ACS Surgery News

SAN DIEGO – Narrow-spectrum antibiotics yield outcomes that are at least comparable, if not better, than broad-spectrum antibiotics when prescribed to children with appendicitis, according to a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.

The study found that in cases of both complicated and uncomplicated appendicitis, rates of hospital readmission were consistently lower for children prescribed narrow-spectrum antibiotics versus broad-spectrum ones.

“Current guidelines recommend what we ended up defining as narrow-spectrum antibiotics, such as cefoxitin, for uncomplicated cases of appendicitis,” said Dr. Matthew P. Kronman of Seattle Children’s Hospital and the study’s lead author. “For the complicated appendicitis cases, the guidelines state that you can either use one of the narrow-spectrum antibiotics, or you can use other agents – such as piperacillin, ticarcillin, ceftazidime, cefepime, or a carbapenem, for example – that we defined as “broad spectrum” because they provide a wider range of protection and have so much activity that patients often don’t need.”

Dr. Kronman and his coinvestigators analyzed the records of 27,306 children aged 3-18 years, admitted to 1 of 23 hospitals for at least 1 day between 2011 and 2013 with appendicitis. The primary outcome was readmission within 30 days for any subsequent abdominal infection or procedure.

Uncomplicated cases accounted for 18.939 of subjects (69.9%), and complicated appendicitis was recorded in the remaining 8.367 (30.1%) of children. Subjects were given broad-spectrum antibiotics in 28.1% of uncomplicated cases and 64.7% of complicated cases.

Overall, 1.0% of patients with uncomplicated appendicitis (189) and 6.0% (498) of complicated cases were readmitted within 30 days. Of the uncomplicated cases, the readmission rate for patients who got broad-spectrum antibiotics was 1.4%, compared with 0.9% for patients who received narrow-spectrum ones; in cases of complicated appendicitis, 6.8% of subjects given broad-spectrum antibiotics were readmitted within 30 days, compared with 4.4% for patients on narrow-spectrum antibiotics.

Multivariate logistic regression was performed on the study population, with adjustments for demographic factors, as well as illness severity and length of stay. Investigators found that age, sex, and insurance type were not factors in the association between broad-spectrum antibiotic intake and readmission within 30 days. However, increased length of stay, illness severity, and placement of a peripherally inserted central catheter line, which was used exclusively for patients with complicated appendicitis, were associated with the primary outcome.

The association between broad-spectrum agents and higher readmission rates could be a result of confounding by indication, wherein patients are given broad-spectrum drugs by physicians because the patients present as very sick, Dr. Kronman said. However, that alone means that they’re at a higher risk for developing complications and being readmitted shortly after receiving treatment, he added.

“But I think it’s reasonable to conclude that those treated with narrow-spectrum antibiotics didn’t do worse, and if they didn’t do worse, there’s no reason that every kid with appendicitis shouldn’t be treated with narrow-spectrum antibiotics because we know that those treated with broader-spectrum antibiotics are more likely to develop colonization with resistant organisms, and can have other complications due to the spectrum of activity brought on by the antibiotics they were given,” Dr. Kronman said. “So if narrow-spectrum antibiotics are just as good, we should try to get every hospital to use them.”

Dr. Kronman did not report any financial disclosures. The study was supported by the Clinical Research Scholars Program at Seattle Children’s Hospital and by the National Center of Advancing Translational Sciences at the National Institutes of Health.

[email protected]

SAN DIEGO – Narrow-spectrum antibiotics yield outcomes that are at least comparable, if not better, than broad-spectrum antibiotics when prescribed to children with appendicitis, according to a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.

The study found that in cases of both complicated and uncomplicated appendicitis, rates of hospital readmission were consistently lower for children prescribed narrow-spectrum antibiotics versus broad-spectrum ones.

“Current guidelines recommend what we ended up defining as narrow-spectrum antibiotics, such as cefoxitin, for uncomplicated cases of appendicitis,” said Dr. Matthew P. Kronman of Seattle Children’s Hospital and the study’s lead author. “For the complicated appendicitis cases, the guidelines state that you can either use one of the narrow-spectrum antibiotics, or you can use other agents – such as piperacillin, ticarcillin, ceftazidime, cefepime, or a carbapenem, for example – that we defined as “broad spectrum” because they provide a wider range of protection and have so much activity that patients often don’t need.”

Dr. Kronman and his coinvestigators analyzed the records of 27,306 children aged 3-18 years, admitted to 1 of 23 hospitals for at least 1 day between 2011 and 2013 with appendicitis. The primary outcome was readmission within 30 days for any subsequent abdominal infection or procedure.

Uncomplicated cases accounted for 18.939 of subjects (69.9%), and complicated appendicitis was recorded in the remaining 8.367 (30.1%) of children. Subjects were given broad-spectrum antibiotics in 28.1% of uncomplicated cases and 64.7% of complicated cases.

Overall, 1.0% of patients with uncomplicated appendicitis (189) and 6.0% (498) of complicated cases were readmitted within 30 days. Of the uncomplicated cases, the readmission rate for patients who got broad-spectrum antibiotics was 1.4%, compared with 0.9% for patients who received narrow-spectrum ones; in cases of complicated appendicitis, 6.8% of subjects given broad-spectrum antibiotics were readmitted within 30 days, compared with 4.4% for patients on narrow-spectrum antibiotics.

Multivariate logistic regression was performed on the study population, with adjustments for demographic factors, as well as illness severity and length of stay. Investigators found that age, sex, and insurance type were not factors in the association between broad-spectrum antibiotic intake and readmission within 30 days. However, increased length of stay, illness severity, and placement of a peripherally inserted central catheter line, which was used exclusively for patients with complicated appendicitis, were associated with the primary outcome.

The association between broad-spectrum agents and higher readmission rates could be a result of confounding by indication, wherein patients are given broad-spectrum drugs by physicians because the patients present as very sick, Dr. Kronman said. However, that alone means that they’re at a higher risk for developing complications and being readmitted shortly after receiving treatment, he added.

“But I think it’s reasonable to conclude that those treated with narrow-spectrum antibiotics didn’t do worse, and if they didn’t do worse, there’s no reason that every kid with appendicitis shouldn’t be treated with narrow-spectrum antibiotics because we know that those treated with broader-spectrum antibiotics are more likely to develop colonization with resistant organisms, and can have other complications due to the spectrum of activity brought on by the antibiotics they were given,” Dr. Kronman said. “So if narrow-spectrum antibiotics are just as good, we should try to get every hospital to use them.”

Dr. Kronman did not report any financial disclosures. The study was supported by the Clinical Research Scholars Program at Seattle Children’s Hospital and by the National Center of Advancing Translational Sciences at the National Institutes of Health.

[email protected]

SAN DIEGO – Narrow-spectrum antibiotics yield outcomes that are at least comparable, if not better, than broad-spectrum antibiotics when prescribed to children with appendicitis, according to a retrospective cohort study presented at the annual meeting of the Pediatric Academic Societies.

The study found that in cases of both complicated and uncomplicated appendicitis, rates of hospital readmission were consistently lower for children prescribed narrow-spectrum antibiotics versus broad-spectrum ones.

“Current guidelines recommend what we ended up defining as narrow-spectrum antibiotics, such as cefoxitin, for uncomplicated cases of appendicitis,” said Dr. Matthew P. Kronman of Seattle Children’s Hospital and the study’s lead author. “For the complicated appendicitis cases, the guidelines state that you can either use one of the narrow-spectrum antibiotics, or you can use other agents – such as piperacillin, ticarcillin, ceftazidime, cefepime, or a carbapenem, for example – that we defined as “broad spectrum” because they provide a wider range of protection and have so much activity that patients often don’t need.”

Dr. Kronman and his coinvestigators analyzed the records of 27,306 children aged 3-18 years, admitted to 1 of 23 hospitals for at least 1 day between 2011 and 2013 with appendicitis. The primary outcome was readmission within 30 days for any subsequent abdominal infection or procedure.

Uncomplicated cases accounted for 18.939 of subjects (69.9%), and complicated appendicitis was recorded in the remaining 8.367 (30.1%) of children. Subjects were given broad-spectrum antibiotics in 28.1% of uncomplicated cases and 64.7% of complicated cases.

Overall, 1.0% of patients with uncomplicated appendicitis (189) and 6.0% (498) of complicated cases were readmitted within 30 days. Of the uncomplicated cases, the readmission rate for patients who got broad-spectrum antibiotics was 1.4%, compared with 0.9% for patients who received narrow-spectrum ones; in cases of complicated appendicitis, 6.8% of subjects given broad-spectrum antibiotics were readmitted within 30 days, compared with 4.4% for patients on narrow-spectrum antibiotics.

Multivariate logistic regression was performed on the study population, with adjustments for demographic factors, as well as illness severity and length of stay. Investigators found that age, sex, and insurance type were not factors in the association between broad-spectrum antibiotic intake and readmission within 30 days. However, increased length of stay, illness severity, and placement of a peripherally inserted central catheter line, which was used exclusively for patients with complicated appendicitis, were associated with the primary outcome.

The association between broad-spectrum agents and higher readmission rates could be a result of confounding by indication, wherein patients are given broad-spectrum drugs by physicians because the patients present as very sick, Dr. Kronman said. However, that alone means that they’re at a higher risk for developing complications and being readmitted shortly after receiving treatment, he added.

“But I think it’s reasonable to conclude that those treated with narrow-spectrum antibiotics didn’t do worse, and if they didn’t do worse, there’s no reason that every kid with appendicitis shouldn’t be treated with narrow-spectrum antibiotics because we know that those treated with broader-spectrum antibiotics are more likely to develop colonization with resistant organisms, and can have other complications due to the spectrum of activity brought on by the antibiotics they were given,” Dr. Kronman said. “So if narrow-spectrum antibiotics are just as good, we should try to get every hospital to use them.”

Dr. Kronman did not report any financial disclosures. The study was supported by the Clinical Research Scholars Program at Seattle Children’s Hospital and by the National Center of Advancing Translational Sciences at the National Institutes of Health.

[email protected]

Most U.S. physicians who made political contributions during the 2013-2014 congressional election cycle donated to Democrats, continuing the trend away from Republicans that was first noted among medical professionals between 1991 and 2012, according to a report published April 27 in JAMA Internal Medicine.

In an analysis of physicians’ federal political contributions, 55% of contributors donated to Democrats and 45% to Republicans during the most recent congressional election cycle. In contrast, general public support resulted in the “Republican surge” in which conservatives gained nine Senate seats and increased their majority in the House, said Adam Bonica, Ph.D., of the department of political science, Stanford (Calif.) University, and his associates.

© BrianAJackson/Thinkstock

The current report shows that the shift away from predominantly Republican and toward predominantly Democratic support, which began in the 1990s, still persists for physicians.

