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Esophageal perforation severity scoring system reliably stratifies patients
The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.
Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.
The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).
Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).
Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.
Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).
Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.
They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.
They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.
“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.
The authors reported having no disclosures.
A webcast of the AATS Annual Meeting presentation of this paper is available.
Dr. Mara B. Antonoff |
Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.
The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.
Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.
Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).
Dr. Mara B. Antonoff |
Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.
The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.
Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.
Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).
Dr. Mara B. Antonoff |
Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.
The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.
Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.
Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).
The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.
Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.
The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).
Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).
Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.
Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).
Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.
They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.
They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.
“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.
The authors reported having no disclosures.
A webcast of the AATS Annual Meeting presentation of this paper is available.
The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.
Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.
The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).
Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).
Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.
Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).
Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.
They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.
They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.
“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.
The authors reported having no disclosures.
A webcast of the AATS Annual Meeting presentation of this paper is available.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Scoring system reliably stratifies patients into low-, intermediate-, and high-risk groups.
Major finding: Patients with a high perforation severity score were 3.37 times more likely to have operative management, compared with low-scoring patients.
Data source: A retrospective study was performed on 288 patients with esophageal perforation at 11 centers since 1990.
Disclosures: The authors presented no relevant disclosures.
Histologic examination of anastomotic stapler doughnuts may not yield clinical benefit
LOS ANGELES – A multicenter of patients who had low anterior resection with stapled anastomosis for rectal cancer found no clinical or economic benefit in routinely sending anastomotic doughnuts for histopathological evaluation.
“Several small studies outside the United States have found no benefit in histologic examination of anastomotic stapler doughnuts,” lead study author Dr. Jeremy Sugrue said at the annual meeting of the American Society of Colon and Rectal Surgeons. “We wanted to see if this held true in our population.”
Dr. Sugrue, of the division of colon and rectal surgery in the department of surgery at the University of Illinois at Chicago, and his associates performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions. The primary outcome was pathologic findings in the doughnuts and their impact on patient management. Secondary outcomes included tumor characteristics that may influence how often a surgeon may send a doughnut to pathology, along with approximate cost.
The mean age of the 486 patients was 60 years, 55% were male, and the mean gross distal margin of the primary tumor specimen was 2.9 cm. “The majority of tumors were located in the middle rectum, and the rest were evenly distributed between the lower rectum, upper rectum, and rectosigmoid regions,” said Dr. Sugrue, who is a general surgery resident. About half of the patients received neoadjuvant radiation or chemotherapy.
Benign findings were found in 33 patients. Among these, 16 had inflammatory changes, including 12 who had nonspecific changes, 3 who had changes from radiation, and 1 had inflammatory bowel disease changes. In addition, 13 patients with benign findings had polyps in their doughnuts (10 hyperplastic and 3 adenomatous), while 4 patients had miscellaneous changes including two cases of vessel micro calcification, one case of diverticuli, and one case of melanosis coli.
Among the 412 patients with malignant findings, 410 (99.5%) had no cancer in the doughnuts and no cancer at the distal resection margin in the primary tumor specimens. “In the two patients where we found cancer in the doughnuts, these patients also had a positive distal margin,” Dr. Sugrue said. “We did not find any patients with a positive distal margin and a negative doughnut. Likewise, we did not find any patients with a negative distal margin or an unexpectedly positive doughnut.”
The researchers also found that patients with low rectal tumors were significantly more likely to have their doughnut sent to pathology, compared with those with rectosigmoid tumors. “However, when we looked at distal margin comparing patients who had doughnuts reported on pathology with those who did not, there was no statistically significant difference,” Dr. Sugrue said. After averaging pathology professional fees and technical fees across all three institutions, he and his associates determined that doughnuts add $643 in cost when processed by pathology as a unique specimen.
Limitations of the study, he said, include its retrospective design, “which inherently introduces selection bias, and we did not perform a precise cost-benefit analysis.”
Dr. Sugrue reported having no financial disclosures.
