Thoracic Surgery News (Archived)

CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

[email protected]

On Twitter @karioakes

CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

[email protected]

On Twitter @karioakes

CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.

Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.

[email protected]

On Twitter @karioakes

After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).

“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”

The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.

In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.

However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.

In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).

“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.

“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.

Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.

Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).

“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”

The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.

After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).

“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”

The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.

In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.

However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.

In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).

“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.

“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.

Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.

Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).

“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”

The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.

After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).

“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”

The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.

In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.

However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.

In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).

“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.

“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.

Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.

Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).

“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”

The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.

Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.

In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).

Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.

In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).

Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.

In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).

In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.

In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).

In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.

One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.

“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.

Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.

On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”

Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.

In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.

Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.

Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.

Dr. Tulzer and coauthors had no financial relationships to disclose.

In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.

In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).

In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.

One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.

“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.

Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.

On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”

Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.

In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.

Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.

Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.

Dr. Tulzer and coauthors had no financial relationships to disclose.

In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.

In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).

In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.

One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.

“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.

Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.

On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”

Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.

In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.

Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.

Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.

Dr. Tulzer and coauthors had no financial relationships to disclose.

VIENNA – Patients with metastatic non–small-cell lung cancer with high levels of PD-L1 who received first-line pembrolizumab treatment had clinically meaningful improvement in their quality of life, compared with patients randomized to chemotherapy, in a prespecified secondary analysis of data from the drug’s pivotal trial.

This boost in quality of life as well as other measures of health status add to the pivotal trial’s primary finding of significantly increased progression-free survival compared with chemotherapy, as well as previously-reported secondary findings of superior overall survival, objective response rate, and safety with pembrolizumab compared with chemotherapy (N Engl J Med. 2016 Nov 10;375[19]:1823-33), Julie R. Brahmer, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.

The primary endpoint of the Study of Pembrolizumab Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non–Small Cell Lung Cancer (KEYNOTE-024) showed an average 4.3-month increase in progression-free survival with pembrolizumab immunotherapy, compared with a standard chemotherapy regimen.

Improved quality of life on top of improved efficacy and safety is an important added benefit from pembrolizumab that should further spur its widespread adoption as first-line treatment for approved patients, Dr. Brahmer said in a video interview.

“When you talk about improving efficacy by months, patients and physicians want to also see improved quality of life,” said Dr. Brahmer, director of thoracic oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. “If symptoms are not improved or there are a ton of side effects with the treatment then use might be low.”

Based on its performance in KEYNOTE-024, pembrolizumab (Keytruda) received Food and Drug Administration approval on Oct. 24, 2016, as first-line treatment for patients with metastatic non–small-cell lung cancer that has a tumor proportion score of at least 50% for programmed death ligand 1 (PD-L1). Pembrolizumab is a monoclonal antibody that binds and blocks PD-1, the immune-cell receptor that tumor-cell PD-L1 binds to make immune cells less active. Other new immune checkpoint inhibitor drugs that act by blocking PD-1 or PD-L1 have shown similar quality of life benefits, she noted.

Routine availability of pembrolizumab as initial treatment for patients who have tumors with this level of PD-L1 expression (and also have no EGFR or ALK genomic aberrations) is shifting practice, Dr. Brahmer said.

“It’s catching on. The limitation right now is making sure patients get tested” for their PD-L1 tumor proportion score at the time they are first diagnosed. “Medical oncologists need to educate pathologists that we need this testing automatically, upfront. It’s not there yet,” she said.

Patients also are enthused. “There is a lot of chemo-exhaustion among patients. They are looking for something different, and something that uses their immune system makes sense.” But only about one quarter of patients have tumors with this level of PD-L1 expression; the others must start chemotherapy first before trying immunotherapy, unless they have an EGFR mutation. Out-of-pocket cost for pembrolizumab is also a major issues for many patients, she said.

KEYNOTE-024 randomized 305 patients at 102 international sites and followed patients for a median of 11 months. Dr. Brahmer and her associates made two primary analyses of patient-reported outcomes. One was measurement of global health status at 15 weeks after the start of treatment using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire designed to assess quality of life. Weighted averaging of the EORTC QCQ-C30 scores showed a mean improvement of 7.8 points (P = .002) in the pembrolizumab patients compared with the chemotherapy patients, a difference Dr. Brahmer called “clinically meaningful” as well as statistically significant.

A second analysis of patient-reported outcomes used a second EORTC instrument, the QLC-LC13, which combines assessment of cough, chest pain, and dyspnea. Treatment with pembrolizumab significantly reduced the time to deterioration as measured by this questionnaire by a relative 34%, (P = .029).

A third analysis looked at 15 individual function or symptom domains that make up the QLQ-C30. In general, these showed more improvements with pembrolizumab than with chemotherapy. One notable subcategory was fatigue, which showed significant improvement with pembrolizumab compared with a small worsening with chemotherapy.

[email protected]

On Twitter @mitchelzoler

VIENNA – Patients with metastatic non–small-cell lung cancer with high levels of PD-L1 who received first-line pembrolizumab treatment had clinically meaningful improvement in their quality of life, compared with patients randomized to chemotherapy, in a prespecified secondary analysis of data from the drug’s pivotal trial.

