In May 2014, a 70-year-old retiree underwent repair of a fracture of her left ankle. The procedure was performed at a local hospital. A splint was applied to the ankle, and a nurse provided crutches.

Following discharge from the hospital, the patient hailed a taxi to take her home. As she was exiting the taxi at her residence, the patient fell and sustained comminuted fractures to the distal radius and distal ulna of her right (dominant) wrist and a trimalleolar fracture to her repaired left ankle.

The plaintiff was transported back to the hospital via ambulance. She underwent closed reduction of her wrist fractures and 11 days later was transferred to another facility for open reduction and internal fixation of her left ankle fracture. Her hospitalizations totaled 13 days and were followed by a course of inpatient rehabilitative therapy; the latter lasted until late August 2014, with a brief interruption in June when she underwent open reduction and internal fixation of her wrist fractures. When she returned home in August, the patient required the assistance of visiting aides and 3 additional months of rehabilitative therapy.

At trial, the plaintiff claimed that her left ankle and her right wrist remained painful, that she sustained a mild residual diminution of each area’s range of motion, and that these residual effects hindered her performance of basic physical activities (eg, cleaning and cooking).

The plaintiff alleged that her fall while exiting the taxi resulted from unsteadiness, which was a lingering effect of morphine that was administered during the repair of her fracture. She sought recovery of damages for past and future pain and suffering from the hospital’s operator. The lawsuit alleged that the nurse had failed to provide instructions on the proper use of crutches, that the nurse had failed to undertake measures that would have diminished the plaintiff’s likelihood of falling, that the nurse’s failures constituted malpractice and negligence, and that the hospital operator was vicariously liable for the nurse’s actions.

The plaintiff claimed that she repeatedly warned that she did not believe that she could safely use the crutches provided by the nurse. She claimed that she was unsteady and lightheaded, and that when she requested a wheelchair, an escort, or an ambulance, the nurse rejected the request. The nursing standards expert for the plaintiff opined that the request should have been satisfied or alternatively, that the nurse should have explained the manner in which a crutch-dependent person could safely enter and exit a vehicle.

Defense counsel claimed that the nurse explained proper use of the crutches, the plaintiff indicated that she understood the explanation, and the plaintiff demonstrated proper use and did not express concern. The defense’s expert contended that the nurse did not have to explain how a crutch-dependent person could safely enter and exit a vehicle and that the plaintiff’s fall resulted from her own failure to exercise appropriate caution. The defense further contended that the plaintiff achieved an excellent recovery.

Continue to: After a 7-day trial...

After a 7-day trial and 3 hours and 45 minutes’ deliberation, the jury found in favor of the plaintiff. It found that the nurse was negligent in her provision of crutches and that the act was a substantial cause of the plaintiff’s injuries. The jury also found that the nurse did not properly explain the use of crutches but determined that the error was not a substantial cause of the plaintiff’s injuries.

VERDICT

The jury awarded the plaintiff a total of $850,000 in damages. The plaintiff also recovered stipulated medical expenses.

COMMENTARY

Medical malpractice litigation involves recovery for acts or omissions that constitute a departure from the standard of care. We all recognize injurious acts—improper esophageal intubation in the emergency department, transection of a nerve in the operating room, or prescription of a contraindicated medication to an allergic patient—and acknowledge damaging omissions, such as failure to screen for colon cancer or recognize treatable diabetes.

However, some cases are disposition related; they arise from how patients are discharged, what instructions they are given, where they go, and what they do after discharge. These cases involve the patient’s medical issues engrafted on his or her transportation, job, and more generally, living environment.

The lay public expects patients to have a right of self-determination, to control the nature and course of their medical care. Yet, the modern lay public also expects the medical profession to act as an authority figure—exercising a degree of paternalism to safeguard patients from harm. This expectation is commonly articulated in retrospect, after something has gone wrong. Consequently, clinicians must be aware of what will happen to the patient after discharge.

Continue to: With all interventions...

With all interventions, weigh the post-discharge consequences. If you give an injection of hydromorphone, you cannot discharge the patient to drive home 45 minutes later. If you have diagnosed vertigo in a patient, you cannot prescribe meclizine and return that patient to her job working on scaffolding 50 ft above ground. If a frail patient lives alone and cannot safely walk, and you’ve started him on furosemide, you cannot discharge him without considering how he will get to the bathroom. Other concerns are even more difficult—for example, the homeless patient who does not have the environment or resources to follow your instructions.

It is tempting to view these concerns as not our responsibility or dismiss them as “not medicine.” Clinicians can feel frustrated at being pulled into the realm of social work, where we are ill equipped to deal with and sort out the patient’s “life problems.” For one thing, we don’t often have the resources to deal with these issues. And for another, addressing the patient’s postdischarge living situation takes time—something in short supply and intangible to the other patients in the waiting room, who are expecting your attention and wondering, “What’s the holdup?”

In the case presented, the plaintiff was a 70-year-old retiree. She was discharged from the hospital with crutches. Crutches are age-old and familiar devices. Nevertheless, crutches are for people who are able to use their arms for weight bearing and propulsion and require a fair amount of physical strength, timing, and dexterity. While a potentially debatable point, an assumption that a 70-year-old patient has the arm strength and dexterity to properly propel herself with crutches may be faulty. There was disagreement between the patient, who claimed she could not safely use the crutches, and the nurse, who said the patient accepted the crutches without concern. The safest course of action would be for discharge personnel to demonstrate the use of crutches, observe the patient using the crutches, and document that in the record.

In this case, it is unclear if the nurse demonstrated how to use the crutches or witnessed the plaintiff demonstrating she could safely use them. The jury found the nurse was negligent “in her provision” of crutches—an act they deemed a substantial cause of the plaintiff’s injuries. Interestingly, the jury did not consider the lack of explanation on the crutches’ use to be a substantial cause of injury. But the bottom line is, they faulted the nurse for the act of giving this patient crutches and awarded $850,000 in damages.

Society is changing. Fifty years ago, jurors would expect people to be familiar with crutches, and if you fell while using them, that was your own fault. Modern jurors expect hospitals and providers to get more involved in what happens to a patient after discharge. The news media has heavily publicized cases of alleged “patient dumping.”

Continue to: As a result...

As a result, we see legislative changes, such as the recently passed California Senate Bill 1152, which requires that homeless patients be fed; provided weather-appropriate clothing, filled prescriptions, and vaccinations; given medical screening, examination, and evaluation that requires the “treating physician” to arrange behavioral health care; and enrolled in “any affordable health insurance coverage for which he or she is eligible.”

Whether it is appropriate to ask hospitals and clinicians to get this involved is beyond the scope of this column. What is clear is that society increasingly expects clinicians and hospitals to take responsibility for patients. This societal change has an impact on the lay public’s perception of what is expected of health care providers. Tomorrow’s juror comes to court with a belief that hospitals and clinicians owe a duty of care that extends beyond the walls of the exam room.

IN SUMMARY

Reality test your post-treatment instructions to be sure they will work for the patient and are not grossly incompatible with his or her known postdischarge environment. To the extent possible, involve discharge planning personnel in your practice. Let your record reflect that you are acting in the patient’s best interest, and evade the temptation to squint narrowly to avoid seeing circumstances in the patient’s life that prevent safe implementation of your plan.

In May 2014, a 70-year-old retiree underwent repair of a fracture of her left ankle. The procedure was performed at a local hospital. A splint was applied to the ankle, and a nurse provided crutches.

Following discharge from the hospital, the patient hailed a taxi to take her home. As she was exiting the taxi at her residence, the patient fell and sustained comminuted fractures to the distal radius and distal ulna of her right (dominant) wrist and a trimalleolar fracture to her repaired left ankle.

The plaintiff was transported back to the hospital via ambulance. She underwent closed reduction of her wrist fractures and 11 days later was transferred to another facility for open reduction and internal fixation of her left ankle fracture. Her hospitalizations totaled 13 days and were followed by a course of inpatient rehabilitative therapy; the latter lasted until late August 2014, with a brief interruption in June when she underwent open reduction and internal fixation of her wrist fractures. When she returned home in August, the patient required the assistance of visiting aides and 3 additional months of rehabilitative therapy.