LOS ANGELES – A multicenter of patients who had low anterior resection with stapled anastomosis for rectal cancer found no clinical or economic benefit in routinely sending anastomotic doughnuts for histopathological evaluation.
“Several small studies outside the United States have found no benefit in histologic examination of anastomotic stapler doughnuts,” lead study author Dr. Jeremy Sugrue said at the annual meeting of the American Society of Colon and Rectal Surgeons. “We wanted to see if this held true in our population.”
Dr. Sugrue, of the division of colon and rectal surgery in the department of surgery at the University of Illinois at Chicago, and his associates performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions. The primary outcome was pathologic findings in the doughnuts and their impact on patient management. Secondary outcomes included tumor characteristics that may influence how often a surgeon may send a doughnut to pathology, along with approximate cost.
The mean age of the 486 patients was 60 years, 55% were male, and the mean gross distal margin of the primary tumor specimen was 2.9 cm. “The majority of tumors were located in the middle rectum, and the rest were evenly distributed between the lower rectum, upper rectum, and rectosigmoid regions,” said Dr. Sugrue, who is a general surgery resident. About half of the patients received neoadjuvant radiation or chemotherapy.
Benign findings were found in 33 patients. Among these, 16 had inflammatory changes, including 12 who had nonspecific changes, 3 who had changes from radiation, and 1 had inflammatory bowel disease changes. In addition, 13 patients with benign findings had polyps in their doughnuts (10 hyperplastic and 3 adenomatous), while 4 patients had miscellaneous changes including two cases of vessel micro calcification, one case of diverticuli, and one case of melanosis coli.
Among the 412 patients with malignant findings, 410 (99.5%) had no cancer in the doughnuts and no cancer at the distal resection margin in the primary tumor specimens. “In the two patients where we found cancer in the doughnuts, these patients also had a positive distal margin,” Dr. Sugrue said. “We did not find any patients with a positive distal margin and a negative doughnut. Likewise, we did not find any patients with a negative distal margin or an unexpectedly positive doughnut.”
The researchers also found that patients with low rectal tumors were significantly more likely to have their doughnut sent to pathology, compared with those with rectosigmoid tumors. “However, when we looked at distal margin comparing patients who had doughnuts reported on pathology with those who did not, there was no statistically significant difference,” Dr. Sugrue said. After averaging pathology professional fees and technical fees across all three institutions, he and his associates determined that doughnuts add $643 in cost when processed by pathology as a unique specimen.
Limitations of the study, he said, include its retrospective design, “which inherently introduces selection bias, and we did not perform a precise cost-benefit analysis.”
Dr. Sugrue reported having no financial disclosures.
LOS ANGELES – A multicenter of patients who had low anterior resection with stapled anastomosis for rectal cancer found no clinical or economic benefit in routinely sending anastomotic doughnuts for histopathological evaluation.
“Several small studies outside the United States have found no benefit in histologic examination of anastomotic stapler doughnuts,” lead study author Dr. Jeremy Sugrue said at the annual meeting of the American Society of Colon and Rectal Surgeons. “We wanted to see if this held true in our population.”
Dr. Sugrue, of the division of colon and rectal surgery in the department of surgery at the University of Illinois at Chicago, and his associates performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions. The primary outcome was pathologic findings in the doughnuts and their impact on patient management. Secondary outcomes included tumor characteristics that may influence how often a surgeon may send a doughnut to pathology, along with approximate cost.
The mean age of the 486 patients was 60 years, 55% were male, and the mean gross distal margin of the primary tumor specimen was 2.9 cm. “The majority of tumors were located in the middle rectum, and the rest were evenly distributed between the lower rectum, upper rectum, and rectosigmoid regions,” said Dr. Sugrue, who is a general surgery resident. About half of the patients received neoadjuvant radiation or chemotherapy.
