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Delays in surgery for advanced esophageal cancer result in significantly worse survival than early surgery

CHICAGO: Delays in surgery for esophageal cancer did not appear to have much impact on patients’ relative survival for early-stage cancer compared with…

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CHICAGO: Delays in surgery for esophageal cancer did not appear to have much impact on patients’ relative survival for early-stage cancer compared with patients who had surgery early, but they did reduce the relative survival rate by almost half for patients with more advanced disease, according to an analysis of the National Cancer Database (NCDB).

Credit: American College of Surgeons

CHICAGO: Delays in surgery for esophageal cancer did not appear to have much impact on patients’ relative survival for early-stage cancer compared with patients who had surgery early, but they did reduce the relative survival rate by almost half for patients with more advanced disease, according to an analysis of the National Cancer Database (NCDB).

The research is published as an “article in press” on the website of the Journal of the American College of Surgeons (JACS) and is one of the earliest studies to examine the impact of an extended three-month delay in esophagectomy for esophageal cancer.

The relative survival rate indicates whether a disease shortens one’s life. It’s a way to compare survival of those who have a specific disease with those who don’t over a given period of time, typically five years from diagnosis date or the start of treatment for those with the disease, according to the National Cancer Institute.

“Timely care should always be the priority for patients,” said senior author Chi-Fu Jeffrey Yang, MD, a thoracic surgeon at Massachusetts General Hospital in Boston and an assistant professor of surgery at Harvard Medical School. “However, there were times during the COVID-19 pandemic when delays to cancer care occurred. This study, using pre-pandemic data, helps us understand the impact of the delay to care for patients with different stages of operable esophageal cancer.”

Added lead author Simar Singh Bajaj, a student at Harvard and a researcher in the department of surgery at Mass General, “When we looked at early versus delayed surgery for patients with stage I cancer, patients in both groups had similar five-year survival rates. However, for patients with stage II or III disease, delayed surgery was associated with worse survival when compared with early surgery.” Stage II and III esophageal cancer is more advanced than Stage I.

“This finding is especially important as we’re still working toward reintegrating services during the pandemic,” Mr. Bajaj said. “We’ve seen a lot of delays in care as hospitals have been overwhelmed with COVID patients.”

About the study

The researchers extracted pre-COVID-19 pandemic surgical cases for esophageal cancer from the NCDB, a joint project of the Commission on Cancer of the American College of Surgeons (ACS) and the American Cancer Society. The NCDB is estimated to include more than 75 percent of the newly diagnosed esophageal cancer cases in the United States.

The researchers compared survival of patients with stage I disease who had early surgery—that is, within four weeks after diagnosis—versus delayed surgery at 12 to 16 weeks after diagnosis. For patients with stage II/III esophageal cancer, the analysis compared results, after timely chemoradiation up to four weeks after diagnosis, of early esophagectomy (nine to 17 weeks after diagnosis) versus delayed surgery (21 to 29 weeks afterward). Propensity-score matching was used to create two comparator subgroups for timing of surgery within each staging group: 134 in each Stage I subgroup and 130 in each Stage II/III subgroup.

Study results

  • The five-year relative survival rate was similar for patients with Stage I disease who had early and delayed surgery: 65% (55.2–73.2%) and 65.1% (55.6–73.1%) percent, respectively (p=0.50).
  • The five-year relative survival rate for patients with stage II/III cancer who had delayed surgery was about 45% worse than those who had early surgery: 22.9% (14.9–31.8%) versus 41.6% (32.1–50.8%), respectively (p=0.006).

Prioritize patients without delaying care

At the start of the COVID-19 pandemic in March 2020, the Centers for Medicare and Medicaid Services announced that “all elective surgeries, non-essential medical, surgical, and dental procedures would be delayed during the 2019 Novel Coronavirus (COVID-19) outbreak” to preserve hospital resources to handle the pandemic.1 Some national medical societies issued triage guidelines for dealing with delays for a host of elective procedures. The ACS and the Thoracic Surgery Outcomes Research Network issued early guidance that recommended a three-month delay of surgery for esophageal cancer in hospitals with resources—intensive-care unit beds, ventilators, hospital staff—stretched thin by the pandemic.2,3

When appointments could be scheduled again, cancer clinicians noticed patients were slow or unlikely to schedule regular cancer screenings.4 However, research findings are just starting to emerge to determine the impact that all of these delays may have had on patient outcomes, including survival for a variety of cancers.

“As we continue to move out of the COVID pandemic, surgeons are trying to address the backlog of patients with esophageal cancer. The point of this study is to consider how we should reintegrate services in such a way that it prioritizes patients that are most at risk,” Mr. Bajaj said.