This boost in quality of life as well as other measures of health status add to the pivotal trial’s primary finding of significantly increased progression-free survival compared with chemotherapy, as well as previously-reported secondary findings of superior overall survival, objective response rate, and safety with pembrolizumab compared with chemotherapy (N Engl J Med. 2016 Nov 10;375[19]:1823-33), Julie R. Brahmer, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.

The primary endpoint of the Study of Pembrolizumab Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non–Small Cell Lung Cancer (KEYNOTE-024) showed an average 4.3-month increase in progression-free survival with pembrolizumab immunotherapy, compared with a standard chemotherapy regimen.

Improved quality of life on top of improved efficacy and safety is an important added benefit from pembrolizumab that should further spur its widespread adoption as first-line treatment for approved patients, Dr. Brahmer said in a video interview.

“When you talk about improving efficacy by months, patients and physicians want to also see improved quality of life,” said Dr. Brahmer, director of thoracic oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. “If symptoms are not improved or there are a ton of side effects with the treatment then use might be low.”

Based on its performance in KEYNOTE-024, pembrolizumab (Keytruda) received Food and Drug Administration approval on Oct. 24, 2016, as first-line treatment for patients with metastatic non–small-cell lung cancer that has a tumor proportion score of at least 50% for programmed death ligand 1 (PD-L1). Pembrolizumab is a monoclonal antibody that binds and blocks PD-1, the immune-cell receptor that tumor-cell PD-L1 binds to make immune cells less active. Other new immune checkpoint inhibitor drugs that act by blocking PD-1 or PD-L1 have shown similar quality of life benefits, she noted.

Routine availability of pembrolizumab as initial treatment for patients who have tumors with this level of PD-L1 expression (and also have no EGFR or ALK genomic aberrations) is shifting practice, Dr. Brahmer said.

“It’s catching on. The limitation right now is making sure patients get tested” for their PD-L1 tumor proportion score at the time they are first diagnosed. “Medical oncologists need to educate pathologists that we need this testing automatically, upfront. It’s not there yet,” she said.

Patients also are enthused. “There is a lot of chemo-exhaustion among patients. They are looking for something different, and something that uses their immune system makes sense.” But only about one quarter of patients have tumors with this level of PD-L1 expression; the others must start chemotherapy first before trying immunotherapy, unless they have an EGFR mutation. Out-of-pocket cost for pembrolizumab is also a major issues for many patients, she said.

KEYNOTE-024 randomized 305 patients at 102 international sites and followed patients for a median of 11 months. Dr. Brahmer and her associates made two primary analyses of patient-reported outcomes. One was measurement of global health status at 15 weeks after the start of treatment using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire designed to assess quality of life. Weighted averaging of the EORTC QCQ-C30 scores showed a mean improvement of 7.8 points (P = .002) in the pembrolizumab patients compared with the chemotherapy patients, a difference Dr. Brahmer called “clinically meaningful” as well as statistically significant.

A second analysis of patient-reported outcomes used a second EORTC instrument, the QLC-LC13, which combines assessment of cough, chest pain, and dyspnea. Treatment with pembrolizumab significantly reduced the time to deterioration as measured by this questionnaire by a relative 34%, (P = .029).

A third analysis looked at 15 individual function or symptom domains that make up the QLQ-C30. In general, these showed more improvements with pembrolizumab than with chemotherapy. One notable subcategory was fatigue, which showed significant improvement with pembrolizumab compared with a small worsening with chemotherapy.

[email protected]

On Twitter @mitchelzoler

VIENNA – Patients with metastatic non–small-cell lung cancer with high levels of PD-L1 who received first-line pembrolizumab treatment had clinically meaningful improvement in their quality of life, compared with patients randomized to chemotherapy, in a prespecified secondary analysis of data from the drug’s pivotal trial.

This boost in quality of life as well as other measures of health status add to the pivotal trial’s primary finding of significantly increased progression-free survival compared with chemotherapy, as well as previously-reported secondary findings of superior overall survival, objective response rate, and safety with pembrolizumab compared with chemotherapy (N Engl J Med. 2016 Nov 10;375[19]:1823-33), Julie R. Brahmer, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.

The primary endpoint of the Study of Pembrolizumab Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non–Small Cell Lung Cancer (KEYNOTE-024) showed an average 4.3-month increase in progression-free survival with pembrolizumab immunotherapy, compared with a standard chemotherapy regimen.

Improved quality of life on top of improved efficacy and safety is an important added benefit from pembrolizumab that should further spur its widespread adoption as first-line treatment for approved patients, Dr. Brahmer said in a video interview.

“When you talk about improving efficacy by months, patients and physicians want to also see improved quality of life,” said Dr. Brahmer, director of thoracic oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. “If symptoms are not improved or there are a ton of side effects with the treatment then use might be low.”