Benign findings were found in 33 patients. Among these, 16 had inflammatory changes, including 12 who had nonspecific changes, 3 who had changes from radiation, and 1 had inflammatory bowel disease changes. In addition, 13 patients with benign findings had polyps in their doughnuts (10 hyperplastic and 3 adenomatous), while 4 patients had miscellaneous changes including two cases of vessel micro calcification, one case of diverticuli, and one case of melanosis coli.
Among the 412 patients with malignant findings, 410 (99.5%) had no cancer in the doughnuts and no cancer at the distal resection margin in the primary tumor specimens. “In the two patients where we found cancer in the doughnuts, these patients also had a positive distal margin,” Dr. Sugrue said. “We did not find any patients with a positive distal margin and a negative doughnut. Likewise, we did not find any patients with a negative distal margin or an unexpectedly positive doughnut.”
The researchers also found that patients with low rectal tumors were significantly more likely to have their doughnut sent to pathology, compared with those with rectosigmoid tumors. “However, when we looked at distal margin comparing patients who had doughnuts reported on pathology with those who did not, there was no statistically significant difference,” Dr. Sugrue said. After averaging pathology professional fees and technical fees across all three institutions, he and his associates determined that doughnuts add $643 in cost when processed by pathology as a unique specimen.
Limitations of the study, he said, include its retrospective design, “which inherently introduces selection bias, and we did not perform a precise cost-benefit analysis.”
Dr. Sugrue reported having no financial disclosures.
AT THE ASCRS ANNUAL MEETING
Key clinical point: The routine histologic examination of anastomotic doughnuts at lower anterior resection for rectal cancer has no clinical benefit.
Major finding: Of the 412 patients with anastomotic doughnuts included in their pathology reports, only 2 had cancer cells in their doughnuts and both of these patients also had a positive distal margin in their primary tumor specimen.
Data source: A retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions.
Disclosures: Dr. Sugrue reported having no financial disclosures.
VIDEO: Identifying patients who will benefit from pulmonary metastasectomy
BALTIMORE – New research from Memorial Sloan Kettering Cancer Center in New York could help surgeons better determine which patients with soft tissue sarcoma may benefit most from pulmonary metastasectomy.
The results of the research, presented at the annual meeting of the American Association for Thoracic Surgery, suggest that preoperative factors such as primary tumor histology and size, number of metastases, time from initial resection of the primary, absence of extrapulmonary disease, and thoracoscopic resection are associated with improved survival in STS patients.
Dr. Garrett L. Walsh, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston, and a discussant on the paper at the meeting, said the study was important because it showed the power of a prospective surgical database, retrospectively viewed in this particular case. He said that the Sloan Kettering research was likely “as good as it’s going to get,” given that a randomized controlled trial is unlikely ever to occur with STS patients.
“Trying to select the patients we think are going to do well with surgery has always been one of the challenging aspects of thoracic surgery,” Dr. Walsh said in a video interview. “This paper may help with better selection of patients from that large cohort who are referred to us for pulmonary metastasectomy.”
Dr. Walsh reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
BALTIMORE – New research from Memorial Sloan Kettering Cancer Center in New York could help surgeons better determine which patients with soft tissue sarcoma may benefit most from pulmonary metastasectomy.
The results of the research, presented at the annual meeting of the American Association for Thoracic Surgery, suggest that preoperative factors such as primary tumor histology and size, number of metastases, time from initial resection of the primary, absence of extrapulmonary disease, and thoracoscopic resection are associated with improved survival in STS patients.
Dr. Garrett L. Walsh, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston, and a discussant on the paper at the meeting, said the study was important because it showed the power of a prospective surgical database, retrospectively viewed in this particular case. He said that the Sloan Kettering research was likely “as good as it’s going to get,” given that a randomized controlled trial is unlikely ever to occur with STS patients.
“Trying to select the patients we think are going to do well with surgery has always been one of the challenging aspects of thoracic surgery,” Dr. Walsh said in a video interview. “This paper may help with better selection of patients from that large cohort who are referred to us for pulmonary metastasectomy.”
