelis the most widely anticipated program in the survey.

Further, nearly one-third of the oncologists said they viewed telisotuzumab as a game changer, with roughly 25% saying they would prescribe the AbbVie ADC. 

https://www.fiercepharma.com/pharma/abbvie-advances-solid-tumor-agenda-fda-nod-lung-cancer-adc-emrelis

Merck Gets FDA Approval for Welireg to Treat Rare Tumors

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR).

https://finance.yahoo.com/news/fda-approves-merck-welireg-belzutifan-211500267.html

Detained Russian-born Harvard scientist criminally charged with smuggling

 A Russian-born researcher at Harvard University who has been held for weeks in an immigration detention center in Louisiana has been criminally charged with attempting to smuggle frog embryo samples into the United States.

Federal prosecutors in Boston announced the smuggling charge against Kseniia Petrova, 31, hours after a federal judge in Vermont heard arguments in a lawsuit she filed that argues the Trump administration has been unlawfully detaining her.

https://www.streetinsider.com/Reuters/Detained+Russian-born+Harvard+scientist+criminally+charged+with+smuggling/24799315.html

Ed Martin Reveals J6 Pipe Bomber Probe Shakeup, Warns DOJ 'Much, Much Worse Than People Think'

 Ed Martin, a senior official in the Trump administration’s Department of Justice, is warning that corruption within federal law enforcement is far more severe than the American public realizes. Martin, who holds the roles of Director of the Weaponization Working Group, Associate Deputy Attorney General, and Pardon Attorney, made the comments during an interview with Tucker Carlson.

Martin weighed in the unresolved case of the January 6, 2021, pipe bomber, expressing frustration with the investigation’s lack of progress, wondering whether the lack of answers may have been intentional. “The pipe bomber—as a prosecutor - I’ve got the pipe bomber case in my office,” Martin told Carlson. Martin revealed FBI Deputy Director Dan Bongino told him that the bureau had reassigned agents to the case, however, the renewed effort was still in it early stages. “It’s been going on for five weeks?” Martin said, likening the past probe to the bumbling “Keystone Cops.”

Martin further criticized the FBI’s previously handling of the case, alleging that basic investigative steps were overlooked. “They didn’t interview some of the people that you would have said, ‘That might be a suspect.’ They hadn’t interviewed him,” he said. Raising concerns about the agency’s competence, he added, “The question becomes, ‘what’s happening here?’ Is it incompetence? It feels worse than incompetence.”

When asked by Carlson whether the DOJ is worse than people believe, Martin went further, declaring, “I think it’s worse than incompetence.” However, he urged that importance of following the facts and not getting ahead of investigations, saying, “The only way forward is not to describe what I think of the motives but to expose over and over again what’s happened. If you expose what happened and the truth gets out, then accountability is possible.

Martin went on to praise Bongino’s efforts, noting, “He is going hammer and tongs at this stuff.” The Trump DOJ official acknowledged the complexity of pursuing accountability, saying, “You can’t arrest everybody in the first month, but you got to get this going.”

Martin then described the issues facing the DOJ as “much, much worse than people think.”

The FBI has begun delivering subpoenaed documents to House Judiciary Committee Republicans, addressing demands for greater “transparency and accountability” within the bureau, the Epoch Times reported in March.

Rep. Jim Jordan (R-OH), chairman of the House Judiciary Committee, had pressed FBI Director Kash Patel in a March 7 letter for information and records allegedly withheld during the tenure of former FBI Director Christopher Wray.

In response, FBI Assistant Director Marshall Yates provided an initial batch of documents covering key issues, including the investigation into pipe bombs discovered near the Democratic and Republican National Committee headquarters in Washington, D.C., in January 2021, as well as the FBI’s interactions with social media platforms and probes into threats against school officials.

Jordan’s push for transparency began with a February 24 letter, sent shortly after Patel’s confirmation as FBI Director. The letter targeted Wray’s leadership, accusing him of “slow-walking” the pipe bomb investigation tied to the January 6, 2021, Capitol riot and questioning the FBI’s use of “confidential human sources” during the event.

Some Republicans have claimed FBI informants were active on January 6, a claim partially substantiated by a December 2024 report from the FBI’s inspector general. While the report confirmed no undercover FBI agents were present, it revealed over two dozen informants were at the Capitol that day, according to the Epoch Times


Tren de Aragua’s ‘Little Devils’ poster child busted after allegedly attacking disabled teen

 The poster child for Tren de Aragua’s baby-faced gang farm system was busted yet again Wednesday — this time for allegedly robbing a 16-year-old autistic boy on Staten Island, police sources told The Post.

