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Revision technique treats graft dysfunction after esophageal reconstruction
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
This series by Dr. Voron and coauthors was “truly remarkable,” given the rarity of esophageal caustic injuries and even rarer occasion of revision surgery, Victor A. Ferraris, MD, PhD, of the University of Kentucky, Lexington, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1386-7). He attributed the series size to the authors’ clinical setting in a trauma entry point for Europe’s largest hospital system – the same hospital that received victims of the terrorist attack at the Bataclan concert hall in Paris in November 2015.
“Voron and coauthors clearly have the benefit of a large referral population and vast medical infrastructure in the Assistance Publique-Hôpitaux de Paris,” Dr. Ferraris said. That volume certainly factors into their ability to achieve “very good outcomes,” he said.
“This seems to be an argument in favor of localization of resources to a single center,” Dr. Ferraris said. “Dr. Voron and coauthors have translated their experience into knowledge that can help other surgeons deal with this difficult problem.”
Dr. Ferraris had no financial relationships to disclose.
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).
Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.
Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.
CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.
Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.
Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.
CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.
Dr. Voron and coauthors had no financial relationships to disclose.
Key clinical point: Cervicosternolaparotomy revision surgery for graft dysfunction after esophageal reconstruction for caustic injuries can achieve good results with acceptable morbidity.
Major finding: Functional success rate after revision CSLap was 85% after a mean follow-up of 4.4 years.
Data source: 55 patients who underwent CSLap revision surgery between 1999 and 2015 at a single center.
Disclosures: Dr. Voron and coauthors had no financial relationships to disclose.
REBOA may be a safe alternative to RTACC in the acute care setting
WASHINGTON – Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.
Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.
Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.
Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.
Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”
All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.
While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.
Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.
Overall, patient survival was dismal. Only one patient who received REBOA survived.
Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.
In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.
“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”
At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.
A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.
In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.
To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.
During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.
Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.
In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.
Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.
The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
[email protected]
On Twitter @jessnicolecraig
WASHINGTON – Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.
Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.
Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.
Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.
Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”
All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.
While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.
Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.
Overall, patient survival was dismal. Only one patient who received REBOA survived.
Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.
In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.
“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”
At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.
A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.
In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.
To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.
During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.
Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.
In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.
Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.
The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
[email protected]
On Twitter @jessnicolecraig
WASHINGTON – Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.
Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.
Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.
Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.
Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”
All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.
While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.
Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.
Overall, patient survival was dismal. Only one patient who received REBOA survived.
Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.
In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.
“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”
At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.
A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.
In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.
To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.
During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.
Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.
In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.
Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.
The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
[email protected]
On Twitter @jessnicolecraig
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: More RTACC patients survived to the operating room (53% vs. 68%), but more REBOA patients experienced return of spontaneous circulation (53% vs. 37%).
Data source: Pilot study involving 36 trauma patients who received either RTACC or REBOA.
Disclosures: The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
Tumor markers may predict anti–PD-L1 treatment response
NATIONAL HARBOR, MD. – Density in tumors of two key immune cells may be a biomarker for response to an inhibitor of programmed death–ligand 1 (PD-L1) among patients with non–small cell lung cancer (NSCLC).
Patients with NSCLC whose tumors bore high densities of both CD8-positive cytotoxic T lymphocytes and PD-L1 had significantly better outcomes when treated with the investigational PD-L1 inhibitor durvalumab than patients with high densities of either cell type alone, reported Sonja Althammer, PhD, a scientist at Definiens AG, maker of the anti–PD-L1 compound.
Dr. Althammer and her colleagues assessed the use of an automated image analysis and pattern recognition system to determine whether tumor-infiltrating CD8-positive cytotoxic T lymphocytes and PD-L1 densities could identify patients most likely to respond to the investigational PD-L1 inhibitor durvalumab.
“The hypothesis that we had in mind was that the interaction between both cell populations is important, so both cell populations should be present,” she said.
The investigators analyzed archived or fresh tumor biopsy samples from 163 patients with untreated or previously treated NSCLC (median 3 prior lines of therapy) who were enrolled in a nonrandomized phase I/II trial evaluating durvalumab in advanced NSCLC and other solid tumors.
They matched CD8 and PD-L1 immunohistochemistry-stained sections from tissues blocks. High PD-L1 expression was defined as a 25% or higher proportion of PD-L1–positive tumor cells with membrane staining at any intensity.
The images were then evaluated with an automated system, with results matched to clinical outcomes based on the densities of CD8-positive and PD-L1–positive cells, and PD-L1 alone from pre-treatment biopsy samples using a discovery set (84 samples) and validation set (79). The datasets were matched on baseline PD-L1 status, histology, Eastern Cooperative Oncology Group performance status, lines of therapy, and response.
In a training set looking at overall response rate (ORR), they found evidence to suggest that the combination of CD8 and PD-L1 positivity was associated with a higher ORR: 42%, compared with 31% for CD8-positive expression alone, 27% for PD-L1–positive alone, and 7% for CD8-positive PD-L1–negative (less than 25% expression) alone.
They then examined the predictive ability of the combined markers, and found that over approximately 28 months of follow-up, patients with CD8-positive and PD-L1–positive dense tumors had better overall survival (median overall survival, 24.3 months), compared with PD-L1–positive only patients (median overall survival, 17.1 months), CD8-positive only patients (median overall survival, 17.8 months), or the entire patient sample (median overall survival, 11.1 months).
Similarly, progression-free survival was also better among patients with high expression of both markers (respective median progression-free survival was 7.3, 3.6, 5.3, and 2.8 months).
Dr. Althammer acknowledged that the findings were preliminary and needed to be confirmed independently in larger studies.
The study was supported by MedImmune. Sonja Althammer is an employee of Definiens AG, which is a subsidiary of MedImmune/AstraZeneca.
NATIONAL HARBOR, MD. – Density in tumors of two key immune cells may be a biomarker for response to an inhibitor of programmed death–ligand 1 (PD-L1) among patients with non–small cell lung cancer (NSCLC).
Patients with NSCLC whose tumors bore high densities of both CD8-positive cytotoxic T lymphocytes and PD-L1 had significantly better outcomes when treated with the investigational PD-L1 inhibitor durvalumab than patients with high densities of either cell type alone, reported Sonja Althammer, PhD, a scientist at Definiens AG, maker of the anti–PD-L1 compound.
Dr. Althammer and her colleagues assessed the use of an automated image analysis and pattern recognition system to determine whether tumor-infiltrating CD8-positive cytotoxic T lymphocytes and PD-L1 densities could identify patients most likely to respond to the investigational PD-L1 inhibitor durvalumab.
“The hypothesis that we had in mind was that the interaction between both cell populations is important, so both cell populations should be present,” she said.
The investigators analyzed archived or fresh tumor biopsy samples from 163 patients with untreated or previously treated NSCLC (median 3 prior lines of therapy) who were enrolled in a nonrandomized phase I/II trial evaluating durvalumab in advanced NSCLC and other solid tumors.
They matched CD8 and PD-L1 immunohistochemistry-stained sections from tissues blocks. High PD-L1 expression was defined as a 25% or higher proportion of PD-L1–positive tumor cells with membrane staining at any intensity.
The images were then evaluated with an automated system, with results matched to clinical outcomes based on the densities of CD8-positive and PD-L1–positive cells, and PD-L1 alone from pre-treatment biopsy samples using a discovery set (84 samples) and validation set (79). The datasets were matched on baseline PD-L1 status, histology, Eastern Cooperative Oncology Group performance status, lines of therapy, and response.
In a training set looking at overall response rate (ORR), they found evidence to suggest that the combination of CD8 and PD-L1 positivity was associated with a higher ORR: 42%, compared with 31% for CD8-positive expression alone, 27% for PD-L1–positive alone, and 7% for CD8-positive PD-L1–negative (less than 25% expression) alone.
They then examined the predictive ability of the combined markers, and found that over approximately 28 months of follow-up, patients with CD8-positive and PD-L1–positive dense tumors had better overall survival (median overall survival, 24.3 months), compared with PD-L1–positive only patients (median overall survival, 17.1 months), CD8-positive only patients (median overall survival, 17.8 months), or the entire patient sample (median overall survival, 11.1 months).
Similarly, progression-free survival was also better among patients with high expression of both markers (respective median progression-free survival was 7.3, 3.6, 5.3, and 2.8 months).
Dr. Althammer acknowledged that the findings were preliminary and needed to be confirmed independently in larger studies.
The study was supported by MedImmune. Sonja Althammer is an employee of Definiens AG, which is a subsidiary of MedImmune/AstraZeneca.