“Given the increasing numbers of women physicians and salaried physicians, who typically ally with the Democrats, in contrast to surgeons, who typically ally with the Republicans, our findings suggest that the medical profession will be challenged to achieve consensus on health policy issues. The profession is unlikely to speak with one voice on questions such as the provision of health insurance or controlling the costs of medical care,” the investigators wrote (JAMA Intern. Med. 2015 April 27 [doi:10.1001/jamainternmed.2015.1332]).

However, this polarization among physicians “may spur both political parties to work harder to maintain and increase physicians’ support. Thus, the political divisions among physicians may have the unintended effect of enhancing the political standing of the medical profession,” they added.

Most U.S. physicians who made political contributions during the 2013-2014 congressional election cycle donated to Democrats, continuing the trend away from Republicans that was first noted among medical professionals between 1991 and 2012, according to a report published April 27 in JAMA Internal Medicine.

In an analysis of physicians’ federal political contributions, 55% of contributors donated to Democrats and 45% to Republicans during the most recent congressional election cycle. In contrast, general public support resulted in the “Republican surge” in which conservatives gained nine Senate seats and increased their majority in the House, said Adam Bonica, Ph.D., of the department of political science, Stanford (Calif.) University, and his associates.

© BrianAJackson/Thinkstock

The current report shows that the shift away from predominantly Republican and toward predominantly Democratic support, which began in the 1990s, still persists for physicians.

“Given the increasing numbers of women physicians and salaried physicians, who typically ally with the Democrats, in contrast to surgeons, who typically ally with the Republicans, our findings suggest that the medical profession will be challenged to achieve consensus on health policy issues. The profession is unlikely to speak with one voice on questions such as the provision of health insurance or controlling the costs of medical care,” the investigators wrote (JAMA Intern. Med. 2015 April 27 [doi:10.1001/jamainternmed.2015.1332]).

However, this polarization among physicians “may spur both political parties to work harder to maintain and increase physicians’ support. Thus, the political divisions among physicians may have the unintended effect of enhancing the political standing of the medical profession,” they added.

Most U.S. physicians who made political contributions during the 2013-2014 congressional election cycle donated to Democrats, continuing the trend away from Republicans that was first noted among medical professionals between 1991 and 2012, according to a report published April 27 in JAMA Internal Medicine.

In an analysis of physicians’ federal political contributions, 55% of contributors donated to Democrats and 45% to Republicans during the most recent congressional election cycle. In contrast, general public support resulted in the “Republican surge” in which conservatives gained nine Senate seats and increased their majority in the House, said Adam Bonica, Ph.D., of the department of political science, Stanford (Calif.) University, and his associates.

© BrianAJackson/Thinkstock

The current report shows that the shift away from predominantly Republican and toward predominantly Democratic support, which began in the 1990s, still persists for physicians.

“Given the increasing numbers of women physicians and salaried physicians, who typically ally with the Democrats, in contrast to surgeons, who typically ally with the Republicans, our findings suggest that the medical profession will be challenged to achieve consensus on health policy issues. The profession is unlikely to speak with one voice on questions such as the provision of health insurance or controlling the costs of medical care,” the investigators wrote (JAMA Intern. Med. 2015 April 27 [doi:10.1001/jamainternmed.2015.1332]).

However, this polarization among physicians “may spur both political parties to work harder to maintain and increase physicians’ support. Thus, the political divisions among physicians may have the unintended effect of enhancing the political standing of the medical profession,” they added.

WASHINGTON – As the Supreme Court prepares to rule this summer on King v. Burwell, Republican Senators are offering plans should the court strike down subsidies to those who have bought health insurance via the federal exchange.

“I suspect that President Obama will create some kind of executive order to allow states to turn [federally run exchanges] into state exchanges, but the law says you can’t establish a state exchange past a certain date. That throws it back to Congress,” Sen. Ron Johnson (R-Wisc.) said at a press conference.

If there isn’t a way forward already in sight, Sen. Johnson said that he thinks the House Republican leadership will do nothing and tell President Obama, “This is a problem of your own making.”

To avoid that kind of posturing – as well as to convince the Supreme Court that a pro-King ruling would not be harmful to patients – Sen. Johnson said, “We need to have a plan in place.”

His bill, S. 1016, the Preserving Freedom and Choice in Health Care Act, at press time had 31 cosponsors, more than the handful of similar bill introduced in the Senate.

“I’m trying to keep this as simple as possible so it has the greatest chance of success,” Sen. Johnson said. “Let’s maintain the status quo, let’s not throw this whole health insurance market into chaos.”

Should the Supreme Court strike down King v. Burwell, S. 1016 would continue through August 2017 subsidies for patients who currently have insurance bought through a federal exchange – temporarily codifying the status quo and the Obama administration’s interpretation of the Affordable Care Act.

The bill also would repeal both the ACA’s individual mandate to have health insurance and its employer mandate to provide health insurance, as well as the essential health benefits package, which Rep. Johnson said is the reason why the ACA makes health insurance expensive.

“A 60-year-old guy like me has to buy an insurance plan that has maternity coverage. When the government mandates that, it establishes a base price, and it’s going to be higher than if you have an insurance marketplace that doesn’t have all that mandated coverage,” he said. “The way this has all been implemented, if you don’t get the subsidies, you’re paying a lot, and you don’t particularly like Obamacare.”

Time is ticking down for a contingency plan: The Supreme Court is expected to rule the first week of June.

“This may not be the final product,” Sen. Johnson said of his bill, which has yet to be scored by the Congressional Budget Office. “There may be some tweaks and some additions to it over the next week or so, and then whatever comes out of that process is what I think leadership will get behind.”

[email protected]

On Twitter @whitneymcknight

WASHINGTON – As the Supreme Court prepares to rule this summer on King v. Burwell, Republican Senators are offering plans should the court strike down subsidies to those who have bought health insurance via the federal exchange.

“I suspect that President Obama will create some kind of executive order to allow states to turn [federally run exchanges] into state exchanges, but the law says you can’t establish a state exchange past a certain date. That throws it back to Congress,” Sen. Ron Johnson (R-Wisc.) said at a press conference.

If there isn’t a way forward already in sight, Sen. Johnson said that he thinks the House Republican leadership will do nothing and tell President Obama, “This is a problem of your own making.”

To avoid that kind of posturing – as well as to convince the Supreme Court that a pro-King ruling would not be harmful to patients – Sen. Johnson said, “We need to have a plan in place.”

His bill, S. 1016, the Preserving Freedom and Choice in Health Care Act, at press time had 31 cosponsors, more than the handful of similar bill introduced in the Senate.

“I’m trying to keep this as simple as possible so it has the greatest chance of success,” Sen. Johnson said. “Let’s maintain the status quo, let’s not throw this whole health insurance market into chaos.”

Should the Supreme Court strike down King v. Burwell, S. 1016 would continue through August 2017 subsidies for patients who currently have insurance bought through a federal exchange – temporarily codifying the status quo and the Obama administration’s interpretation of the Affordable Care Act.

The bill also would repeal both the ACA’s individual mandate to have health insurance and its employer mandate to provide health insurance, as well as the essential health benefits package, which Rep. Johnson said is the reason why the ACA makes health insurance expensive.

“A 60-year-old guy like me has to buy an insurance plan that has maternity coverage. When the government mandates that, it establishes a base price, and it’s going to be higher than if you have an insurance marketplace that doesn’t have all that mandated coverage,” he said. “The way this has all been implemented, if you don’t get the subsidies, you’re paying a lot, and you don’t particularly like Obamacare.”

Time is ticking down for a contingency plan: The Supreme Court is expected to rule the first week of June.

“This may not be the final product,” Sen. Johnson said of his bill, which has yet to be scored by the Congressional Budget Office. “There may be some tweaks and some additions to it over the next week or so, and then whatever comes out of that process is what I think leadership will get behind.”

[email protected]

On Twitter @whitneymcknight

WASHINGTON – As the Supreme Court prepares to rule this summer on King v. Burwell, Republican Senators are offering plans should the court strike down subsidies to those who have bought health insurance via the federal exchange.

“I suspect that President Obama will create some kind of executive order to allow states to turn [federally run exchanges] into state exchanges, but the law says you can’t establish a state exchange past a certain date. That throws it back to Congress,” Sen. Ron Johnson (R-Wisc.) said at a press conference.

If there isn’t a way forward already in sight, Sen. Johnson said that he thinks the House Republican leadership will do nothing and tell President Obama, “This is a problem of your own making.”

To avoid that kind of posturing – as well as to convince the Supreme Court that a pro-King ruling would not be harmful to patients – Sen. Johnson said, “We need to have a plan in place.”

His bill, S. 1016, the Preserving Freedom and Choice in Health Care Act, at press time had 31 cosponsors, more than the handful of similar bill introduced in the Senate.

“I’m trying to keep this as simple as possible so it has the greatest chance of success,” Sen. Johnson said. “Let’s maintain the status quo, let’s not throw this whole health insurance market into chaos.”

Should the Supreme Court strike down King v. Burwell, S. 1016 would continue through August 2017 subsidies for patients who currently have insurance bought through a federal exchange – temporarily codifying the status quo and the Obama administration’s interpretation of the Affordable Care Act.

The bill also would repeal both the ACA’s individual mandate to have health insurance and its employer mandate to provide health insurance, as well as the essential health benefits package, which Rep. Johnson said is the reason why the ACA makes health insurance expensive.

“A 60-year-old guy like me has to buy an insurance plan that has maternity coverage. When the government mandates that, it establishes a base price, and it’s going to be higher than if you have an insurance marketplace that doesn’t have all that mandated coverage,” he said. “The way this has all been implemented, if you don’t get the subsidies, you’re paying a lot, and you don’t particularly like Obamacare.”

Time is ticking down for a contingency plan: The Supreme Court is expected to rule the first week of June.

“This may not be the final product,” Sen. Johnson said of his bill, which has yet to be scored by the Congressional Budget Office. “There may be some tweaks and some additions to it over the next week or so, and then whatever comes out of that process is what I think leadership will get behind.”

[email protected]

On Twitter @whitneymcknight

SAN DIEGO – A technique that causes tumors to glow allowed surgeons to identify pulmonary adenocarcinomas accurately and quickly in the operating room, according to findings presented at the annual meeting of the American Surgical Association.

The molecular imaging technique, dubbed an “optical biopsy,” was 100% accurate in identifying pulmonary adenocarcinomas in wedge resection of lung nodules. Using an agent derived from fireflies, Dr. Sunil Singhal and his associates at the University of Pennsylvania, Philadelphia, tagged a ligand specific to lung adenocarcinoma and infused patients with the preparation before surgery so that cancerous nodules would light up in the operating room.