Based on its performance in KEYNOTE-024, pembrolizumab (Keytruda) received Food and Drug Administration approval on Oct. 24, 2016, as first-line treatment for patients with metastatic non–small-cell lung cancer that has a tumor proportion score of at least 50% for programmed death ligand 1 (PD-L1). Pembrolizumab is a monoclonal antibody that binds and blocks PD-1, the immune-cell receptor that tumor-cell PD-L1 binds to make immune cells less active. Other new immune checkpoint inhibitor drugs that act by blocking PD-1 or PD-L1 have shown similar quality of life benefits, she noted.

Routine availability of pembrolizumab as initial treatment for patients who have tumors with this level of PD-L1 expression (and also have no EGFR or ALK genomic aberrations) is shifting practice, Dr. Brahmer said.

“It’s catching on. The limitation right now is making sure patients get tested” for their PD-L1 tumor proportion score at the time they are first diagnosed. “Medical oncologists need to educate pathologists that we need this testing automatically, upfront. It’s not there yet,” she said.

Patients also are enthused. “There is a lot of chemo-exhaustion among patients. They are looking for something different, and something that uses their immune system makes sense.” But only about one quarter of patients have tumors with this level of PD-L1 expression; the others must start chemotherapy first before trying immunotherapy, unless they have an EGFR mutation. Out-of-pocket cost for pembrolizumab is also a major issues for many patients, she said.

KEYNOTE-024 randomized 305 patients at 102 international sites and followed patients for a median of 11 months. Dr. Brahmer and her associates made two primary analyses of patient-reported outcomes. One was measurement of global health status at 15 weeks after the start of treatment using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire designed to assess quality of life. Weighted averaging of the EORTC QCQ-C30 scores showed a mean improvement of 7.8 points (P = .002) in the pembrolizumab patients compared with the chemotherapy patients, a difference Dr. Brahmer called “clinically meaningful” as well as statistically significant.

A second analysis of patient-reported outcomes used a second EORTC instrument, the QLC-LC13, which combines assessment of cough, chest pain, and dyspnea. Treatment with pembrolizumab significantly reduced the time to deterioration as measured by this questionnaire by a relative 34%, (P = .029).

A third analysis looked at 15 individual function or symptom domains that make up the QLQ-C30. In general, these showed more improvements with pembrolizumab than with chemotherapy. One notable subcategory was fatigue, which showed significant improvement with pembrolizumab compared with a small worsening with chemotherapy.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Adding respiratory rate and suspected blunt chest injury to a trauma assessment in the field significantly improved the appropriate triaging of level III trauma patients.

When the assessment specifically evaluated for tachypnea in the setting of blunt chest injury, undertriaging improved by 1.2%, John Yonge, MD, said at the annual clinical congress of the American College of Surgeons.
 

“When we applied this new criteria to our 10-year study, we identified 661 patients who should have been activated as a level I or level II,” but instead were assessed as less critically injured, Dr. Yonge said in an interview. This initial misstep significantly extended the time before patients could have critical surgical procedures and was related to higher mortality among them.

Dr. Yonge, a surgical fellow at Oregon Health & Science University, Portland, and his mentor Martin Schreiber, MD, conducted the retrospective study of 7,880 trauma patients admitted at level III activation from 2004 to 2014. The OHSU trauma system has three activation levels.

• Level I activations are reserved for the most critically injured patients; attending trauma surgeon and anesthesiologist presence is mandatory.

• Level II activations capture moderate to severe injuries; trauma surgeon and respiratory therapist presence is mandated.

• Level III activations are designed to capture patients who do not require an immediate lifesaving intervention; the presence of the trauma surgery chief resident and attending emergency medicine physician is mandatory.

Patients were considered undertriaged if they were admitted as level III activations, but then required a critical intervention (chest tube placement, intubation, needle thoracostomy, or intracranial pressure monitoring) in the emergency department or ultimately met level I or II activation criteria.

Among all the level III patients, 466 (6%) were undertriaged: 390 were undertriaged based on the existing level I or II activation criteria, and 76 were considered undertriaged based on the need for a critical intervention.

Most of the undertriaged patients (65%) met criteria for level I activation; the rest should have been triaged as level II patients. Compared with appropriately staged level III patients, mortality among the undertriaged patients was significantly higher (3.2% vs. 0.6%). Undertriaged patients also experienced longer delays before initiation of major emergency surgery: a mean of 147 minutes, compared with 106 minutes for appropriately triaged level I patients and 62 minutes for appropriately triaged level II patients.

Dr. Yonge then looked for clinical measures that would improve triage. Tachypnea (respiratory rate of more than 20 breaths per minute) in the field stood out as a significant factor. Tachypneic patients who had a suspected chest injury were 70% more likely to be undertriaged than were those with a normal respiratory rate. Tachypnea was significantly associated with a diagnosis of flail chest, emergency department intubation, and chest tube placement.

The team then constructed a new triage criterion for patients with suspected chest injury – tachypnea combined with suspected blunt thoracic injury. By applying that model to their study population of level III patients, they determined that the level III undertriage rate would be reduced by 1.2%.