The pint-sized Venezuelan vandal, who has at least a dozen busts on his rap sheet despite being just 15, is believed to be part of the “Little Devils” crew of young migrant gangbangers terrorizing the Big Apple.

Their notorious punk is now charged with second-degree robbery after cops nabbed him in a May 5 attack at the Staten Island Mall.

The baby-faced Venezuelan migrant was picked up by cops Wednesday in connection to a violent robbery.

“Short of murder, there is no mechanism to hold juvenile offenders accountable,” one law enforcement source griped.

“The individuals responsible for these crimes against some of the most vulnerable individuals — the disabled,” the source said. “They’re responsible for victimizing dozens, and it’s a revolving door.”

The tiny terror is a member of “Diablos de la 42” — or Devils of 42nd Street — an underage offshoot of Tda, the violent Venezuelan gang that has established a foothold in tax-funded Big Apple shelters.

The NYPD has identified about 40 documented members of the Diablos, with 30 “associates” as young as 11 who help carry out mob robberies and assaults in Midtown and beyond, according to sources.

Two members of the Venezuelan gang called “Diablos de las 42” (Devils of 42nd Street) were brought out of the 120th Precinct of the NYPD to face criminal charges for second degree robbery.Gregory P. Mango

“They’re building quite the criminal resume,” NYPD Chief of Detectives Joseph Kenny said Wednesday. “The first five, six robberies they commit, there’s no consequences. But they are steadily building a substantial criminal resume.

“They’re cowards. They won’t do anything one-on-one,” the chief added. “That’s their motive — wolfpack robberies against soft targets.”

But because they are minors, they typically get little more than a slap on the wrist under New York State’s lenient juvenile justice laws.

Albany lawmakers passed the “Raise the Age” law in 2018, increasing the age of criminal responsibility from 16 to 18. The following year the state legislature went one step further, barring bail on most crimes. 

It has been a boon for the underage migrant goons, including the “Little Devil,” who was busted with his 17-year-old accomplice on Wednesday. 

The older suspect also has had numerous run-ins with the law, with collars in Manhattan, Brooklyn and Staten Island before the May 5 attack, police said. 

Police said four youngsters were behind the violent sagaelisoul_2009

Yet, both of their cases will now bounce to family court, where the proceedings are sealed and the penalties close to non-existent.

In the mini-gang’s latest crime, police sources said the 15-year-old migrant punk was one of at least four Diablo members who punched and kicked the young disabled victim.

The brazen gang, which is fond of posting their criminal escapades on social media, then allegedly snatched the battered victim’s bag and $38 in cash before fleeing, cops said.

“They weren’t in the mall to buy Mother’s Day gifts,” Kenny said. 

In the latest example, police sources said the teen was part of at least four Diablo members that punched and kicked the disabled victim.

The gang then allegedly snatched the victim’s bag and $38 in cash before fleeing, cops said.

The victim, who sources described as being autistic, was injured but didn’t have to be hospitalized.

The NYPD on Tuesday had blasted out a surveillance image of one of the four young suspects they wanted to speak to in the wake of the ordeal.

The suspect is believed to be part of a crew of young gang members terrorizing the Big Apple,Obtained by the NY Post

It wasn’t clear, though, if the person of interest in the surveillance image was the same alleged poster child gangbanger or one of his thug pals. 

The youngster, who immigration sources say crossed the US-Mexico border at Eagle Pass, Texas, in May 2023, was nabbed last October for allegedly pulling a knife on a man in Midtown and stealing his phone.

Last year, he allegedly went on a crime spree and was allegedly part of a crew who surrounded two straphangers on a 7 train in Queens and attacked them with brass knuckles on May 28, 2024, police said.

On June 2, he was charged with robbing three people at knifepoint on Roosevelt Avenue in Queens, and six days later was accused of snatching a phone in Central Park.

In July, he was charged in two alleged incidents — ganging up on a victim to steal a phone on East 60th Street, and snatching a chain from a 4 train straphanger in Manhattan.

By early September, he had been busted for allegedly snatching chains and phones from victims in four more incidents, sources said. 

“There is no deterrence,” a police source told The Post last year about the troublesome teen. “You have a 15-year-old who continues to treat the city like his personal video game.”

https://nypost.com/2025/05/14/us-news/tren-de-araguas-little-devils-poster-child-picked-up-by-cops-after-allegedly-attacking-disabled-teen/