At trial, the plaintiff claimed that her left ankle and her right wrist remained painful, that she sustained a mild residual diminution of each area’s range of motion, and that these residual effects hindered her performance of basic physical activities (eg, cleaning and cooking).

The plaintiff alleged that her fall while exiting the taxi resulted from unsteadiness, which was a lingering effect of morphine that was administered during the repair of her fracture. She sought recovery of damages for past and future pain and suffering from the hospital’s operator. The lawsuit alleged that the nurse had failed to provide instructions on the proper use of crutches, that the nurse had failed to undertake measures that would have diminished the plaintiff’s likelihood of falling, that the nurse’s failures constituted malpractice and negligence, and that the hospital operator was vicariously liable for the nurse’s actions.

The plaintiff claimed that she repeatedly warned that she did not believe that she could safely use the crutches provided by the nurse. She claimed that she was unsteady and lightheaded, and that when she requested a wheelchair, an escort, or an ambulance, the nurse rejected the request. The nursing standards expert for the plaintiff opined that the request should have been satisfied or alternatively, that the nurse should have explained the manner in which a crutch-dependent person could safely enter and exit a vehicle.

Defense counsel claimed that the nurse explained proper use of the crutches, the plaintiff indicated that she understood the explanation, and the plaintiff demonstrated proper use and did not express concern. The defense’s expert contended that the nurse did not have to explain how a crutch-dependent person could safely enter and exit a vehicle and that the plaintiff’s fall resulted from her own failure to exercise appropriate caution. The defense further contended that the plaintiff achieved an excellent recovery.

Continue to: After a 7-day trial...

After a 7-day trial and 3 hours and 45 minutes’ deliberation, the jury found in favor of the plaintiff. It found that the nurse was negligent in her provision of crutches and that the act was a substantial cause of the plaintiff’s injuries. The jury also found that the nurse did not properly explain the use of crutches but determined that the error was not a substantial cause of the plaintiff’s injuries.

VERDICT

The jury awarded the plaintiff a total of $850,000 in damages. The plaintiff also recovered stipulated medical expenses.

COMMENTARY

Medical malpractice litigation involves recovery for acts or omissions that constitute a departure from the standard of care. We all recognize injurious acts—improper esophageal intubation in the emergency department, transection of a nerve in the operating room, or prescription of a contraindicated medication to an allergic patient—and acknowledge damaging omissions, such as failure to screen for colon cancer or recognize treatable diabetes.

However, some cases are disposition related; they arise from how patients are discharged, what instructions they are given, where they go, and what they do after discharge. These cases involve the patient’s medical issues engrafted on his or her transportation, job, and more generally, living environment.

The lay public expects patients to have a right of self-determination, to control the nature and course of their medical care. Yet, the modern lay public also expects the medical profession to act as an authority figure—exercising a degree of paternalism to safeguard patients from harm. This expectation is commonly articulated in retrospect, after something has gone wrong. Consequently, clinicians must be aware of what will happen to the patient after discharge.

Continue to: With all interventions...

With all interventions, weigh the post-discharge consequences. If you give an injection of hydromorphone, you cannot discharge the patient to drive home 45 minutes later. If you have diagnosed vertigo in a patient, you cannot prescribe meclizine and return that patient to her job working on scaffolding 50 ft above ground. If a frail patient lives alone and cannot safely walk, and you’ve started him on furosemide, you cannot discharge him without considering how he will get to the bathroom. Other concerns are even more difficult—for example, the homeless patient who does not have the environment or resources to follow your instructions.

It is tempting to view these concerns as not our responsibility or dismiss them as “not medicine.” Clinicians can feel frustrated at being pulled into the realm of social work, where we are ill equipped to deal with and sort out the patient’s “life problems.” For one thing, we don’t often have the resources to deal with these issues. And for another, addressing the patient’s postdischarge living situation takes time—something in short supply and intangible to the other patients in the waiting room, who are expecting your attention and wondering, “What’s the holdup?”

In the case presented, the plaintiff was a 70-year-old retiree. She was discharged from the hospital with crutches. Crutches are age-old and familiar devices. Nevertheless, crutches are for people who are able to use their arms for weight bearing and propulsion and require a fair amount of physical strength, timing, and dexterity. While a potentially debatable point, an assumption that a 70-year-old patient has the arm strength and dexterity to properly propel herself with crutches may be faulty. There was disagreement between the patient, who claimed she could not safely use the crutches, and the nurse, who said the patient accepted the crutches without concern. The safest course of action would be for discharge personnel to demonstrate the use of crutches, observe the patient using the crutches, and document that in the record.

In this case, it is unclear if the nurse demonstrated how to use the crutches or witnessed the plaintiff demonstrating she could safely use them. The jury found the nurse was negligent “in her provision” of crutches—an act they deemed a substantial cause of the plaintiff’s injuries. Interestingly, the jury did not consider the lack of explanation on the crutches’ use to be a substantial cause of injury. But the bottom line is, they faulted the nurse for the act of giving this patient crutches and awarded $850,000 in damages.

Society is changing. Fifty years ago, jurors would expect people to be familiar with crutches, and if you fell while using them, that was your own fault. Modern jurors expect hospitals and providers to get more involved in what happens to a patient after discharge. The news media has heavily publicized cases of alleged “patient dumping.”

Continue to: As a result...

As a result, we see legislative changes, such as the recently passed California Senate Bill 1152, which requires that homeless patients be fed; provided weather-appropriate clothing, filled prescriptions, and vaccinations; given medical screening, examination, and evaluation that requires the “treating physician” to arrange behavioral health care; and enrolled in “any affordable health insurance coverage for which he or she is eligible.”

Whether it is appropriate to ask hospitals and clinicians to get this involved is beyond the scope of this column. What is clear is that society increasingly expects clinicians and hospitals to take responsibility for patients. This societal change has an impact on the lay public’s perception of what is expected of health care providers. Tomorrow’s juror comes to court with a belief that hospitals and clinicians owe a duty of care that extends beyond the walls of the exam room.

IN SUMMARY

Reality test your post-treatment instructions to be sure they will work for the patient and are not grossly incompatible with his or her known postdischarge environment. To the extent possible, involve discharge planning personnel in your practice. Let your record reflect that you are acting in the patient’s best interest, and evade the temptation to squint narrowly to avoid seeing circumstances in the patient’s life that prevent safe implementation of your plan.

In May 2014, a 70-year-old retiree underwent repair of a fracture of her left ankle. The procedure was performed at a local hospital. A splint was applied to the ankle, and a nurse provided crutches.

Following discharge from the hospital, the patient hailed a taxi to take her home. As she was exiting the taxi at her residence, the patient fell and sustained comminuted fractures to the distal radius and distal ulna of her right (dominant) wrist and a trimalleolar fracture to her repaired left ankle.

The plaintiff was transported back to the hospital via ambulance. She underwent closed reduction of her wrist fractures and 11 days later was transferred to another facility for open reduction and internal fixation of her left ankle fracture. Her hospitalizations totaled 13 days and were followed by a course of inpatient rehabilitative therapy; the latter lasted until late August 2014, with a brief interruption in June when she underwent open reduction and internal fixation of her wrist fractures. When she returned home in August, the patient required the assistance of visiting aides and 3 additional months of rehabilitative therapy.

At trial, the plaintiff claimed that her left ankle and her right wrist remained painful, that she sustained a mild residual diminution of each area’s range of motion, and that these residual effects hindered her performance of basic physical activities (eg, cleaning and cooking).

The plaintiff alleged that her fall while exiting the taxi resulted from unsteadiness, which was a lingering effect of morphine that was administered during the repair of her fracture. She sought recovery of damages for past and future pain and suffering from the hospital’s operator. The lawsuit alleged that the nurse had failed to provide instructions on the proper use of crutches, that the nurse had failed to undertake measures that would have diminished the plaintiff’s likelihood of falling, that the nurse’s failures constituted malpractice and negligence, and that the hospital operator was vicariously liable for the nurse’s actions.