Tying the physiologic marker of tachypnea to a suspected clinical diagnosis is a key factor, Dr. Yonge noted. “Just adding tachypnea doesn’t help us. In fact, it would overwhelm us, because a trauma patient could very well be tachypneic because he’s experiencing panic. But tying it to a suspected clinical diagnosis gives us a meaningful result.”

He confirmed this linkage with an additional analysis. “We looked to see how severely injured these patients were and found that 71% of them had an Abbreviated Injury Score (AIS) to the chest of 3 or more, indicating a severe chest injury. Only 29% had an AIS of 2 or less. So this proves that respiratory rate is a valid triage criterion and can be used to identify patients who need a higher level of trauma care.”

The challenge now, Dr. Yonge said, is incorporating the marker into clinical practice. “It doesn’t matter how many statistics you do, if you can’t educate the prehospital providers in this, it’s useless. They are the crux of the trauma system.”

Although national guidelines do recommend assessing respiratory rate as part of field triage, it often isn’t recorded or is only estimated, Dr. Yonge said. That’s one reason he used the 20-breaths-per-minute cutoff rate. “It doesn’t even take a full minute to assess this, but it can make a big improvement in care.”

Neither he nor Dr. Schreiber had any financial disclosures.

[email protected]

On Twitter @alz_gal

WASHINGTON – Adding respiratory rate and suspected blunt chest injury to a trauma assessment in the field significantly improved the appropriate triaging of level III trauma patients.

When the assessment specifically evaluated for tachypnea in the setting of blunt chest injury, undertriaging improved by 1.2%, John Yonge, MD, said at the annual clinical congress of the American College of Surgeons.
 

“When we applied this new criteria to our 10-year study, we identified 661 patients who should have been activated as a level I or level II,” but instead were assessed as less critically injured, Dr. Yonge said in an interview. This initial misstep significantly extended the time before patients could have critical surgical procedures and was related to higher mortality among them.

Dr. Yonge, a surgical fellow at Oregon Health & Science University, Portland, and his mentor Martin Schreiber, MD, conducted the retrospective study of 7,880 trauma patients admitted at level III activation from 2004 to 2014. The OHSU trauma system has three activation levels.

• Level I activations are reserved for the most critically injured patients; attending trauma surgeon and anesthesiologist presence is mandatory.

• Level II activations capture moderate to severe injuries; trauma surgeon and respiratory therapist presence is mandated.

• Level III activations are designed to capture patients who do not require an immediate lifesaving intervention; the presence of the trauma surgery chief resident and attending emergency medicine physician is mandatory.

Patients were considered undertriaged if they were admitted as level III activations, but then required a critical intervention (chest tube placement, intubation, needle thoracostomy, or intracranial pressure monitoring) in the emergency department or ultimately met level I or II activation criteria.

Among all the level III patients, 466 (6%) were undertriaged: 390 were undertriaged based on the existing level I or II activation criteria, and 76 were considered undertriaged based on the need for a critical intervention.

Most of the undertriaged patients (65%) met criteria for level I activation; the rest should have been triaged as level II patients. Compared with appropriately staged level III patients, mortality among the undertriaged patients was significantly higher (3.2% vs. 0.6%). Undertriaged patients also experienced longer delays before initiation of major emergency surgery: a mean of 147 minutes, compared with 106 minutes for appropriately triaged level I patients and 62 minutes for appropriately triaged level II patients.

Dr. Yonge then looked for clinical measures that would improve triage. Tachypnea (respiratory rate of more than 20 breaths per minute) in the field stood out as a significant factor. Tachypneic patients who had a suspected chest injury were 70% more likely to be undertriaged than were those with a normal respiratory rate. Tachypnea was significantly associated with a diagnosis of flail chest, emergency department intubation, and chest tube placement.

The team then constructed a new triage criterion for patients with suspected chest injury – tachypnea combined with suspected blunt thoracic injury. By applying that model to their study population of level III patients, they determined that the level III undertriage rate would be reduced by 1.2%.

Tying the physiologic marker of tachypnea to a suspected clinical diagnosis is a key factor, Dr. Yonge noted. “Just adding tachypnea doesn’t help us. In fact, it would overwhelm us, because a trauma patient could very well be tachypneic because he’s experiencing panic. But tying it to a suspected clinical diagnosis gives us a meaningful result.”

He confirmed this linkage with an additional analysis. “We looked to see how severely injured these patients were and found that 71% of them had an Abbreviated Injury Score (AIS) to the chest of 3 or more, indicating a severe chest injury. Only 29% had an AIS of 2 or less. So this proves that respiratory rate is a valid triage criterion and can be used to identify patients who need a higher level of trauma care.”

The challenge now, Dr. Yonge said, is incorporating the marker into clinical practice. “It doesn’t matter how many statistics you do, if you can’t educate the prehospital providers in this, it’s useless. They are the crux of the trauma system.”