Dr. Walsh reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
BALTIMORE – New research from Memorial Sloan Kettering Cancer Center in New York could help surgeons better determine which patients with soft tissue sarcoma may benefit most from pulmonary metastasectomy.
The results of the research, presented at the annual meeting of the American Association for Thoracic Surgery, suggest that preoperative factors such as primary tumor histology and size, number of metastases, time from initial resection of the primary, absence of extrapulmonary disease, and thoracoscopic resection are associated with improved survival in STS patients.
Dr. Garrett L. Walsh, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston, and a discussant on the paper at the meeting, said the study was important because it showed the power of a prospective surgical database, retrospectively viewed in this particular case. He said that the Sloan Kettering research was likely “as good as it’s going to get,” given that a randomized controlled trial is unlikely ever to occur with STS patients.
“Trying to select the patients we think are going to do well with surgery has always been one of the challenging aspects of thoracic surgery,” Dr. Walsh said in a video interview. “This paper may help with better selection of patients from that large cohort who are referred to us for pulmonary metastasectomy.”
Dr. Walsh reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
AT THE AATS ANNUAL MEETING
Accuracy of gene test for thyroid nodules questioned
BALTIMORE – Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.
When fine-needle aspiration biopsy of thyroid nodules comes back inconclusive, clinicians have increasingly utilized the Afirma gene expression classifier (GEC) to rule out malignancy, but a retrospective analysis of almost 200 patients with indeterminate biopsy results along with a pooled analysis of 11 previous studies has raised questions about the negative predictive value of the test.
“The Afirma GEC test has substantial variability in performance,” said Dr. Zaid Al-Qurayshi of Tulane University, New Orleans, who reported the results at the annual meeting of the American Association of Endocrine Surgeons. “This variability cannot be explained based on differences in prevalence alone, but may also be the result of intrinsic test properties.”
The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.
The researchers undertook the study in light of an American Thyroid Association (ATA) statement last year that concluded that test results are predicated on the clinician knowing the prevalence of malignancy within each indeterminate cytologic category at his/her own institution. Without this information, the performance of the diagnostic tests may vary substantially (Thyroid. 2015;25:760-8).
The single-center, retrospective cohort analysis included 192 patients with 210 indeterminate biopsy results, 145 of whom had surgery with 154 thyroid nodules. With a malignancy prevalence of 45%, the expected negative predictive value (NPV) of the test was estimated to be 85%, Dr. Al-Qurayshi said. However, the actual observed NPV was 69%. “If the prevalence was assumed to be 25%, the expected NPV was estimated to be 94%, while the observed NPV would have been 85%,” Dr. Al-Qurayshi said.
The researchers calculated the expected NPV by adopting the sensitivity and specificity rates of the test as reported in previous studies, while they calculated the observed NPV based on the actual negative rate among the Tulane cohort, Dr. Al-Qurayshi said.
Dr. Al-Qurayshi and colleagues then compared their results with pooled data from 11 other studies of the Afirma GEC. The pooled data analysis included 1,303 patients and yielded a malignancy prevalence of 31.1%, with a range of 29%-35%, and a pooled NPV of 92%, with a range of 87%-96%, Dr. Al-Qurayshi said.
“A lot of previously published studies took the sensitivity and specificity that were previously reported for granted, and now we are showing this sensitivity is all over the place,” Dr. Al-Qurayshi said. “Now, we don’t know which is the true one, and we need a larger clinical trial first to determine the true properties. Then we can ask how the prevalence in one’s institution is affecting the performance of the test.”
In an interview, Dr. Emad Kandil, senior study coauthor, also of Tulane, said the 69% NPV of the Tulane cohort puts the diagnostic scenario “back to ground zero, which is similar to what we had prior to the use of the new commercially available genetic tests.” He added, “A larger, randomized trial of the Afirma GEC test should answer those questions.”