NATIONAL HARBOR, MD. – Density in tumors of two key immune cells may be a biomarker for response to an inhibitor of programmed death–ligand 1 (PD-L1) among patients with non–small cell lung cancer (NSCLC).
Patients with NSCLC whose tumors bore high densities of both CD8-positive cytotoxic T lymphocytes and PD-L1 had significantly better outcomes when treated with the investigational PD-L1 inhibitor durvalumab than patients with high densities of either cell type alone, reported Sonja Althammer, PhD, a scientist at Definiens AG, maker of the anti–PD-L1 compound.
Dr. Althammer and her colleagues assessed the use of an automated image analysis and pattern recognition system to determine whether tumor-infiltrating CD8-positive cytotoxic T lymphocytes and PD-L1 densities could identify patients most likely to respond to the investigational PD-L1 inhibitor durvalumab.
“The hypothesis that we had in mind was that the interaction between both cell populations is important, so both cell populations should be present,” she said.
The investigators analyzed archived or fresh tumor biopsy samples from 163 patients with untreated or previously treated NSCLC (median 3 prior lines of therapy) who were enrolled in a nonrandomized phase I/II trial evaluating durvalumab in advanced NSCLC and other solid tumors.
They matched CD8 and PD-L1 immunohistochemistry-stained sections from tissues blocks. High PD-L1 expression was defined as a 25% or higher proportion of PD-L1–positive tumor cells with membrane staining at any intensity.
The images were then evaluated with an automated system, with results matched to clinical outcomes based on the densities of CD8-positive and PD-L1–positive cells, and PD-L1 alone from pre-treatment biopsy samples using a discovery set (84 samples) and validation set (79). The datasets were matched on baseline PD-L1 status, histology, Eastern Cooperative Oncology Group performance status, lines of therapy, and response.
In a training set looking at overall response rate (ORR), they found evidence to suggest that the combination of CD8 and PD-L1 positivity was associated with a higher ORR: 42%, compared with 31% for CD8-positive expression alone, 27% for PD-L1–positive alone, and 7% for CD8-positive PD-L1–negative (less than 25% expression) alone.
They then examined the predictive ability of the combined markers, and found that over approximately 28 months of follow-up, patients with CD8-positive and PD-L1–positive dense tumors had better overall survival (median overall survival, 24.3 months), compared with PD-L1–positive only patients (median overall survival, 17.1 months), CD8-positive only patients (median overall survival, 17.8 months), or the entire patient sample (median overall survival, 11.1 months).
Similarly, progression-free survival was also better among patients with high expression of both markers (respective median progression-free survival was 7.3, 3.6, 5.3, and 2.8 months).
Dr. Althammer acknowledged that the findings were preliminary and needed to be confirmed independently in larger studies.
The study was supported by MedImmune. Sonja Althammer is an employee of Definiens AG, which is a subsidiary of MedImmune/AstraZeneca.
AT SITC 2016
Key clinical point: Tumor expression of two cell types may predict responses to anti–PD-L1 immunotherapy.
Major finding: High tumor densities of CD8-postive cytotoxic T lymphocytes and the programmed death-ligand 1 were associated with improved overall response rates and survival in patients with advanced non–small cell lung cancer treated with a PD-L1 inhibitor.
Data source: Imaging study of samples from 163 patients enrolled in a nonrandomized phase I/II trial.
Disclosures: The study was supported by MedImmune. Sonja Althammer is an employee of Definiens AG, which is a subsidiary of MedImmune/AstraZeneca.
Detecting PH in IPF ‘more art than science’
LOS ANGELES – When it comes to the optimal management of pulmonary hypertension (PH) in patients with idiopathic pulmonary fibrosis (IPF), there are more questions than definitive answers, according to Brett E. Fenster, MD, FACC.
“Is PH in IPF a disease marker, an independent treatment target, or both?” he asked attendees at the annual meeting of the American College of Chest Physicians. “I think we have conflicting information about that.”
The prevalence of PH is estimated to be 10% in patients with mild to moderate IPF and tends to progress slowly. Common features of PH in IPF patients include shortness of breath, a greater degree of exertional desaturation, and an increased mortality rate.
Dr. Fenster described the ability to detect PH in IPF patients as “more art than science. A lot of different work has been done to look at different testing to get at the patients that may have PH that is a comorbid disease to their IPF. But a lot of times it comes down to assessing their level of dyspnea proportional to their level of disease. In those patients where we think there is something else going on besides their IPF, we’ll oftentimes get an echocardiogram and try to look at their right heart to see if they have features of PH. If it looks like they do, we will circle back and look at the amount of lung disease they have as characterized by their chest imaging, by their pulmonary function testing, and getting a blood gas. If this patient has findings of right heart enlargement, systolic dysfunction, et cetera, that clues us more into looking at PH and referring them to a center that has expertise in that version of PH.”
According to the most recent European Society of Cardiology/European Respiratory Society guidelines, the diagnosis of chronic obstructive pulmonary disease (COPD)/IPF/combined pulmonary fibrosis and emphysema (CPFE) without PH can be considered when the mean pulmonary artery pressure (mPAP) on right heart catheterization is less than 25 mm Hg. The diagnosis of COPD/IPF/CPFE with PH, based on these same guidelines, can be considered when the mPAP is 25 mm Hg or more. A patient may have COPD/IPF/CPFE with severe PH when his or her mPAP exceeds 35 mm Hg, or is 25 mm Hg or greater in the presence of a low cardiac output, the guidelines says (Eur Heart J. 2016;37:67-119). “That begins to separate out a group that may potentially benefit from targeted PH therapy,” Dr. Fenster said.
Current treatment approaches include long-term oxygen, diuretics, transplant, and pulmonary rehabilitation, but Dr. Fenster said there is sparse data on the optimal treatment approach. A study of sildenafil in IPF known as STEP-IPF failed to increase 6-minute walking test distance but improved diffusion capacity of carbon monoxide, quality of life, and arterial oxygenation (N Engl J Med. 2010;363:620-8). A study evaluating riociguat for idiopathic interstitial pneumonitis PH was discontinued early because of increased risk of death and adverse events. More recently, the drug ambrisentan was found to be ineffective at reducing the rate of IPF progression and was linked to an increase in disease progression events, including a decline in pulmonary function test values, hospitalization, and death, in the ARTEMIS-IPF trial (Ann Intern Med. 2013;158:641-9).
Randomized, placebo-controlled studies of bosentan in IPF give researchers pause for hope, Dr. Fenster said. BUILD-1 demonstrated a trend toward delayed time to death, delayed disease progression, improved quality of life, and no clear worsening of IPF (Am J Respir Crit Care Med. 2008;177[1]:75-81), while BUILD-3 showed a significant improvement in forced vital capacity (FVC) and carbon monoxide diffusing capacity (Am J Respir Crit Care Med. 2011;184[1]:92-9). A more recent trial evaluated IV treprostinil in 15 patients with interstitial lung disease and PH (Thorax 2014;69[2]:123-9). Eight of the patients had IPF. “After 12 weeks of treprostinil therapy, almost all of them experienced some degree of improvement in their walk distance,” said Dr. Fenster, who was not involved with the study. “Perhaps more importantly there were significant improvements in almost all parameters from their right heart catheterizations. So when we think about how to treat these patients, we have to weigh the risks and benefits of what we make potentially worse with our IPF therapy, such as worsening hypoxia, V/Q mismatch, disease progression, and volume overload. On the flip side, we might be improving right heart hemodynamics and RV function, which are prognostic in this disease. What’s the net balance of these things in terms of how it translates into functional capacity, quality of life, hospitalization, and mortality? We don’t know.”
According to Dr. Fenster, current data suggest that future IPF PH research should focus on prostanoid pathways and not on the estrogen-receptor and riociguat pathways to determine effective treatments. “We have numerous studies showing potential harm with IPF PH therapy, so we need to very much wade cautiously into this arena,” he said. “There is a potential role for PH therapy in IPF, but we will likely need to study patients with severe PH and IPF to show benefit. I think that’s where we’ll have the most success.”
Dr. Fenster reported having no relevant financial disclosures.
LOS ANGELES – When it comes to the optimal management of pulmonary hypertension (PH) in patients with idiopathic pulmonary fibrosis (IPF), there are more questions than definitive answers, according to Brett E. Fenster, MD, FACC.
“Is PH in IPF a disease marker, an independent treatment target, or both?” he asked attendees at the annual meeting of the American College of Chest Physicians. “I think we have conflicting information about that.”