The plaintiff claimed that she repeatedly warned that she did not believe that she could safely use the crutches provided by the nurse. She claimed that she was unsteady and lightheaded, and that when she requested a wheelchair, an escort, or an ambulance, the nurse rejected the request. The nursing standards expert for the plaintiff opined that the request should have been satisfied or alternatively, that the nurse should have explained the manner in which a crutch-dependent person could safely enter and exit a vehicle.

Defense counsel claimed that the nurse explained proper use of the crutches, the plaintiff indicated that she understood the explanation, and the plaintiff demonstrated proper use and did not express concern. The defense’s expert contended that the nurse did not have to explain how a crutch-dependent person could safely enter and exit a vehicle and that the plaintiff’s fall resulted from her own failure to exercise appropriate caution. The defense further contended that the plaintiff achieved an excellent recovery.

Continue to: After a 7-day trial...

After a 7-day trial and 3 hours and 45 minutes’ deliberation, the jury found in favor of the plaintiff. It found that the nurse was negligent in her provision of crutches and that the act was a substantial cause of the plaintiff’s injuries. The jury also found that the nurse did not properly explain the use of crutches but determined that the error was not a substantial cause of the plaintiff’s injuries.

VERDICT

The jury awarded the plaintiff a total of $850,000 in damages. The plaintiff also recovered stipulated medical expenses.

COMMENTARY

Medical malpractice litigation involves recovery for acts or omissions that constitute a departure from the standard of care. We all recognize injurious acts—improper esophageal intubation in the emergency department, transection of a nerve in the operating room, or prescription of a contraindicated medication to an allergic patient—and acknowledge damaging omissions, such as failure to screen for colon cancer or recognize treatable diabetes.

However, some cases are disposition related; they arise from how patients are discharged, what instructions they are given, where they go, and what they do after discharge. These cases involve the patient’s medical issues engrafted on his or her transportation, job, and more generally, living environment.

The lay public expects patients to have a right of self-determination, to control the nature and course of their medical care. Yet, the modern lay public also expects the medical profession to act as an authority figure—exercising a degree of paternalism to safeguard patients from harm. This expectation is commonly articulated in retrospect, after something has gone wrong. Consequently, clinicians must be aware of what will happen to the patient after discharge.

Continue to: With all interventions...

With all interventions, weigh the post-discharge consequences. If you give an injection of hydromorphone, you cannot discharge the patient to drive home 45 minutes later. If you have diagnosed vertigo in a patient, you cannot prescribe meclizine and return that patient to her job working on scaffolding 50 ft above ground. If a frail patient lives alone and cannot safely walk, and you’ve started him on furosemide, you cannot discharge him without considering how he will get to the bathroom. Other concerns are even more difficult—for example, the homeless patient who does not have the environment or resources to follow your instructions.

It is tempting to view these concerns as not our responsibility or dismiss them as “not medicine.” Clinicians can feel frustrated at being pulled into the realm of social work, where we are ill equipped to deal with and sort out the patient’s “life problems.” For one thing, we don’t often have the resources to deal with these issues. And for another, addressing the patient’s postdischarge living situation takes time—something in short supply and intangible to the other patients in the waiting room, who are expecting your attention and wondering, “What’s the holdup?”

In the case presented, the plaintiff was a 70-year-old retiree. She was discharged from the hospital with crutches. Crutches are age-old and familiar devices. Nevertheless, crutches are for people who are able to use their arms for weight bearing and propulsion and require a fair amount of physical strength, timing, and dexterity. While a potentially debatable point, an assumption that a 70-year-old patient has the arm strength and dexterity to properly propel herself with crutches may be faulty. There was disagreement between the patient, who claimed she could not safely use the crutches, and the nurse, who said the patient accepted the crutches without concern. The safest course of action would be for discharge personnel to demonstrate the use of crutches, observe the patient using the crutches, and document that in the record.

In this case, it is unclear if the nurse demonstrated how to use the crutches or witnessed the plaintiff demonstrating she could safely use them. The jury found the nurse was negligent “in her provision” of crutches—an act they deemed a substantial cause of the plaintiff’s injuries. Interestingly, the jury did not consider the lack of explanation on the crutches’ use to be a substantial cause of injury. But the bottom line is, they faulted the nurse for the act of giving this patient crutches and awarded $850,000 in damages.

Society is changing. Fifty years ago, jurors would expect people to be familiar with crutches, and if you fell while using them, that was your own fault. Modern jurors expect hospitals and providers to get more involved in what happens to a patient after discharge. The news media has heavily publicized cases of alleged “patient dumping.”

Continue to: As a result...

As a result, we see legislative changes, such as the recently passed California Senate Bill 1152, which requires that homeless patients be fed; provided weather-appropriate clothing, filled prescriptions, and vaccinations; given medical screening, examination, and evaluation that requires the “treating physician” to arrange behavioral health care; and enrolled in “any affordable health insurance coverage for which he or she is eligible.”

Whether it is appropriate to ask hospitals and clinicians to get this involved is beyond the scope of this column. What is clear is that society increasingly expects clinicians and hospitals to take responsibility for patients. This societal change has an impact on the lay public’s perception of what is expected of health care providers. Tomorrow’s juror comes to court with a belief that hospitals and clinicians owe a duty of care that extends beyond the walls of the exam room.

IN SUMMARY

Reality test your post-treatment instructions to be sure they will work for the patient and are not grossly incompatible with his or her known postdischarge environment. To the extent possible, involve discharge planning personnel in your practice. Let your record reflect that you are acting in the patient’s best interest, and evade the temptation to squint narrowly to avoid seeing circumstances in the patient’s life that prevent safe implementation of your plan.

A cell-free DNA (cfDNA) test, or “liquid biopsy,” identifies more biomarkers and does so more quickly than tissue-based genotyping for guiding treatment in newly diagnosed advanced non–small cell lung cancer (NSCLC), according to a finding from a prospective study.

In 282 patients with newly diagnosed advanced NSCLC who were enrolled in the multicenter Noninvasive versus Invasive Lung Evaluation (NILE) study between July 2016 and April 2018, the “well-validated, comprehensive, and highly sensitive test” – Guardant360 – detected at least one guideline-recommended biomarker mutation in significantly more cases than did tissue-based tests alone (77 vs. 60 patients), Vassiliki A. Papadimitrakopoulou, MD, reported during a press conference highlighting data to be presented at the upcoming American Association for Cancer Research annual meeting in Atlanta.

“Additionally, the cfDNA results were delivered significantly faster than the standard-of-care tissue results [median, 9 vs. 15 days],” said Dr. Papadimitrakopoulou, chief of the section of thoracic medical oncology and the Jay and Lori Eisenberg Distinguished Professor in the department of thoracic/head and neck medical oncology at the University of Texas MD Anderson Cancer Center, Houston.


Guardant360 assesses for all guideline-recommended genomic biomarkers, Dr. Papadimitrakopoulou said, noting that nine such biomarkers have been identified. All biomarkers identified using the liquid biopsy were also detected in tissue every time.

“Plasma cfDNA testing therefore had 100% positive predictive value,” she said.

This is important, because “we know that about 30% of patients with newly diagnosed advanced non–small lung cancer have therapeutically targetable genomic alterations that make them eligible for targeted therapies,” she said.

“Identifying these patients is important, as the response rate to the properly identified targeted therapy is higher than response rates to first-line chemotherapy or immune checkpoint inhibitor therapy,” she added, explaining that tissue-based assessment has long been the standard of care option for identifying genomic biomarkers, but is limited by the risks associated with the biopsy procedure, the inability to test for all relevant mutations, and the time it takes – up to 30 days – to obtain results.

“[The NILE] results have very exciting implications for clinical practice, especially in light of the expanding list of genomic biomarkers to be assessed,” she said, concluding that the findings from NILE – the largest study of newly diagnosed advanced NSCLC – demonstrate that the clinical utility of this well-validated, comprehensive, sensitive cfDNA test “is cardinal in identification of patients with guideline-recommended biomarker-positive tumors, and it is an alternative to SOC [standard of care] tissue testing in the first-line testing.”