Although national guidelines do recommend assessing respiratory rate as part of field triage, it often isn’t recorded or is only estimated, Dr. Yonge said. That’s one reason he used the 20-breaths-per-minute cutoff rate. “It doesn’t even take a full minute to assess this, but it can make a big improvement in care.”

Neither he nor Dr. Schreiber had any financial disclosures.

[email protected]

On Twitter @alz_gal

WASHINGTON – Adding respiratory rate and suspected blunt chest injury to a trauma assessment in the field significantly improved the appropriate triaging of level III trauma patients.

When the assessment specifically evaluated for tachypnea in the setting of blunt chest injury, undertriaging improved by 1.2%, John Yonge, MD, said at the annual clinical congress of the American College of Surgeons.
 

“When we applied this new criteria to our 10-year study, we identified 661 patients who should have been activated as a level I or level II,” but instead were assessed as less critically injured, Dr. Yonge said in an interview. This initial misstep significantly extended the time before patients could have critical surgical procedures and was related to higher mortality among them.

Dr. Yonge, a surgical fellow at Oregon Health & Science University, Portland, and his mentor Martin Schreiber, MD, conducted the retrospective study of 7,880 trauma patients admitted at level III activation from 2004 to 2014. The OHSU trauma system has three activation levels.

• Level I activations are reserved for the most critically injured patients; attending trauma surgeon and anesthesiologist presence is mandatory.

• Level II activations capture moderate to severe injuries; trauma surgeon and respiratory therapist presence is mandated.

• Level III activations are designed to capture patients who do not require an immediate lifesaving intervention; the presence of the trauma surgery chief resident and attending emergency medicine physician is mandatory.

Patients were considered undertriaged if they were admitted as level III activations, but then required a critical intervention (chest tube placement, intubation, needle thoracostomy, or intracranial pressure monitoring) in the emergency department or ultimately met level I or II activation criteria.

Among all the level III patients, 466 (6%) were undertriaged: 390 were undertriaged based on the existing level I or II activation criteria, and 76 were considered undertriaged based on the need for a critical intervention.

Most of the undertriaged patients (65%) met criteria for level I activation; the rest should have been triaged as level II patients. Compared with appropriately staged level III patients, mortality among the undertriaged patients was significantly higher (3.2% vs. 0.6%). Undertriaged patients also experienced longer delays before initiation of major emergency surgery: a mean of 147 minutes, compared with 106 minutes for appropriately triaged level I patients and 62 minutes for appropriately triaged level II patients.

Dr. Yonge then looked for clinical measures that would improve triage. Tachypnea (respiratory rate of more than 20 breaths per minute) in the field stood out as a significant factor. Tachypneic patients who had a suspected chest injury were 70% more likely to be undertriaged than were those with a normal respiratory rate. Tachypnea was significantly associated with a diagnosis of flail chest, emergency department intubation, and chest tube placement.

The team then constructed a new triage criterion for patients with suspected chest injury – tachypnea combined with suspected blunt thoracic injury. By applying that model to their study population of level III patients, they determined that the level III undertriage rate would be reduced by 1.2%.

Tying the physiologic marker of tachypnea to a suspected clinical diagnosis is a key factor, Dr. Yonge noted. “Just adding tachypnea doesn’t help us. In fact, it would overwhelm us, because a trauma patient could very well be tachypneic because he’s experiencing panic. But tying it to a suspected clinical diagnosis gives us a meaningful result.”

He confirmed this linkage with an additional analysis. “We looked to see how severely injured these patients were and found that 71% of them had an Abbreviated Injury Score (AIS) to the chest of 3 or more, indicating a severe chest injury. Only 29% had an AIS of 2 or less. So this proves that respiratory rate is a valid triage criterion and can be used to identify patients who need a higher level of trauma care.”

The challenge now, Dr. Yonge said, is incorporating the marker into clinical practice. “It doesn’t matter how many statistics you do, if you can’t educate the prehospital providers in this, it’s useless. They are the crux of the trauma system.”

Although national guidelines do recommend assessing respiratory rate as part of field triage, it often isn’t recorded or is only estimated, Dr. Yonge said. That’s one reason he used the 20-breaths-per-minute cutoff rate. “It doesn’t even take a full minute to assess this, but it can make a big improvement in care.”

Neither he nor Dr. Schreiber had any financial disclosures.

[email protected]

On Twitter @alz_gal

VIENNA – Stereotactic body radiotherapy (SBRT) proved too toxic for many of patients recruited into a multinational phase II trial with centrally-located lung tumors.

The majority of patients experienced some type of adverse effect, with 28% experiencing serious (grade 3-5) adverse effects.

“Our major concern now is that we had six cases of grade 5 bleedings,” Karen Lindberg, MD, said at the World Conference on Lung Cancer. “Tumor location seems to be a risk factor for bleeding,” she added, with five of the six cases seen in patients who had tumors close to a main bronchus (group A). The other case was in patient who had tumors close to a lobular bronchus (group B).

“The classical definition of a centrally-located lung tumor is a tumor residing within or touching an imaginary zone 2 cm around the proximal bronchial tree,” explained Dr. Lindberg of Karolinska University Hospital and the Karolinska Institutet in Stockholm, who presented the first results of the Nordic HILUS Trial.