About 800,000 surgeries for cancer are performed in the United States annually, and surgery remains the most effective overall treatment since it affords the opportunity for complete resection and accurate staging, but technical challenges presist in many cancer surgeries, including the difficulty of ensuring negative margins, identifying in situ disease, and ascertaining which lymph nodes are malignant, Dr. Singhal noted.

“We depend on our hands, eyes and intuition,” he said. “This is fallible.”

The molecular imaging technique developed by Dr. Singhal and his colleagues has the potential to improve surgical precision by giving surgeons a clear visual indication of which tissue is malignant and needs to be excised. The technique identifies a receptor specific to a particular type of cancer cell and tags an appropriate ligand with a molecule that glows – a fluorophore – before surgery. With uptake of the tagged ligand, the tumor cells glow visibly and are clearly identified during surgery.

The small proof-of-principle study used fluorescein bound to a folate ligand for folate receptor alpha (FRalpha). This receptor is specific to pulmonary adenocarcinoma, the most commonly diagnosed cancer among the approximately 250,000 solitary pulmonary nodules detected as incidental findings on CT scans.

The 30 solitary pulmonary nodules in the study underwent a wedge resection and an optical biopsy, since patients had all received the fluorescein-tagged ligand infusion before surgery. Nineteen of the tumors fluoresced and were provisionally identified as pulmonary adenocarcinoma. Of the 11 that did not fluoresce, five were later identified as benign, three were other types of lung cancer, and three represented metastatic disease.

All nodules also were subject to frozen section, with provisional identification of 13 as lung adenocarcinoma, 8 as cancer of unknown origin, 6 as benign, 2 as metastatic renal adenocarcinoma, and 1 as a nonadenocarcinoma lung cancer.

One of the nodules read as benign on frozen section had been correctly identified as pulmonary adenocarcinoma by optical biopsy, which had 100% positive predictive value for pulmonary adenocarcinoma in this series, according to Dr. Singhal.

He stressed, however, that this technique should not be viewed as a replacement for pathology, but rather as an adjunct.

“If the tumor glows, we predict lung adenocarcinoma. If the tumor does not glow, we have no information and we follow the standard of care,” he said.

Going forward, Dr. Singhal and his colleagues plan to identify other candidate ligands for tagging, as well as developing fluorophores in a variety of colors. These could be infused simultaneously and allow differentiation between various tumor types. They also are developing materials that glow in the near-infrared spectrum and are detectable by specialized cameras.

Discussant Dr. Fabrizio Michelassi, chairman of the department of surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian/Weill Cornell Medical Center, asked whether the technique would be useful in identifying malignant sites in a diffusely inflamed field. Addressing the examples of Barrett’s esophagus and Crohn’s disease, Dr. Singhal affirmed the utility of optical biopsy in these conditions.

“As long as you have blood supply to that location, you can use whatever molecular contrast agent you want,” he said.

Dr. David Harpole, vice chief of the division of surgical services at Duke University Medical Center, applauded Dr. Singhal and his colleagues for taking a pertinent clinical problem to the laboratory. “Rapid intraoperative assessment of suspicious nodules is important,” he said, calling for a multi-institutional prospective cohort analysis to move the work forward.

The investigators reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.

SAN DIEGO – A technique that causes tumors to glow allowed surgeons to identify pulmonary adenocarcinomas accurately and quickly in the operating room, according to findings presented at the annual meeting of the American Surgical Association.

The molecular imaging technique, dubbed an “optical biopsy,” was 100% accurate in identifying pulmonary adenocarcinomas in wedge resection of lung nodules. Using an agent derived from fireflies, Dr. Sunil Singhal and his associates at the University of Pennsylvania, Philadelphia, tagged a ligand specific to lung adenocarcinoma and infused patients with the preparation before surgery so that cancerous nodules would light up in the operating room.

About 800,000 surgeries for cancer are performed in the United States annually, and surgery remains the most effective overall treatment since it affords the opportunity for complete resection and accurate staging, but technical challenges presist in many cancer surgeries, including the difficulty of ensuring negative margins, identifying in situ disease, and ascertaining which lymph nodes are malignant, Dr. Singhal noted.

“We depend on our hands, eyes and intuition,” he said. “This is fallible.”

The molecular imaging technique developed by Dr. Singhal and his colleagues has the potential to improve surgical precision by giving surgeons a clear visual indication of which tissue is malignant and needs to be excised. The technique identifies a receptor specific to a particular type of cancer cell and tags an appropriate ligand with a molecule that glows – a fluorophore – before surgery. With uptake of the tagged ligand, the tumor cells glow visibly and are clearly identified during surgery.

The small proof-of-principle study used fluorescein bound to a folate ligand for folate receptor alpha (FRalpha). This receptor is specific to pulmonary adenocarcinoma, the most commonly diagnosed cancer among the approximately 250,000 solitary pulmonary nodules detected as incidental findings on CT scans.

The 30 solitary pulmonary nodules in the study underwent a wedge resection and an optical biopsy, since patients had all received the fluorescein-tagged ligand infusion before surgery. Nineteen of the tumors fluoresced and were provisionally identified as pulmonary adenocarcinoma. Of the 11 that did not fluoresce, five were later identified as benign, three were other types of lung cancer, and three represented metastatic disease.

All nodules also were subject to frozen section, with provisional identification of 13 as lung adenocarcinoma, 8 as cancer of unknown origin, 6 as benign, 2 as metastatic renal adenocarcinoma, and 1 as a nonadenocarcinoma lung cancer.

One of the nodules read as benign on frozen section had been correctly identified as pulmonary adenocarcinoma by optical biopsy, which had 100% positive predictive value for pulmonary adenocarcinoma in this series, according to Dr. Singhal.

He stressed, however, that this technique should not be viewed as a replacement for pathology, but rather as an adjunct.

“If the tumor glows, we predict lung adenocarcinoma. If the tumor does not glow, we have no information and we follow the standard of care,” he said.

Going forward, Dr. Singhal and his colleagues plan to identify other candidate ligands for tagging, as well as developing fluorophores in a variety of colors. These could be infused simultaneously and allow differentiation between various tumor types. They also are developing materials that glow in the near-infrared spectrum and are detectable by specialized cameras.

Discussant Dr. Fabrizio Michelassi, chairman of the department of surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian/Weill Cornell Medical Center, asked whether the technique would be useful in identifying malignant sites in a diffusely inflamed field. Addressing the examples of Barrett’s esophagus and Crohn’s disease, Dr. Singhal affirmed the utility of optical biopsy in these conditions.

“As long as you have blood supply to that location, you can use whatever molecular contrast agent you want,” he said.

Dr. David Harpole, vice chief of the division of surgical services at Duke University Medical Center, applauded Dr. Singhal and his colleagues for taking a pertinent clinical problem to the laboratory. “Rapid intraoperative assessment of suspicious nodules is important,” he said, calling for a multi-institutional prospective cohort analysis to move the work forward.

The investigators reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.

SAN DIEGO – A technique that causes tumors to glow allowed surgeons to identify pulmonary adenocarcinomas accurately and quickly in the operating room, according to findings presented at the annual meeting of the American Surgical Association.

The molecular imaging technique, dubbed an “optical biopsy,” was 100% accurate in identifying pulmonary adenocarcinomas in wedge resection of lung nodules. Using an agent derived from fireflies, Dr. Sunil Singhal and his associates at the University of Pennsylvania, Philadelphia, tagged a ligand specific to lung adenocarcinoma and infused patients with the preparation before surgery so that cancerous nodules would light up in the operating room.

About 800,000 surgeries for cancer are performed in the United States annually, and surgery remains the most effective overall treatment since it affords the opportunity for complete resection and accurate staging, but technical challenges presist in many cancer surgeries, including the difficulty of ensuring negative margins, identifying in situ disease, and ascertaining which lymph nodes are malignant, Dr. Singhal noted.

“We depend on our hands, eyes and intuition,” he said. “This is fallible.”

The molecular imaging technique developed by Dr. Singhal and his colleagues has the potential to improve surgical precision by giving surgeons a clear visual indication of which tissue is malignant and needs to be excised. The technique identifies a receptor specific to a particular type of cancer cell and tags an appropriate ligand with a molecule that glows – a fluorophore – before surgery. With uptake of the tagged ligand, the tumor cells glow visibly and are clearly identified during surgery.

The small proof-of-principle study used fluorescein bound to a folate ligand for folate receptor alpha (FRalpha). This receptor is specific to pulmonary adenocarcinoma, the most commonly diagnosed cancer among the approximately 250,000 solitary pulmonary nodules detected as incidental findings on CT scans.

The 30 solitary pulmonary nodules in the study underwent a wedge resection and an optical biopsy, since patients had all received the fluorescein-tagged ligand infusion before surgery. Nineteen of the tumors fluoresced and were provisionally identified as pulmonary adenocarcinoma. Of the 11 that did not fluoresce, five were later identified as benign, three were other types of lung cancer, and three represented metastatic disease.

All nodules also were subject to frozen section, with provisional identification of 13 as lung adenocarcinoma, 8 as cancer of unknown origin, 6 as benign, 2 as metastatic renal adenocarcinoma, and 1 as a nonadenocarcinoma lung cancer.

One of the nodules read as benign on frozen section had been correctly identified as pulmonary adenocarcinoma by optical biopsy, which had 100% positive predictive value for pulmonary adenocarcinoma in this series, according to Dr. Singhal.

He stressed, however, that this technique should not be viewed as a replacement for pathology, but rather as an adjunct.

“If the tumor glows, we predict lung adenocarcinoma. If the tumor does not glow, we have no information and we follow the standard of care,” he said.

Going forward, Dr. Singhal and his colleagues plan to identify other candidate ligands for tagging, as well as developing fluorophores in a variety of colors. These could be infused simultaneously and allow differentiation between various tumor types. They also are developing materials that glow in the near-infrared spectrum and are detectable by specialized cameras.

Discussant Dr. Fabrizio Michelassi, chairman of the department of surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian/Weill Cornell Medical Center, asked whether the technique would be useful in identifying malignant sites in a diffusely inflamed field. Addressing the examples of Barrett’s esophagus and Crohn’s disease, Dr. Singhal affirmed the utility of optical biopsy in these conditions.

“As long as you have blood supply to that location, you can use whatever molecular contrast agent you want,” he said.

Dr. David Harpole, vice chief of the division of surgical services at Duke University Medical Center, applauded Dr. Singhal and his colleagues for taking a pertinent clinical problem to the laboratory. “Rapid intraoperative assessment of suspicious nodules is important,” he said, calling for a multi-institutional prospective cohort analysis to move the work forward.

The investigators reported no relevant financial disclosures. The study was supported by the National Institutes of Health, the Department of Defense, and the Veterans Health Administration.

GENEVA – The tests widely available today that use a cancer patient’s tumor DNA that circulates in the blood to detect a treatment-altering lung cancer mutation vary widely in sensitivity, meaning that using circulating DNA to identify a clinically important mutation should be limited to when biopsying the primary does not yield enough DNA for testing.