Clinical follow-up of patients is ongoing, she noted.

This study was funded by Guardant Health. Dr. Papadimitrakopoulou serves on the advisory boards of several pharmaceutical companies. She reported receiving CME speaker fees from F. Hoffmann–La Roche, and has received research support from Eli Lilly, Novartis, Merck, AstraZeneca, F. Hoffmann–La Roche, Nektar Therapeutics, Janssen, Bristol-Myers Squibb, Checkmate, Incyte and Guardant Health.

SOURCE: Papadimitrakopoulou VA et al. AACR 2019, Abstract 4460..

A cell-free DNA (cfDNA) test, or “liquid biopsy,” identifies more biomarkers and does so more quickly than tissue-based genotyping for guiding treatment in newly diagnosed advanced non–small cell lung cancer (NSCLC), according to a finding from a prospective study.

In 282 patients with newly diagnosed advanced NSCLC who were enrolled in the multicenter Noninvasive versus Invasive Lung Evaluation (NILE) study between July 2016 and April 2018, the “well-validated, comprehensive, and highly sensitive test” – Guardant360 – detected at least one guideline-recommended biomarker mutation in significantly more cases than did tissue-based tests alone (77 vs. 60 patients), Vassiliki A. Papadimitrakopoulou, MD, reported during a press conference highlighting data to be presented at the upcoming American Association for Cancer Research annual meeting in Atlanta.

“Additionally, the cfDNA results were delivered significantly faster than the standard-of-care tissue results [median, 9 vs. 15 days],” said Dr. Papadimitrakopoulou, chief of the section of thoracic medical oncology and the Jay and Lori Eisenberg Distinguished Professor in the department of thoracic/head and neck medical oncology at the University of Texas MD Anderson Cancer Center, Houston.


Guardant360 assesses for all guideline-recommended genomic biomarkers, Dr. Papadimitrakopoulou said, noting that nine such biomarkers have been identified. All biomarkers identified using the liquid biopsy were also detected in tissue every time.

“Plasma cfDNA testing therefore had 100% positive predictive value,” she said.

This is important, because “we know that about 30% of patients with newly diagnosed advanced non–small lung cancer have therapeutically targetable genomic alterations that make them eligible for targeted therapies,” she said.

“Identifying these patients is important, as the response rate to the properly identified targeted therapy is higher than response rates to first-line chemotherapy or immune checkpoint inhibitor therapy,” she added, explaining that tissue-based assessment has long been the standard of care option for identifying genomic biomarkers, but is limited by the risks associated with the biopsy procedure, the inability to test for all relevant mutations, and the time it takes – up to 30 days – to obtain results.

“[The NILE] results have very exciting implications for clinical practice, especially in light of the expanding list of genomic biomarkers to be assessed,” she said, concluding that the findings from NILE – the largest study of newly diagnosed advanced NSCLC – demonstrate that the clinical utility of this well-validated, comprehensive, sensitive cfDNA test “is cardinal in identification of patients with guideline-recommended biomarker-positive tumors, and it is an alternative to SOC [standard of care] tissue testing in the first-line testing.”

Clinical follow-up of patients is ongoing, she noted.

This study was funded by Guardant Health. Dr. Papadimitrakopoulou serves on the advisory boards of several pharmaceutical companies. She reported receiving CME speaker fees from F. Hoffmann–La Roche, and has received research support from Eli Lilly, Novartis, Merck, AstraZeneca, F. Hoffmann–La Roche, Nektar Therapeutics, Janssen, Bristol-Myers Squibb, Checkmate, Incyte and Guardant Health.

SOURCE: Papadimitrakopoulou VA et al. AACR 2019, Abstract 4460..

A cell-free DNA (cfDNA) test, or “liquid biopsy,” identifies more biomarkers and does so more quickly than tissue-based genotyping for guiding treatment in newly diagnosed advanced non–small cell lung cancer (NSCLC), according to a finding from a prospective study.

In 282 patients with newly diagnosed advanced NSCLC who were enrolled in the multicenter Noninvasive versus Invasive Lung Evaluation (NILE) study between July 2016 and April 2018, the “well-validated, comprehensive, and highly sensitive test” – Guardant360 – detected at least one guideline-recommended biomarker mutation in significantly more cases than did tissue-based tests alone (77 vs. 60 patients), Vassiliki A. Papadimitrakopoulou, MD, reported during a press conference highlighting data to be presented at the upcoming American Association for Cancer Research annual meeting in Atlanta.

“Additionally, the cfDNA results were delivered significantly faster than the standard-of-care tissue results [median, 9 vs. 15 days],” said Dr. Papadimitrakopoulou, chief of the section of thoracic medical oncology and the Jay and Lori Eisenberg Distinguished Professor in the department of thoracic/head and neck medical oncology at the University of Texas MD Anderson Cancer Center, Houston.


Guardant360 assesses for all guideline-recommended genomic biomarkers, Dr. Papadimitrakopoulou said, noting that nine such biomarkers have been identified. All biomarkers identified using the liquid biopsy were also detected in tissue every time.

“Plasma cfDNA testing therefore had 100% positive predictive value,” she said.

This is important, because “we know that about 30% of patients with newly diagnosed advanced non–small lung cancer have therapeutically targetable genomic alterations that make them eligible for targeted therapies,” she said.

“Identifying these patients is important, as the response rate to the properly identified targeted therapy is higher than response rates to first-line chemotherapy or immune checkpoint inhibitor therapy,” she added, explaining that tissue-based assessment has long been the standard of care option for identifying genomic biomarkers, but is limited by the risks associated with the biopsy procedure, the inability to test for all relevant mutations, and the time it takes – up to 30 days – to obtain results.

“[The NILE] results have very exciting implications for clinical practice, especially in light of the expanding list of genomic biomarkers to be assessed,” she said, concluding that the findings from NILE – the largest study of newly diagnosed advanced NSCLC – demonstrate that the clinical utility of this well-validated, comprehensive, sensitive cfDNA test “is cardinal in identification of patients with guideline-recommended biomarker-positive tumors, and it is an alternative to SOC [standard of care] tissue testing in the first-line testing.”

Clinical follow-up of patients is ongoing, she noted.

This study was funded by Guardant Health. Dr. Papadimitrakopoulou serves on the advisory boards of several pharmaceutical companies. She reported receiving CME speaker fees from F. Hoffmann–La Roche, and has received research support from Eli Lilly, Novartis, Merck, AstraZeneca, F. Hoffmann–La Roche, Nektar Therapeutics, Janssen, Bristol-Myers Squibb, Checkmate, Incyte and Guardant Health.

SOURCE: Papadimitrakopoulou VA et al. AACR 2019, Abstract 4460..

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m² from the current60 mL/min per 1.73 m².

The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m² who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

[email protected]

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m² from the current60 mL/min per 1.73 m².

The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m² who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

[email protected]

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m² from the current60 mL/min per 1.73 m².

The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m² who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

[email protected]

The FP was concerned that this could be melanoma.

He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)

During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP was concerned that this could be melanoma.

He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)

During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP was concerned that this could be melanoma.

He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)

During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Primary care physician growth trails population growth, and it could impact U.S. life expectancy. Opportunities are being missed for advance care planning for elderly ICU patients. Insulin-treated diabetes in pregnancy carries a strong preterm risk. And U.S. measles cases are up to 159 for the year.

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Primary care physician growth trails population growth, and it could impact U.S. life expectancy. Opportunities are being missed for advance care planning for elderly ICU patients. Insulin-treated diabetes in pregnancy carries a strong preterm risk. And U.S. measles cases are up to 159 for the year.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify

Primary care physician growth trails population growth, and it could impact U.S. life expectancy. Opportunities are being missed for advance care planning for elderly ICU patients. Insulin-treated diabetes in pregnancy carries a strong preterm risk. And U.S. measles cases are up to 159 for the year.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

Pain is becoming a fact of life for more and more people, and they are turning to opioids to treat it, according to a survey sponsored by the National Center for Complementary and Integrative Health.