“When we designed this study we wanted to look at very centrally located tumors, so we tightened up this definition to look at tumors that occurred within 1 cm around the proximal bronchial tree,” she said at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.

During the trial, SBRT was to be delivered at a dose of 7 Gray (Gy) in 8 fractions at 65%-75% isodose lines to ultra-centrally-located tumors. Dose constraints were stipulated for tumors situated very close to the spinal cord, contralateral main bronchus, and trachea, with some dosing recommendations on reducing the dose delivered to tumors that were ipsilateral to the main bronchus, or very close to the esophagus or heart.

A total of 74 patients with centrally-located, locally progressive tumors, which were less than 5 cm in size and due to non–small-cell lung cancer (NSCLC) or metastatic lung disease from another solid tumor, were recruited. Patients had to have a good performance status and life expectancy of 3 months.

Patients with brain metastases or tumors that reached through the wall of a main bronchus were excluded as were those who were taking any concomitant systemic therapy.

The mean age of the recruited patients was 71 years; 58 (78%) had NSCLC, of which 20 (27%) had adenomas and 19 (26%) had squamous cell cancers. Of those with secondary lung tumors, eight (11%), had primary renal cell carcinoma and four (5%) had colorectal cancer.

After a follow-up of 18.6 months, 31 (42%) patients had died.

The most common adverse events reported were grade 1-2 dyspnea, cough, and fatigue. However, there was a high rate of grade 3 (dyspnea, fatigue, pain, pneumonitis, and heart rhythm disturbance), 4 (pain, lung infection, fever, heart rhythm disturbance, fistula, and pneumothorax) and 5 toxicities (pneumonitis and bleeding).

Bleeding often occurred without warning and had an acute onset and toll.

Seven patients (six in group A and one in group B) may have suffered grade 5 side effects; six patients experienced lethal hemoptysis after a median of 15.5 months (2.5-21 months) and one patient suffered from a lethal pneumonitis 5 months post study treatment. The reintroduction of TKIs may also have played a role, Dr. Lindberg suggested.

SBRT for early stage NSCLC is very effective and “generates outstanding tumor control”, said Feng-Ming Kong, MD, of Indiana University, Indianapolis, who was invited to comment on the findings.

Most studies of SBRT have looked at peripherally-located tumors, however, so the study by the NORDIC Study Group provides valuable information on a more centrally-located approach. The big question of course is what caused the bleeding.

“What percentage of TKI patients had bleeding and how many of them had a TKI without bleeding?” Dr. Kong asked. Other questions around dosing remain: How much radiation was delivered to the great vessels such as the pulmonary artery, and how much of the dose hit critical structures? And, were tumors invading the pulmonary artery?

“SBRT may be applied for centrally-located tumors safely with other prescription regimens, she suggested, such as 10-11 Gy given in 5 fractions. That is assuming that “the dose limits of normal tissues are strictly controlled and the patients are carefully selected to exclude T4 diseases for adjacent organ invasion.”

The NORDIC SBRT Study Group conducted the study. Dr. Lindberg had no conflicts of interest to disclose. Dr. Kong has received research grants from the National Cancer Institute (part of the National Institutes of Health) and speakers honorarium and travel support from Varian Medical.

VIENNA – Stereotactic body radiotherapy (SBRT) proved too toxic for many of patients recruited into a multinational phase II trial with centrally-located lung tumors.

The majority of patients experienced some type of adverse effect, with 28% experiencing serious (grade 3-5) adverse effects.

“Our major concern now is that we had six cases of grade 5 bleedings,” Karen Lindberg, MD, said at the World Conference on Lung Cancer. “Tumor location seems to be a risk factor for bleeding,” she added, with five of the six cases seen in patients who had tumors close to a main bronchus (group A). The other case was in patient who had tumors close to a lobular bronchus (group B).

“The classical definition of a centrally-located lung tumor is a tumor residing within or touching an imaginary zone 2 cm around the proximal bronchial tree,” explained Dr. Lindberg of Karolinska University Hospital and the Karolinska Institutet in Stockholm, who presented the first results of the Nordic HILUS Trial.

“When we designed this study we wanted to look at very centrally located tumors, so we tightened up this definition to look at tumors that occurred within 1 cm around the proximal bronchial tree,” she said at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.

During the trial, SBRT was to be delivered at a dose of 7 Gray (Gy) in 8 fractions at 65%-75% isodose lines to ultra-centrally-located tumors. Dose constraints were stipulated for tumors situated very close to the spinal cord, contralateral main bronchus, and trachea, with some dosing recommendations on reducing the dose delivered to tumors that were ipsilateral to the main bronchus, or very close to the esophagus or heart.

A total of 74 patients with centrally-located, locally progressive tumors, which were less than 5 cm in size and due to non–small-cell lung cancer (NSCLC) or metastatic lung disease from another solid tumor, were recruited. Patients had to have a good performance status and life expectancy of 3 months.