“It is important to use robust and sensitive methods” when trying to match treatment to the molecular specificities of each patient’s tumor, Dr. Martin Reck said at the European Lung Cancer Conference.

Mitchel L. Zoler/Frontline Medical News

Results from a study that prospectively compared DNA analysis for mutations in the epidermal growth factor receptor (EGFR) gene in tumor biopsies from 1,162 patients with advanced non–small cell lung cancer with DNA analysis of circulating tumor DNA (ctDNA) from the same patients showed that ctDNA analysis had 46% sensitivity, compared with tumor biopsy DNA, reported Dr. Reck, a thoracic oncologist at the Lung Clinic in Grosshandsdorf, Germany. This high level of false-negative results with ctDNA analysis produced a positive predictive value of 78%. In contrast, ctDNA has a specificity of 97% and a negative predictive value of 90%.

The results from the international study, which included 881 patients from seven European countries plus 281 patients from Japan, highlighted the divergent concordance among EGFR mutation comparisons of ctDNA and biopsy DNA depending on which DNA tests were used. Participating physicians could order whichever genetic analyses they wanted. A subanalysis of the study showed, for example, that among the 138 patients whose tumor and ctDNAs were both evaluated for EGFR mutations using the therascreen test marketed by QIAGEN the concordance rose to 95%, the sensitivity of ctDNA was 73%, and the positive predictive value was 94%, Dr. Reck reported.

The Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) enrolled patients with either newly diagnosed, locally advanced stage IIIA or IIIB metastatic non–small cell lung cancer or patients with recurrent non–small cell lung cancer following surgical resection. Patients averaged about 67 years old, and about 85% had stage IV disease. The genetic analyses identified EGFR mutations in 31% of the Japanese patients and in 12% of those in Europe.

[email protected]

On Twitter @mitchelzoler

GENEVA – The tests widely available today that use a cancer patient’s tumor DNA that circulates in the blood to detect a treatment-altering lung cancer mutation vary widely in sensitivity, meaning that using circulating DNA to identify a clinically important mutation should be limited to when biopsying the primary does not yield enough DNA for testing.

“It is important to use robust and sensitive methods” when trying to match treatment to the molecular specificities of each patient’s tumor, Dr. Martin Reck said at the European Lung Cancer Conference.

Mitchel L. Zoler/Frontline Medical News

Results from a study that prospectively compared DNA analysis for mutations in the epidermal growth factor receptor (EGFR) gene in tumor biopsies from 1,162 patients with advanced non–small cell lung cancer with DNA analysis of circulating tumor DNA (ctDNA) from the same patients showed that ctDNA analysis had 46% sensitivity, compared with tumor biopsy DNA, reported Dr. Reck, a thoracic oncologist at the Lung Clinic in Grosshandsdorf, Germany. This high level of false-negative results with ctDNA analysis produced a positive predictive value of 78%. In contrast, ctDNA has a specificity of 97% and a negative predictive value of 90%.

The results from the international study, which included 881 patients from seven European countries plus 281 patients from Japan, highlighted the divergent concordance among EGFR mutation comparisons of ctDNA and biopsy DNA depending on which DNA tests were used. Participating physicians could order whichever genetic analyses they wanted. A subanalysis of the study showed, for example, that among the 138 patients whose tumor and ctDNAs were both evaluated for EGFR mutations using the therascreen test marketed by QIAGEN the concordance rose to 95%, the sensitivity of ctDNA was 73%, and the positive predictive value was 94%, Dr. Reck reported.

The Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) enrolled patients with either newly diagnosed, locally advanced stage IIIA or IIIB metastatic non–small cell lung cancer or patients with recurrent non–small cell lung cancer following surgical resection. Patients averaged about 67 years old, and about 85% had stage IV disease. The genetic analyses identified EGFR mutations in 31% of the Japanese patients and in 12% of those in Europe.

[email protected]

On Twitter @mitchelzoler

GENEVA – The tests widely available today that use a cancer patient’s tumor DNA that circulates in the blood to detect a treatment-altering lung cancer mutation vary widely in sensitivity, meaning that using circulating DNA to identify a clinically important mutation should be limited to when biopsying the primary does not yield enough DNA for testing.

“It is important to use robust and sensitive methods” when trying to match treatment to the molecular specificities of each patient’s tumor, Dr. Martin Reck said at the European Lung Cancer Conference.

Mitchel L. Zoler/Frontline Medical News

Results from a study that prospectively compared DNA analysis for mutations in the epidermal growth factor receptor (EGFR) gene in tumor biopsies from 1,162 patients with advanced non–small cell lung cancer with DNA analysis of circulating tumor DNA (ctDNA) from the same patients showed that ctDNA analysis had 46% sensitivity, compared with tumor biopsy DNA, reported Dr. Reck, a thoracic oncologist at the Lung Clinic in Grosshandsdorf, Germany. This high level of false-negative results with ctDNA analysis produced a positive predictive value of 78%. In contrast, ctDNA has a specificity of 97% and a negative predictive value of 90%.

The results from the international study, which included 881 patients from seven European countries plus 281 patients from Japan, highlighted the divergent concordance among EGFR mutation comparisons of ctDNA and biopsy DNA depending on which DNA tests were used. Participating physicians could order whichever genetic analyses they wanted. A subanalysis of the study showed, for example, that among the 138 patients whose tumor and ctDNAs were both evaluated for EGFR mutations using the therascreen test marketed by QIAGEN the concordance rose to 95%, the sensitivity of ctDNA was 73%, and the positive predictive value was 94%, Dr. Reck reported.

The Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) enrolled patients with either newly diagnosed, locally advanced stage IIIA or IIIB metastatic non–small cell lung cancer or patients with recurrent non–small cell lung cancer following surgical resection. Patients averaged about 67 years old, and about 85% had stage IV disease. The genetic analyses identified EGFR mutations in 31% of the Japanese patients and in 12% of those in Europe.

[email protected]

On Twitter @mitchelzoler

Women with breast cancer and BRCA1 mutations had a lower risk of mortality if they underwent oophorectomy, and the benefit was apparent beyond age 50, investigators reported online April 23 in JAMA Oncology.

In the entire cohort that included women with BRCA1 and BRCA2 mutations, breast cancer–related mortality was reduced 56%, and all-cause mortality (including 9 deaths due to ovarian cancer) was reduced 65% with oophorectomy (adjusted HR, 0.35; 95% CI, 0.22-0.56; P < .001).

Dr. Kelly Metcalfe of the Women’s College Research Institute, Toronto, and her colleagues provided evidence in support of BRCA1 testing in women with early-stage breast cancer at the time of diagnosis.

“The data presented here suggest that oophorectomy should be discussed with the patient [with a BRCA1 mutation] shortly after diagnosis. We recommend that the operation be performed in the first year of treatment to maximize the benefit,” the investigators wrote (JAMA Oncol. 2015 Apr. 23 [doi:10.1001/jamaoncol.2015.0658]).

The historical cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and early-stage breast cancer diagnosed between 1975 and 2008. In order to examine the impact of subsequent oophorectomy on mortality risk due to breast cancer, a requirement for inclusion was that both ovaries be intact at the time of diagnosis. The subsequent oophorectomy group included 345 women.

Among the women who underwent oophorectomy, women with a BRCA1 mutation had a significantly reduced risk of breast cancer–related death, but the association was not significant for those with BRCA2 mutations. However, the number of BRCA2 carriers was much smaller than the number of BRCA1 carriers, and the 95% CI range was wide (0.23-1.43). A larger sample is required to determine the strength of an association.

Regardless of BRCA1/2 mutation status, in patients with estrogen receptor–negative breast cancer, oophorectomy had a protective effect (HR, 0.07; 95% CI, 0.01-0.51; P = .009).

Among 14 women over age 50 with estrogen receptor–negative cancer who did not undergo oophorectomy, 3 (21%) died; of the 15 who underwent the surgery, none died. Based on this finding, and a previous study indicating a protective effect of oophorectomy on the risk of primary breast cancer in women over 50, the researchers concluded that “the postmenopausal ovary remains active in terms of androgen production and that this affects cancer risk and progression, either directly or through aromatization to estrogen.”

Women with breast cancer and BRCA1 mutations had a lower risk of mortality if they underwent oophorectomy, and the benefit was apparent beyond age 50, investigators reported online April 23 in JAMA Oncology.

In the entire cohort that included women with BRCA1 and BRCA2 mutations, breast cancer–related mortality was reduced 56%, and all-cause mortality (including 9 deaths due to ovarian cancer) was reduced 65% with oophorectomy (adjusted HR, 0.35; 95% CI, 0.22-0.56; P < .001).

Dr. Kelly Metcalfe of the Women’s College Research Institute, Toronto, and her colleagues provided evidence in support of BRCA1 testing in women with early-stage breast cancer at the time of diagnosis.

“The data presented here suggest that oophorectomy should be discussed with the patient [with a BRCA1 mutation] shortly after diagnosis. We recommend that the operation be performed in the first year of treatment to maximize the benefit,” the investigators wrote (JAMA Oncol. 2015 Apr. 23 [doi:10.1001/jamaoncol.2015.0658]).

The historical cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and early-stage breast cancer diagnosed between 1975 and 2008. In order to examine the impact of subsequent oophorectomy on mortality risk due to breast cancer, a requirement for inclusion was that both ovaries be intact at the time of diagnosis. The subsequent oophorectomy group included 345 women.

Among the women who underwent oophorectomy, women with a BRCA1 mutation had a significantly reduced risk of breast cancer–related death, but the association was not significant for those with BRCA2 mutations. However, the number of BRCA2 carriers was much smaller than the number of BRCA1 carriers, and the 95% CI range was wide (0.23-1.43). A larger sample is required to determine the strength of an association.

Regardless of BRCA1/2 mutation status, in patients with estrogen receptor–negative breast cancer, oophorectomy had a protective effect (HR, 0.07; 95% CI, 0.01-0.51; P = .009).

Among 14 women over age 50 with estrogen receptor–negative cancer who did not undergo oophorectomy, 3 (21%) died; of the 15 who underwent the surgery, none died. Based on this finding, and a previous study indicating a protective effect of oophorectomy on the risk of primary breast cancer in women over 50, the researchers concluded that “the postmenopausal ovary remains active in terms of androgen production and that this affects cancer risk and progression, either directly or through aromatization to estrogen.”

Women with breast cancer and BRCA1 mutations had a lower risk of mortality if they underwent oophorectomy, and the benefit was apparent beyond age 50, investigators reported online April 23 in JAMA Oncology.

In the entire cohort that included women with BRCA1 and BRCA2 mutations, breast cancer–related mortality was reduced 56%, and all-cause mortality (including 9 deaths due to ovarian cancer) was reduced 65% with oophorectomy (adjusted HR, 0.35; 95% CI, 0.22-0.56; P < .001).