The seminal study for the Afirma GEC, authored by Dr. Erik Alexander of Brigham and Women’s Hospital, Boston, in 2012, reported a 92% NPV with the test (N Engl J Med. 2012;367:705-15).
“The first thought was that they had different results because their population was different,” Dr. Al-Qurayshi said. “The ATA statement noted that it is the clinician’s responsibility to determine if this test is appropriate for their population or not, but the performance of the test doesn’t just depend on the population property, but it also depends on the intrinsic testing properties.”
Dr. Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors had no financial disclosures.
BALTIMORE – Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.
When fine-needle aspiration biopsy of thyroid nodules comes back inconclusive, clinicians have increasingly utilized the Afirma gene expression classifier (GEC) to rule out malignancy, but a retrospective analysis of almost 200 patients with indeterminate biopsy results along with a pooled analysis of 11 previous studies has raised questions about the negative predictive value of the test.
“The Afirma GEC test has substantial variability in performance,” said Dr. Zaid Al-Qurayshi of Tulane University, New Orleans, who reported the results at the annual meeting of the American Association of Endocrine Surgeons. “This variability cannot be explained based on differences in prevalence alone, but may also be the result of intrinsic test properties.”
The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.
The researchers undertook the study in light of an American Thyroid Association (ATA) statement last year that concluded that test results are predicated on the clinician knowing the prevalence of malignancy within each indeterminate cytologic category at his/her own institution. Without this information, the performance of the diagnostic tests may vary substantially (Thyroid. 2015;25:760-8).
The single-center, retrospective cohort analysis included 192 patients with 210 indeterminate biopsy results, 145 of whom had surgery with 154 thyroid nodules. With a malignancy prevalence of 45%, the expected negative predictive value (NPV) of the test was estimated to be 85%, Dr. Al-Qurayshi said. However, the actual observed NPV was 69%. “If the prevalence was assumed to be 25%, the expected NPV was estimated to be 94%, while the observed NPV would have been 85%,” Dr. Al-Qurayshi said.
The researchers calculated the expected NPV by adopting the sensitivity and specificity rates of the test as reported in previous studies, while they calculated the observed NPV based on the actual negative rate among the Tulane cohort, Dr. Al-Qurayshi said.
Dr. Al-Qurayshi and colleagues then compared their results with pooled data from 11 other studies of the Afirma GEC. The pooled data analysis included 1,303 patients and yielded a malignancy prevalence of 31.1%, with a range of 29%-35%, and a pooled NPV of 92%, with a range of 87%-96%, Dr. Al-Qurayshi said.
“A lot of previously published studies took the sensitivity and specificity that were previously reported for granted, and now we are showing this sensitivity is all over the place,” Dr. Al-Qurayshi said. “Now, we don’t know which is the true one, and we need a larger clinical trial first to determine the true properties. Then we can ask how the prevalence in one’s institution is affecting the performance of the test.”
In an interview, Dr. Emad Kandil, senior study coauthor, also of Tulane, said the 69% NPV of the Tulane cohort puts the diagnostic scenario “back to ground zero, which is similar to what we had prior to the use of the new commercially available genetic tests.” He added, “A larger, randomized trial of the Afirma GEC test should answer those questions.”
The seminal study for the Afirma GEC, authored by Dr. Erik Alexander of Brigham and Women’s Hospital, Boston, in 2012, reported a 92% NPV with the test (N Engl J Med. 2012;367:705-15).
“The first thought was that they had different results because their population was different,” Dr. Al-Qurayshi said. “The ATA statement noted that it is the clinician’s responsibility to determine if this test is appropriate for their population or not, but the performance of the test doesn’t just depend on the population property, but it also depends on the intrinsic testing properties.”
Dr. Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors had no financial disclosures.
BALTIMORE – Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.
When fine-needle aspiration biopsy of thyroid nodules comes back inconclusive, clinicians have increasingly utilized the Afirma gene expression classifier (GEC) to rule out malignancy, but a retrospective analysis of almost 200 patients with indeterminate biopsy results along with a pooled analysis of 11 previous studies has raised questions about the negative predictive value of the test.