Patients with brain metastases or tumors that reached through the wall of a main bronchus were excluded as were those who were taking any concomitant systemic therapy.

The mean age of the recruited patients was 71 years; 58 (78%) had NSCLC, of which 20 (27%) had adenomas and 19 (26%) had squamous cell cancers. Of those with secondary lung tumors, eight (11%), had primary renal cell carcinoma and four (5%) had colorectal cancer.

After a follow-up of 18.6 months, 31 (42%) patients had died.

The most common adverse events reported were grade 1-2 dyspnea, cough, and fatigue. However, there was a high rate of grade 3 (dyspnea, fatigue, pain, pneumonitis, and heart rhythm disturbance), 4 (pain, lung infection, fever, heart rhythm disturbance, fistula, and pneumothorax) and 5 toxicities (pneumonitis and bleeding).

Bleeding often occurred without warning and had an acute onset and toll.

Seven patients (six in group A and one in group B) may have suffered grade 5 side effects; six patients experienced lethal hemoptysis after a median of 15.5 months (2.5-21 months) and one patient suffered from a lethal pneumonitis 5 months post study treatment. The reintroduction of TKIs may also have played a role, Dr. Lindberg suggested.

SBRT for early stage NSCLC is very effective and “generates outstanding tumor control”, said Feng-Ming Kong, MD, of Indiana University, Indianapolis, who was invited to comment on the findings.

Most studies of SBRT have looked at peripherally-located tumors, however, so the study by the NORDIC Study Group provides valuable information on a more centrally-located approach. The big question of course is what caused the bleeding.

“What percentage of TKI patients had bleeding and how many of them had a TKI without bleeding?” Dr. Kong asked. Other questions around dosing remain: How much radiation was delivered to the great vessels such as the pulmonary artery, and how much of the dose hit critical structures? And, were tumors invading the pulmonary artery?

“SBRT may be applied for centrally-located tumors safely with other prescription regimens, she suggested, such as 10-11 Gy given in 5 fractions. That is assuming that “the dose limits of normal tissues are strictly controlled and the patients are carefully selected to exclude T4 diseases for adjacent organ invasion.”

The NORDIC SBRT Study Group conducted the study. Dr. Lindberg had no conflicts of interest to disclose. Dr. Kong has received research grants from the National Cancer Institute (part of the National Institutes of Health) and speakers honorarium and travel support from Varian Medical.

VIENNA – Stereotactic body radiotherapy (SBRT) proved too toxic for many of patients recruited into a multinational phase II trial with centrally-located lung tumors.

The majority of patients experienced some type of adverse effect, with 28% experiencing serious (grade 3-5) adverse effects.

“Our major concern now is that we had six cases of grade 5 bleedings,” Karen Lindberg, MD, said at the World Conference on Lung Cancer. “Tumor location seems to be a risk factor for bleeding,” she added, with five of the six cases seen in patients who had tumors close to a main bronchus (group A). The other case was in patient who had tumors close to a lobular bronchus (group B).

“The classical definition of a centrally-located lung tumor is a tumor residing within or touching an imaginary zone 2 cm around the proximal bronchial tree,” explained Dr. Lindberg of Karolinska University Hospital and the Karolinska Institutet in Stockholm, who presented the first results of the Nordic HILUS Trial.

“When we designed this study we wanted to look at very centrally located tumors, so we tightened up this definition to look at tumors that occurred within 1 cm around the proximal bronchial tree,” she said at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.

During the trial, SBRT was to be delivered at a dose of 7 Gray (Gy) in 8 fractions at 65%-75% isodose lines to ultra-centrally-located tumors. Dose constraints were stipulated for tumors situated very close to the spinal cord, contralateral main bronchus, and trachea, with some dosing recommendations on reducing the dose delivered to tumors that were ipsilateral to the main bronchus, or very close to the esophagus or heart.

A total of 74 patients with centrally-located, locally progressive tumors, which were less than 5 cm in size and due to non–small-cell lung cancer (NSCLC) or metastatic lung disease from another solid tumor, were recruited. Patients had to have a good performance status and life expectancy of 3 months.

Patients with brain metastases or tumors that reached through the wall of a main bronchus were excluded as were those who were taking any concomitant systemic therapy.

The mean age of the recruited patients was 71 years; 58 (78%) had NSCLC, of which 20 (27%) had adenomas and 19 (26%) had squamous cell cancers. Of those with secondary lung tumors, eight (11%), had primary renal cell carcinoma and four (5%) had colorectal cancer.

After a follow-up of 18.6 months, 31 (42%) patients had died.

The most common adverse events reported were grade 1-2 dyspnea, cough, and fatigue. However, there was a high rate of grade 3 (dyspnea, fatigue, pain, pneumonitis, and heart rhythm disturbance), 4 (pain, lung infection, fever, heart rhythm disturbance, fistula, and pneumothorax) and 5 toxicities (pneumonitis and bleeding).

Bleeding often occurred without warning and had an acute onset and toll.