Dr. Kelly Metcalfe of the Women’s College Research Institute, Toronto, and her colleagues provided evidence in support of BRCA1 testing in women with early-stage breast cancer at the time of diagnosis.

“The data presented here suggest that oophorectomy should be discussed with the patient [with a BRCA1 mutation] shortly after diagnosis. We recommend that the operation be performed in the first year of treatment to maximize the benefit,” the investigators wrote (JAMA Oncol. 2015 Apr. 23 [doi:10.1001/jamaoncol.2015.0658]).

The historical cohort study evaluated 676 women with BRCA1 or BRCA2 mutations and early-stage breast cancer diagnosed between 1975 and 2008. In order to examine the impact of subsequent oophorectomy on mortality risk due to breast cancer, a requirement for inclusion was that both ovaries be intact at the time of diagnosis. The subsequent oophorectomy group included 345 women.

Among the women who underwent oophorectomy, women with a BRCA1 mutation had a significantly reduced risk of breast cancer–related death, but the association was not significant for those with BRCA2 mutations. However, the number of BRCA2 carriers was much smaller than the number of BRCA1 carriers, and the 95% CI range was wide (0.23-1.43). A larger sample is required to determine the strength of an association.

Regardless of BRCA1/2 mutation status, in patients with estrogen receptor–negative breast cancer, oophorectomy had a protective effect (HR, 0.07; 95% CI, 0.01-0.51; P = .009).

Among 14 women over age 50 with estrogen receptor–negative cancer who did not undergo oophorectomy, 3 (21%) died; of the 15 who underwent the surgery, none died. Based on this finding, and a previous study indicating a protective effect of oophorectomy on the risk of primary breast cancer in women over 50, the researchers concluded that “the postmenopausal ovary remains active in terms of androgen production and that this affects cancer risk and progression, either directly or through aromatization to estrogen.”

For patients in early septic shock, goal-directed therapy based on continuously monitoring central venous oxygen saturation did not improve outcomes compared with standard care, according to a multicenter randomized trial reported in the New England Journal of Medicine and at the annual meeting of the International Society on Intensive Care and Emergency Medicine.

All-cause mortality at 90 days was 29% for both study arms, and costs of care were similar, reported Paul R. Mouncey of the Intensive Care National Audit and Research Centre, London, and his associates. The trial is the last of three planned studies of early, goal-directed therapy (EGDT), “all of which showed that EGDT was not superior to usual care,” the investigators wrote (N. Engl. J. Med. 2015 Mar. 17 [doi:10.1056/NEJMoa1500896]).

Support for EGDT originated mainly from a single-center, proof-of-concept study in 2001 by Dr. Emanuel Rivers and associates, who reported lower hospital mortality and length of stay when patients in early septic shock received 6 hours of treatment aimed at optimizing oxygen transport (N. Engl. J. Med. 2001;345:1368-77).

The protocol called for continuously monitoring central venous pressure, mean arterial pressure, and central venous oxygen saturation to guide use of intravenous fluids, vasoactive drugs, and red-cell transfusions. But uptake of EGDT has been limited, and clinicians have been concerned about the validity of the results and the complexity, risks, and costs of implementing EGDT, Mr. Mouncey and his associates said.

For the study, they randomized 1,260 patients with signs of early septic shock to either EGDT or standard care. All patients received intravenous antibiotics and adequate fluid resuscitation. The EGDT group also underwent a 6-hour resuscitation protocol that included monitoring central venous oxygen saturation, with additional treatment decisions left up to the treating clinician.

In all, 29.5% of patients who received EGDT died within 90 days, as did 29.2% of patients who received standard care (P = .90). The EGDT group received more intravenous fluids, vasoactive drugs, and red-cell transfusions and had significantly worse organ-failure scores, more days of advanced cardiovascular support, and longer ICU stays, but had no improvement in health-related quality of life or other secondary outcomes, the researchers reported.

“On average, EGDT increased costs, and the probability that it was cost-effective was below 20%,” they wrote. “Our results suggest that techniques used in usual resuscitation have evolved over the 15 years since the landmark study by Rivers et al.”

The United Kingdom National Institute for Health Research health technology assessment program funded the study. Nine coauthors reported receiving grants from the NIHR. One coauthor reported grants from ImaCor and Cheetah Medical. The other authors declared no relevant conflicts of interest.

For patients in early septic shock, goal-directed therapy based on continuously monitoring central venous oxygen saturation did not improve outcomes compared with standard care, according to a multicenter randomized trial reported in the New England Journal of Medicine and at the annual meeting of the International Society on Intensive Care and Emergency Medicine.

All-cause mortality at 90 days was 29% for both study arms, and costs of care were similar, reported Paul R. Mouncey of the Intensive Care National Audit and Research Centre, London, and his associates. The trial is the last of three planned studies of early, goal-directed therapy (EGDT), “all of which showed that EGDT was not superior to usual care,” the investigators wrote (N. Engl. J. Med. 2015 Mar. 17 [doi:10.1056/NEJMoa1500896]).

Support for EGDT originated mainly from a single-center, proof-of-concept study in 2001 by Dr. Emanuel Rivers and associates, who reported lower hospital mortality and length of stay when patients in early septic shock received 6 hours of treatment aimed at optimizing oxygen transport (N. Engl. J. Med. 2001;345:1368-77).

The protocol called for continuously monitoring central venous pressure, mean arterial pressure, and central venous oxygen saturation to guide use of intravenous fluids, vasoactive drugs, and red-cell transfusions. But uptake of EGDT has been limited, and clinicians have been concerned about the validity of the results and the complexity, risks, and costs of implementing EGDT, Mr. Mouncey and his associates said.

For the study, they randomized 1,260 patients with signs of early septic shock to either EGDT or standard care. All patients received intravenous antibiotics and adequate fluid resuscitation. The EGDT group also underwent a 6-hour resuscitation protocol that included monitoring central venous oxygen saturation, with additional treatment decisions left up to the treating clinician.

In all, 29.5% of patients who received EGDT died within 90 days, as did 29.2% of patients who received standard care (P = .90). The EGDT group received more intravenous fluids, vasoactive drugs, and red-cell transfusions and had significantly worse organ-failure scores, more days of advanced cardiovascular support, and longer ICU stays, but had no improvement in health-related quality of life or other secondary outcomes, the researchers reported.

“On average, EGDT increased costs, and the probability that it was cost-effective was below 20%,” they wrote. “Our results suggest that techniques used in usual resuscitation have evolved over the 15 years since the landmark study by Rivers et al.”

The United Kingdom National Institute for Health Research health technology assessment program funded the study. Nine coauthors reported receiving grants from the NIHR. One coauthor reported grants from ImaCor and Cheetah Medical. The other authors declared no relevant conflicts of interest.

For patients in early septic shock, goal-directed therapy based on continuously monitoring central venous oxygen saturation did not improve outcomes compared with standard care, according to a multicenter randomized trial reported in the New England Journal of Medicine and at the annual meeting of the International Society on Intensive Care and Emergency Medicine.

All-cause mortality at 90 days was 29% for both study arms, and costs of care were similar, reported Paul R. Mouncey of the Intensive Care National Audit and Research Centre, London, and his associates. The trial is the last of three planned studies of early, goal-directed therapy (EGDT), “all of which showed that EGDT was not superior to usual care,” the investigators wrote (N. Engl. J. Med. 2015 Mar. 17 [doi:10.1056/NEJMoa1500896]).

Support for EGDT originated mainly from a single-center, proof-of-concept study in 2001 by Dr. Emanuel Rivers and associates, who reported lower hospital mortality and length of stay when patients in early septic shock received 6 hours of treatment aimed at optimizing oxygen transport (N. Engl. J. Med. 2001;345:1368-77).

The protocol called for continuously monitoring central venous pressure, mean arterial pressure, and central venous oxygen saturation to guide use of intravenous fluids, vasoactive drugs, and red-cell transfusions. But uptake of EGDT has been limited, and clinicians have been concerned about the validity of the results and the complexity, risks, and costs of implementing EGDT, Mr. Mouncey and his associates said.

For the study, they randomized 1,260 patients with signs of early septic shock to either EGDT or standard care. All patients received intravenous antibiotics and adequate fluid resuscitation. The EGDT group also underwent a 6-hour resuscitation protocol that included monitoring central venous oxygen saturation, with additional treatment decisions left up to the treating clinician.

In all, 29.5% of patients who received EGDT died within 90 days, as did 29.2% of patients who received standard care (P = .90). The EGDT group received more intravenous fluids, vasoactive drugs, and red-cell transfusions and had significantly worse organ-failure scores, more days of advanced cardiovascular support, and longer ICU stays, but had no improvement in health-related quality of life or other secondary outcomes, the researchers reported.

“On average, EGDT increased costs, and the probability that it was cost-effective was below 20%,” they wrote. “Our results suggest that techniques used in usual resuscitation have evolved over the 15 years since the landmark study by Rivers et al.”

The United Kingdom National Institute for Health Research health technology assessment program funded the study. Nine coauthors reported receiving grants from the NIHR. One coauthor reported grants from ImaCor and Cheetah Medical. The other authors declared no relevant conflicts of interest.

The name is still evolving, but the idea of a more patient-centered cesarean delivery is beginning to take root in American hospitals.

At Cedars-Sinai Medical Center, where roughly 35% of the 6,500 deliveries each year are by cesarean, an obstetrics-gynecology “customization of care” task force is working to standardize what is being referred to nationally as gentle or natural cesareans, as well as family- or patient-centered cesarean delivery.

Central to the approach is parent involvement, keeping mothers and infants together, and transferring the baby onto the mother’s chest for early skin-to-skin contact after delivery.

“When they find out they have the option to do skin-to-skin, it relieves a lot of the anxiety, especially if the C-section is unplanned,” said Dr. Paola Aghajanian, director of labor and delivery and the Maternal-Fetal Care Unit at the Los Angeles–based hospital.

During a traditional cesarean, it’s at least 30 minutes and in most cases up to 60 minutes before the mother can hold her baby. But with a gentle cesarean, Apgar testing is performed on the mother’s chest, while warm blankets are used to maintain the infant’s temperature.

At Cedars-Sinai, they are working to reduce maternal sedation and eliminate extraneous conversations in the operating room. The hospital is also in the process of ordering clear surgical drapes so that mothers and their partners can watch the birth, Dr. Aghajanian said. The use of clear drapes has been popularized by Dr. William Camann, director of obstetric anesthesia at Brigham and Women’s Hospital in Boston, who said the idea came to him after watching open heart surgery at another hospital where the drapes were used to enhance coordination and communication between anesthesiologists and cardiothoracic surgeons.