Researchers looked at nearly 2 decades-worth of cumulative data from the Medical Expenditure Panel Survey (MEPS). They found that since 1997/1998, pain prevalence in US adults rose by 25%.

In 1997/1998, about 33% of American adults had at ≤ 1 painful health condition. In 2013/2014, that proportion was 41%. For about 68 million people, moderate-to-severe pain was interfering with normal work activities. And those people were turning more often to strong opioids—eg, fentanyl, morphine, oxycodone—for help. Use of opioids to manage pain more than doubled in just 10 years: from 4.1 million (11.5%) in 2001/2002 to 10.5 million (24.3%) in 2013/2014.

People with severe pain-related interference also were more likely to have had > 4 opioid prescriptions and to have visited a doctor’s office > 6 times for pain compared with those with minimal pain-related interference.

Opioid use peaked between 2005 and 2012, but since 2012, opioid use has slightly declined. The researchers say this ties to a reduction in use of weak opioids and in the number of patients reporting only 1 opioid prescription.

The survey also found some small downward shifts in health care visits. Ambulatory office visits plateaued between 2001/2002 and 2007/2008 and decreased through 2013/2014. The researchers also found small but statistically significant drops in pain-related emergency department visits and overnight hospital stays.

The researchers say their findings suggest more education about the risk/benefit ratio of opioids “appears warranted.”

Pain is becoming a fact of life for more and more people, and they are turning to opioids to treat it, according to a survey sponsored by the National Center for Complementary and Integrative Health.

Researchers looked at nearly 2 decades-worth of cumulative data from the Medical Expenditure Panel Survey (MEPS). They found that since 1997/1998, pain prevalence in US adults rose by 25%.

In 1997/1998, about 33% of American adults had at ≤ 1 painful health condition. In 2013/2014, that proportion was 41%. For about 68 million people, moderate-to-severe pain was interfering with normal work activities. And those people were turning more often to strong opioids—eg, fentanyl, morphine, oxycodone—for help. Use of opioids to manage pain more than doubled in just 10 years: from 4.1 million (11.5%) in 2001/2002 to 10.5 million (24.3%) in 2013/2014.

People with severe pain-related interference also were more likely to have had > 4 opioid prescriptions and to have visited a doctor’s office > 6 times for pain compared with those with minimal pain-related interference.

Opioid use peaked between 2005 and 2012, but since 2012, opioid use has slightly declined. The researchers say this ties to a reduction in use of weak opioids and in the number of patients reporting only 1 opioid prescription.

The survey also found some small downward shifts in health care visits. Ambulatory office visits plateaued between 2001/2002 and 2007/2008 and decreased through 2013/2014. The researchers also found small but statistically significant drops in pain-related emergency department visits and overnight hospital stays.

The researchers say their findings suggest more education about the risk/benefit ratio of opioids “appears warranted.”

Pain is becoming a fact of life for more and more people, and they are turning to opioids to treat it, according to a survey sponsored by the National Center for Complementary and Integrative Health.

Researchers looked at nearly 2 decades-worth of cumulative data from the Medical Expenditure Panel Survey (MEPS). They found that since 1997/1998, pain prevalence in US adults rose by 25%.

In 1997/1998, about 33% of American adults had at ≤ 1 painful health condition. In 2013/2014, that proportion was 41%. For about 68 million people, moderate-to-severe pain was interfering with normal work activities. And those people were turning more often to strong opioids—eg, fentanyl, morphine, oxycodone—for help. Use of opioids to manage pain more than doubled in just 10 years: from 4.1 million (11.5%) in 2001/2002 to 10.5 million (24.3%) in 2013/2014.

People with severe pain-related interference also were more likely to have had > 4 opioid prescriptions and to have visited a doctor’s office > 6 times for pain compared with those with minimal pain-related interference.

Opioid use peaked between 2005 and 2012, but since 2012, opioid use has slightly declined. The researchers say this ties to a reduction in use of weak opioids and in the number of patients reporting only 1 opioid prescription.

The survey also found some small downward shifts in health care visits. Ambulatory office visits plateaued between 2001/2002 and 2007/2008 and decreased through 2013/2014. The researchers also found small but statistically significant drops in pain-related emergency department visits and overnight hospital stays.

The researchers say their findings suggest more education about the risk/benefit ratio of opioids “appears warranted.”

SAN DIEGO – A new study of ICU patients in the Netherlands shows a heightened risk of developing new chronic conditions in patients after an intensive care stay. The research showed rising likelihood of conditions such as depression, diabetes, and heart disease.

By merging two existing databases, the researchers were able to capture a more comprehensive picture of post-ICU patients. “We were able to include almost the entire country,” Ilse van Beusekom, a PhD candidate in health sciences at the University of Amsterdam and data manager at the National Intensive Care Evaluation (NICE) foundation, said in an interview.

Ms. van Beusekom presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published in Critical Care Medicine.

The work compared 56,760 ICU survivors from 81 facilities across the Netherlands to 75,232 age-, sex-, and socioeconomic status–matched controls. The mean age was 65 years and 60% of the population was male. “The types of chronic conditions are the same, only the prevalences are different,” said Ms. van Beusekom.

The researchers compared chronic conditions in the year before ICU admission and the year after, based on data pulled from the NICE national quality database, which includes data describing the first 24 hours of ICU admission, and the Vektis insurance claims database, which includes information on medical treatment. Before ICU admission, 45% of the ICU population was free of chronic conditions, as were 62% of controls. One chronic condition was present in 36% of ICU patients, versus 29% of controls, and two or more conditions were present in 19% versus 9% of controls.

The ICU population was more likely to have high cholesterol (16% vs. 14%), heart disease (14% vs. 6%), chronic obstructive pulmonary disease (8% vs. 3%), type II diabetes (8% vs. 6%), type I diabetes (6% vs. 3%), and depression (6% vs. 4%).

The ICU population also was at greater risk of developing one or more new chronic conditions during the year following their stay. The risk was three- to fourfold higher throughout age ranges.

The study suggests the need for greater follow-up after an ICU admission in order to help patients cope with lingering problems. Ms. van Beusekom noted that there are follow-up programs in the Netherlands for several patient groups, but none for ICU survivors. One possibility would be to have the patient return to the ICU 3 months or so after release to discuss their diagnosis, treatment, and any lingering concerns. “A lot of people don’t know that their complaints are linked with the ICU visit,” said Ms. van Beusekom.

Timothy G. Buchman, MD, professor of surgery at Emory University, Atlanta, who moderated the session, wondered why the ICU seems to be an inflection point for developing new chronic conditions. Could it simply be because patients are sicker to begin with and have reached an inflection point of their illness, or could the treatments in ICU be contributing to or exposing those conditions? Ms. van Beusekom believed it was likely a combination of factors, and she referred to data she had not presented showing that even control patients who had been to the hospital (though not the ICU) during the study period were at lower risk of new chronic conditions than ICU patients.

Ms. van Beusekom’s group plans to investigate ICU-related variables that might be associated with risk of chronic conditions.

The study was not funded. Ms. van Beusekom had no relevant disclosures.

SOURCE: van Beusekom I et al. CCC48, Abstract Crit Care Med. 2019;47:324-30.

SAN DIEGO – A new study of ICU patients in the Netherlands shows a heightened risk of developing new chronic conditions in patients after an intensive care stay. The research showed rising likelihood of conditions such as depression, diabetes, and heart disease.

By merging two existing databases, the researchers were able to capture a more comprehensive picture of post-ICU patients. “We were able to include almost the entire country,” Ilse van Beusekom, a PhD candidate in health sciences at the University of Amsterdam and data manager at the National Intensive Care Evaluation (NICE) foundation, said in an interview.

Ms. van Beusekom presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published in Critical Care Medicine.

The work compared 56,760 ICU survivors from 81 facilities across the Netherlands to 75,232 age-, sex-, and socioeconomic status–matched controls. The mean age was 65 years and 60% of the population was male. “The types of chronic conditions are the same, only the prevalences are different,” said Ms. van Beusekom.