“The Afirma GEC test has substantial variability in performance,” said Dr. Zaid Al-Qurayshi of Tulane University, New Orleans, who reported the results at the annual meeting of the American Association of Endocrine Surgeons. “This variability cannot be explained based on differences in prevalence alone, but may also be the result of intrinsic test properties.”
The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.
The researchers undertook the study in light of an American Thyroid Association (ATA) statement last year that concluded that test results are predicated on the clinician knowing the prevalence of malignancy within each indeterminate cytologic category at his/her own institution. Without this information, the performance of the diagnostic tests may vary substantially (Thyroid. 2015;25:760-8).
The single-center, retrospective cohort analysis included 192 patients with 210 indeterminate biopsy results, 145 of whom had surgery with 154 thyroid nodules. With a malignancy prevalence of 45%, the expected negative predictive value (NPV) of the test was estimated to be 85%, Dr. Al-Qurayshi said. However, the actual observed NPV was 69%. “If the prevalence was assumed to be 25%, the expected NPV was estimated to be 94%, while the observed NPV would have been 85%,” Dr. Al-Qurayshi said.
The researchers calculated the expected NPV by adopting the sensitivity and specificity rates of the test as reported in previous studies, while they calculated the observed NPV based on the actual negative rate among the Tulane cohort, Dr. Al-Qurayshi said.
Dr. Al-Qurayshi and colleagues then compared their results with pooled data from 11 other studies of the Afirma GEC. The pooled data analysis included 1,303 patients and yielded a malignancy prevalence of 31.1%, with a range of 29%-35%, and a pooled NPV of 92%, with a range of 87%-96%, Dr. Al-Qurayshi said.
“A lot of previously published studies took the sensitivity and specificity that were previously reported for granted, and now we are showing this sensitivity is all over the place,” Dr. Al-Qurayshi said. “Now, we don’t know which is the true one, and we need a larger clinical trial first to determine the true properties. Then we can ask how the prevalence in one’s institution is affecting the performance of the test.”
In an interview, Dr. Emad Kandil, senior study coauthor, also of Tulane, said the 69% NPV of the Tulane cohort puts the diagnostic scenario “back to ground zero, which is similar to what we had prior to the use of the new commercially available genetic tests.” He added, “A larger, randomized trial of the Afirma GEC test should answer those questions.”
The seminal study for the Afirma GEC, authored by Dr. Erik Alexander of Brigham and Women’s Hospital, Boston, in 2012, reported a 92% NPV with the test (N Engl J Med. 2012;367:705-15).
“The first thought was that they had different results because their population was different,” Dr. Al-Qurayshi said. “The ATA statement noted that it is the clinician’s responsibility to determine if this test is appropriate for their population or not, but the performance of the test doesn’t just depend on the population property, but it also depends on the intrinsic testing properties.”
Dr. Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors had no financial disclosures.
At AAES 2016
Key clinical point: Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.
Major finding: With a malignancy prevalence of 45%, the expected negative predictive value of the test was estimated to be 85%, but the actual observed NPV was 69%.
Data source: A single-center, retrospective cohort analysis involving 145 patients with 154 thyroid nodules.
Disclosures: Coauthor Dr. Emad Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors reported having no financial disclosures.
VIDEO: Wedge resection beats SBRT for stage I lung cancer treatment
BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.
While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.
“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”
Dr. Weder reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.
While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.
“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”
Dr. Weder reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.
While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.
“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”
Dr. Weder reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
AT AATS 2016
Thyroid tumor reclassification eases burden, raises diagnostic questions
The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.
“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”
The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).
Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.
Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.
Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.
The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.
The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.
“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”
Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.
“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.
One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.
“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.
Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.
The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.
“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”
The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).
Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.
Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.
Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.
The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.
The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.
“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”
Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.
“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.
One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.
“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.
Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.
The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.
“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”
The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).
Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.
Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.
Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.
The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.
The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.
“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”
Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.
“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.
One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.
“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.
Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.
FROM JAMA ONCOLOGY
Key clinical point: The recent reclassification of EFVPTC as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) has important clinical and psychological implications for patients.
Major finding: 109 patients with noninvasive EFVPTC were alive and had no evidence of disease at a median of 13 years follow-up. Most of those patients (67%) were treated only with lobectomy, and none received radioiodine treatment.
Data source: A retrospective study of 210 patients.
Disclosures: Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.
Primary small cell cancer of the anus rare, but devastating
LOS ANGELES – Primary small cell cancer of the anus is a rare but devastating condition and overall survival may not be improved with surgical treatment.
Those are key findings from what is believed to be the largest analysis of its kind to date.
“There are very limited data for patients with anal small cell cancers who need preoperative counseling and risk stratification,” study author Dr. Cornelius A. Thiels said in an interview at the annual meeting of the American Society of Colon and Rectal Surgeons. “There are also no data to guide treatment, so, until now, management was based on the treatment of small cell of the lung, and other anal cancers.”
Cancers of the anal canal are estimated to represent about 2.5% of all gastrointestinal neoplasms, while primary small cell cancer of the anus is believed to account for less than 1% of all anal neoplasms, according to Dr. Thiels, who is a third-year general surgery resident in the department of surgery and a surgical outcomes fellow in the Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery at the Mayo Clinic, Rochester, Minn.
In an effort to evaluate the outcomes of patients with primary small cell cancer of the anus, the researchers reviewed their own institutional experience in treating nine patients with this condition between from 1994-2014, as well as National Cancer Data Base (NCDB) records of 174 patients from 1998-2014. The NCDB is maintained by collecting data prospectively from more than 1,500 facilities across the United States and is estimated to capture approximately 70% of all newly diagnosed cases of cancer annually. Institutional data allowed the researchers to identify details, including how these patients presented and what type of chemotherapy they received. However, analysis of a national database was necessary given the rarity of the diagnosis.
In the analysis of NCDB records, the mean patient age was 59 years and 74% were female. Most of the tumors (95%) were high grade and the majority of patients presented with advanced disease (50 with stage IV disease, 49 with stage III disease, 29 with stage II disease, 25 with stage I disease, and 21 with unknown stage). Overall survival was 66% at 12 months and 29% at 36 months. Among patients with stage I-III disease, survival was 72% at 12 months and 39% at 36 months.
Of the 103 patients with stage I-III disease, 95% received medical therapy, 70% underwent medical management alone, while 30% underwent surgery with curative intent. Patients who did not undergo surgery tended to have a higher stage of disease, compared with those who did (57% vs. 26%: P = .005). Overall survival at 36 months was similar between the two groups (33.9% in the surgery group vs. 35.8% in the no surgery group; P = .87).
“Unfortunately, it seems from our own experience and from national data that additional research is needed to determine how best to treat these patients and that surgery may not prolong survival in many of these patients,” Dr. Thiels said. “Although additional research is needed to optimize outcomes for these patients, harnessing the power of a national cancer database like the NCDB allows us to improve our understanding of these otherwise extremely rare, and difficult to study, tumors.”
Dr. Thiels reported having no financial disclosures.
LOS ANGELES – Primary small cell cancer of the anus is a rare but devastating condition and overall survival may not be improved with surgical treatment.
Those are key findings from what is believed to be the largest analysis of its kind to date.
“There are very limited data for patients with anal small cell cancers who need preoperative counseling and risk stratification,” study author Dr. Cornelius A. Thiels said in an interview at the annual meeting of the American Society of Colon and Rectal Surgeons. “There are also no data to guide treatment, so, until now, management was based on the treatment of small cell of the lung, and other anal cancers.”
Cancers of the anal canal are estimated to represent about 2.5% of all gastrointestinal neoplasms, while primary small cell cancer of the anus is believed to account for less than 1% of all anal neoplasms, according to Dr. Thiels, who is a third-year general surgery resident in the department of surgery and a surgical outcomes fellow in the Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery at the Mayo Clinic, Rochester, Minn.