Courtesy Brigham and Women&#039;s Hospital

The clear drapes have been met with tremendous approval, particularly from mothers, and reduce the potential risk for infection, though it is already very low, said Dr. Camann, an early adopter of what the Brigham calls “gentle cesareans.”

Over the last 4 years they’ve made other adjustments, including moving ECG leads from the chest to a more lateral position, shifting monitors so mothers can have more mobility to interact with or breastfeed the baby, and liberalizing policies so a second support person or doula can be present.

There’s more traffic and sharing of the “real estate” at the head of the bed for surgeons and anesthesiologists and a different rhythm in baby care for pediatricians and nurses, Dr. Camann said, but the changes don’t require more space or add to the cost of the procedure.

“It’s more of a change in attitude, thinking a little bit outside the box,” he said. “A phrase I often use is ‘When you enter a cesarean delivery, turn off your surgical mentality.’ Even though it’s still an operating room, and it’s still a surgery, there are some different things that we can do that really just have to do with the attitude of everyone in the room, basically re-engineering the way we think about some of the traditional practices that go along in an operating room.”

Shifting those long-standing practices requires buy-in from around the hospital and multiple simulations to ensure everyone in the room understands their new role, family physician Dr. Susanna Magee, another early adopter of the approach and director of maternal child health at Memorial Hospital of Rhode Island in Pawtucket.

“This is absolutely a paradigm shift,” she said. “This is different from other operations, and it’s a difficult thing for surgeons, anesthesiologists, or nurses to get their heads around.”

The hospital recently published its experience with 144 “gentle cesarean births” from 2009 to 2013, and has seen no increase in complications, operating room times, or infection rates (J. Am. Board Fam. Med. 2014;27:690-3).

Beginning in 2011, they implemented gentle cesarean even in nonscheduled or urgent cesareans, recognizing the potential for false-positive fetal monitoring and the probability of a healthy infant even in cases of a persistent category II fetal heart tracing, Dr. Magee said.

Courtesy Brigham and Women&#039;s Hospital

Immediate skin-to-skin contact after cesarean is now the standard of care at the hospital and has prompted some women who knew they would require a cesarean delivery to transfer care to the Rhode Island hospital, according to Dr. Magee. Gentle cesareans have also been an selling point for the Brigham, Dr. Camann said.

“I suspect there will be some marketing from hospitals who are looking to say we can offer this, but my suspicion is hospitals would be in a better position to market that their cesarean section rates are at or below the national average,” said Dr. Wanda Filer, president-elect of the American Academy of Family Physicians. “The gentle C-section in and of itself is not going to be their competitive advantage. It would be interesting to see if they choose that because I think there could be upsides, but also opportunities for backlash.”

Sources interviewed for this article were all quick to point out that they are not advocating increasing the number of cesarean deliveries, but instead trying to enrich the experience for women who are already candidates for an operative birth.

“Some people have said you’re actually making cesareans so pleasant that you might change the cesarean section rate, maybe encourage people to have a cesarean, and I want to directly address that by saying it is simply not the case at all,” Dr. Camann said. “A cesarean should be done only if there are appropriate medical indications, nothing to do with the whole concept we are discussing here. But if there are appropriate medical indications for a cesarean, we can do certain things to make it a better experience.”

The new approach reflects the move toward more patient-centered care across all specialties and rising demand over the past decade for more natural birth processes, both Dr. Aghajanian and Dr. Magee observed.

“It was truly patients that brought it to our attention, and I think that’s important. It’s a patient-centered technique,” Dr. Magee said, adding that the highest compliment came from a mother who remarked, “I know you did surgery on me, but this was a birth.”

Some recent media reports have cast the approach as a major shift in cesarean delivery, but there’s nothing radical about it, according to ob.gyn. Dr. Jeff Livingston and certified nurse-midwife Ms. Rachel Zimmer, both with MacArthur Medical Center in Irving, Texas.

“We’re making minor adjustments with the patient and her family’s interests at heart, always doing it safely, but making it a more personalized and individualized experience,” he said.

For many patients, the most appreciable difference about their “family-centered cesarean” is that they get to actively participate and plan their birth, just as they would with a vaginal birth, Ms. Zimmer said.

For Dr. Livingston, the biggest change is pausing after the baby’s head enters the abdominal field to allow external compression from the uterus to help expel lung liquids, a technique described in an early report on “the natural cesarean” by obstetricians in the United Kingdom and Australia (BJOG 2008;115:1037-42).

An opaque surgical drape is lowered and the mother’s head elevated by the anesthesiologist to let parents watch the birth, but not all patients choose to do so, he said.

Overall awareness of family-centered cesareans is low among new mothers, and they are performed upon request, not as the standard of care, Dr. Livingston noted.

And the trend is being seen outside large urban centers, as well. In Peoria, Ill., Dr. Michael Leonardi of OSF Saint Francis Medical Center, said patients at his hospital are requesting family-centered cesareans. At the same time, the hospital continues to get referrals for the management of placenta accreta from women who’ve had too many cesareans, reflecting the need to have the “bigger conversation” with patients about what they and the hospital can do to safely avoid the primary cesarean and interventions that increase cesarean risk, such as induction of labor with an unfavorable cervix, he said.

“A piece to patient-centered care is not me telling the patient what to do and being paternalistic, but making sure people have the information they need, in a way that makes sense to them, so they can make an informed decision,” Dr. Leonardi said.

[email protected]

The name is still evolving, but the idea of a more patient-centered cesarean delivery is beginning to take root in American hospitals.

At Cedars-Sinai Medical Center, where roughly 35% of the 6,500 deliveries each year are by cesarean, an obstetrics-gynecology “customization of care” task force is working to standardize what is being referred to nationally as gentle or natural cesareans, as well as family- or patient-centered cesarean delivery.

Central to the approach is parent involvement, keeping mothers and infants together, and transferring the baby onto the mother’s chest for early skin-to-skin contact after delivery.

“When they find out they have the option to do skin-to-skin, it relieves a lot of the anxiety, especially if the C-section is unplanned,” said Dr. Paola Aghajanian, director of labor and delivery and the Maternal-Fetal Care Unit at the Los Angeles–based hospital.

During a traditional cesarean, it’s at least 30 minutes and in most cases up to 60 minutes before the mother can hold her baby. But with a gentle cesarean, Apgar testing is performed on the mother’s chest, while warm blankets are used to maintain the infant’s temperature.

At Cedars-Sinai, they are working to reduce maternal sedation and eliminate extraneous conversations in the operating room. The hospital is also in the process of ordering clear surgical drapes so that mothers and their partners can watch the birth, Dr. Aghajanian said. The use of clear drapes has been popularized by Dr. William Camann, director of obstetric anesthesia at Brigham and Women’s Hospital in Boston, who said the idea came to him after watching open heart surgery at another hospital where the drapes were used to enhance coordination and communication between anesthesiologists and cardiothoracic surgeons.

Courtesy Brigham and Women&#039;s Hospital

The clear drapes have been met with tremendous approval, particularly from mothers, and reduce the potential risk for infection, though it is already very low, said Dr. Camann, an early adopter of what the Brigham calls “gentle cesareans.”

Over the last 4 years they’ve made other adjustments, including moving ECG leads from the chest to a more lateral position, shifting monitors so mothers can have more mobility to interact with or breastfeed the baby, and liberalizing policies so a second support person or doula can be present.

There’s more traffic and sharing of the “real estate” at the head of the bed for surgeons and anesthesiologists and a different rhythm in baby care for pediatricians and nurses, Dr. Camann said, but the changes don’t require more space or add to the cost of the procedure.

“It’s more of a change in attitude, thinking a little bit outside the box,” he said. “A phrase I often use is ‘When you enter a cesarean delivery, turn off your surgical mentality.’ Even though it’s still an operating room, and it’s still a surgery, there are some different things that we can do that really just have to do with the attitude of everyone in the room, basically re-engineering the way we think about some of the traditional practices that go along in an operating room.”

Shifting those long-standing practices requires buy-in from around the hospital and multiple simulations to ensure everyone in the room understands their new role, family physician Dr. Susanna Magee, another early adopter of the approach and director of maternal child health at Memorial Hospital of Rhode Island in Pawtucket.

“This is absolutely a paradigm shift,” she said. “This is different from other operations, and it’s a difficult thing for surgeons, anesthesiologists, or nurses to get their heads around.”

The hospital recently published its experience with 144 “gentle cesarean births” from 2009 to 2013, and has seen no increase in complications, operating room times, or infection rates (J. Am. Board Fam. Med. 2014;27:690-3).

Beginning in 2011, they implemented gentle cesarean even in nonscheduled or urgent cesareans, recognizing the potential for false-positive fetal monitoring and the probability of a healthy infant even in cases of a persistent category II fetal heart tracing, Dr. Magee said.

Courtesy Brigham and Women&#039;s Hospital

Immediate skin-to-skin contact after cesarean is now the standard of care at the hospital and has prompted some women who knew they would require a cesarean delivery to transfer care to the Rhode Island hospital, according to Dr. Magee. Gentle cesareans have also been an selling point for the Brigham, Dr. Camann said.

“I suspect there will be some marketing from hospitals who are looking to say we can offer this, but my suspicion is hospitals would be in a better position to market that their cesarean section rates are at or below the national average,” said Dr. Wanda Filer, president-elect of the American Academy of Family Physicians. “The gentle C-section in and of itself is not going to be their competitive advantage. It would be interesting to see if they choose that because I think there could be upsides, but also opportunities for backlash.”

Sources interviewed for this article were all quick to point out that they are not advocating increasing the number of cesarean deliveries, but instead trying to enrich the experience for women who are already candidates for an operative birth.

“Some people have said you’re actually making cesareans so pleasant that you might change the cesarean section rate, maybe encourage people to have a cesarean, and I want to directly address that by saying it is simply not the case at all,” Dr. Camann said. “A cesarean should be done only if there are appropriate medical indications, nothing to do with the whole concept we are discussing here. But if there are appropriate medical indications for a cesarean, we can do certain things to make it a better experience.”

The new approach reflects the move toward more patient-centered care across all specialties and rising demand over the past decade for more natural birth processes, both Dr. Aghajanian and Dr. Magee observed.

“It was truly patients that brought it to our attention, and I think that’s important. It’s a patient-centered technique,” Dr. Magee said, adding that the highest compliment came from a mother who remarked, “I know you did surgery on me, but this was a birth.”

Some recent media reports have cast the approach as a major shift in cesarean delivery, but there’s nothing radical about it, according to ob.gyn. Dr. Jeff Livingston and certified nurse-midwife Ms. Rachel Zimmer, both with MacArthur Medical Center in Irving, Texas.

“We’re making minor adjustments with the patient and her family’s interests at heart, always doing it safely, but making it a more personalized and individualized experience,” he said.

For many patients, the most appreciable difference about their “family-centered cesarean” is that they get to actively participate and plan their birth, just as they would with a vaginal birth, Ms. Zimmer said.

For Dr. Livingston, the biggest change is pausing after the baby’s head enters the abdominal field to allow external compression from the uterus to help expel lung liquids, a technique described in an early report on “the natural cesarean” by obstetricians in the United Kingdom and Australia (BJOG 2008;115:1037-42).

An opaque surgical drape is lowered and the mother’s head elevated by the anesthesiologist to let parents watch the birth, but not all patients choose to do so, he said.

Overall awareness of family-centered cesareans is low among new mothers, and they are performed upon request, not as the standard of care, Dr. Livingston noted.

And the trend is being seen outside large urban centers, as well. In Peoria, Ill., Dr. Michael Leonardi of OSF Saint Francis Medical Center, said patients at his hospital are requesting family-centered cesareans. At the same time, the hospital continues to get referrals for the management of placenta accreta from women who’ve had too many cesareans, reflecting the need to have the “bigger conversation” with patients about what they and the hospital can do to safely avoid the primary cesarean and interventions that increase cesarean risk, such as induction of labor with an unfavorable cervix, he said.

“A piece to patient-centered care is not me telling the patient what to do and being paternalistic, but making sure people have the information they need, in a way that makes sense to them, so they can make an informed decision,” Dr. Leonardi said.

[email protected]

The name is still evolving, but the idea of a more patient-centered cesarean delivery is beginning to take root in American hospitals.

At Cedars-Sinai Medical Center, where roughly 35% of the 6,500 deliveries each year are by cesarean, an obstetrics-gynecology “customization of care” task force is working to standardize what is being referred to nationally as gentle or natural cesareans, as well as family- or patient-centered cesarean delivery.

Central to the approach is parent involvement, keeping mothers and infants together, and transferring the baby onto the mother’s chest for early skin-to-skin contact after delivery.

“When they find out they have the option to do skin-to-skin, it relieves a lot of the anxiety, especially if the C-section is unplanned,” said Dr. Paola Aghajanian, director of labor and delivery and the Maternal-Fetal Care Unit at the Los Angeles–based hospital.

During a traditional cesarean, it’s at least 30 minutes and in most cases up to 60 minutes before the mother can hold her baby. But with a gentle cesarean, Apgar testing is performed on the mother’s chest, while warm blankets are used to maintain the infant’s temperature.

At Cedars-Sinai, they are working to reduce maternal sedation and eliminate extraneous conversations in the operating room. The hospital is also in the process of ordering clear surgical drapes so that mothers and their partners can watch the birth, Dr. Aghajanian said. The use of clear drapes has been popularized by Dr. William Camann, director of obstetric anesthesia at Brigham and Women’s Hospital in Boston, who said the idea came to him after watching open heart surgery at another hospital where the drapes were used to enhance coordination and communication between anesthesiologists and cardiothoracic surgeons.

Courtesy Brigham and Women&#039;s Hospital

The clear drapes have been met with tremendous approval, particularly from mothers, and reduce the potential risk for infection, though it is already very low, said Dr. Camann, an early adopter of what the Brigham calls “gentle cesareans.”

Over the last 4 years they’ve made other adjustments, including moving ECG leads from the chest to a more lateral position, shifting monitors so mothers can have more mobility to interact with or breastfeed the baby, and liberalizing policies so a second support person or doula can be present.

There’s more traffic and sharing of the “real estate” at the head of the bed for surgeons and anesthesiologists and a different rhythm in baby care for pediatricians and nurses, Dr. Camann said, but the changes don’t require more space or add to the cost of the procedure.

“It’s more of a change in attitude, thinking a little bit outside the box,” he said. “A phrase I often use is ‘When you enter a cesarean delivery, turn off your surgical mentality.’ Even though it’s still an operating room, and it’s still a surgery, there are some different things that we can do that really just have to do with the attitude of everyone in the room, basically re-engineering the way we think about some of the traditional practices that go along in an operating room.”

Shifting those long-standing practices requires buy-in from around the hospital and multiple simulations to ensure everyone in the room understands their new role, family physician Dr. Susanna Magee, another early adopter of the approach and director of maternal child health at Memorial Hospital of Rhode Island in Pawtucket.

“This is absolutely a paradigm shift,” she said. “This is different from other operations, and it’s a difficult thing for surgeons, anesthesiologists, or nurses to get their heads around.”

The hospital recently published its experience with 144 “gentle cesarean births” from 2009 to 2013, and has seen no increase in complications, operating room times, or infection rates (J. Am. Board Fam. Med. 2014;27:690-3).

Beginning in 2011, they implemented gentle cesarean even in nonscheduled or urgent cesareans, recognizing the potential for false-positive fetal monitoring and the probability of a healthy infant even in cases of a persistent category II fetal heart tracing, Dr. Magee said.

Courtesy Brigham and Women&#039;s Hospital

Immediate skin-to-skin contact after cesarean is now the standard of care at the hospital and has prompted some women who knew they would require a cesarean delivery to transfer care to the Rhode Island hospital, according to Dr. Magee. Gentle cesareans have also been an selling point for the Brigham, Dr. Camann said.

“I suspect there will be some marketing from hospitals who are looking to say we can offer this, but my suspicion is hospitals would be in a better position to market that their cesarean section rates are at or below the national average,” said Dr. Wanda Filer, president-elect of the American Academy of Family Physicians. “The gentle C-section in and of itself is not going to be their competitive advantage. It would be interesting to see if they choose that because I think there could be upsides, but also opportunities for backlash.”

Sources interviewed for this article were all quick to point out that they are not advocating increasing the number of cesarean deliveries, but instead trying to enrich the experience for women who are already candidates for an operative birth.

“Some people have said you’re actually making cesareans so pleasant that you might change the cesarean section rate, maybe encourage people to have a cesarean, and I want to directly address that by saying it is simply not the case at all,” Dr. Camann said. “A cesarean should be done only if there are appropriate medical indications, nothing to do with the whole concept we are discussing here. But if there are appropriate medical indications for a cesarean, we can do certain things to make it a better experience.”

The new approach reflects the move toward more patient-centered care across all specialties and rising demand over the past decade for more natural birth processes, both Dr. Aghajanian and Dr. Magee observed.

“It was truly patients that brought it to our attention, and I think that’s important. It’s a patient-centered technique,” Dr. Magee said, adding that the highest compliment came from a mother who remarked, “I know you did surgery on me, but this was a birth.”

Some recent media reports have cast the approach as a major shift in cesarean delivery, but there’s nothing radical about it, according to ob.gyn. Dr. Jeff Livingston and certified nurse-midwife Ms. Rachel Zimmer, both with MacArthur Medical Center in Irving, Texas.

“We’re making minor adjustments with the patient and her family’s interests at heart, always doing it safely, but making it a more personalized and individualized experience,” he said.

For many patients, the most appreciable difference about their “family-centered cesarean” is that they get to actively participate and plan their birth, just as they would with a vaginal birth, Ms. Zimmer said.

For Dr. Livingston, the biggest change is pausing after the baby’s head enters the abdominal field to allow external compression from the uterus to help expel lung liquids, a technique described in an early report on “the natural cesarean” by obstetricians in the United Kingdom and Australia (BJOG 2008;115:1037-42).

An opaque surgical drape is lowered and the mother’s head elevated by the anesthesiologist to let parents watch the birth, but not all patients choose to do so, he said.

Overall awareness of family-centered cesareans is low among new mothers, and they are performed upon request, not as the standard of care, Dr. Livingston noted.

And the trend is being seen outside large urban centers, as well. In Peoria, Ill., Dr. Michael Leonardi of OSF Saint Francis Medical Center, said patients at his hospital are requesting family-centered cesareans. At the same time, the hospital continues to get referrals for the management of placenta accreta from women who’ve had too many cesareans, reflecting the need to have the “bigger conversation” with patients about what they and the hospital can do to safely avoid the primary cesarean and interventions that increase cesarean risk, such as induction of labor with an unfavorable cervix, he said.

“A piece to patient-centered care is not me telling the patient what to do and being paternalistic, but making sure people have the information they need, in a way that makes sense to them, so they can make an informed decision,” Dr. Leonardi said.

[email protected]

CHICAGO – Sentinel lymph node mapping is a safe, less extensive alternative to lymph node dissection in women with endometrial cancer regardless of the clinically suspected risk of metastases, suggest a pair of retrospective cohort studies reported at the annual meeting of the Society of Gynecologic Oncology.

“The role and extent of surgical staging in endometrial carcinoma is controversial. The various strategies range from no lymphadenectomy to a full lymphadenectomy dissection up to the renal vessels,” said Dr. Ane Gerda Zahl Eriksson, a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, New York.

Susan London/Frontline Medical News

“The use of SLN [sentinel lymph node] mapping is emerging as an acceptable approach for nodal assessment in endometrial carcinoma. However, as always when introducing a novel management strategy, we must be mindful not to compromise oncologic outcome or otherwise inflict harm on our patients by our approach,” she added.

Dr. Eriksson and colleagues assessed clinicopathologic outcomes according to nodal assessment approach among women with low-risk endometrial cancer, defined as that with endometrioid histology of any grade with myometrial invasion of less than 50%.

They compared 493 women who had selective lymph node dissection (LND) at the Mayo Clinic between 2004 and 2008 according to an institutional algorithm (complete pelvic and para-aortic lymphadenectomy to the renal veins in cases deemed at risk for nodal metastasis) with 642 women who had SLN mapping at the Memorial Sloan Kettering Cancer Center between 2006 and 2013 according to an institutional algorithm. The SLNs were evaluated by pathologic ultrastaging and were considered positive whether they had macrometastases, micrometastases, or isolated tumor cells.

Results showed that patients in the SLN cohort were more likely to have pelvic nodes excised (93% vs. 58%) and less likely to have para-aortic nodes excised (14% vs. 50%), Dr. Eriksson reported.

Markedly fewer lymph nodes were removed per patient with the SLN algorithm, yet it yielded a higher detection rate of stage IIIC1 disease (4.8% vs. 1.8%) and similar detection rates of stage IIIA/B and stage IIIC2 disease.

Patients in the SLN cohort were more than twice as likely to receive adjuvant therapy (27% vs. 12%). (Dr. Eriksson noted that patients in the SLN cohort who had positive nodes were offered the same adjuvant therapy options regardless of the amount of metastases found in the nodes.)

With a median follow-up of 2.1 years in the SLN cohort and 3.5 years in the LND cohort, the cohorts had statistically indistinguishable 3-year rates of freedom from isolated nodal recurrence (99.6% in each) and disease-free survival (94.9% and 96.8%).

“The application of the SLN algorithm does not appear to compromise oncologic outcome in this short follow-up. The value of SLN dissection or selective lymphadenectomy in patients with tumors equal to or less than 2 cm remains controversial,” Dr. Eriksson commented. “The clinical significance of disease detected on ultrastaging and the role of adjuvant therapy in these patients remains to be determined.”