The researchers compared chronic conditions in the year before ICU admission and the year after, based on data pulled from the NICE national quality database, which includes data describing the first 24 hours of ICU admission, and the Vektis insurance claims database, which includes information on medical treatment. Before ICU admission, 45% of the ICU population was free of chronic conditions, as were 62% of controls. One chronic condition was present in 36% of ICU patients, versus 29% of controls, and two or more conditions were present in 19% versus 9% of controls.

The ICU population was more likely to have high cholesterol (16% vs. 14%), heart disease (14% vs. 6%), chronic obstructive pulmonary disease (8% vs. 3%), type II diabetes (8% vs. 6%), type I diabetes (6% vs. 3%), and depression (6% vs. 4%).

The ICU population also was at greater risk of developing one or more new chronic conditions during the year following their stay. The risk was three- to fourfold higher throughout age ranges.

The study suggests the need for greater follow-up after an ICU admission in order to help patients cope with lingering problems. Ms. van Beusekom noted that there are follow-up programs in the Netherlands for several patient groups, but none for ICU survivors. One possibility would be to have the patient return to the ICU 3 months or so after release to discuss their diagnosis, treatment, and any lingering concerns. “A lot of people don’t know that their complaints are linked with the ICU visit,” said Ms. van Beusekom.

Timothy G. Buchman, MD, professor of surgery at Emory University, Atlanta, who moderated the session, wondered why the ICU seems to be an inflection point for developing new chronic conditions. Could it simply be because patients are sicker to begin with and have reached an inflection point of their illness, or could the treatments in ICU be contributing to or exposing those conditions? Ms. van Beusekom believed it was likely a combination of factors, and she referred to data she had not presented showing that even control patients who had been to the hospital (though not the ICU) during the study period were at lower risk of new chronic conditions than ICU patients.

Ms. van Beusekom’s group plans to investigate ICU-related variables that might be associated with risk of chronic conditions.

The study was not funded. Ms. van Beusekom had no relevant disclosures.

SOURCE: van Beusekom I et al. CCC48, Abstract Crit Care Med. 2019;47:324-30.

SAN DIEGO – A new study of ICU patients in the Netherlands shows a heightened risk of developing new chronic conditions in patients after an intensive care stay. The research showed rising likelihood of conditions such as depression, diabetes, and heart disease.

By merging two existing databases, the researchers were able to capture a more comprehensive picture of post-ICU patients. “We were able to include almost the entire country,” Ilse van Beusekom, a PhD candidate in health sciences at the University of Amsterdam and data manager at the National Intensive Care Evaluation (NICE) foundation, said in an interview.

Ms. van Beusekom presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published in Critical Care Medicine.

The work compared 56,760 ICU survivors from 81 facilities across the Netherlands to 75,232 age-, sex-, and socioeconomic status–matched controls. The mean age was 65 years and 60% of the population was male. “The types of chronic conditions are the same, only the prevalences are different,” said Ms. van Beusekom.

The researchers compared chronic conditions in the year before ICU admission and the year after, based on data pulled from the NICE national quality database, which includes data describing the first 24 hours of ICU admission, and the Vektis insurance claims database, which includes information on medical treatment. Before ICU admission, 45% of the ICU population was free of chronic conditions, as were 62% of controls. One chronic condition was present in 36% of ICU patients, versus 29% of controls, and two or more conditions were present in 19% versus 9% of controls.

The ICU population was more likely to have high cholesterol (16% vs. 14%), heart disease (14% vs. 6%), chronic obstructive pulmonary disease (8% vs. 3%), type II diabetes (8% vs. 6%), type I diabetes (6% vs. 3%), and depression (6% vs. 4%).

The ICU population also was at greater risk of developing one or more new chronic conditions during the year following their stay. The risk was three- to fourfold higher throughout age ranges.

The study suggests the need for greater follow-up after an ICU admission in order to help patients cope with lingering problems. Ms. van Beusekom noted that there are follow-up programs in the Netherlands for several patient groups, but none for ICU survivors. One possibility would be to have the patient return to the ICU 3 months or so after release to discuss their diagnosis, treatment, and any lingering concerns. “A lot of people don’t know that their complaints are linked with the ICU visit,” said Ms. van Beusekom.

Timothy G. Buchman, MD, professor of surgery at Emory University, Atlanta, who moderated the session, wondered why the ICU seems to be an inflection point for developing new chronic conditions. Could it simply be because patients are sicker to begin with and have reached an inflection point of their illness, or could the treatments in ICU be contributing to or exposing those conditions? Ms. van Beusekom believed it was likely a combination of factors, and she referred to data she had not presented showing that even control patients who had been to the hospital (though not the ICU) during the study period were at lower risk of new chronic conditions than ICU patients.

Ms. van Beusekom’s group plans to investigate ICU-related variables that might be associated with risk of chronic conditions.

The study was not funded. Ms. van Beusekom had no relevant disclosures.

SOURCE: van Beusekom I et al. CCC48, Abstract Crit Care Med. 2019;47:324-30.

Hemodynamic complications of arteriovenous (AV) access are uncommon but can be potentially life threatening. Fistulas and grafts can cause a decrease in systemic vascular resistance and secondary increase in cardiac output in patients who may already have myocardial dysfunction secondary to their end-stage renal disease.¹ This increased cardiac output is usually insignificant but in rare cases can result in clinically significant cardiac failure. Patients with high-output fistulas with volume flow greater than 2 L/min may be at increased risk of heart failure but volume flow less than 2 L/min does not preclude this complication.²

In patients with AV access–related heart failure, optimal medical management and reduction of fistula flow or ligation of the dialysis access should be considered. If continued hemodialysis is necessary, loss of a functioning dialysis access is problematic and difficult management decisions must be made. Following successful renal transplantation, ligation of vascular access in the presence of symptomatic heart failure may represent a straightforward decision. Nonetheless, there is no clear consensus of how to manage patent fistulas or grafts in patients following renal transplantation in the absence of significant cardiac symptoms with particular concern to the important issues of transplant survival and long-term cardiac prognosis. Yaffe and Greenstein³ recommend preservation of almost all fistulas after transplantation in the absence of significant complications such as venous hypertension, pseudoaneurysm, significant high-output cardiac failure or hand ischemia. They recommend taking into account the 10-year adjusted renal transplantation graft survival rates and the relative paucity of donors, recognizing the possibility that the patient may have to return to dialysis at some point in the future. They also reference the lack of information regarding the beneficial impact of fistula ligation on cardiac morphology and function as a rationale for access preservation.

A recent presentation at the American Heart Association Scientific Sessions by Michael B. Stokes, MD,⁴ from the department of cardiology at Royal Adelaide Hospital in Australia, suggests that cardiovascular disease is responsible for 40% of deaths among kidney transplant recipients and that left ventricular (LV) mass is strongly associated with cardiovascular mortality.

He states that, although there is no guideline consensus on the management of an AV fistula following successful renal transplantation, the fistula continues to contribute adversely to cardiac remodeling and function. The lack of previous randomized controlled trials in this area led Dr. Stokes and his colleagues to randomly assign 64 patients at least 1 year following successful kidney transplantation with stable renal function and a functioning AV fistula to either fistula ligation or no intervention. All patients underwent cardiac MRI at baseline and 6 months.

The primary endpoint of decrease in LV mass at 6 months was significant in the ligation group but not in the control group. The ligation group also had significant decrease in LV end diastolic volume, LV end systolic volume, and multiple other parameters. In addition, NT-proBNP levels and left atrial volume were significantly reduced in the ligation group when compared with the control group. Complications in the ligation group included six patients with thrombosis of their fistula vein and two infections, all of which resolved with outpatient anti-inflammatory or antimicrobial therapy.

Dr. Stokes believes that control patients in his study face “persisting and substantial deleterious cardiac remodeling” and that “further investigation would clarify the impact of AV fistula ligation on clinical outcomes following kidney transplantation.”

I believe this is important information and represents the first randomized controlled data regarding the long-term adverse cardiac effects of a patent fistula after renal transplantation. Unfortunately, information regarding baseline fistula volume flow is not provided in this abstract. As discussed earlier, patients with high-flow fistulas may be at increased risk of heart failure and hemodynamic data can be critical in establishing an algorithm for managing these challenging patients.