That prioritization means patients with stage II/III esophageal cancer should get surgery “as soon as possible,” he said. Although the researchers found no difference in survival for early versus delayed surgery for patients with stage I esophageal cancer, he warned that’s not a valid reason to delay their care. “This study should not be used to recommend delays in any circumstance, just because for stage I disease we didn’t see that there was an adverse impact to survival when you delayed surgery,” he said. “Esophageal cancer surgery should always be performed as promptly as possible.”

Guidance for future response

The findings provide esophageal cancer guidance for responding to future pandemics or COVID surges, Mr. Bajaj said. “Triage is all about prioritizing patients and trying to treat the most vulnerable first in order to give them the best chance of survival,” he said.

“This study highlights the differences in early-stage and advanced-stage esophageal cancer and helps us to realize how important timely treatment is,” said Shanda H. Blackmon, MD, MPH, FACS, a thoracic surgeon at Mayo Clinic in Rochester, Minn., who was not involved with the study.

Being mindful of treatment delays for esophageal cancer patients is critical at any time, she said. “Many esophageal patients have significant delays in diagnosis as the majority of these patients don’t present until they’re symptomatic, and, frequently, by the time they do present, they have advanced disease,” Dr. Blackmon said.

The study also provides important information in the event of another COVID-19 variant surge or pandemic, she said. “We would need to prepare in such a way that we could minimize delays by creating lists that allow us to prioritize patients according to the severity of disease.”

Study coauthors are Kavya M. Shah, Alexandra L. Potter, and Uma Sachdeva, MD, PhD of the department of surgery at Massachusetts General Hospital; Nicholas R. Mayne, MD, of the department of medicine at Duke University in Durham, N.C.; and Mong-Wei Lin, MD, PhD, of the department of thoracic surgery at the National Taiwan University in Taipei.

None of the study authors have any disclosures. Dr. Blackmon also has no disclosures.

Citation: Early Versus Delayed Surgery for Esophageal Cancer During the COVID-19 Pandemic. Journal of American College of Surgeons. DOI: 10.1097/XCS.0000000000000133

___

1 CMS Releases Recommendations on Adult Elective Surgeries, Non-Essential Medical, Surgical, and Dental Procedures During COVID-19 Response. Centers for Medicare and Medicaid Services; 2020. Available at https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental. Accessed May 9, 2022.

2 COVID-19 Guidelines for Triage of Thoracic Patients. American College of Surgeons; 2020. Accessed May 3,4, 2022. http://www.facs.org/covid-19/clinical-guidance/elective-case/thoracic-cancer

3Antonoff M, Backhus L, Boffa DJ, et al. COVID-19 Guidance for Triage of Operations for Thoracic Malignancies: A Consensus Statement from Thoracic Surgery Outcomes Research Network. Ann Thorac Surg. 2020;110(2):692-696.

4 Juong RH, Nelson H, Mullet TW, et al. A national quality improvement study identifying and addressing cancer screening deficits due to the COVID- 19 pandemic. Cancer. 2022 Jun 1;128(11):2119-2125.

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About the American College of Surgeons
The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 84,000 members and is the largest organization of surgeons in the world. “FACS” designates a surgeon is a Fellow of the American College of Surgeons.

The Journal of the American College of Surgeons (JACS) is the official scientific journal of ACS. Each month, JACS publishes peer-reviewed original contributions on all aspects of surgery, with the goal of providing its readership the highest quality rapid retrieval of information relevant to surgeons.


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Government

FDA to soon authorize Pfizer’s COVID booster shot for younger kids – NYT

U.S. health regulators are expected to authorize a booster shot of Pfizer/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as May 17, the…

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FDA to soon authorize Pfizer’s COVID booster shot for younger kids – NYT

(Reuters) – U.S. health regulators are expected to authorize a booster shot of Pfizer (PFE.N)/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as Tuesday, the New York Times reported on Monday, citing people familiar with the matter.

The companies submitted an application to the U.S. Food and Drug Administration for the authorization last month.

They have cited data from a mid- to late-stage study showing a third dose of their shot increased protection against the original coronavirus version and the Omicron variant among children in the age group. read more

It is unclear how much demand there is for the third dose in the age group. Just 28.8% of children aged 5 to 11 are fully vaccinated, according to data from the U.S. Centers for Disease Control and Prevention.

Empty vials of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine are seen at The Michener Institute, in Toronto, Canada January 4, 2021 in this file photo. REUTERS/Carlos Osorio/File Photo

A meeting of outside vaccine experts on an advisory committee to the Centers for Disease Control and Prevention has been scheduled for Thursday, the report said.

The FDA declined to comment, while Pfizer and BioNTech did not respond to requests for comment.

Reporting by Mrinalika Roy in Bengaluru; Editing by Anil D’Silva

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-authorize-pfizers-covid-booster-shot-younger-kids-soon-nyt-2022-05-16

 

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Government

FDA declines to authorize common antidepressant as COVID treatment

The U.S. Food and Drug Administration decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying the data has not shown the drug…

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FDA declines to authorize common antidepressant as COVID treatment

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(Reuters) – The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown the drug to be an effective therapeutic for fighting the virus.

“Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization,” the agency said in a document published on Monday.

University of Minnesota professor Dr. David Boulware submitted the emergency use authorization request to the FDA that would have allowed doctors to prescribe fluvoxamine maleate to treat COVID-19 in non-hospitalized patients.

The generic drug belongs to an old, widely-used class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

Boulware said that his request is less urgent with the availability of drugs like Pfizer Inc’s (PFE.N) Paxlovid, but he still believes the data supports the drug’s use in some COVID patients.

“There are effective therapeutics that are available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications,” Boulware said in an interview. “And if you go elsewhere in the world, low- and middle-income countries, they have access to no therapeutics.”

Boulware’s submission relied on data from three trials, especially a study of 1,497 non-hospitalized COVID patients in Brazil.

While the Brazilian study met its primary endpoint, showing a roughly 30% drop in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment, which measured reduction in emergency department visits lasting more than 6 hours.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Boulware said FDA had used a different measure to count hospitalizations in other drug trials, including only acute care that lasted at least 24 hours.

“The standard that they were holding for fluvoxamine was a different standard than the other big pharma trials, with Paxlovid and (Merck’s) molnupiravir and the monoclonals,” he said of other authorized COVID therapeutics.

“I was really quite disappointed that they did that,” he said.

Reporting by Leroy Leo in Bengaluru and Michael Erman in New Jersey; Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declines-authorize-common-antidepressant-covid-treatment-2022-05-16

 

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Spread & Containment

Coronavirus may be linked to cases of severe hepatitis in children

A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis…

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Coronavirus may be linked to cases of severe hepatitis in children

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(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

SARS-CoV-2 could be at root of mysterious hepatitis in kids

A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.

Children with COVID-19 are at significantly increased risk for liver dysfunction afterward, according to a report posted on Saturday on medRxiv ahead of peer review. But most of the children with acute hepatitis – which is generally rare in that age group – do not report a previous SARS-CoV-2 infection. Instead, the majority have been found to be infected with an adenovirus called 41F, which is not known to attack the liver. It is possible that the affected children, many of whom are too young to be vaccinated, may have had mild or asymptomatic COVID infections that went unnoticed, a separate team of researchers suggest in The Lancet Gastroenterology & Hepatology. If that were true, they theorize, then lingering particles of the coronavirus in the gastrointestinal tract in these children could be priming the immune system to over-react to adenovirus-41F with high amounts of inflammatory proteins that ultimately damage the liver.

A firefighter from the Marins-Pompiers of Marseille (Marseille Naval Fire Battalion) administers a nasal swab to a child at a testing site for coronavirus disease (COVID-19) in Marseille, France, September 17, 2020. REUTERS/Eric Gaillard

“We suggest that children with acute hepatitis be investigated for SARS-CoV-2 persistence in stool” and for other signals that the liver damage is happening because the spike protein of the coronavirus is a “superantigen” that over-sensitizes the immune system, they said.

Face-down position unhelpful for awake patients

For hospitalized COVID-19 patients who are breathing on their own but with supplemental oxygen, lying face down might not help prevent them from eventually needing mechanical ventilation, according to a new study.

In the study, 400 patients were randomly assigned to usual care or to standard care plus intermittently lying on their stomach, a position known to improve the course of illness in sedated patients on mechanical ventilators. Over the next 30 days, 34.1% in the prone-positioning group and 40.5% in the usual-care group needed to be intubated and put on a ventilator, a difference that was not statistically significant. There might have been a reduction in the risk for intubation with prone positioning among some of the patients, researchers said on Monday in JAMA, but they could not confirm it statistically from their data. The average duration of prone positioning per day was roughly five hours, less than the target of eight to 10 hours per day.

“Long hours of awake prone positioning are challenging and highly influenced by patient comfort and preference,” the researchers said. “The most common reason for interruption of prone positioning was patient request, which might have been related to overall subjective improvement or related to discomfort from prone positioning.”

Click for a Reuters graphic on vaccines in development.

Reporting by Nancy Lapid and Megan Brooks; Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/coronavirus-may-be-linked-cases-severe-hepatitis-children-2022-05-16

 

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