The prevalence of PH is estimated to be 10% in patients with mild to moderate IPF and tends to progress slowly. Common features of PH in IPF patients include shortness of breath, a greater degree of exertional desaturation, and an increased mortality rate.
Dr. Fenster described the ability to detect PH in IPF patients as “more art than science. A lot of different work has been done to look at different testing to get at the patients that may have PH that is a comorbid disease to their IPF. But a lot of times it comes down to assessing their level of dyspnea proportional to their level of disease. In those patients where we think there is something else going on besides their IPF, we’ll oftentimes get an echocardiogram and try to look at their right heart to see if they have features of PH. If it looks like they do, we will circle back and look at the amount of lung disease they have as characterized by their chest imaging, by their pulmonary function testing, and getting a blood gas. If this patient has findings of right heart enlargement, systolic dysfunction, et cetera, that clues us more into looking at PH and referring them to a center that has expertise in that version of PH.”
According to the most recent European Society of Cardiology/European Respiratory Society guidelines, the diagnosis of chronic obstructive pulmonary disease (COPD)/IPF/combined pulmonary fibrosis and emphysema (CPFE) without PH can be considered when the mean pulmonary artery pressure (mPAP) on right heart catheterization is less than 25 mm Hg. The diagnosis of COPD/IPF/CPFE with PH, based on these same guidelines, can be considered when the mPAP is 25 mm Hg or more. A patient may have COPD/IPF/CPFE with severe PH when his or her mPAP exceeds 35 mm Hg, or is 25 mm Hg or greater in the presence of a low cardiac output, the guidelines says (Eur Heart J. 2016;37:67-119). “That begins to separate out a group that may potentially benefit from targeted PH therapy,” Dr. Fenster said.
Current treatment approaches include long-term oxygen, diuretics, transplant, and pulmonary rehabilitation, but Dr. Fenster said there is sparse data on the optimal treatment approach. A study of sildenafil in IPF known as STEP-IPF failed to increase 6-minute walking test distance but improved diffusion capacity of carbon monoxide, quality of life, and arterial oxygenation (N Engl J Med. 2010;363:620-8). A study evaluating riociguat for idiopathic interstitial pneumonitis PH was discontinued early because of increased risk of death and adverse events. More recently, the drug ambrisentan was found to be ineffective at reducing the rate of IPF progression and was linked to an increase in disease progression events, including a decline in pulmonary function test values, hospitalization, and death, in the ARTEMIS-IPF trial (Ann Intern Med. 2013;158:641-9).
Randomized, placebo-controlled studies of bosentan in IPF give researchers pause for hope, Dr. Fenster said. BUILD-1 demonstrated a trend toward delayed time to death, delayed disease progression, improved quality of life, and no clear worsening of IPF (Am J Respir Crit Care Med. 2008;177[1]:75-81), while BUILD-3 showed a significant improvement in forced vital capacity (FVC) and carbon monoxide diffusing capacity (Am J Respir Crit Care Med. 2011;184[1]:92-9). A more recent trial evaluated IV treprostinil in 15 patients with interstitial lung disease and PH (Thorax 2014;69[2]:123-9). Eight of the patients had IPF. “After 12 weeks of treprostinil therapy, almost all of them experienced some degree of improvement in their walk distance,” said Dr. Fenster, who was not involved with the study. “Perhaps more importantly there were significant improvements in almost all parameters from their right heart catheterizations. So when we think about how to treat these patients, we have to weigh the risks and benefits of what we make potentially worse with our IPF therapy, such as worsening hypoxia, V/Q mismatch, disease progression, and volume overload. On the flip side, we might be improving right heart hemodynamics and RV function, which are prognostic in this disease. What’s the net balance of these things in terms of how it translates into functional capacity, quality of life, hospitalization, and mortality? We don’t know.”
According to Dr. Fenster, current data suggest that future IPF PH research should focus on prostanoid pathways and not on the estrogen-receptor and riociguat pathways to determine effective treatments. “We have numerous studies showing potential harm with IPF PH therapy, so we need to very much wade cautiously into this arena,” he said. “There is a potential role for PH therapy in IPF, but we will likely need to study patients with severe PH and IPF to show benefit. I think that’s where we’ll have the most success.”
Dr. Fenster reported having no relevant financial disclosures.
LOS ANGELES – When it comes to the optimal management of pulmonary hypertension (PH) in patients with idiopathic pulmonary fibrosis (IPF), there are more questions than definitive answers, according to Brett E. Fenster, MD, FACC.
“Is PH in IPF a disease marker, an independent treatment target, or both?” he asked attendees at the annual meeting of the American College of Chest Physicians. “I think we have conflicting information about that.”
The prevalence of PH is estimated to be 10% in patients with mild to moderate IPF and tends to progress slowly. Common features of PH in IPF patients include shortness of breath, a greater degree of exertional desaturation, and an increased mortality rate.
Dr. Fenster described the ability to detect PH in IPF patients as “more art than science. A lot of different work has been done to look at different testing to get at the patients that may have PH that is a comorbid disease to their IPF. But a lot of times it comes down to assessing their level of dyspnea proportional to their level of disease. In those patients where we think there is something else going on besides their IPF, we’ll oftentimes get an echocardiogram and try to look at their right heart to see if they have features of PH. If it looks like they do, we will circle back and look at the amount of lung disease they have as characterized by their chest imaging, by their pulmonary function testing, and getting a blood gas. If this patient has findings of right heart enlargement, systolic dysfunction, et cetera, that clues us more into looking at PH and referring them to a center that has expertise in that version of PH.”
According to the most recent European Society of Cardiology/European Respiratory Society guidelines, the diagnosis of chronic obstructive pulmonary disease (COPD)/IPF/combined pulmonary fibrosis and emphysema (CPFE) without PH can be considered when the mean pulmonary artery pressure (mPAP) on right heart catheterization is less than 25 mm Hg. The diagnosis of COPD/IPF/CPFE with PH, based on these same guidelines, can be considered when the mPAP is 25 mm Hg or more. A patient may have COPD/IPF/CPFE with severe PH when his or her mPAP exceeds 35 mm Hg, or is 25 mm Hg or greater in the presence of a low cardiac output, the guidelines says (Eur Heart J. 2016;37:67-119). “That begins to separate out a group that may potentially benefit from targeted PH therapy,” Dr. Fenster said.
Current treatment approaches include long-term oxygen, diuretics, transplant, and pulmonary rehabilitation, but Dr. Fenster said there is sparse data on the optimal treatment approach. A study of sildenafil in IPF known as STEP-IPF failed to increase 6-minute walking test distance but improved diffusion capacity of carbon monoxide, quality of life, and arterial oxygenation (N Engl J Med. 2010;363:620-8). A study evaluating riociguat for idiopathic interstitial pneumonitis PH was discontinued early because of increased risk of death and adverse events. More recently, the drug ambrisentan was found to be ineffective at reducing the rate of IPF progression and was linked to an increase in disease progression events, including a decline in pulmonary function test values, hospitalization, and death, in the ARTEMIS-IPF trial (Ann Intern Med. 2013;158:641-9).
Randomized, placebo-controlled studies of bosentan in IPF give researchers pause for hope, Dr. Fenster said. BUILD-1 demonstrated a trend toward delayed time to death, delayed disease progression, improved quality of life, and no clear worsening of IPF (Am J Respir Crit Care Med. 2008;177[1]:75-81), while BUILD-3 showed a significant improvement in forced vital capacity (FVC) and carbon monoxide diffusing capacity (Am J Respir Crit Care Med. 2011;184[1]:92-9). A more recent trial evaluated IV treprostinil in 15 patients with interstitial lung disease and PH (Thorax 2014;69[2]:123-9). Eight of the patients had IPF. “After 12 weeks of treprostinil therapy, almost all of them experienced some degree of improvement in their walk distance,” said Dr. Fenster, who was not involved with the study. “Perhaps more importantly there were significant improvements in almost all parameters from their right heart catheterizations. So when we think about how to treat these patients, we have to weigh the risks and benefits of what we make potentially worse with our IPF therapy, such as worsening hypoxia, V/Q mismatch, disease progression, and volume overload. On the flip side, we might be improving right heart hemodynamics and RV function, which are prognostic in this disease. What’s the net balance of these things in terms of how it translates into functional capacity, quality of life, hospitalization, and mortality? We don’t know.”
According to Dr. Fenster, current data suggest that future IPF PH research should focus on prostanoid pathways and not on the estrogen-receptor and riociguat pathways to determine effective treatments. “We have numerous studies showing potential harm with IPF PH therapy, so we need to very much wade cautiously into this arena,” he said. “There is a potential role for PH therapy in IPF, but we will likely need to study patients with severe PH and IPF to show benefit. I think that’s where we’ll have the most success.”
Dr. Fenster reported having no relevant financial disclosures.
Tobacco-related cancer incidence, mortality drop
Tobacco-related cancer incidence and mortality rates dropped from 2004 to 2013, the Centers for Disease Control and Prevention reported in the Morbidity and Mortality Weekly Report published on Nov. 11, 2016.
Overall, tobacco-related invasive cancer incidence decreased from 206 cases per 100,000 during 2004-2008 to 193 cases per 100,000 during 2009-2013.
The announcement of this data marks a continuation of the downward trend that has been observed since the 1990s, lead author S. Jane Henley, MSPH, and her associates at the CDC wrote in the report (MMWR. 2016 Nov 11;65[44]:1212-8).
Despite this continued decline in tobacco-related cancer incidence and mortality rates, the tobacco-related cancer burden remains high, and disparities in the rates and decline of tobacco-related cancer persists.
“Tobacco use remains the leading preventable cause of disease and death in the United States,” reported Henley and her associates. For each year between 2009 and 2013, an estimated 660,000 Americans were diagnosed with tobacco-related cancer, and an estimated 343,000 people died from those cancers, according to the investigators’ analysis of data collected by the United States Cancer Statistics working group, which compiles data from multiple nationwide sources including the National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.
Tobacco-related cancer incidence and deaths were higher among men than women and higher among blacks than any other ethnic group. However, the cancer incidence and mortality rates also declined the fastest among men and blacks, compared with women and other ethnic groups, respectively.
Cancer incidence and death were also highest and decreased the most slowly in counties with lower educational attainment or highest poverty. Conversely, cancer incidence and mortality was the lowest and decreased the most quickly in metropolitan areas with populations greater than 1 million people.
Given that an estimated 40% of cancers diagnosed in the country and 3 in 10 cancer deaths are attributable to cigarette smoking and the use of smokeless tobacco, it is imperative that the CDC implement programs to help the almost 6 million smokers quit, CDC director Tom Frieden, MD, said in an associated telebriefing. Most people who smoke want to quit, and the health care system should do all it can to help them, Dr. Frieden said. At the same time, he echoed a claim from Henley’s paper, which said many tobacco-related cancers could be prevented by reducing tobacco use through implementation of evidence-based tobacco prevention and control interventions, such as increasing tobacco product prices, enforcing smoke-free laws, and promoting anti-tobacco mass media campaigns. These programs should be tailored to local geographic areas and demographics given the continued inconsistent progress and persistent disparities in tobacco-related cancer incidence and mortality, Dr. Frieden added.
[email protected]
On Twitter @jessnicolecraig
Tobacco-related cancer incidence and mortality rates dropped from 2004 to 2013, the Centers for Disease Control and Prevention reported in the Morbidity and Mortality Weekly Report published on Nov. 11, 2016.
Overall, tobacco-related invasive cancer incidence decreased from 206 cases per 100,000 during 2004-2008 to 193 cases per 100,000 during 2009-2013.
The announcement of this data marks a continuation of the downward trend that has been observed since the 1990s, lead author S. Jane Henley, MSPH, and her associates at the CDC wrote in the report (MMWR. 2016 Nov 11;65[44]:1212-8).
Despite this continued decline in tobacco-related cancer incidence and mortality rates, the tobacco-related cancer burden remains high, and disparities in the rates and decline of tobacco-related cancer persists.
“Tobacco use remains the leading preventable cause of disease and death in the United States,” reported Henley and her associates. For each year between 2009 and 2013, an estimated 660,000 Americans were diagnosed with tobacco-related cancer, and an estimated 343,000 people died from those cancers, according to the investigators’ analysis of data collected by the United States Cancer Statistics working group, which compiles data from multiple nationwide sources including the National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.
Tobacco-related cancer incidence and deaths were higher among men than women and higher among blacks than any other ethnic group. However, the cancer incidence and mortality rates also declined the fastest among men and blacks, compared with women and other ethnic groups, respectively.
Cancer incidence and death were also highest and decreased the most slowly in counties with lower educational attainment or highest poverty. Conversely, cancer incidence and mortality was the lowest and decreased the most quickly in metropolitan areas with populations greater than 1 million people.
Given that an estimated 40% of cancers diagnosed in the country and 3 in 10 cancer deaths are attributable to cigarette smoking and the use of smokeless tobacco, it is imperative that the CDC implement programs to help the almost 6 million smokers quit, CDC director Tom Frieden, MD, said in an associated telebriefing. Most people who smoke want to quit, and the health care system should do all it can to help them, Dr. Frieden said. At the same time, he echoed a claim from Henley’s paper, which said many tobacco-related cancers could be prevented by reducing tobacco use through implementation of evidence-based tobacco prevention and control interventions, such as increasing tobacco product prices, enforcing smoke-free laws, and promoting anti-tobacco mass media campaigns. These programs should be tailored to local geographic areas and demographics given the continued inconsistent progress and persistent disparities in tobacco-related cancer incidence and mortality, Dr. Frieden added.
[email protected]
On Twitter @jessnicolecraig
Tobacco-related cancer incidence and mortality rates dropped from 2004 to 2013, the Centers for Disease Control and Prevention reported in the Morbidity and Mortality Weekly Report published on Nov. 11, 2016.
Overall, tobacco-related invasive cancer incidence decreased from 206 cases per 100,000 during 2004-2008 to 193 cases per 100,000 during 2009-2013.
The announcement of this data marks a continuation of the downward trend that has been observed since the 1990s, lead author S. Jane Henley, MSPH, and her associates at the CDC wrote in the report (MMWR. 2016 Nov 11;65[44]:1212-8).
Despite this continued decline in tobacco-related cancer incidence and mortality rates, the tobacco-related cancer burden remains high, and disparities in the rates and decline of tobacco-related cancer persists.
“Tobacco use remains the leading preventable cause of disease and death in the United States,” reported Henley and her associates. For each year between 2009 and 2013, an estimated 660,000 Americans were diagnosed with tobacco-related cancer, and an estimated 343,000 people died from those cancers, according to the investigators’ analysis of data collected by the United States Cancer Statistics working group, which compiles data from multiple nationwide sources including the National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.
Tobacco-related cancer incidence and deaths were higher among men than women and higher among blacks than any other ethnic group. However, the cancer incidence and mortality rates also declined the fastest among men and blacks, compared with women and other ethnic groups, respectively.
Cancer incidence and death were also highest and decreased the most slowly in counties with lower educational attainment or highest poverty. Conversely, cancer incidence and mortality was the lowest and decreased the most quickly in metropolitan areas with populations greater than 1 million people.
Given that an estimated 40% of cancers diagnosed in the country and 3 in 10 cancer deaths are attributable to cigarette smoking and the use of smokeless tobacco, it is imperative that the CDC implement programs to help the almost 6 million smokers quit, CDC director Tom Frieden, MD, said in an associated telebriefing. Most people who smoke want to quit, and the health care system should do all it can to help them, Dr. Frieden said. At the same time, he echoed a claim from Henley’s paper, which said many tobacco-related cancers could be prevented by reducing tobacco use through implementation of evidence-based tobacco prevention and control interventions, such as increasing tobacco product prices, enforcing smoke-free laws, and promoting anti-tobacco mass media campaigns. These programs should be tailored to local geographic areas and demographics given the continued inconsistent progress and persistent disparities in tobacco-related cancer incidence and mortality, Dr. Frieden added.
[email protected]
On Twitter @jessnicolecraig
FROM MMWR
Key clinical point:
Major finding: Tobacco-related cancer mortality dropped from 108 deaths per 100,000 during 2004-2008 to 100 per 100,000 during 2009-2013.
Data source: Retrospective analysis of United States Cancer Statistics data for 2004 to 2013.
Disclosures: This study was sponsored by the Centers for Disease Control and Prevention. The authors’ disclosures were not reported.
Home oxygen upped survival in PAH with severely impaired DLCO
LOS ANGELES – Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.
“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.
That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.
“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”
The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.
A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.
The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.
Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.
Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.
Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.
Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.
LOS ANGELES – Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.
“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.
That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.
“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”
The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.
A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.
The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.
Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.
Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.
Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.
Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.
LOS ANGELES – Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.
“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.
That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.
“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”
The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.
A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.
The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.
Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.
Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.
Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.
Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.
Key clinical point:
Major finding: PAH patients with severe DLCO impairment who received oxygen had a significantly higher probability of survival than those who didn’t receive oxygen (HR, 0.56; P = .0033).
Data source: An analysis of 3,046 patients in the U.S. multicenter, observational REVEAL disease registry.
Disclosures: Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.
Delayed bleeding possible with EBUS-TBNA on antiplatelets
LOS ANGELES – There might be a slight increase in delayed bleeding when patients have endobronchial ultrasound with transbronchial needle aspiration within 5 days of taking oral antiplatelets, according to a review of 404 patients at Riverside Methodist Hospital in Columbus, Ohio.
This study is unusual in that it looked at the 48 hour mark. Previous studies have tended to focus on immediate bleeding events that require the procedure to be stopped; only some of that research has found an increased bleeding risk with antiplatelet therapy.
In the study at Riverside Methodist, none of the 20 patients on dual antiplatelet therapy – clopidogrel (Plavix) plus aspirin – bled during the procedure, but one (5%) had a hemoglobin drop of more than 2 g within 48 hours and another was readmitted to the hospital within 48 hours for procedure-related hemoptysis. Overall, the delayed bleeding event rate for patients using the dual antiplatelet therapy was 10%. Additionally, one of the 13 patients (7.7%) on clopidogrel alone experienced a greater than 2 g drop in hemoglobin.
Among the 270 patients not exposed to antiplatelets, the overall bleeding event rate was 2.6%, and the event rate for delayed bleeding was 1.1%. Four patients (1.5%) bled during the procedure, two (0.7%) had hemoglobin drops greater than 2 g within 48 hours, and one (0.4%) was readmitted for hemoptysis.
There were no bleeding events in the 101 patients who only took aspirin.
“There was a trend toward delayed bleeding events in patients” on clopidogrel or dual antiplatelets. “It’s worth considering a thoughtful pause in decision making. Maybe with the bleeding events we’re seeing, it would be worthwhile, if possible, to defer” endobronchial ultrasound with transbronchial needle aspiration “until after the antiplatelet therapy,” said Kevin Swiatek, DO, a medicine resident at Riverside.
Patients were excluded from the study if they had histories of bleeding or clotting disorders; low platelet counts; or if they were on anticoagulation. Subjects on antiplatelets were about 10 years older, on average, than those who were not (about 68 versus 59 years old), and more likely to have had a heart attack or stroke, and to be hypertensive.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – There might be a slight increase in delayed bleeding when patients have endobronchial ultrasound with transbronchial needle aspiration within 5 days of taking oral antiplatelets, according to a review of 404 patients at Riverside Methodist Hospital in Columbus, Ohio.
This study is unusual in that it looked at the 48 hour mark. Previous studies have tended to focus on immediate bleeding events that require the procedure to be stopped; only some of that research has found an increased bleeding risk with antiplatelet therapy.
In the study at Riverside Methodist, none of the 20 patients on dual antiplatelet therapy – clopidogrel (Plavix) plus aspirin – bled during the procedure, but one (5%) had a hemoglobin drop of more than 2 g within 48 hours and another was readmitted to the hospital within 48 hours for procedure-related hemoptysis. Overall, the delayed bleeding event rate for patients using the dual antiplatelet therapy was 10%. Additionally, one of the 13 patients (7.7%) on clopidogrel alone experienced a greater than 2 g drop in hemoglobin.
Among the 270 patients not exposed to antiplatelets, the overall bleeding event rate was 2.6%, and the event rate for delayed bleeding was 1.1%. Four patients (1.5%) bled during the procedure, two (0.7%) had hemoglobin drops greater than 2 g within 48 hours, and one (0.4%) was readmitted for hemoptysis.
There were no bleeding events in the 101 patients who only took aspirin.
“There was a trend toward delayed bleeding events in patients” on clopidogrel or dual antiplatelets. “It’s worth considering a thoughtful pause in decision making. Maybe with the bleeding events we’re seeing, it would be worthwhile, if possible, to defer” endobronchial ultrasound with transbronchial needle aspiration “until after the antiplatelet therapy,” said Kevin Swiatek, DO, a medicine resident at Riverside.
Patients were excluded from the study if they had histories of bleeding or clotting disorders; low platelet counts; or if they were on anticoagulation. Subjects on antiplatelets were about 10 years older, on average, than those who were not (about 68 versus 59 years old), and more likely to have had a heart attack or stroke, and to be hypertensive.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – There might be a slight increase in delayed bleeding when patients have endobronchial ultrasound with transbronchial needle aspiration within 5 days of taking oral antiplatelets, according to a review of 404 patients at Riverside Methodist Hospital in Columbus, Ohio.
This study is unusual in that it looked at the 48 hour mark. Previous studies have tended to focus on immediate bleeding events that require the procedure to be stopped; only some of that research has found an increased bleeding risk with antiplatelet therapy.
In the study at Riverside Methodist, none of the 20 patients on dual antiplatelet therapy – clopidogrel (Plavix) plus aspirin – bled during the procedure, but one (5%) had a hemoglobin drop of more than 2 g within 48 hours and another was readmitted to the hospital within 48 hours for procedure-related hemoptysis. Overall, the delayed bleeding event rate for patients using the dual antiplatelet therapy was 10%. Additionally, one of the 13 patients (7.7%) on clopidogrel alone experienced a greater than 2 g drop in hemoglobin.
Among the 270 patients not exposed to antiplatelets, the overall bleeding event rate was 2.6%, and the event rate for delayed bleeding was 1.1%. Four patients (1.5%) bled during the procedure, two (0.7%) had hemoglobin drops greater than 2 g within 48 hours, and one (0.4%) was readmitted for hemoptysis.
There were no bleeding events in the 101 patients who only took aspirin.
“There was a trend toward delayed bleeding events in patients” on clopidogrel or dual antiplatelets. “It’s worth considering a thoughtful pause in decision making. Maybe with the bleeding events we’re seeing, it would be worthwhile, if possible, to defer” endobronchial ultrasound with transbronchial needle aspiration “until after the antiplatelet therapy,” said Kevin Swiatek, DO, a medicine resident at Riverside.
Patients were excluded from the study if they had histories of bleeding or clotting disorders; low platelet counts; or if they were on anticoagulation. Subjects on antiplatelets were about 10 years older, on average, than those who were not (about 68 versus 59 years old), and more likely to have had a heart attack or stroke, and to be hypertensive.
There was no industry funding for the work, and the investigators had no disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Ten percent of patients on dual antiplatelet therapy bled within 48 hours, versus 1.1% of those not on antiplatelet therapy.
Data source: Single-center review of 404 patients.
Disclosures: There was no industry funding for the work, and the investigators had no disclosures.
Indacaterol/glycopyrronium OK as preferred COPD treatment
AT CHEST 2016
LOS ANGELES – Indacaterol/glycopyrronium was superior to salmeterol/fluticasone at reducing the risk and rate of moderate to severe exacerbations in chronic obstructive pulmonary disease (COPD) patients with more than one or zero to one exacerbations in the previous year, results from an indirect comparison showed.
“Acute exacerbations of COPD are associated with accelerated decline in lung function and increased mortality,” Kenneth R. Chapman, MD, said at the annual meeting of the American College of Chest Physicians. “Current GOLD [Global Initiative for Chronic Obstructive Lung Disease] strategy recommends LABA/ICS [long-acting beta-agonist/inhaled corticosteroid] combination, and/or LAMA [long-acting muscarinic antagonist] as the first-line treatment, and LABA/LAMA as an alternative treatment for COPD patients at a high risk of exacerbations.”
In an effort to examine the reduction in moderate or severe exacerbations in COPD patients taking indacaterol/glycopyrronium (a combination of a LABA bronchodilator and a LAMA bronchodilator) or salmeterol/fluticasone (a LABA and inhaled glucocorticoid combination), researchers compared results from the FLAME and LANTERN trials. The FLAME study evaluated the rate and risk of exacerbations with indacaterol/glycopyrronium versus salmeterol/fluticasone in 3,362 moderate to very severe COPD patients with at least one exacerbation in the previous year (N Engl J Med. 2016;374[23]:2222-34).The LANTERN study compared the efficacy and safety of indacaterol/glycopyrronium versus salmeterol/fluticasone in 744 moderate to very severe COPD patients with 0-1 exacerbation in the previous year (Int J Chron Obstruct Pulmon Dis. 2015;10:1015-26).
Dr. Chapman, professor of medicine at the University of Toronto, reported that in the FLAME study, which was 52 weeks long, indacaterol/glycopyrronium significantly reduced the annualized rate of moderate or severe COPD exacerbations in patients who had one or more exacerbation in the previous year (a rate ratio of 0.83; P less than 0.001), which translated in to a clinically meaningful 17% reduction, compared with their counterparts taking salmeterol/fluticasone. In the LANTERN study, which was 26 weeks long, indacaterol/glycopyrronium also significantly reduced the annualized rate of patients who had 0-1 exacerbation in the previous year, compared with those taking salmeterol/fluticasone (RR, 0.69; P = .048).
In FLAME, indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 22% risk reduction, compared with salmeterol/fluticasone (hazard ratio, 0.78; P less than .001). Similar findings were observed in LANTERN; indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 35% risk reduction, compared with salmeterol/fluticasone (HR, 0.65; P less than .028).
“These results suggest that LABA/LAMA combinations such as indacaterol/glycopyrronium can be considered as a preferred treatment option in the management of COPD patients, irrespective of exacerbation history,” Dr. Chapman said.He went on to note that in FLAME, the incidence of pneumonia was 3.2% in the indacaterol/glycopyrronium group, compared with 4.8% in the salmeterol/fluticasone group P = .02). In LANTERN, the incidence of pneumonia was 0.8% in the indacaterol/glycopyrronium group, compared with 2.7% in the salmeterol/fluticasone group. Finally, in FLAME, the incidence of oral candidiasis was 1.2% in the indacaterol/glycopyrronium group, compared with 4.2% in the salmeterol/fluticasone group (P less than .001). In LANTERN, the respective values were 0% and 0.3%.
Dr. Chapman reported having numerous financial disclosures, including receiving consulting fees and research grants from Novartis.
[email protected]
AT CHEST 2016
LOS ANGELES – Indacaterol/glycopyrronium was superior to salmeterol/fluticasone at reducing the risk and rate of moderate to severe exacerbations in chronic obstructive pulmonary disease (COPD) patients with more than one or zero to one exacerbations in the previous year, results from an indirect comparison showed.
“Acute exacerbations of COPD are associated with accelerated decline in lung function and increased mortality,” Kenneth R. Chapman, MD, said at the annual meeting of the American College of Chest Physicians. “Current GOLD [Global Initiative for Chronic Obstructive Lung Disease] strategy recommends LABA/ICS [long-acting beta-agonist/inhaled corticosteroid] combination, and/or LAMA [long-acting muscarinic antagonist] as the first-line treatment, and LABA/LAMA as an alternative treatment for COPD patients at a high risk of exacerbations.”
In an effort to examine the reduction in moderate or severe exacerbations in COPD patients taking indacaterol/glycopyrronium (a combination of a LABA bronchodilator and a LAMA bronchodilator) or salmeterol/fluticasone (a LABA and inhaled glucocorticoid combination), researchers compared results from the FLAME and LANTERN trials. The FLAME study evaluated the rate and risk of exacerbations with indacaterol/glycopyrronium versus salmeterol/fluticasone in 3,362 moderate to very severe COPD patients with at least one exacerbation in the previous year (N Engl J Med. 2016;374[23]:2222-34).The LANTERN study compared the efficacy and safety of indacaterol/glycopyrronium versus salmeterol/fluticasone in 744 moderate to very severe COPD patients with 0-1 exacerbation in the previous year (Int J Chron Obstruct Pulmon Dis. 2015;10:1015-26).
Dr. Chapman, professor of medicine at the University of Toronto, reported that in the FLAME study, which was 52 weeks long, indacaterol/glycopyrronium significantly reduced the annualized rate of moderate or severe COPD exacerbations in patients who had one or more exacerbation in the previous year (a rate ratio of 0.83; P less than 0.001), which translated in to a clinically meaningful 17% reduction, compared with their counterparts taking salmeterol/fluticasone. In the LANTERN study, which was 26 weeks long, indacaterol/glycopyrronium also significantly reduced the annualized rate of patients who had 0-1 exacerbation in the previous year, compared with those taking salmeterol/fluticasone (RR, 0.69; P = .048).
In FLAME, indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 22% risk reduction, compared with salmeterol/fluticasone (hazard ratio, 0.78; P less than .001). Similar findings were observed in LANTERN; indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 35% risk reduction, compared with salmeterol/fluticasone (HR, 0.65; P less than .028).
“These results suggest that LABA/LAMA combinations such as indacaterol/glycopyrronium can be considered as a preferred treatment option in the management of COPD patients, irrespective of exacerbation history,” Dr. Chapman said.He went on to note that in FLAME, the incidence of pneumonia was 3.2% in the indacaterol/glycopyrronium group, compared with 4.8% in the salmeterol/fluticasone group P = .02). In LANTERN, the incidence of pneumonia was 0.8% in the indacaterol/glycopyrronium group, compared with 2.7% in the salmeterol/fluticasone group. Finally, in FLAME, the incidence of oral candidiasis was 1.2% in the indacaterol/glycopyrronium group, compared with 4.2% in the salmeterol/fluticasone group (P less than .001). In LANTERN, the respective values were 0% and 0.3%.
Dr. Chapman reported having numerous financial disclosures, including receiving consulting fees and research grants from Novartis.
[email protected]
AT CHEST 2016
LOS ANGELES – Indacaterol/glycopyrronium was superior to salmeterol/fluticasone at reducing the risk and rate of moderate to severe exacerbations in chronic obstructive pulmonary disease (COPD) patients with more than one or zero to one exacerbations in the previous year, results from an indirect comparison showed.
“Acute exacerbations of COPD are associated with accelerated decline in lung function and increased mortality,” Kenneth R. Chapman, MD, said at the annual meeting of the American College of Chest Physicians. “Current GOLD [Global Initiative for Chronic Obstructive Lung Disease] strategy recommends LABA/ICS [long-acting beta-agonist/inhaled corticosteroid] combination, and/or LAMA [long-acting muscarinic antagonist] as the first-line treatment, and LABA/LAMA as an alternative treatment for COPD patients at a high risk of exacerbations.”
In an effort to examine the reduction in moderate or severe exacerbations in COPD patients taking indacaterol/glycopyrronium (a combination of a LABA bronchodilator and a LAMA bronchodilator) or salmeterol/fluticasone (a LABA and inhaled glucocorticoid combination), researchers compared results from the FLAME and LANTERN trials. The FLAME study evaluated the rate and risk of exacerbations with indacaterol/glycopyrronium versus salmeterol/fluticasone in 3,362 moderate to very severe COPD patients with at least one exacerbation in the previous year (N Engl J Med. 2016;374[23]:2222-34).The LANTERN study compared the efficacy and safety of indacaterol/glycopyrronium versus salmeterol/fluticasone in 744 moderate to very severe COPD patients with 0-1 exacerbation in the previous year (Int J Chron Obstruct Pulmon Dis. 2015;10:1015-26).
Dr. Chapman, professor of medicine at the University of Toronto, reported that in the FLAME study, which was 52 weeks long, indacaterol/glycopyrronium significantly reduced the annualized rate of moderate or severe COPD exacerbations in patients who had one or more exacerbation in the previous year (a rate ratio of 0.83; P less than 0.001), which translated in to a clinically meaningful 17% reduction, compared with their counterparts taking salmeterol/fluticasone. In the LANTERN study, which was 26 weeks long, indacaterol/glycopyrronium also significantly reduced the annualized rate of patients who had 0-1 exacerbation in the previous year, compared with those taking salmeterol/fluticasone (RR, 0.69; P = .048).
In FLAME, indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 22% risk reduction, compared with salmeterol/fluticasone (hazard ratio, 0.78; P less than .001). Similar findings were observed in LANTERN; indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 35% risk reduction, compared with salmeterol/fluticasone (HR, 0.65; P less than .028).
“These results suggest that LABA/LAMA combinations such as indacaterol/glycopyrronium can be considered as a preferred treatment option in the management of COPD patients, irrespective of exacerbation history,” Dr. Chapman said.He went on to note that in FLAME, the incidence of pneumonia was 3.2% in the indacaterol/glycopyrronium group, compared with 4.8% in the salmeterol/fluticasone group P = .02). In LANTERN, the incidence of pneumonia was 0.8% in the indacaterol/glycopyrronium group, compared with 2.7% in the salmeterol/fluticasone group. Finally, in FLAME, the incidence of oral candidiasis was 1.2% in the indacaterol/glycopyrronium group, compared with 4.2% in the salmeterol/fluticasone group (P less than .001). In LANTERN, the respective values were 0% and 0.3%.
Dr. Chapman reported having numerous financial disclosures, including receiving consulting fees and research grants from Novartis.
[email protected]
Key clinical point:
Major finding: Indacaterol/glycopyrronium significantly reduced the annualized rate of moderate or severe COPD exacerbations in patients who had one or more exacerbation in the previous year (a rate ratio of 0.83; P less than 0.001), which translated into a clinically meaningful 17% reduction, compared with their counterparts taking salmeterol/fluticasone.
Data source: An indirect comparison of 3,362 patients in the FLAME study and 744 patients in the LANTERN study.
Disclosures: Dr. Chapman reported having numerous financial disclosures, including receiving consulting fees and research grants from Novartis.
Optimal MPE management requires early pulmonology referral
LOS ANGELES – About half of patients with symptomatic malignant pleural effusions at McGill University Health Centre in Montreal had unnecessary procedures and hospital admissions before definitive treatment with chemical pleurodesis or indwelling pleural catheters, according to researchers.
Instead of chest taps to relieve symptoms followed by referrals for definitive treatment, some patients got chest tubes – without pleurodesis – after presenting to the emergency department and being referred to radiology; they were then admitted to the hospital for a few days while the tubes were in place. In short, cancer patients were wasting what time they had left on medical care they didn’t need, and incurring unnecessary costs, said lead investigator Benjamin Shieh, MD, formerly at McGill but now an interventional pulmonology fellow at the University of Calgary. 
McGill is a tertiary care center able to perform both definitive procedures, so “we should be a center of excellence. I imagine there are similar situations” at other hospitals, especially those without the resources of McGill, Dr. Shieh said at the annual meeting of the American College of Chest Physicians.
McGill has taken several steps to address the problem, including early ED referral to the pulmonology service and discouraging radiology from placing chest tubes for malignant pleural effusions (MPE). “I think we can avoid a big proportion of hospitalizations for MPE, and certainly a proportion of repeat [ED] visits,” said senior author Anne Gonzalez, MD, an attending pulmonologist at McGill.
The investigators looked into the issue after noting that a lot of their MPE cases had been hospitalized with chest tubes. They reviewed 72 symptomatic MPE cases in 69 patients treated in 2014 and 2015. Management was ideal in 36 cases (50%), meaning that, prior to definitive treatment, patients had no more than two pleural taps for symptom relief, no more than one ED visit, no chest tubes without pleurodesis, and no hospitalizations. “We thought this would be reasonable to try to achieve for MPE,” since there’s no definition of ideal management, Dr. Shieh said.
Nonideal patients had a mean of 2.5 pleural procedures – almost twice the number in the ideal group – before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed in 27 cases (38%) for an average of 3.7 days; 28 cases (39%) were hospitalized. Nonideal patients were far more likely to present first to the ED, and ED presentations were more likely to get chest tubes and be admitted. All the cases were eventually treated definitively, 68 with indwelling pleural catheters and 4 by thoracoscopic talc insufflation. Time from initial presentation to definitive palliation was about 1 month in both groups. The investigators didn’t consider rate of effusion recurrence, which might help explain why the ideal group wasn’t treated sooner; they might not have needed it. The higher number of ED visits in the nonideal group suggests that they may have had quicker recurrences, and should have been treated sooner, Dr. Gonzalez said.
The patients were 70 years old, on average, and about 60% were women. Lung and breast were the most common cancers.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – About half of patients with symptomatic malignant pleural effusions at McGill University Health Centre in Montreal had unnecessary procedures and hospital admissions before definitive treatment with chemical pleurodesis or indwelling pleural catheters, according to researchers.
Instead of chest taps to relieve symptoms followed by referrals for definitive treatment, some patients got chest tubes – without pleurodesis – after presenting to the emergency department and being referred to radiology; they were then admitted to the hospital for a few days while the tubes were in place. In short, cancer patients were wasting what time they had left on medical care they didn’t need, and incurring unnecessary costs, said lead investigator Benjamin Shieh, MD, formerly at McGill but now an interventional pulmonology fellow at the University of Calgary.
McGill is a tertiary care center able to perform both definitive procedures, so “we should be a center of excellence. I imagine there are similar situations” at other hospitals, especially those without the resources of McGill, Dr. Shieh said at the annual meeting of the American College of Chest Physicians.
McGill has taken several steps to address the problem, including early ED referral to the pulmonology service and discouraging radiology from placing chest tubes for malignant pleural effusions (MPE). “I think we can avoid a big proportion of hospitalizations for MPE, and certainly a proportion of repeat [ED] visits,” said senior author Anne Gonzalez, MD, an attending pulmonologist at McGill.
The investigators looked into the issue after noting that a lot of their MPE cases had been hospitalized with chest tubes. They reviewed 72 symptomatic MPE cases in 69 patients treated in 2014 and 2015. Management was ideal in 36 cases (50%), meaning that, prior to definitive treatment, patients had no more than two pleural taps for symptom relief, no more than one ED visit, no chest tubes without pleurodesis, and no hospitalizations. “We thought this would be reasonable to try to achieve for MPE,” since there’s no definition of ideal management, Dr. Shieh said.
Nonideal patients had a mean of 2.5 pleural procedures – almost twice the number in the ideal group – before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed in 27 cases (38%) for an average of 3.7 days; 28 cases (39%) were hospitalized. Nonideal patients were far more likely to present first to the ED, and ED presentations were more likely to get chest tubes and be admitted. All the cases were eventually treated definitively, 68 with indwelling pleural catheters and 4 by thoracoscopic talc insufflation. Time from initial presentation to definitive palliation was about 1 month in both groups. The investigators didn’t consider rate of effusion recurrence, which might help explain why the ideal group wasn’t treated sooner; they might not have needed it. The higher number of ED visits in the nonideal group suggests that they may have had quicker recurrences, and should have been treated sooner, Dr. Gonzalez said.
The patients were 70 years old, on average, and about 60% were women. Lung and breast were the most common cancers.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – About half of patients with symptomatic malignant pleural effusions at McGill University Health Centre in Montreal had unnecessary procedures and hospital admissions before definitive treatment with chemical pleurodesis or indwelling pleural catheters, according to researchers.
Instead of chest taps to relieve symptoms followed by referrals for definitive treatment, some patients got chest tubes – without pleurodesis – after presenting to the emergency department and being referred to radiology; they were then admitted to the hospital for a few days while the tubes were in place. In short, cancer patients were wasting what time they had left on medical care they didn’t need, and incurring unnecessary costs, said lead investigator Benjamin Shieh, MD, formerly at McGill but now an interventional pulmonology fellow at the University of Calgary.
McGill is a tertiary care center able to perform both definitive procedures, so “we should be a center of excellence. I imagine there are similar situations” at other hospitals, especially those without the resources of McGill, Dr. Shieh said at the annual meeting of the American College of Chest Physicians.
McGill has taken several steps to address the problem, including early ED referral to the pulmonology service and discouraging radiology from placing chest tubes for malignant pleural effusions (MPE). “I think we can avoid a big proportion of hospitalizations for MPE, and certainly a proportion of repeat [ED] visits,” said senior author Anne Gonzalez, MD, an attending pulmonologist at McGill.
The investigators looked into the issue after noting that a lot of their MPE cases had been hospitalized with chest tubes. They reviewed 72 symptomatic MPE cases in 69 patients treated in 2014 and 2015. Management was ideal in 36 cases (50%), meaning that, prior to definitive treatment, patients had no more than two pleural taps for symptom relief, no more than one ED visit, no chest tubes without pleurodesis, and no hospitalizations. “We thought this would be reasonable to try to achieve for MPE,” since there’s no definition of ideal management, Dr. Shieh said.
Nonideal patients had a mean of 2.5 pleural procedures – almost twice the number in the ideal group – before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed in 27 cases (38%) for an average of 3.7 days; 28 cases (39%) were hospitalized. Nonideal patients were far more likely to present first to the ED, and ED presentations were more likely to get chest tubes and be admitted. All the cases were eventually treated definitively, 68 with indwelling pleural catheters and 4 by thoracoscopic talc insufflation. Time from initial presentation to definitive palliation was about 1 month in both groups. The investigators didn’t consider rate of effusion recurrence, which might help explain why the ideal group wasn’t treated sooner; they might not have needed it. The higher number of ED visits in the nonideal group suggests that they may have had quicker recurrences, and should have been treated sooner, Dr. Gonzalez said.
The patients were 70 years old, on average, and about 60% were women. Lung and breast were the most common cancers.
There was no industry funding for the work, and the investigators had no disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Those patients had a mean of 2.5 pleural procedures before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed for an average of 3.7 days.
Data source: Review of 72 MPE cases in 69 patients.
Disclosures: There was no industry funding for the work, and the investigators had no disclosures.
Blood assay rapidly identifies lung cancer mutations
LOS ANGELES – A newer blood test (GeneStrat from Biodesix) identified genetic mutations in lung tumors in about 24 hours, allowing for an early start of mutation-specific chemotherapy, in an investigation from Gundersen Health System in La Crosse, Wis.
Interventional pulmonologists drew blood samples when they performed biopsies on 84 patients with highly suspicious lung nodules and submitted both blood and tissue for mutation analysis. The blood was analyzed by Biodesix, the maker of GeneStrat, a commercially available digital droplet polymerase change reaction assay launched in 2015. The company sent the results back in an average of 24.1 hours, and all within 72 hours. The mutation results from tissue analysis took 2-3 weeks.
Fifteen patients (18%) had actionable epidermal growth factor receptor, anaplastic lymphoma kinase, or K-Ras protein gene mutations, and were candidates for targeted therapy. Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%. The tissue testing picked up two mutations missed by blood testing. One of the two mutations is rare and was not included in the blood assay. Meanwhile, the assay caught a mutation missed on tissue analysis.
She and her colleagues are now routinely using GeneStrat to guide initial lung cancer therapy. “The turnaround time is fantastic. It allows us to have [the mutation status] when oncologists meet with patients for the very first time,” she said.
It “definitely” makes a difference. “If you have an actionable mutation and there’s a targeted chemotherapy” – such as erlotinib (Tarceva) for epidermal growth factor receptor mutation patients – it can be started right out of the gate. “Time to treatment is very important,” not just psychologically for patients but also for them to have the best chance against the tumor. The sooner “we can start a targeted therapy,” the better outcomes are likely to be, Dr. Mattingley said.
When mutation status is delayed, patients might be started “on the wrong therapy upfront, and it’s really hard to back up and start over again,” she said.
“Once we give patients a diagnosis of lung cancer, the next thing they should hear right away is how we are going to attack it. We felt strongly [that there was a] need to look at this to see if we could truly expedite the time from diagnosis to treatment. We believe our patients should have no sleepless nights,” Dr. Mattingley said.
There’s also usually not much tissue left after genetic work-up to send into a clinical trial. Using blood to identify mutations “may allow us to conserve our tissue block for future trials, but still get the genetic information we need to start treatment plans for our patients,” she said.
There was no company funding for the work, but Dr. Mattingley is a speaker for GeneStrat’s maker, Biodesix.
The results of this study are very promising. The high concordance between liquid biopsies and tissue biopsies as well as the short turn-around time for the results of the liquid biopsies makes a big difference in terms of getting patients started on appropriate therapy sooner rather than later. We need additional studies to find out if liquid biopsies will be good for detection of other molecular alterations such as ROS-1 and EGFR acquired mutation T790M.
The results of this study are very promising. The high concordance between liquid biopsies and tissue biopsies as well as the short turn-around time for the results of the liquid biopsies makes a big difference in terms of getting patients started on appropriate therapy sooner rather than later. We need additional studies to find out if liquid biopsies will be good for detection of other molecular alterations such as ROS-1 and EGFR acquired mutation T790M.
The results of this study are very promising. The high concordance between liquid biopsies and tissue biopsies as well as the short turn-around time for the results of the liquid biopsies makes a big difference in terms of getting patients started on appropriate therapy sooner rather than later. We need additional studies to find out if liquid biopsies will be good for detection of other molecular alterations such as ROS-1 and EGFR acquired mutation T790M.
LOS ANGELES – A newer blood test (GeneStrat from Biodesix) identified genetic mutations in lung tumors in about 24 hours, allowing for an early start of mutation-specific chemotherapy, in an investigation from Gundersen Health System in La Crosse, Wis.
Interventional pulmonologists drew blood samples when they performed biopsies on 84 patients with highly suspicious lung nodules and submitted both blood and tissue for mutation analysis. The blood was analyzed by Biodesix, the maker of GeneStrat, a commercially available digital droplet polymerase change reaction assay launched in 2015. The company sent the results back in an average of 24.1 hours, and all within 72 hours. The mutation results from tissue analysis took 2-3 weeks.
Fifteen patients (18%) had actionable epidermal growth factor receptor, anaplastic lymphoma kinase, or K-Ras protein gene mutations, and were candidates for targeted therapy. Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%. The tissue testing picked up two mutations missed by blood testing. One of the two mutations is rare and was not included in the blood assay. Meanwhile, the assay caught a mutation missed on tissue analysis.
She and her colleagues are now routinely using GeneStrat to guide initial lung cancer therapy. “The turnaround time is fantastic. It allows us to have [the mutation status] when oncologists meet with patients for the very first time,” she said.
It “definitely” makes a difference. “If you have an actionable mutation and there’s a targeted chemotherapy” – such as erlotinib (Tarceva) for epidermal growth factor receptor mutation patients – it can be started right out of the gate. “Time to treatment is very important,” not just psychologically for patients but also for them to have the best chance against the tumor. The sooner “we can start a targeted therapy,” the better outcomes are likely to be, Dr. Mattingley said.
When mutation status is delayed, patients might be started “on the wrong therapy upfront, and it’s really hard to back up and start over again,” she said.
“Once we give patients a diagnosis of lung cancer, the next thing they should hear right away is how we are going to attack it. We felt strongly [that there was a] need to look at this to see if we could truly expedite the time from diagnosis to treatment. We believe our patients should have no sleepless nights,” Dr. Mattingley said.
There’s also usually not much tissue left after genetic work-up to send into a clinical trial. Using blood to identify mutations “may allow us to conserve our tissue block for future trials, but still get the genetic information we need to start treatment plans for our patients,” she said.
There was no company funding for the work, but Dr. Mattingley is a speaker for GeneStrat’s maker, Biodesix.
LOS ANGELES – A newer blood test (GeneStrat from Biodesix) identified genetic mutations in lung tumors in about 24 hours, allowing for an early start of mutation-specific chemotherapy, in an investigation from Gundersen Health System in La Crosse, Wis.
Interventional pulmonologists drew blood samples when they performed biopsies on 84 patients with highly suspicious lung nodules and submitted both blood and tissue for mutation analysis. The blood was analyzed by Biodesix, the maker of GeneStrat, a commercially available digital droplet polymerase change reaction assay launched in 2015. The company sent the results back in an average of 24.1 hours, and all within 72 hours. The mutation results from tissue analysis took 2-3 weeks.
Fifteen patients (18%) had actionable epidermal growth factor receptor, anaplastic lymphoma kinase, or K-Ras protein gene mutations, and were candidates for targeted therapy. Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%. The tissue testing picked up two mutations missed by blood testing. One of the two mutations is rare and was not included in the blood assay. Meanwhile, the assay caught a mutation missed on tissue analysis.
She and her colleagues are now routinely using GeneStrat to guide initial lung cancer therapy. “The turnaround time is fantastic. It allows us to have [the mutation status] when oncologists meet with patients for the very first time,” she said.
It “definitely” makes a difference. “If you have an actionable mutation and there’s a targeted chemotherapy” – such as erlotinib (Tarceva) for epidermal growth factor receptor mutation patients – it can be started right out of the gate. “Time to treatment is very important,” not just psychologically for patients but also for them to have the best chance against the tumor. The sooner “we can start a targeted therapy,” the better outcomes are likely to be, Dr. Mattingley said.
When mutation status is delayed, patients might be started “on the wrong therapy upfront, and it’s really hard to back up and start over again,” she said.
“Once we give patients a diagnosis of lung cancer, the next thing they should hear right away is how we are going to attack it. We felt strongly [that there was a] need to look at this to see if we could truly expedite the time from diagnosis to treatment. We believe our patients should have no sleepless nights,” Dr. Mattingley said.
There’s also usually not much tissue left after genetic work-up to send into a clinical trial. Using blood to identify mutations “may allow us to conserve our tissue block for future trials, but still get the genetic information we need to start treatment plans for our patients,” she said.
There was no company funding for the work, but Dr. Mattingley is a speaker for GeneStrat’s maker, Biodesix.
AT CHEST 2016
Key clinical point:
Major finding: Compared with tissue testing, the blood assay had a sensitivity of 88% and a specificity of 99%.
Data source: Eighty-four patients with highly suspicious lung nodules.
Disclosures: There was no company funding for the work, but the presenter is a paid speaker for GeneStrat’s maker, Biodesix.