“Prospective assessment of the SLN algorithm is needed and underway,” she concluded. “Our findings support the use of either strategy for endometrial cancer staging with no apparent detriment to the SLN algorithm.”

In the second study, investigators led by Dr. Jennifer A. Ducie, also a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, performed a similar analysis among women with intermediate-risk endometrial cancer, defined as that having endometrioid histology with any grade and at least 50% myometrial invasion, and high-risk endometrial cancer, defined as serous or clear cell carcinoma.

Susan London/Frontline Medical News

In the intermediate-risk group, there were 82 patients in the SLN cohort and 107 patients in the LND cohort. The groups had a similar detection rate of stage IIIC disease overall (35% and 28%), but the SLN cohort had a higher rate of detection of stage IIIC1 disease (32% vs. 11%) and the LND cohort had a higher rate of detection of stage IIIC2 disease (17% vs. 4%), Dr. Ducie reported.

In the high-risk group, there were 120 patients in the SLN cohort and 103 patients in the LND cohort. Patients in the SLN cohort were more likely to have pelvic nodes removed (98% vs. 85%) but had fewer nodes removed (11 vs. 30). Among patients who had para-aortic nodes removed, the SLN cohort was similarly as likely as the LND cohort to have positive nodes, but had a smaller median number positive (two vs. five). The rate of detection of stage IIIC disease overall (23% vs. 19%) and of the substages was statistically indistinguishable.

“Though both strategies yield similar detection rates of stage IIIC disease, it remains to be determined if removal of more normal-appearing lymph nodes will improve survival,” Dr. Ducie concluded. “A limitation of this portion of our collaborative study is that we don’t address adjuvant therapy or outcomes, but these will be addressed in future analyses.”

CHICAGO – Sentinel lymph node mapping is a safe, less extensive alternative to lymph node dissection in women with endometrial cancer regardless of the clinically suspected risk of metastases, suggest a pair of retrospective cohort studies reported at the annual meeting of the Society of Gynecologic Oncology.

“The role and extent of surgical staging in endometrial carcinoma is controversial. The various strategies range from no lymphadenectomy to a full lymphadenectomy dissection up to the renal vessels,” said Dr. Ane Gerda Zahl Eriksson, a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, New York.

Susan London/Frontline Medical News

“The use of SLN [sentinel lymph node] mapping is emerging as an acceptable approach for nodal assessment in endometrial carcinoma. However, as always when introducing a novel management strategy, we must be mindful not to compromise oncologic outcome or otherwise inflict harm on our patients by our approach,” she added.

Dr. Eriksson and colleagues assessed clinicopathologic outcomes according to nodal assessment approach among women with low-risk endometrial cancer, defined as that with endometrioid histology of any grade with myometrial invasion of less than 50%.

They compared 493 women who had selective lymph node dissection (LND) at the Mayo Clinic between 2004 and 2008 according to an institutional algorithm (complete pelvic and para-aortic lymphadenectomy to the renal veins in cases deemed at risk for nodal metastasis) with 642 women who had SLN mapping at the Memorial Sloan Kettering Cancer Center between 2006 and 2013 according to an institutional algorithm. The SLNs were evaluated by pathologic ultrastaging and were considered positive whether they had macrometastases, micrometastases, or isolated tumor cells.

Results showed that patients in the SLN cohort were more likely to have pelvic nodes excised (93% vs. 58%) and less likely to have para-aortic nodes excised (14% vs. 50%), Dr. Eriksson reported.

Markedly fewer lymph nodes were removed per patient with the SLN algorithm, yet it yielded a higher detection rate of stage IIIC1 disease (4.8% vs. 1.8%) and similar detection rates of stage IIIA/B and stage IIIC2 disease.

Patients in the SLN cohort were more than twice as likely to receive adjuvant therapy (27% vs. 12%). (Dr. Eriksson noted that patients in the SLN cohort who had positive nodes were offered the same adjuvant therapy options regardless of the amount of metastases found in the nodes.)

With a median follow-up of 2.1 years in the SLN cohort and 3.5 years in the LND cohort, the cohorts had statistically indistinguishable 3-year rates of freedom from isolated nodal recurrence (99.6% in each) and disease-free survival (94.9% and 96.8%).

“The application of the SLN algorithm does not appear to compromise oncologic outcome in this short follow-up. The value of SLN dissection or selective lymphadenectomy in patients with tumors equal to or less than 2 cm remains controversial,” Dr. Eriksson commented. “The clinical significance of disease detected on ultrastaging and the role of adjuvant therapy in these patients remains to be determined.”

“Prospective assessment of the SLN algorithm is needed and underway,” she concluded. “Our findings support the use of either strategy for endometrial cancer staging with no apparent detriment to the SLN algorithm.”

In the second study, investigators led by Dr. Jennifer A. Ducie, also a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, performed a similar analysis among women with intermediate-risk endometrial cancer, defined as that having endometrioid histology with any grade and at least 50% myometrial invasion, and high-risk endometrial cancer, defined as serous or clear cell carcinoma.

Susan London/Frontline Medical News

In the intermediate-risk group, there were 82 patients in the SLN cohort and 107 patients in the LND cohort. The groups had a similar detection rate of stage IIIC disease overall (35% and 28%), but the SLN cohort had a higher rate of detection of stage IIIC1 disease (32% vs. 11%) and the LND cohort had a higher rate of detection of stage IIIC2 disease (17% vs. 4%), Dr. Ducie reported.

In the high-risk group, there were 120 patients in the SLN cohort and 103 patients in the LND cohort. Patients in the SLN cohort were more likely to have pelvic nodes removed (98% vs. 85%) but had fewer nodes removed (11 vs. 30). Among patients who had para-aortic nodes removed, the SLN cohort was similarly as likely as the LND cohort to have positive nodes, but had a smaller median number positive (two vs. five). The rate of detection of stage IIIC disease overall (23% vs. 19%) and of the substages was statistically indistinguishable.

“Though both strategies yield similar detection rates of stage IIIC disease, it remains to be determined if removal of more normal-appearing lymph nodes will improve survival,” Dr. Ducie concluded. “A limitation of this portion of our collaborative study is that we don’t address adjuvant therapy or outcomes, but these will be addressed in future analyses.”

CHICAGO – Sentinel lymph node mapping is a safe, less extensive alternative to lymph node dissection in women with endometrial cancer regardless of the clinically suspected risk of metastases, suggest a pair of retrospective cohort studies reported at the annual meeting of the Society of Gynecologic Oncology.

“The role and extent of surgical staging in endometrial carcinoma is controversial. The various strategies range from no lymphadenectomy to a full lymphadenectomy dissection up to the renal vessels,” said Dr. Ane Gerda Zahl Eriksson, a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, New York.

Susan London/Frontline Medical News

“The use of SLN [sentinel lymph node] mapping is emerging as an acceptable approach for nodal assessment in endometrial carcinoma. However, as always when introducing a novel management strategy, we must be mindful not to compromise oncologic outcome or otherwise inflict harm on our patients by our approach,” she added.

Dr. Eriksson and colleagues assessed clinicopathologic outcomes according to nodal assessment approach among women with low-risk endometrial cancer, defined as that with endometrioid histology of any grade with myometrial invasion of less than 50%.

They compared 493 women who had selective lymph node dissection (LND) at the Mayo Clinic between 2004 and 2008 according to an institutional algorithm (complete pelvic and para-aortic lymphadenectomy to the renal veins in cases deemed at risk for nodal metastasis) with 642 women who had SLN mapping at the Memorial Sloan Kettering Cancer Center between 2006 and 2013 according to an institutional algorithm. The SLNs were evaluated by pathologic ultrastaging and were considered positive whether they had macrometastases, micrometastases, or isolated tumor cells.

Results showed that patients in the SLN cohort were more likely to have pelvic nodes excised (93% vs. 58%) and less likely to have para-aortic nodes excised (14% vs. 50%), Dr. Eriksson reported.

Markedly fewer lymph nodes were removed per patient with the SLN algorithm, yet it yielded a higher detection rate of stage IIIC1 disease (4.8% vs. 1.8%) and similar detection rates of stage IIIA/B and stage IIIC2 disease.

Patients in the SLN cohort were more than twice as likely to receive adjuvant therapy (27% vs. 12%). (Dr. Eriksson noted that patients in the SLN cohort who had positive nodes were offered the same adjuvant therapy options regardless of the amount of metastases found in the nodes.)

With a median follow-up of 2.1 years in the SLN cohort and 3.5 years in the LND cohort, the cohorts had statistically indistinguishable 3-year rates of freedom from isolated nodal recurrence (99.6% in each) and disease-free survival (94.9% and 96.8%).

“The application of the SLN algorithm does not appear to compromise oncologic outcome in this short follow-up. The value of SLN dissection or selective lymphadenectomy in patients with tumors equal to or less than 2 cm remains controversial,” Dr. Eriksson commented. “The clinical significance of disease detected on ultrastaging and the role of adjuvant therapy in these patients remains to be determined.”

“Prospective assessment of the SLN algorithm is needed and underway,” she concluded. “Our findings support the use of either strategy for endometrial cancer staging with no apparent detriment to the SLN algorithm.”

In the second study, investigators led by Dr. Jennifer A. Ducie, also a surgical fellow in gynecologic oncology at the Memorial Sloan Kettering Cancer Center, performed a similar analysis among women with intermediate-risk endometrial cancer, defined as that having endometrioid histology with any grade and at least 50% myometrial invasion, and high-risk endometrial cancer, defined as serous or clear cell carcinoma.

Susan London/Frontline Medical News

In the intermediate-risk group, there were 82 patients in the SLN cohort and 107 patients in the LND cohort. The groups had a similar detection rate of stage IIIC disease overall (35% and 28%), but the SLN cohort had a higher rate of detection of stage IIIC1 disease (32% vs. 11%) and the LND cohort had a higher rate of detection of stage IIIC2 disease (17% vs. 4%), Dr. Ducie reported.

In the high-risk group, there were 120 patients in the SLN cohort and 103 patients in the LND cohort. Patients in the SLN cohort were more likely to have pelvic nodes removed (98% vs. 85%) but had fewer nodes removed (11 vs. 30). Among patients who had para-aortic nodes removed, the SLN cohort was similarly as likely as the LND cohort to have positive nodes, but had a smaller median number positive (two vs. five). The rate of detection of stage IIIC disease overall (23% vs. 19%) and of the substages was statistically indistinguishable.

“Though both strategies yield similar detection rates of stage IIIC disease, it remains to be determined if removal of more normal-appearing lymph nodes will improve survival,” Dr. Ducie concluded. “A limitation of this portion of our collaborative study is that we don’t address adjuvant therapy or outcomes, but these will be addressed in future analyses.”