Ligation of a functioning and asymptomatic access in a patient with a successful renal transplant should be recommended only after informed discussion with the patient weighing the ongoing potential negative effects on cardiac function of continued access patency versus the potential need for future hemodialysis. Dr. Stokes presents interesting data that must be considered in this controversy. I believe that, in the absence of a universally applicable algorithm, the clinical decision to recommend AV fistula ligation after successful kidney transplantation should be individualized and based on ongoing assessment of cardiac and renal function and fistula complications and hemodynamics.

References

1. Eur Heart J 2017;38:1913-23.

2. Nephrol Dial Transplant 2008;23:282-7.

3. J Vasc Access 2012;13:405-8.

4. Stokes MB, et al. LBS.05 – Late Breaking Clinical Trial: Hot News in HF. Presented at American Heart Association Scientific Sessions. 2018 Nov 10-12. Chicago.
 

Larry A. Scher, MD, is a vascular surgeon at the Montefiore Greene Medical Arts Pavilion, New York, and an associate medical editor for Vascular Specialist.

Hemodynamic complications of arteriovenous (AV) access are uncommon but can be potentially life threatening. Fistulas and grafts can cause a decrease in systemic vascular resistance and secondary increase in cardiac output in patients who may already have myocardial dysfunction secondary to their end-stage renal disease.¹ This increased cardiac output is usually insignificant but in rare cases can result in clinically significant cardiac failure. Patients with high-output fistulas with volume flow greater than 2 L/min may be at increased risk of heart failure but volume flow less than 2 L/min does not preclude this complication.²

In patients with AV access–related heart failure, optimal medical management and reduction of fistula flow or ligation of the dialysis access should be considered. If continued hemodialysis is necessary, loss of a functioning dialysis access is problematic and difficult management decisions must be made. Following successful renal transplantation, ligation of vascular access in the presence of symptomatic heart failure may represent a straightforward decision. Nonetheless, there is no clear consensus of how to manage patent fistulas or grafts in patients following renal transplantation in the absence of significant cardiac symptoms with particular concern to the important issues of transplant survival and long-term cardiac prognosis. Yaffe and Greenstein³ recommend preservation of almost all fistulas after transplantation in the absence of significant complications such as venous hypertension, pseudoaneurysm, significant high-output cardiac failure or hand ischemia. They recommend taking into account the 10-year adjusted renal transplantation graft survival rates and the relative paucity of donors, recognizing the possibility that the patient may have to return to dialysis at some point in the future. They also reference the lack of information regarding the beneficial impact of fistula ligation on cardiac morphology and function as a rationale for access preservation.

A recent presentation at the American Heart Association Scientific Sessions by Michael B. Stokes, MD,⁴ from the department of cardiology at Royal Adelaide Hospital in Australia, suggests that cardiovascular disease is responsible for 40% of deaths among kidney transplant recipients and that left ventricular (LV) mass is strongly associated with cardiovascular mortality.

He states that, although there is no guideline consensus on the management of an AV fistula following successful renal transplantation, the fistula continues to contribute adversely to cardiac remodeling and function. The lack of previous randomized controlled trials in this area led Dr. Stokes and his colleagues to randomly assign 64 patients at least 1 year following successful kidney transplantation with stable renal function and a functioning AV fistula to either fistula ligation or no intervention. All patients underwent cardiac MRI at baseline and 6 months.

The primary endpoint of decrease in LV mass at 6 months was significant in the ligation group but not in the control group. The ligation group also had significant decrease in LV end diastolic volume, LV end systolic volume, and multiple other parameters. In addition, NT-proBNP levels and left atrial volume were significantly reduced in the ligation group when compared with the control group. Complications in the ligation group included six patients with thrombosis of their fistula vein and two infections, all of which resolved with outpatient anti-inflammatory or antimicrobial therapy.

Dr. Stokes believes that control patients in his study face “persisting and substantial deleterious cardiac remodeling” and that “further investigation would clarify the impact of AV fistula ligation on clinical outcomes following kidney transplantation.”

I believe this is important information and represents the first randomized controlled data regarding the long-term adverse cardiac effects of a patent fistula after renal transplantation. Unfortunately, information regarding baseline fistula volume flow is not provided in this abstract. As discussed earlier, patients with high-flow fistulas may be at increased risk of heart failure and hemodynamic data can be critical in establishing an algorithm for managing these challenging patients.

Ligation of a functioning and asymptomatic access in a patient with a successful renal transplant should be recommended only after informed discussion with the patient weighing the ongoing potential negative effects on cardiac function of continued access patency versus the potential need for future hemodialysis. Dr. Stokes presents interesting data that must be considered in this controversy. I believe that, in the absence of a universally applicable algorithm, the clinical decision to recommend AV fistula ligation after successful kidney transplantation should be individualized and based on ongoing assessment of cardiac and renal function and fistula complications and hemodynamics.

References

1. Eur Heart J 2017;38:1913-23.

2. Nephrol Dial Transplant 2008;23:282-7.

3. J Vasc Access 2012;13:405-8.

4. Stokes MB, et al. LBS.05 – Late Breaking Clinical Trial: Hot News in HF. Presented at American Heart Association Scientific Sessions. 2018 Nov 10-12. Chicago.
 

Larry A. Scher, MD, is a vascular surgeon at the Montefiore Greene Medical Arts Pavilion, New York, and an associate medical editor for Vascular Specialist.

Hemodynamic complications of arteriovenous (AV) access are uncommon but can be potentially life threatening. Fistulas and grafts can cause a decrease in systemic vascular resistance and secondary increase in cardiac output in patients who may already have myocardial dysfunction secondary to their end-stage renal disease.¹ This increased cardiac output is usually insignificant but in rare cases can result in clinically significant cardiac failure. Patients with high-output fistulas with volume flow greater than 2 L/min may be at increased risk of heart failure but volume flow less than 2 L/min does not preclude this complication.²

In patients with AV access–related heart failure, optimal medical management and reduction of fistula flow or ligation of the dialysis access should be considered. If continued hemodialysis is necessary, loss of a functioning dialysis access is problematic and difficult management decisions must be made. Following successful renal transplantation, ligation of vascular access in the presence of symptomatic heart failure may represent a straightforward decision. Nonetheless, there is no clear consensus of how to manage patent fistulas or grafts in patients following renal transplantation in the absence of significant cardiac symptoms with particular concern to the important issues of transplant survival and long-term cardiac prognosis. Yaffe and Greenstein³ recommend preservation of almost all fistulas after transplantation in the absence of significant complications such as venous hypertension, pseudoaneurysm, significant high-output cardiac failure or hand ischemia. They recommend taking into account the 10-year adjusted renal transplantation graft survival rates and the relative paucity of donors, recognizing the possibility that the patient may have to return to dialysis at some point in the future. They also reference the lack of information regarding the beneficial impact of fistula ligation on cardiac morphology and function as a rationale for access preservation.

A recent presentation at the American Heart Association Scientific Sessions by Michael B. Stokes, MD,⁴ from the department of cardiology at Royal Adelaide Hospital in Australia, suggests that cardiovascular disease is responsible for 40% of deaths among kidney transplant recipients and that left ventricular (LV) mass is strongly associated with cardiovascular mortality.

He states that, although there is no guideline consensus on the management of an AV fistula following successful renal transplantation, the fistula continues to contribute adversely to cardiac remodeling and function. The lack of previous randomized controlled trials in this area led Dr. Stokes and his colleagues to randomly assign 64 patients at least 1 year following successful kidney transplantation with stable renal function and a functioning AV fistula to either fistula ligation or no intervention. All patients underwent cardiac MRI at baseline and 6 months.

The primary endpoint of decrease in LV mass at 6 months was significant in the ligation group but not in the control group. The ligation group also had significant decrease in LV end diastolic volume, LV end systolic volume, and multiple other parameters. In addition, NT-proBNP levels and left atrial volume were significantly reduced in the ligation group when compared with the control group. Complications in the ligation group included six patients with thrombosis of their fistula vein and two infections, all of which resolved with outpatient anti-inflammatory or antimicrobial therapy.