Seven patients (six in group A and one in group B) may have suffered grade 5 side effects; six patients experienced lethal hemoptysis after a median of 15.5 months (2.5-21 months) and one patient suffered from a lethal pneumonitis 5 months post study treatment. The reintroduction of TKIs may also have played a role, Dr. Lindberg suggested.

SBRT for early stage NSCLC is very effective and “generates outstanding tumor control”, said Feng-Ming Kong, MD, of Indiana University, Indianapolis, who was invited to comment on the findings.

Most studies of SBRT have looked at peripherally-located tumors, however, so the study by the NORDIC Study Group provides valuable information on a more centrally-located approach. The big question of course is what caused the bleeding.

“What percentage of TKI patients had bleeding and how many of them had a TKI without bleeding?” Dr. Kong asked. Other questions around dosing remain: How much radiation was delivered to the great vessels such as the pulmonary artery, and how much of the dose hit critical structures? And, were tumors invading the pulmonary artery?

“SBRT may be applied for centrally-located tumors safely with other prescription regimens, she suggested, such as 10-11 Gy given in 5 fractions. That is assuming that “the dose limits of normal tissues are strictly controlled and the patients are carefully selected to exclude T4 diseases for adjacent organ invasion.”

The NORDIC SBRT Study Group conducted the study. Dr. Lindberg had no conflicts of interest to disclose. Dr. Kong has received research grants from the National Cancer Institute (part of the National Institutes of Health) and speakers honorarium and travel support from Varian Medical.

Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.

Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.

President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.

Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.

Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.

“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”

More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.

In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.

“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”

“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”

Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.

While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.

While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”

“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”

Mr. Trump also has called for Medicaid reform, with block grants to the states.

“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”

Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.

“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”

Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.

Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.

“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”

Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.

Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.

The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.

“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”

In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.

If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.

“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”

However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.

“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”

The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.

The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.

The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.

There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”

Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”

“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”

The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.

Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”

Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.

Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.

“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”

Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.

Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.

“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”

[email protected]
[email protected]
On Twitter @legal_med
 

Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.

Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.

President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.

Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.

Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.

“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”

More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.

In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.

“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”

“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”

Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.

While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.

While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”

“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”

Mr. Trump also has called for Medicaid reform, with block grants to the states.

“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”

Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.

“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”

Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.

Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.

“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”

Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.

Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.

The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.

“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”

In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.

If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.

“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”

However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.

“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”

The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.

The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.

The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.

There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”

Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”

“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”

The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.

Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”

Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.

Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.

“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”

Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.

Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.

“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”

[email protected]
[email protected]
On Twitter @legal_med
 

Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.

Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.

President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.

Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.

Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.

“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”

More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.

In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.

“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”

“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”

Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.

While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.

While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”

“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”

Mr. Trump also has called for Medicaid reform, with block grants to the states.

“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”

Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.

“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”

Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.

Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.

“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”

Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.

Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.

The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.

“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”

In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.

If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.

“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”

However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.

“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”

The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.

The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.

The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.

There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”

Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”

“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”

The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.

Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”

Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.

Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.

“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”

Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.

Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.

“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”

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VIENNA – The investigational agent alisertib plus paclitaxel improved progression-free survival (PFS), compared with paclitaxel plus placebo, in a randomized, double-blind, phase II study of patients with relapsed or refractory small-cell lung cancer (SCLC).

The median PFS was 3.32 months with alisertib/paclitaxel and 2.17 months with paclitaxel/placebo, giving an overall 30% improvement with the combination (hazard ratio, 0.71; 95% confidence interval, 0.509-0.985; P = .038).

Sara Freeman/Frontline Medical News

VIENNA – The investigational agent alisertib plus paclitaxel improved progression-free survival (PFS), compared with paclitaxel plus placebo, in a randomized, double-blind, phase II study of patients with relapsed or refractory small-cell lung cancer (SCLC).

The median PFS was 3.32 months with alisertib/paclitaxel and 2.17 months with paclitaxel/placebo, giving an overall 30% improvement with the combination (hazard ratio, 0.71; 95% confidence interval, 0.509-0.985; P = .038).

Sara Freeman/Frontline Medical News

VIENNA – The investigational agent alisertib plus paclitaxel improved progression-free survival (PFS), compared with paclitaxel plus placebo, in a randomized, double-blind, phase II study of patients with relapsed or refractory small-cell lung cancer (SCLC).

The median PFS was 3.32 months with alisertib/paclitaxel and 2.17 months with paclitaxel/placebo, giving an overall 30% improvement with the combination (hazard ratio, 0.71; 95% confidence interval, 0.509-0.985; P = .038).

Sara Freeman/Frontline Medical News

AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at The AATS Centennial.

The meeting will take place April 29 - May 3, 2017
Boston, MA.

Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).

Deadline: January 20, 2017

More information

Share:

AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at The AATS Centennial.

The meeting will take place April 29 - May 3, 2017
Boston, MA.

Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).

Deadline: January 20, 2017

More information

Share:

AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at The AATS Centennial.

The meeting will take place April 29 - May 3, 2017
Boston, MA.

Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).

Deadline: January 20, 2017

More information

Share: