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Overall survival for metastatic urothelial carcinoma approaching 2 years
This is according to a review of the recent therapeutic advances and ongoing clinical trials in metastatic urothelial carcinoma.
“Survival in the metastatic setting is 12-15 months with cisplatin-based combination chemotherapy, but only 3-6 months if left untreated,” wrote Srikala S. Sridhar, MD, of the University of Toronto, and colleagues. Their report is in Therapeutic Advances in Medical Oncology. “More recently, with the advent of immunotherapy, antibody-drug conjugates, and targeted agents, the treatment landscape has changed significantly, with overall survival now approaching two years.”
Both the incidence and mortality from bladder cancer have risen over the past few decades. Around 5% of patients are metastatic at presentation, but nearly half of patients with muscle-invasive bladder cancer will eventually relapse and develop metastatic disease.
For first-line treatment in metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the preferred option with response rates up to 72%, but durability is an issue with most patients experiencing disease progression. In patients with locally advanced or metastatic disease, who are not eligible for cisplatin-based chemotherapy and whose tumors express PD-L1, or patients who are not eligible for any platinum-based regimen regardless of PD-L1 status, the immune checkpoint inhibitors atezolizumab and pembrolizumab have received accelerated Food and Drug administration approval. More recently, pembrolizumab gained full FDA approval for use in patients not eligible to receive platinum-based chemotherapy.
While phase 3 studies are evaluating chemotherapy combined with atezolizumab or pembrolizumab, the results have not been promising. Moreover, the decreased survival observed in the immunotherapy-alone arms of these trials led the FDA to issue a warning that single agent immunotherapy should be used only in patients who are not eligible for cisplatin-based therapy and have PD-L1 expression, or in those not eligible for any platinum-based regimens regardless of PD-L1 expression.
“More intensive treatment in metastatic urothelial carcinoma is not always better,” the authors wrote. “Some of the reasons for this could be that chemotherapy and immunotherapy are targeting a similar population of cells, or that chemotherapy and immunotherapy are antagonistic on some level.”
[embed:render:related:node:205273]
Maintenance strategies are considered standard of care for other advanced solid tumors. In patients with bladder cancer without disease progression after a first line platinum-based chemotherapy, maintenance avelumab, an anti PD-L1, has shown an overall survival of 21.4 months versus 14.3 months with best supportive care, a finding that the authors described as “practice changing.” Meanwhile, a separate trial showed increased progression-free survival with maintenance pembrolizumab, but no increased overall survival.
For second-line treatment, immunotherapy is currently the standard of care in patients with disease progression during or after platinum-based chemotherapy. While the efficiency of five anti PD-1 and PD-L1 antibodies has been reported in the second-line setting, pembrolizumab is the only immune checkpoint inhibitor to receive full FDA approval. Atezolizumab, nivolumab, avelumab, and durvalumab have received accelerated approval.
“In urothelial carcinomas, PD-1 appears to have an advantage over anti PD-L1 in the second-line setting, but in the maintenance setting, it seems to be the opposite,” the authors wrote.
Erdafitinib is the only fibroblast growth factor receptor (FGFR) inhibitor approved for locally advanced or metastatic urothelial carcinoma, progressing on platinum-based chemotherapy. The oral potent tyrosine kinase inhibitor of FGFR 1-4 is approved for use only in patients with susceptible FGFR3 gene mutations or FGFR2/3 gene fusions. Despite being approved for second-line treatment, erdafitinib is used mainly in third-line treatment after progression on immunotherapy.
The antibody drug conjugates sacituzumab govitecan and enfortumab vedotin, which have gained accelerated FDA approval, provide other options for patients with metastatic urothelial carcinoma resistant to chemotherapy and checkpoint inhibitors. As these antibody drug conjugates have different mechanisms of action and toxicity profiles, they could be used in the same patient throughout the disease course, but further research is needed. Meanwhile, many chemotherapy options, including docetaxel, gemcitabine, ifosfamide, and pemetrexed, have been tested in metastatic urothelial carcinoma with some response after platinum-based treatment.
“A number of studies evaluating promising therapeutic strategies are still ongoing and will hopefully provide information for some important unanswered questions and further guide treatment sequencing in advanced urothelial carcinoma,” the authors wrote.
They declared that there are no conflicts of interest.
This is according to a review of the recent therapeutic advances and ongoing clinical trials in metastatic urothelial carcinoma.
“Survival in the metastatic setting is 12-15 months with cisplatin-based combination chemotherapy, but only 3-6 months if left untreated,” wrote Srikala S. Sridhar, MD, of the University of Toronto, and colleagues. Their report is in Therapeutic Advances in Medical Oncology. “More recently, with the advent of immunotherapy, antibody-drug conjugates, and targeted agents, the treatment landscape has changed significantly, with overall survival now approaching two years.”
Both the incidence and mortality from bladder cancer have risen over the past few decades. Around 5% of patients are metastatic at presentation, but nearly half of patients with muscle-invasive bladder cancer will eventually relapse and develop metastatic disease.
For first-line treatment in metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the preferred option with response rates up to 72%, but durability is an issue with most patients experiencing disease progression. In patients with locally advanced or metastatic disease, who are not eligible for cisplatin-based chemotherapy and whose tumors express PD-L1, or patients who are not eligible for any platinum-based regimen regardless of PD-L1 status, the immune checkpoint inhibitors atezolizumab and pembrolizumab have received accelerated Food and Drug administration approval. More recently, pembrolizumab gained full FDA approval for use in patients not eligible to receive platinum-based chemotherapy.
While phase 3 studies are evaluating chemotherapy combined with atezolizumab or pembrolizumab, the results have not been promising. Moreover, the decreased survival observed in the immunotherapy-alone arms of these trials led the FDA to issue a warning that single agent immunotherapy should be used only in patients who are not eligible for cisplatin-based therapy and have PD-L1 expression, or in those not eligible for any platinum-based regimens regardless of PD-L1 expression.
“More intensive treatment in metastatic urothelial carcinoma is not always better,” the authors wrote. “Some of the reasons for this could be that chemotherapy and immunotherapy are targeting a similar population of cells, or that chemotherapy and immunotherapy are antagonistic on some level.”
[embed:render:related:node:205273]
Maintenance strategies are considered standard of care for other advanced solid tumors. In patients with bladder cancer without disease progression after a first line platinum-based chemotherapy, maintenance avelumab, an anti PD-L1, has shown an overall survival of 21.4 months versus 14.3 months with best supportive care, a finding that the authors described as “practice changing.” Meanwhile, a separate trial showed increased progression-free survival with maintenance pembrolizumab, but no increased overall survival.
For second-line treatment, immunotherapy is currently the standard of care in patients with disease progression during or after platinum-based chemotherapy. While the efficiency of five anti PD-1 and PD-L1 antibodies has been reported in the second-line setting, pembrolizumab is the only immune checkpoint inhibitor to receive full FDA approval. Atezolizumab, nivolumab, avelumab, and durvalumab have received accelerated approval.
“In urothelial carcinomas, PD-1 appears to have an advantage over anti PD-L1 in the second-line setting, but in the maintenance setting, it seems to be the opposite,” the authors wrote.
Erdafitinib is the only fibroblast growth factor receptor (FGFR) inhibitor approved for locally advanced or metastatic urothelial carcinoma, progressing on platinum-based chemotherapy. The oral potent tyrosine kinase inhibitor of FGFR 1-4 is approved for use only in patients with susceptible FGFR3 gene mutations or FGFR2/3 gene fusions. Despite being approved for second-line treatment, erdafitinib is used mainly in third-line treatment after progression on immunotherapy.
The antibody drug conjugates sacituzumab govitecan and enfortumab vedotin, which have gained accelerated FDA approval, provide other options for patients with metastatic urothelial carcinoma resistant to chemotherapy and checkpoint inhibitors. As these antibody drug conjugates have different mechanisms of action and toxicity profiles, they could be used in the same patient throughout the disease course, but further research is needed. Meanwhile, many chemotherapy options, including docetaxel, gemcitabine, ifosfamide, and pemetrexed, have been tested in metastatic urothelial carcinoma with some response after platinum-based treatment.
“A number of studies evaluating promising therapeutic strategies are still ongoing and will hopefully provide information for some important unanswered questions and further guide treatment sequencing in advanced urothelial carcinoma,” the authors wrote.
They declared that there are no conflicts of interest.
This is according to a review of the recent therapeutic advances and ongoing clinical trials in metastatic urothelial carcinoma.
“Survival in the metastatic setting is 12-15 months with cisplatin-based combination chemotherapy, but only 3-6 months if left untreated,” wrote Srikala S. Sridhar, MD, of the University of Toronto, and colleagues. Their report is in Therapeutic Advances in Medical Oncology. “More recently, with the advent of immunotherapy, antibody-drug conjugates, and targeted agents, the treatment landscape has changed significantly, with overall survival now approaching two years.”
Both the incidence and mortality from bladder cancer have risen over the past few decades. Around 5% of patients are metastatic at presentation, but nearly half of patients with muscle-invasive bladder cancer will eventually relapse and develop metastatic disease.
For first-line treatment in metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the preferred option with response rates up to 72%, but durability is an issue with most patients experiencing disease progression. In patients with locally advanced or metastatic disease, who are not eligible for cisplatin-based chemotherapy and whose tumors express PD-L1, or patients who are not eligible for any platinum-based regimen regardless of PD-L1 status, the immune checkpoint inhibitors atezolizumab and pembrolizumab have received accelerated Food and Drug administration approval. More recently, pembrolizumab gained full FDA approval for use in patients not eligible to receive platinum-based chemotherapy.
While phase 3 studies are evaluating chemotherapy combined with atezolizumab or pembrolizumab, the results have not been promising. Moreover, the decreased survival observed in the immunotherapy-alone arms of these trials led the FDA to issue a warning that single agent immunotherapy should be used only in patients who are not eligible for cisplatin-based therapy and have PD-L1 expression, or in those not eligible for any platinum-based regimens regardless of PD-L1 expression.
“More intensive treatment in metastatic urothelial carcinoma is not always better,” the authors wrote. “Some of the reasons for this could be that chemotherapy and immunotherapy are targeting a similar population of cells, or that chemotherapy and immunotherapy are antagonistic on some level.”
[embed:render:related:node:205273]
Maintenance strategies are considered standard of care for other advanced solid tumors. In patients with bladder cancer without disease progression after a first line platinum-based chemotherapy, maintenance avelumab, an anti PD-L1, has shown an overall survival of 21.4 months versus 14.3 months with best supportive care, a finding that the authors described as “practice changing.” Meanwhile, a separate trial showed increased progression-free survival with maintenance pembrolizumab, but no increased overall survival.
For second-line treatment, immunotherapy is currently the standard of care in patients with disease progression during or after platinum-based chemotherapy. While the efficiency of five anti PD-1 and PD-L1 antibodies has been reported in the second-line setting, pembrolizumab is the only immune checkpoint inhibitor to receive full FDA approval. Atezolizumab, nivolumab, avelumab, and durvalumab have received accelerated approval.
“In urothelial carcinomas, PD-1 appears to have an advantage over anti PD-L1 in the second-line setting, but in the maintenance setting, it seems to be the opposite,” the authors wrote.
Erdafitinib is the only fibroblast growth factor receptor (FGFR) inhibitor approved for locally advanced or metastatic urothelial carcinoma, progressing on platinum-based chemotherapy. The oral potent tyrosine kinase inhibitor of FGFR 1-4 is approved for use only in patients with susceptible FGFR3 gene mutations or FGFR2/3 gene fusions. Despite being approved for second-line treatment, erdafitinib is used mainly in third-line treatment after progression on immunotherapy.
The antibody drug conjugates sacituzumab govitecan and enfortumab vedotin, which have gained accelerated FDA approval, provide other options for patients with metastatic urothelial carcinoma resistant to chemotherapy and checkpoint inhibitors. As these antibody drug conjugates have different mechanisms of action and toxicity profiles, they could be used in the same patient throughout the disease course, but further research is needed. Meanwhile, many chemotherapy options, including docetaxel, gemcitabine, ifosfamide, and pemetrexed, have been tested in metastatic urothelial carcinoma with some response after platinum-based treatment.
“A number of studies evaluating promising therapeutic strategies are still ongoing and will hopefully provide information for some important unanswered questions and further guide treatment sequencing in advanced urothelial carcinoma,” the authors wrote.
They declared that there are no conflicts of interest.
FROM THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
In and out surgeries become the norm during pandemic
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Lung cancer screening rates in U.S. nowhere near goal
according to a review and meta-analysis published in the Journal of Thoracic Oncology.
“Lung cancer screening is effective in reducing mortality, particularly when patients adhere to follow-up recommendations standardized by the Lung CT Screening Reporting & Data System (Lung-RADS),” Yannan Lin, MD, MPH, of the University of California, Los Angeles, and colleagues wrote. ”Patient adherence to Lung-RADS–recommended screening intervals is suboptimal across clinical lung cancer screening programs in the U.S., especially among patients with Lung-RADS category 1-2 results.”
Lung cancer screening can identify tumors at earlier, more treatable stages, but patients with lung cancer diagnoses based on new nodules at incidence screening have shown shortened survivals. The National Lung Screening Trial (NLST) has shown a 20% relative reduction in lung cancer mortality with low-dose chest CT screening relative to chest radiography. The Lung-RADS guidelines to standardize the reporting of lung cancer screening were developed based on findings from the NLST and other screening studies, partly to reduce false-positive rates. Lung-RADS scores are based upon nodule size, characteristics and location, with management guidelines specific to Lung-RADS categories, ranging from low-dose chest CT in 12 months for Lung-RADS 1-2 to chest CT, PET/CT, or tissue sampling for Lung-RADS 4B/X.
The rate of adherence to lung cancer screening based on Lung-RADS guidelines is unclear. This systematic review and meta-analysis looked at patient adherence to Lung-RADS recommended screening intervals in clinical practice.
The meta-analysis included 21 studies. The pooled adherence rate was 57% for defined adherence, which included an annual incidence screen performed within 15 months, among 6,689 patients and 65% for anytime adherence among 5,085 patients. The authors noted that overall rates of adherence to Lung-RADS recommended screening intervals in clinical practices is low as compared with the over 90% adherence seen in the NLST, adversely affecting the mortality benefits of lung cancer screening.
Higher adherence rates were found in patients with Lung-RADS 3 (risk for lung cancer, 1%-2%) and 4 (risk, >5%) than Lung-RADS 1 and 2 (risk, <1%; P < .05), which the authors said suggests that tailored interventions based on Lung-RADS categories may be beneficial.
“It is likely that patients and referrers are more concerned about nodules at a higher risk for lung cancer, prompting greater adherence to recommended screening intervals in Lung-RADS 3-4,” the authors wrote. “It is crucial that patients and referrers alike understand that screening is most effective when performed regularly, including for those with negative baseline screens, as de novo nodules, those detected after a negative screen, are more aggressive than those detected at baseline screen.”
These low adherence rates seen in the clinical practices could be explained by patient characteristics, insurance coverage and interventions to ensure adherence, among other factors.
Further, inconsistent reporting of adherence rates was observed. Standardized reporting of adherence rates to lung cancer screening is needed to identify interventions to improve adherence, the authors wrote.
The authors of this study noted no conflicts of interest.
according to a review and meta-analysis published in the Journal of Thoracic Oncology.
“Lung cancer screening is effective in reducing mortality, particularly when patients adhere to follow-up recommendations standardized by the Lung CT Screening Reporting & Data System (Lung-RADS),” Yannan Lin, MD, MPH, of the University of California, Los Angeles, and colleagues wrote. ”Patient adherence to Lung-RADS–recommended screening intervals is suboptimal across clinical lung cancer screening programs in the U.S., especially among patients with Lung-RADS category 1-2 results.”
Lung cancer screening can identify tumors at earlier, more treatable stages, but patients with lung cancer diagnoses based on new nodules at incidence screening have shown shortened survivals. The National Lung Screening Trial (NLST) has shown a 20% relative reduction in lung cancer mortality with low-dose chest CT screening relative to chest radiography. The Lung-RADS guidelines to standardize the reporting of lung cancer screening were developed based on findings from the NLST and other screening studies, partly to reduce false-positive rates. Lung-RADS scores are based upon nodule size, characteristics and location, with management guidelines specific to Lung-RADS categories, ranging from low-dose chest CT in 12 months for Lung-RADS 1-2 to chest CT, PET/CT, or tissue sampling for Lung-RADS 4B/X.
The rate of adherence to lung cancer screening based on Lung-RADS guidelines is unclear. This systematic review and meta-analysis looked at patient adherence to Lung-RADS recommended screening intervals in clinical practice.
The meta-analysis included 21 studies. The pooled adherence rate was 57% for defined adherence, which included an annual incidence screen performed within 15 months, among 6,689 patients and 65% for anytime adherence among 5,085 patients. The authors noted that overall rates of adherence to Lung-RADS recommended screening intervals in clinical practices is low as compared with the over 90% adherence seen in the NLST, adversely affecting the mortality benefits of lung cancer screening.
Higher adherence rates were found in patients with Lung-RADS 3 (risk for lung cancer, 1%-2%) and 4 (risk, >5%) than Lung-RADS 1 and 2 (risk, <1%; P < .05), which the authors said suggests that tailored interventions based on Lung-RADS categories may be beneficial.
“It is likely that patients and referrers are more concerned about nodules at a higher risk for lung cancer, prompting greater adherence to recommended screening intervals in Lung-RADS 3-4,” the authors wrote. “It is crucial that patients and referrers alike understand that screening is most effective when performed regularly, including for those with negative baseline screens, as de novo nodules, those detected after a negative screen, are more aggressive than those detected at baseline screen.”
These low adherence rates seen in the clinical practices could be explained by patient characteristics, insurance coverage and interventions to ensure adherence, among other factors.
Further, inconsistent reporting of adherence rates was observed. Standardized reporting of adherence rates to lung cancer screening is needed to identify interventions to improve adherence, the authors wrote.
The authors of this study noted no conflicts of interest.
according to a review and meta-analysis published in the Journal of Thoracic Oncology.
“Lung cancer screening is effective in reducing mortality, particularly when patients adhere to follow-up recommendations standardized by the Lung CT Screening Reporting & Data System (Lung-RADS),” Yannan Lin, MD, MPH, of the University of California, Los Angeles, and colleagues wrote. ”Patient adherence to Lung-RADS–recommended screening intervals is suboptimal across clinical lung cancer screening programs in the U.S., especially among patients with Lung-RADS category 1-2 results.”
Lung cancer screening can identify tumors at earlier, more treatable stages, but patients with lung cancer diagnoses based on new nodules at incidence screening have shown shortened survivals. The National Lung Screening Trial (NLST) has shown a 20% relative reduction in lung cancer mortality with low-dose chest CT screening relative to chest radiography. The Lung-RADS guidelines to standardize the reporting of lung cancer screening were developed based on findings from the NLST and other screening studies, partly to reduce false-positive rates. Lung-RADS scores are based upon nodule size, characteristics and location, with management guidelines specific to Lung-RADS categories, ranging from low-dose chest CT in 12 months for Lung-RADS 1-2 to chest CT, PET/CT, or tissue sampling for Lung-RADS 4B/X.
The rate of adherence to lung cancer screening based on Lung-RADS guidelines is unclear. This systematic review and meta-analysis looked at patient adherence to Lung-RADS recommended screening intervals in clinical practice.
The meta-analysis included 21 studies. The pooled adherence rate was 57% for defined adherence, which included an annual incidence screen performed within 15 months, among 6,689 patients and 65% for anytime adherence among 5,085 patients. The authors noted that overall rates of adherence to Lung-RADS recommended screening intervals in clinical practices is low as compared with the over 90% adherence seen in the NLST, adversely affecting the mortality benefits of lung cancer screening.
Higher adherence rates were found in patients with Lung-RADS 3 (risk for lung cancer, 1%-2%) and 4 (risk, >5%) than Lung-RADS 1 and 2 (risk, <1%; P < .05), which the authors said suggests that tailored interventions based on Lung-RADS categories may be beneficial.
“It is likely that patients and referrers are more concerned about nodules at a higher risk for lung cancer, prompting greater adherence to recommended screening intervals in Lung-RADS 3-4,” the authors wrote. “It is crucial that patients and referrers alike understand that screening is most effective when performed regularly, including for those with negative baseline screens, as de novo nodules, those detected after a negative screen, are more aggressive than those detected at baseline screen.”
These low adherence rates seen in the clinical practices could be explained by patient characteristics, insurance coverage and interventions to ensure adherence, among other factors.
Further, inconsistent reporting of adherence rates was observed. Standardized reporting of adherence rates to lung cancer screening is needed to identify interventions to improve adherence, the authors wrote.
The authors of this study noted no conflicts of interest.
FROM THE JOURNAL OF THORACIC ONCOLOGY
‘Excellent short-term outcomes’ seen in HCV+ liver transplants to HCV– recipients
Liver transplantation using hepatitis C virus (HCV)-seropositive grafts to HCV-seronegative recipients resulted in “excellent short-term outcomes,” according to the results of a prospective, multicenter study reported in the Journal of Hepatology.
A total of 34 HCV– liver transplantation recipients received grafts from HCV+ donors (20 HCV viremic and 14 nonviremic) from January 2018 to September 2019, according to Bashar Aqel, MD, of the Mayo Clinic, Phoenix, Ariz., and colleagues.
Seven of the grafts were obtained from donation after cardiac death (DCD). Six recipients underwent simultaneous liver/kidney (SLK) transplant, and four patients were repeat liver transplants.
Sustained viral response
None of the recipients of an HCV nonviremic graft developed HCV viremia. However, all 20 patients who received HCV viremic grafts had HCV viremia confirmed within 3 days after liver transplant. Direct-acting antiviral (DAA) treatment was started at the median time of 27.5 days in these patients.
All 20 patients successfully completed the treatment and achieved a sustained viral response. In addition, the DAA treatment was well tolerated with minimal adverse events, according to the researchers.
However, one patient died, having developed HCV-related acute membranous nephropathy that resulted in end-stage kidney disease. In addition, a recipient of an HCV nonviremic graft died with acute myocardial infarction 610 days post liver transplant, the authors reported.
“This multicenter study demonstrated LT [liver transplantation] using HCV-seropositive grafts to HCV-seronegative recipients resulted in acceptable short-term outcomes even with the use of DCD grafts and expansion into SLK or repeat LT. However, a careful ongoing assessment regarding patient and graft selection, complications, and the timing of treatment is required,” the researchers concluded.
The study was funded in part by the McIver Estate Young Investigator Benefactor Award. The authors reported they had no potential conflicts.
SOURCE: Aqel B et al. J Hepatol. 2020, Nov 11. doi: 10.1016/j.jhep.2020.11.005.
Liver transplantation using hepatitis C virus (HCV)-seropositive grafts to HCV-seronegative recipients resulted in “excellent short-term outcomes,” according to the results of a prospective, multicenter study reported in the Journal of Hepatology.
A total of 34 HCV– liver transplantation recipients received grafts from HCV+ donors (20 HCV viremic and 14 nonviremic) from January 2018 to September 2019, according to Bashar Aqel, MD, of the Mayo Clinic, Phoenix, Ariz., and colleagues.
Seven of the grafts were obtained from donation after cardiac death (DCD). Six recipients underwent simultaneous liver/kidney (SLK) transplant, and four patients were repeat liver transplants.
Sustained viral response
None of the recipients of an HCV nonviremic graft developed HCV viremia. However, all 20 patients who received HCV viremic grafts had HCV viremia confirmed within 3 days after liver transplant. Direct-acting antiviral (DAA) treatment was started at the median time of 27.5 days in these patients.
All 20 patients successfully completed the treatment and achieved a sustained viral response. In addition, the DAA treatment was well tolerated with minimal adverse events, according to the researchers.
However, one patient died, having developed HCV-related acute membranous nephropathy that resulted in end-stage kidney disease. In addition, a recipient of an HCV nonviremic graft died with acute myocardial infarction 610 days post liver transplant, the authors reported.
“This multicenter study demonstrated LT [liver transplantation] using HCV-seropositive grafts to HCV-seronegative recipients resulted in acceptable short-term outcomes even with the use of DCD grafts and expansion into SLK or repeat LT. However, a careful ongoing assessment regarding patient and graft selection, complications, and the timing of treatment is required,” the researchers concluded.
The study was funded in part by the McIver Estate Young Investigator Benefactor Award. The authors reported they had no potential conflicts.
SOURCE: Aqel B et al. J Hepatol. 2020, Nov 11. doi: 10.1016/j.jhep.2020.11.005.
Liver transplantation using hepatitis C virus (HCV)-seropositive grafts to HCV-seronegative recipients resulted in “excellent short-term outcomes,” according to the results of a prospective, multicenter study reported in the Journal of Hepatology.
A total of 34 HCV– liver transplantation recipients received grafts from HCV+ donors (20 HCV viremic and 14 nonviremic) from January 2018 to September 2019, according to Bashar Aqel, MD, of the Mayo Clinic, Phoenix, Ariz., and colleagues.
Seven of the grafts were obtained from donation after cardiac death (DCD). Six recipients underwent simultaneous liver/kidney (SLK) transplant, and four patients were repeat liver transplants.
Sustained viral response
None of the recipients of an HCV nonviremic graft developed HCV viremia. However, all 20 patients who received HCV viremic grafts had HCV viremia confirmed within 3 days after liver transplant. Direct-acting antiviral (DAA) treatment was started at the median time of 27.5 days in these patients.
All 20 patients successfully completed the treatment and achieved a sustained viral response. In addition, the DAA treatment was well tolerated with minimal adverse events, according to the researchers.
However, one patient died, having developed HCV-related acute membranous nephropathy that resulted in end-stage kidney disease. In addition, a recipient of an HCV nonviremic graft died with acute myocardial infarction 610 days post liver transplant, the authors reported.
“This multicenter study demonstrated LT [liver transplantation] using HCV-seropositive grafts to HCV-seronegative recipients resulted in acceptable short-term outcomes even with the use of DCD grafts and expansion into SLK or repeat LT. However, a careful ongoing assessment regarding patient and graft selection, complications, and the timing of treatment is required,” the researchers concluded.
The study was funded in part by the McIver Estate Young Investigator Benefactor Award. The authors reported they had no potential conflicts.
SOURCE: Aqel B et al. J Hepatol. 2020, Nov 11. doi: 10.1016/j.jhep.2020.11.005.
FROM JOURNAL OF HEPATOLOGY
Survey of Mohs surgeons highlights its use in invasive melanoma
of members of the American College of Mohs Surgery.
Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.
The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.
It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.
With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.
That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.
The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).
There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.
The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.
The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)
[embed:render:related:node:211095]
Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.
“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.
Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”
Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.
“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.
Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.
The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.
Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.
Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.
SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
of members of the American College of Mohs Surgery.
Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.
The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.
It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.
With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.
That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.
The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).
There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.
The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.
The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)
[embed:render:related:node:211095]
Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.
“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.
Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”
Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.
“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.
Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.
The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.
Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.
Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.
SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
of members of the American College of Mohs Surgery.
Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.
The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.
It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.
With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.
That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.
The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).
There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.
The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.
The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)
[embed:render:related:node:211095]
Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.
“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.
Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”
Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.
“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.
Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.
The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.
Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.
Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.
SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
FROM DERMATOLOGIC SURGERY
Predicting complications of cytoreductive nephrectomy in metastatic RCC
according to an analysis of registry data.
Higher intraoperative blood loss was also associated with low-grade postoperative complications. Intraoperative complications were more likely in patients who had concurrent thrombectomy and surgery on adjacent organs.
Eduard Roussel, MD, of University Hospitals Leuven (Belgium) and colleagues reported these findings in European Urology Oncology.
The authors noted that the role of CN in metastatic RCC is controversial. The CARMENA trial, published in the New England Journal of Medicine, “shifted treatment paradigms” away from surgery by suggesting that sunitinib alone is noninferior to sunitinib after CN.
“Nonetheless, there is a general consensus that certain selected subgroups of patients with low-volume, single-site metastases and few adverse IMDC [International Metastatic Renal Cell Carcinoma Database Consortium] criteria would still benefit from the continued use of upfront CN,” the authors wrote.
They advised clinicians to weigh the risks and benefits of CN, particularly because “postoperative morbidity might preclude or delay the use of subsequent systemic therapies.” However, the risk/benefit calculation for CN has been difficult because past investigations have tended to focus only on survival outcomes, so there isn’t much data on morbidity, the authors wrote.
Patient characteristics and complications
To investigate morbidity associated with CN, Dr. Roussel and colleagues reviewed data from the Registry of Metastatic RCC (REMARCC). The team analyzed the clinical records of 736 patients who underwent nephrectomy for metastatic RCC during 1980-2019.
The patients’ median age was 63 years (range, 55-70 years), and about three-quarters were men. The majority had clear cell carcinoma, and the lungs were the most common site of metastases.
More than 97% of procedures were complete nephrectomies, and the rest were partial. The median estimated blood loss was 400 mL, and the median follow-up was 16.5 months.
There were 69 patients who had intraoperative complications, most commonly bleeding (n = 25), spleen laceration (n = 13), and vascular injury (n = 11).
There were 217 patients who had postoperative complications, including 45 patients with high-grade complications (grade 3-5) and 10 who died.
The most common postoperative complications were vascular/lymphatic in nature. These occurred in 67 patients and included 10 lymphoceles.
“[G]iven the relatively high rate of postoperative lymphoceles, which is probably attributable to the performance of lymph node dissections and the lack of proven oncological survival benefit thereof, surgeons might reconsider the performance of lymphadenectomy during CN,” the investigators wrote.
Other common postoperative complications included infectious and cardiopulmonary issues, which occurred in 42 and 39 patients, respectively.
Predictors of complications
Thrombectomy and adjacent organ removal were significant predictors of intraoperative complications on multivariable analysis. The odds ratios were 1.38 (P = .009) for thrombectomy and 2.71 (P = .004) for adjacent organ removal.
Estimated blood loss was a significant predictor of low- and high-grade postoperative complications. The OR for high-grade complications per 200 mL of blood lost was 1.06 (P = .007), and the OR for low-grade complications per 200 mL blood lost was 1.09 (P = .001).
There was a strong inverse correlation with CN case load at each center and high-grade postoperative complications, which highlights “the impact of centralization of care on postoperative outcomes in complex surgical scenarios,” the investigators wrote. The OR per 25 cases was 0.88 (P = .04).
Results were largely the same when the analysis was limited to the 560 subjects treated since 2006, in the targeted therapy era, except that adjacent organ removal as a predictor of intraoperative complications did not quite reach statistical significance (P = .06).
The presurgery risk factors identified in this study should assist with presurgical counseling, said Zachery Reichert, MD, PhD, a genitourinary medical oncologist and assistant professor at the University of Michigan, Ann Arbor, who was not involved in this study.
“This is especially important for patients who require thrombectomy or adjacent organ removal or do not have access to a surgeon with high cytoreductive nephrectomy caseloads,” he said.
Dr. Reichert reported having no disclosures. There was no external funding for this study, and the investigators didn’t have any disclosures.
SOURCE: Roussel E et al. Eur Urol Oncol. 2020 Aug;3(4):523-9.
according to an analysis of registry data.
Higher intraoperative blood loss was also associated with low-grade postoperative complications. Intraoperative complications were more likely in patients who had concurrent thrombectomy and surgery on adjacent organs.
Eduard Roussel, MD, of University Hospitals Leuven (Belgium) and colleagues reported these findings in European Urology Oncology.
The authors noted that the role of CN in metastatic RCC is controversial. The CARMENA trial, published in the New England Journal of Medicine, “shifted treatment paradigms” away from surgery by suggesting that sunitinib alone is noninferior to sunitinib after CN.
“Nonetheless, there is a general consensus that certain selected subgroups of patients with low-volume, single-site metastases and few adverse IMDC [International Metastatic Renal Cell Carcinoma Database Consortium] criteria would still benefit from the continued use of upfront CN,” the authors wrote.
They advised clinicians to weigh the risks and benefits of CN, particularly because “postoperative morbidity might preclude or delay the use of subsequent systemic therapies.” However, the risk/benefit calculation for CN has been difficult because past investigations have tended to focus only on survival outcomes, so there isn’t much data on morbidity, the authors wrote.
Patient characteristics and complications
To investigate morbidity associated with CN, Dr. Roussel and colleagues reviewed data from the Registry of Metastatic RCC (REMARCC). The team analyzed the clinical records of 736 patients who underwent nephrectomy for metastatic RCC during 1980-2019.
The patients’ median age was 63 years (range, 55-70 years), and about three-quarters were men. The majority had clear cell carcinoma, and the lungs were the most common site of metastases.
More than 97% of procedures were complete nephrectomies, and the rest were partial. The median estimated blood loss was 400 mL, and the median follow-up was 16.5 months.
There were 69 patients who had intraoperative complications, most commonly bleeding (n = 25), spleen laceration (n = 13), and vascular injury (n = 11).
There were 217 patients who had postoperative complications, including 45 patients with high-grade complications (grade 3-5) and 10 who died.
The most common postoperative complications were vascular/lymphatic in nature. These occurred in 67 patients and included 10 lymphoceles.
“[G]iven the relatively high rate of postoperative lymphoceles, which is probably attributable to the performance of lymph node dissections and the lack of proven oncological survival benefit thereof, surgeons might reconsider the performance of lymphadenectomy during CN,” the investigators wrote.
Other common postoperative complications included infectious and cardiopulmonary issues, which occurred in 42 and 39 patients, respectively.
Predictors of complications
Thrombectomy and adjacent organ removal were significant predictors of intraoperative complications on multivariable analysis. The odds ratios were 1.38 (P = .009) for thrombectomy and 2.71 (P = .004) for adjacent organ removal.
Estimated blood loss was a significant predictor of low- and high-grade postoperative complications. The OR for high-grade complications per 200 mL of blood lost was 1.06 (P = .007), and the OR for low-grade complications per 200 mL blood lost was 1.09 (P = .001).
There was a strong inverse correlation with CN case load at each center and high-grade postoperative complications, which highlights “the impact of centralization of care on postoperative outcomes in complex surgical scenarios,” the investigators wrote. The OR per 25 cases was 0.88 (P = .04).
Results were largely the same when the analysis was limited to the 560 subjects treated since 2006, in the targeted therapy era, except that adjacent organ removal as a predictor of intraoperative complications did not quite reach statistical significance (P = .06).
The presurgery risk factors identified in this study should assist with presurgical counseling, said Zachery Reichert, MD, PhD, a genitourinary medical oncologist and assistant professor at the University of Michigan, Ann Arbor, who was not involved in this study.
“This is especially important for patients who require thrombectomy or adjacent organ removal or do not have access to a surgeon with high cytoreductive nephrectomy caseloads,” he said.
Dr. Reichert reported having no disclosures. There was no external funding for this study, and the investigators didn’t have any disclosures.
SOURCE: Roussel E et al. Eur Urol Oncol. 2020 Aug;3(4):523-9.
according to an analysis of registry data.
Higher intraoperative blood loss was also associated with low-grade postoperative complications. Intraoperative complications were more likely in patients who had concurrent thrombectomy and surgery on adjacent organs.
Eduard Roussel, MD, of University Hospitals Leuven (Belgium) and colleagues reported these findings in European Urology Oncology.
The authors noted that the role of CN in metastatic RCC is controversial. The CARMENA trial, published in the New England Journal of Medicine, “shifted treatment paradigms” away from surgery by suggesting that sunitinib alone is noninferior to sunitinib after CN.
“Nonetheless, there is a general consensus that certain selected subgroups of patients with low-volume, single-site metastases and few adverse IMDC [International Metastatic Renal Cell Carcinoma Database Consortium] criteria would still benefit from the continued use of upfront CN,” the authors wrote.
They advised clinicians to weigh the risks and benefits of CN, particularly because “postoperative morbidity might preclude or delay the use of subsequent systemic therapies.” However, the risk/benefit calculation for CN has been difficult because past investigations have tended to focus only on survival outcomes, so there isn’t much data on morbidity, the authors wrote.
Patient characteristics and complications
To investigate morbidity associated with CN, Dr. Roussel and colleagues reviewed data from the Registry of Metastatic RCC (REMARCC). The team analyzed the clinical records of 736 patients who underwent nephrectomy for metastatic RCC during 1980-2019.
The patients’ median age was 63 years (range, 55-70 years), and about three-quarters were men. The majority had clear cell carcinoma, and the lungs were the most common site of metastases.
More than 97% of procedures were complete nephrectomies, and the rest were partial. The median estimated blood loss was 400 mL, and the median follow-up was 16.5 months.
There were 69 patients who had intraoperative complications, most commonly bleeding (n = 25), spleen laceration (n = 13), and vascular injury (n = 11).
There were 217 patients who had postoperative complications, including 45 patients with high-grade complications (grade 3-5) and 10 who died.
The most common postoperative complications were vascular/lymphatic in nature. These occurred in 67 patients and included 10 lymphoceles.
“[G]iven the relatively high rate of postoperative lymphoceles, which is probably attributable to the performance of lymph node dissections and the lack of proven oncological survival benefit thereof, surgeons might reconsider the performance of lymphadenectomy during CN,” the investigators wrote.
Other common postoperative complications included infectious and cardiopulmonary issues, which occurred in 42 and 39 patients, respectively.
Predictors of complications
Thrombectomy and adjacent organ removal were significant predictors of intraoperative complications on multivariable analysis. The odds ratios were 1.38 (P = .009) for thrombectomy and 2.71 (P = .004) for adjacent organ removal.
Estimated blood loss was a significant predictor of low- and high-grade postoperative complications. The OR for high-grade complications per 200 mL of blood lost was 1.06 (P = .007), and the OR for low-grade complications per 200 mL blood lost was 1.09 (P = .001).
There was a strong inverse correlation with CN case load at each center and high-grade postoperative complications, which highlights “the impact of centralization of care on postoperative outcomes in complex surgical scenarios,” the investigators wrote. The OR per 25 cases was 0.88 (P = .04).
Results were largely the same when the analysis was limited to the 560 subjects treated since 2006, in the targeted therapy era, except that adjacent organ removal as a predictor of intraoperative complications did not quite reach statistical significance (P = .06).
The presurgery risk factors identified in this study should assist with presurgical counseling, said Zachery Reichert, MD, PhD, a genitourinary medical oncologist and assistant professor at the University of Michigan, Ann Arbor, who was not involved in this study.
“This is especially important for patients who require thrombectomy or adjacent organ removal or do not have access to a surgeon with high cytoreductive nephrectomy caseloads,” he said.
Dr. Reichert reported having no disclosures. There was no external funding for this study, and the investigators didn’t have any disclosures.
SOURCE: Roussel E et al. Eur Urol Oncol. 2020 Aug;3(4):523-9.
FROM EUROPEAN UROLOGY ONCOLOGY
Study identifies risk factors for infection after transbronchial biopsy
Among patients who undergo endobronchial ultrasound-guided transbronchial biopsy using a guide sheath (EBUS-GS-TBB) for diagnosing lung cancer, cavitation and low-density areas inside the target lesion on CT and stenosis of the responsible bronchus are risk factors for infection after the procedure, according to a study published in CHEST.
“Infectious complications after [transbronchial biopsy] constitute a serious clinical problem because they might delay the start of treatment or cause the intended treatment to be modified to a milder one,” said Tomohide Souma, MD, of the department of respiratory medicine at Fujita Health University in Toyoake, Japan, and colleagues. “The precise mechanism of such complications is still unclear, and effective prophylaxis procedures have not been established. ... Thus, it is very important to identify the risk factors for infectious complications after TBB if and when these complications are to be avoided.”
To evaluate potential risk factors for infectious complications after EBUS-GS-TBB in a large sample of patients, Dr. Souma and colleagues retrospectively studied the medical records of 1,045 consecutive patients (median age, 72; 68% male) who underwent EBUS-GS-TBB between January 2013 and December 2017 at Fujita Health University Hospital.
In all, 47 patients developed infections, a cumulative incidence of about 4.5%. Infections included pneumonia (51.1%), intratumoral infection (29.8%), and three cases each of lung abscess, pleurisy, and empyema. Three patients, two with empyema and one with lung abscess, died within 1 month before administration of anticancer treatment. “In total, more than 40% of patients with post–EBUS-GS-TBB infection were unable to receive preplanned anticancer treatment,” the researchers said.
On multivariate analysis, cavitation in the lesion (odds ratio, 3.63), low-density areas in the lesion (OR, 13.26), and bronchoscopic findings of responsible bronchus stenosis (OR, 7.82) were significantly associated with development of infections post biopsy.
An analysis that matched 89 patients who received prophylactic antibiotics with controls who did not receive prophylactic antibiotics did not find that prophylactic antibiotics significantly reduced the likelihood of post–EBUS-GS-TBB infection.
“Notably, three risk factors found in our study indicate that the inflammation-prone status of lesions may be the most important factor for developing post–EBUS-TBB infection,” Dr. Souma and colleagues said. “Although our study does not rebuff the role of antibiotics in postbronchoscopy infection therapy, clinicians should notify patients that post-TBB infection may occur despite the use of prophylactic antibiotics. We recommend that careful and frequent follow-up be applied to patients undergoing diagnostic EBUS-GS-TBB with reference to the risk factors identified in our study.”
A. Christine Argento, MD, FCCP, assistant professor of medicine and thoracic surgery and director of the interventional pulmonary fellowship program at Northwestern University, Chicago, noted that this is an important study on a topic that has not been well described in the past.
“This paper ... identifies three factors that were associated with infectious complications – namely, cavitation, low density areas, and a visibly stenosed bronchus leading to the lesion,” she said. “When planning bronchoscopy to sample lesions that fit one of these three criteria, I will likely be more cautious in the future meaning that in these cases, I would limit biopsies to 6-8 pieces which is typically sufficient and I would minimize any trauma to the bronchus leading to the lesion, as if the bronchus is already stenosed on bronchoscopic inspection it is likely inflamed and will only be exacerbated by repeated manipulation and insertions with the bronchoscope and guide sheath leading to a postobstructive phenomenon that was observed in this cohort.
“As far as pleurisy and empyema, it is not described if [the investigators] used fluoroscopy, but this would be an important aspect,” she added. “Ideally, one would not cause disruption of the pleural surface as contamination from the lung to the pleural space can have serious and prolonged infectious consequences as was reported in this study. Fluoroscopy would help the operator to avoid taking samples that would be too close to the pleural surface and could potentially decrease this complication.
“In the United States, it is not always standard practice to see patients 5-7 days following bronchoscopy to assess for complications. Although some of these patients would have presented for evaluation with symptoms, presumably several of these patients would not have. Also pre- and postbronchoscopy labs are not commonly drawn in the United States and so a rise in white blood cells or C-reactive protein would not be known.
“Finally, [the investigators] point out that prophylactic antibiotics do not seem to be effective, and I would agree based on their results. I would only consider using antibiotics as a directed measure if the patient develops infectious complications and the antibiotic choice and duration of therapy would be tailored to the specific complication encountered,” she said.
The researchers had no disclosures.
SOURCE: Souma T et al. CHEST. 2020 Mar 4. doi: 10.1016/j.chest.2020.02.025.
Among patients who undergo endobronchial ultrasound-guided transbronchial biopsy using a guide sheath (EBUS-GS-TBB) for diagnosing lung cancer, cavitation and low-density areas inside the target lesion on CT and stenosis of the responsible bronchus are risk factors for infection after the procedure, according to a study published in CHEST.
“Infectious complications after [transbronchial biopsy] constitute a serious clinical problem because they might delay the start of treatment or cause the intended treatment to be modified to a milder one,” said Tomohide Souma, MD, of the department of respiratory medicine at Fujita Health University in Toyoake, Japan, and colleagues. “The precise mechanism of such complications is still unclear, and effective prophylaxis procedures have not been established. ... Thus, it is very important to identify the risk factors for infectious complications after TBB if and when these complications are to be avoided.”
To evaluate potential risk factors for infectious complications after EBUS-GS-TBB in a large sample of patients, Dr. Souma and colleagues retrospectively studied the medical records of 1,045 consecutive patients (median age, 72; 68% male) who underwent EBUS-GS-TBB between January 2013 and December 2017 at Fujita Health University Hospital.
In all, 47 patients developed infections, a cumulative incidence of about 4.5%. Infections included pneumonia (51.1%), intratumoral infection (29.8%), and three cases each of lung abscess, pleurisy, and empyema. Three patients, two with empyema and one with lung abscess, died within 1 month before administration of anticancer treatment. “In total, more than 40% of patients with post–EBUS-GS-TBB infection were unable to receive preplanned anticancer treatment,” the researchers said.
On multivariate analysis, cavitation in the lesion (odds ratio, 3.63), low-density areas in the lesion (OR, 13.26), and bronchoscopic findings of responsible bronchus stenosis (OR, 7.82) were significantly associated with development of infections post biopsy.
An analysis that matched 89 patients who received prophylactic antibiotics with controls who did not receive prophylactic antibiotics did not find that prophylactic antibiotics significantly reduced the likelihood of post–EBUS-GS-TBB infection.
“Notably, three risk factors found in our study indicate that the inflammation-prone status of lesions may be the most important factor for developing post–EBUS-TBB infection,” Dr. Souma and colleagues said. “Although our study does not rebuff the role of antibiotics in postbronchoscopy infection therapy, clinicians should notify patients that post-TBB infection may occur despite the use of prophylactic antibiotics. We recommend that careful and frequent follow-up be applied to patients undergoing diagnostic EBUS-GS-TBB with reference to the risk factors identified in our study.”
A. Christine Argento, MD, FCCP, assistant professor of medicine and thoracic surgery and director of the interventional pulmonary fellowship program at Northwestern University, Chicago, noted that this is an important study on a topic that has not been well described in the past.
“This paper ... identifies three factors that were associated with infectious complications – namely, cavitation, low density areas, and a visibly stenosed bronchus leading to the lesion,” she said. “When planning bronchoscopy to sample lesions that fit one of these three criteria, I will likely be more cautious in the future meaning that in these cases, I would limit biopsies to 6-8 pieces which is typically sufficient and I would minimize any trauma to the bronchus leading to the lesion, as if the bronchus is already stenosed on bronchoscopic inspection it is likely inflamed and will only be exacerbated by repeated manipulation and insertions with the bronchoscope and guide sheath leading to a postobstructive phenomenon that was observed in this cohort.
“As far as pleurisy and empyema, it is not described if [the investigators] used fluoroscopy, but this would be an important aspect,” she added. “Ideally, one would not cause disruption of the pleural surface as contamination from the lung to the pleural space can have serious and prolonged infectious consequences as was reported in this study. Fluoroscopy would help the operator to avoid taking samples that would be too close to the pleural surface and could potentially decrease this complication.
“In the United States, it is not always standard practice to see patients 5-7 days following bronchoscopy to assess for complications. Although some of these patients would have presented for evaluation with symptoms, presumably several of these patients would not have. Also pre- and postbronchoscopy labs are not commonly drawn in the United States and so a rise in white blood cells or C-reactive protein would not be known.
“Finally, [the investigators] point out that prophylactic antibiotics do not seem to be effective, and I would agree based on their results. I would only consider using antibiotics as a directed measure if the patient develops infectious complications and the antibiotic choice and duration of therapy would be tailored to the specific complication encountered,” she said.
The researchers had no disclosures.
SOURCE: Souma T et al. CHEST. 2020 Mar 4. doi: 10.1016/j.chest.2020.02.025.
Among patients who undergo endobronchial ultrasound-guided transbronchial biopsy using a guide sheath (EBUS-GS-TBB) for diagnosing lung cancer, cavitation and low-density areas inside the target lesion on CT and stenosis of the responsible bronchus are risk factors for infection after the procedure, according to a study published in CHEST.
“Infectious complications after [transbronchial biopsy] constitute a serious clinical problem because they might delay the start of treatment or cause the intended treatment to be modified to a milder one,” said Tomohide Souma, MD, of the department of respiratory medicine at Fujita Health University in Toyoake, Japan, and colleagues. “The precise mechanism of such complications is still unclear, and effective prophylaxis procedures have not been established. ... Thus, it is very important to identify the risk factors for infectious complications after TBB if and when these complications are to be avoided.”
To evaluate potential risk factors for infectious complications after EBUS-GS-TBB in a large sample of patients, Dr. Souma and colleagues retrospectively studied the medical records of 1,045 consecutive patients (median age, 72; 68% male) who underwent EBUS-GS-TBB between January 2013 and December 2017 at Fujita Health University Hospital.
In all, 47 patients developed infections, a cumulative incidence of about 4.5%. Infections included pneumonia (51.1%), intratumoral infection (29.8%), and three cases each of lung abscess, pleurisy, and empyema. Three patients, two with empyema and one with lung abscess, died within 1 month before administration of anticancer treatment. “In total, more than 40% of patients with post–EBUS-GS-TBB infection were unable to receive preplanned anticancer treatment,” the researchers said.
On multivariate analysis, cavitation in the lesion (odds ratio, 3.63), low-density areas in the lesion (OR, 13.26), and bronchoscopic findings of responsible bronchus stenosis (OR, 7.82) were significantly associated with development of infections post biopsy.
An analysis that matched 89 patients who received prophylactic antibiotics with controls who did not receive prophylactic antibiotics did not find that prophylactic antibiotics significantly reduced the likelihood of post–EBUS-GS-TBB infection.
“Notably, three risk factors found in our study indicate that the inflammation-prone status of lesions may be the most important factor for developing post–EBUS-TBB infection,” Dr. Souma and colleagues said. “Although our study does not rebuff the role of antibiotics in postbronchoscopy infection therapy, clinicians should notify patients that post-TBB infection may occur despite the use of prophylactic antibiotics. We recommend that careful and frequent follow-up be applied to patients undergoing diagnostic EBUS-GS-TBB with reference to the risk factors identified in our study.”
A. Christine Argento, MD, FCCP, assistant professor of medicine and thoracic surgery and director of the interventional pulmonary fellowship program at Northwestern University, Chicago, noted that this is an important study on a topic that has not been well described in the past.
“This paper ... identifies three factors that were associated with infectious complications – namely, cavitation, low density areas, and a visibly stenosed bronchus leading to the lesion,” she said. “When planning bronchoscopy to sample lesions that fit one of these three criteria, I will likely be more cautious in the future meaning that in these cases, I would limit biopsies to 6-8 pieces which is typically sufficient and I would minimize any trauma to the bronchus leading to the lesion, as if the bronchus is already stenosed on bronchoscopic inspection it is likely inflamed and will only be exacerbated by repeated manipulation and insertions with the bronchoscope and guide sheath leading to a postobstructive phenomenon that was observed in this cohort.
“As far as pleurisy and empyema, it is not described if [the investigators] used fluoroscopy, but this would be an important aspect,” she added. “Ideally, one would not cause disruption of the pleural surface as contamination from the lung to the pleural space can have serious and prolonged infectious consequences as was reported in this study. Fluoroscopy would help the operator to avoid taking samples that would be too close to the pleural surface and could potentially decrease this complication.
“In the United States, it is not always standard practice to see patients 5-7 days following bronchoscopy to assess for complications. Although some of these patients would have presented for evaluation with symptoms, presumably several of these patients would not have. Also pre- and postbronchoscopy labs are not commonly drawn in the United States and so a rise in white blood cells or C-reactive protein would not be known.
“Finally, [the investigators] point out that prophylactic antibiotics do not seem to be effective, and I would agree based on their results. I would only consider using antibiotics as a directed measure if the patient develops infectious complications and the antibiotic choice and duration of therapy would be tailored to the specific complication encountered,” she said.
The researchers had no disclosures.
SOURCE: Souma T et al. CHEST. 2020 Mar 4. doi: 10.1016/j.chest.2020.02.025.
FROM CHEST
In rectal cancer, fragmented care linked to lower survival
SAN FRANCISCO – In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.
The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.
Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.
The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.
“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.
In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).
Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).
The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.
The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.
Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.
Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”
The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.
SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.
SAN FRANCISCO – In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.
The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.
Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.
The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.
“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.
In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).
Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).
The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.
The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.
Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.
Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”
The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.
SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.
SAN FRANCISCO – In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.
The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.
Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.
The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.
“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.
In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).
Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).
The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.
The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.
Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.
Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”
The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.
SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.
REPORTING FROM CLINICAL CONGRESS 2019
In duodenal neuroendocrine tumors, resection technique matters
SAN DIEGO – according to a study presented at the annual Digestive Disease Week.
In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.
Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.
In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.
The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.
Assessment of resection margin status was performed independently by pathologists at each study center.
“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.
The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.
In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.
“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.
Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.
“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.
Dr. Ragheb reported no outside sources of funding and no conflicts of interest.
SAN DIEGO – according to a study presented at the annual Digestive Disease Week.
In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.
Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.
In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.
The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.
Assessment of resection margin status was performed independently by pathologists at each study center.
“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.
The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.
In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.
“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.
Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.
“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.
Dr. Ragheb reported no outside sources of funding and no conflicts of interest.
SAN DIEGO – according to a study presented at the annual Digestive Disease Week.
In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.
Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.
In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.
The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.
Assessment of resection margin status was performed independently by pathologists at each study center.
“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.
The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.
In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.
“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.
Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.
“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.
Dr. Ragheb reported no outside sources of funding and no conflicts of interest.
REPORTING FROM DDW 2019
Skip metastasis rate low in node-negative oral cancers
In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.
The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.
Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.
“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.
SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.
However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.
Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.
Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.
The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).
Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.
These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.
“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”
Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.
SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.
While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.
The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.
The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.
The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.
Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .
Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.
While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.
The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.
The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.
The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.
Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .
Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.
While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.
The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.
The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.
The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.
Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .
In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.
The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.
Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.
“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.
SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.
However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.
Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.
Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.
The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).
Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.
These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.
“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”
Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.
SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.
The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.
Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.
“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.
SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.
However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.
Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.
Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.
The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).
Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.
These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.
“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”
Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.
SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
FROM JAMA OTOLARYNGOLOGY–HEAD & NECK SURGERY
Key clinical point: In patients with clinically node-negative oral cavity cancers, rates of skip metastasis to neck level IV are extremely low, meaning that supraomohyoid neck dissection is likely sufficient for most cases.
Major finding: The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5%.
Study details: A meta-analysis of 11 retrospective studies and 2 randomized clinical trials, including a total of 1,359 patients who had undergone neck dissection.
Disclosures: The study authors reported no conflicts of interest.
Source: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.