Dr. Stokes believes that control patients in his study face “persisting and substantial deleterious cardiac remodeling” and that “further investigation would clarify the impact of AV fistula ligation on clinical outcomes following kidney transplantation.”

I believe this is important information and represents the first randomized controlled data regarding the long-term adverse cardiac effects of a patent fistula after renal transplantation. Unfortunately, information regarding baseline fistula volume flow is not provided in this abstract. As discussed earlier, patients with high-flow fistulas may be at increased risk of heart failure and hemodynamic data can be critical in establishing an algorithm for managing these challenging patients.

Ligation of a functioning and asymptomatic access in a patient with a successful renal transplant should be recommended only after informed discussion with the patient weighing the ongoing potential negative effects on cardiac function of continued access patency versus the potential need for future hemodialysis. Dr. Stokes presents interesting data that must be considered in this controversy. I believe that, in the absence of a universally applicable algorithm, the clinical decision to recommend AV fistula ligation after successful kidney transplantation should be individualized and based on ongoing assessment of cardiac and renal function and fistula complications and hemodynamics.

References

1. Eur Heart J 2017;38:1913-23.

2. Nephrol Dial Transplant 2008;23:282-7.

3. J Vasc Access 2012;13:405-8.

4. Stokes MB, et al. LBS.05 – Late Breaking Clinical Trial: Hot News in HF. Presented at American Heart Association Scientific Sessions. 2018 Nov 10-12. Chicago.
 

Larry A. Scher, MD, is a vascular surgeon at the Montefiore Greene Medical Arts Pavilion, New York, and an associate medical editor for Vascular Specialist.

Lymphadenectomy in women with advanced ovarian cancer and normal lymph nodes does not appear to improve overall or progression-free survival, according to a randomized trial of 647 women with newly-diagnosed advanced ovarian cancer who were undergoing macroscopically complete resection.

The women were randomized during the resection to either undergo systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy. The study excluded women with obvious node involvement.

The median overall survival rates were similar between the two groups; 65.5 months in the lymphadenectomy group and 69.2 months in the no-lymphadenectomy group (HR 1.06, P = .65). There was also no significant difference between the two groups in median progression-free survival, which was 25.5 months in both.

While overall quality of life was similar between the two groups, there were some significant points of difference. Patients who underwent lymphadenectomy experienced significantly longer surgical times, and greater median blood loss, which in turn led to a higher rate of blood transfusions and higher rate of postoperative admission to intensive care.

The 60-day mortality rates were also significantly higher among the lymphadenectomy group – 3.1% vs. 0.9% (P = .049) – as was the rate of repeat laparotomies for complications (12.4% vs. 6.5%, P = .01), mainly due to bowel leakage or fistula.

While systematic pelvic and para-aortic lymphadenectomy is often used in patients with advanced ovarian cancer, there is limited evidence in its favor from randomized clinical trials, wrote Philipp Harter, MD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte, Germany, and his coauthors. The report is in the New England Journal of Medicine

“In this trial, patients with advanced ovarian cancer who underwent macroscopically complete resection did not benefit from systematic lymphadenectomy,” the authors wrote. “In contrast, lymphadenectomy resulted in treatment burden and harm to patients.”

The research group also tried to account for the level of surgical experience in each of the 52 centers involved in the study, and found no difference in treatment outcomes between high-recruiting centers and low-recruiting centers. All the centers also had to demonstrate their proficiency with the lymphadenectomy procedure before participating in the study.

“Accordingly, the quality of surgery and the numbers of resected lymph nodes were higher than in previous gynecologic oncologic clinical trials analyzing this issue,” they wrote.

The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.

SOURCE: Harter P et al. N Engl J Med. 2019 Feb 27 doi: 10.1056/NEJMoa1808424.

Lymphadenectomy in women with advanced ovarian cancer and normal lymph nodes does not appear to improve overall or progression-free survival, according to a randomized trial of 647 women with newly-diagnosed advanced ovarian cancer who were undergoing macroscopically complete resection.

The women were randomized during the resection to either undergo systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy. The study excluded women with obvious node involvement.

The median overall survival rates were similar between the two groups; 65.5 months in the lymphadenectomy group and 69.2 months in the no-lymphadenectomy group (HR 1.06, P = .65). There was also no significant difference between the two groups in median progression-free survival, which was 25.5 months in both.

While overall quality of life was similar between the two groups, there were some significant points of difference. Patients who underwent lymphadenectomy experienced significantly longer surgical times, and greater median blood loss, which in turn led to a higher rate of blood transfusions and higher rate of postoperative admission to intensive care.

The 60-day mortality rates were also significantly higher among the lymphadenectomy group – 3.1% vs. 0.9% (P = .049) – as was the rate of repeat laparotomies for complications (12.4% vs. 6.5%, P = .01), mainly due to bowel leakage or fistula.

While systematic pelvic and para-aortic lymphadenectomy is often used in patients with advanced ovarian cancer, there is limited evidence in its favor from randomized clinical trials, wrote Philipp Harter, MD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte, Germany, and his coauthors. The report is in the New England Journal of Medicine

“In this trial, patients with advanced ovarian cancer who underwent macroscopically complete resection did not benefit from systematic lymphadenectomy,” the authors wrote. “In contrast, lymphadenectomy resulted in treatment burden and harm to patients.”

The research group also tried to account for the level of surgical experience in each of the 52 centers involved in the study, and found no difference in treatment outcomes between high-recruiting centers and low-recruiting centers. All the centers also had to demonstrate their proficiency with the lymphadenectomy procedure before participating in the study.

“Accordingly, the quality of surgery and the numbers of resected lymph nodes were higher than in previous gynecologic oncologic clinical trials analyzing this issue,” they wrote.

The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.

SOURCE: Harter P et al. N Engl J Med. 2019 Feb 27 doi: 10.1056/NEJMoa1808424.

Lymphadenectomy in women with advanced ovarian cancer and normal lymph nodes does not appear to improve overall or progression-free survival, according to a randomized trial of 647 women with newly-diagnosed advanced ovarian cancer who were undergoing macroscopically complete resection.

The women were randomized during the resection to either undergo systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy. The study excluded women with obvious node involvement.

The median overall survival rates were similar between the two groups; 65.5 months in the lymphadenectomy group and 69.2 months in the no-lymphadenectomy group (HR 1.06, P = .65). There was also no significant difference between the two groups in median progression-free survival, which was 25.5 months in both.

While overall quality of life was similar between the two groups, there were some significant points of difference. Patients who underwent lymphadenectomy experienced significantly longer surgical times, and greater median blood loss, which in turn led to a higher rate of blood transfusions and higher rate of postoperative admission to intensive care.

The 60-day mortality rates were also significantly higher among the lymphadenectomy group – 3.1% vs. 0.9% (P = .049) – as was the rate of repeat laparotomies for complications (12.4% vs. 6.5%, P = .01), mainly due to bowel leakage or fistula.

While systematic pelvic and para-aortic lymphadenectomy is often used in patients with advanced ovarian cancer, there is limited evidence in its favor from randomized clinical trials, wrote Philipp Harter, MD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte, Germany, and his coauthors. The report is in the New England Journal of Medicine

“In this trial, patients with advanced ovarian cancer who underwent macroscopically complete resection did not benefit from systematic lymphadenectomy,” the authors wrote. “In contrast, lymphadenectomy resulted in treatment burden and harm to patients.”

The research group also tried to account for the level of surgical experience in each of the 52 centers involved in the study, and found no difference in treatment outcomes between high-recruiting centers and low-recruiting centers. All the centers also had to demonstrate their proficiency with the lymphadenectomy procedure before participating in the study.

“Accordingly, the quality of surgery and the numbers of resected lymph nodes were higher than in previous gynecologic oncologic clinical trials analyzing this issue,” they wrote.

The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.

SOURCE: Harter P et al. N Engl J Med. 2019 Feb 27 doi: 10.1056/NEJMoa1808424.