In an effort to evaluate the outcomes of patients with primary small cell cancer of the anus, the researchers reviewed their own institutional experience in treating nine patients with this condition between from 1994-2014, as well as National Cancer Data Base (NCDB) records of 174 patients from 1998-2014. The NCDB is maintained by collecting data prospectively from more than 1,500 facilities across the United States and is estimated to capture approximately 70% of all newly diagnosed cases of cancer annually. Institutional data allowed the researchers to identify details, including how these patients presented and what type of chemotherapy they received. However, analysis of a national database was necessary given the rarity of the diagnosis.
In the analysis of NCDB records, the mean patient age was 59 years and 74% were female. Most of the tumors (95%) were high grade and the majority of patients presented with advanced disease (50 with stage IV disease, 49 with stage III disease, 29 with stage II disease, 25 with stage I disease, and 21 with unknown stage). Overall survival was 66% at 12 months and 29% at 36 months. Among patients with stage I-III disease, survival was 72% at 12 months and 39% at 36 months.
Of the 103 patients with stage I-III disease, 95% received medical therapy, 70% underwent medical management alone, while 30% underwent surgery with curative intent. Patients who did not undergo surgery tended to have a higher stage of disease, compared with those who did (57% vs. 26%: P = .005). Overall survival at 36 months was similar between the two groups (33.9% in the surgery group vs. 35.8% in the no surgery group; P = .87).
“Unfortunately, it seems from our own experience and from national data that additional research is needed to determine how best to treat these patients and that surgery may not prolong survival in many of these patients,” Dr. Thiels said. “Although additional research is needed to optimize outcomes for these patients, harnessing the power of a national cancer database like the NCDB allows us to improve our understanding of these otherwise extremely rare, and difficult to study, tumors.”
Dr. Thiels reported having no financial disclosures.
LOS ANGELES – Primary small cell cancer of the anus is a rare but devastating condition and overall survival may not be improved with surgical treatment.
Those are key findings from what is believed to be the largest analysis of its kind to date.
“There are very limited data for patients with anal small cell cancers who need preoperative counseling and risk stratification,” study author Dr. Cornelius A. Thiels said in an interview at the annual meeting of the American Society of Colon and Rectal Surgeons. “There are also no data to guide treatment, so, until now, management was based on the treatment of small cell of the lung, and other anal cancers.”
Cancers of the anal canal are estimated to represent about 2.5% of all gastrointestinal neoplasms, while primary small cell cancer of the anus is believed to account for less than 1% of all anal neoplasms, according to Dr. Thiels, who is a third-year general surgery resident in the department of surgery and a surgical outcomes fellow in the Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery at the Mayo Clinic, Rochester, Minn.
In an effort to evaluate the outcomes of patients with primary small cell cancer of the anus, the researchers reviewed their own institutional experience in treating nine patients with this condition between from 1994-2014, as well as National Cancer Data Base (NCDB) records of 174 patients from 1998-2014. The NCDB is maintained by collecting data prospectively from more than 1,500 facilities across the United States and is estimated to capture approximately 70% of all newly diagnosed cases of cancer annually. Institutional data allowed the researchers to identify details, including how these patients presented and what type of chemotherapy they received. However, analysis of a national database was necessary given the rarity of the diagnosis.
In the analysis of NCDB records, the mean patient age was 59 years and 74% were female. Most of the tumors (95%) were high grade and the majority of patients presented with advanced disease (50 with stage IV disease, 49 with stage III disease, 29 with stage II disease, 25 with stage I disease, and 21 with unknown stage). Overall survival was 66% at 12 months and 29% at 36 months. Among patients with stage I-III disease, survival was 72% at 12 months and 39% at 36 months.
Of the 103 patients with stage I-III disease, 95% received medical therapy, 70% underwent medical management alone, while 30% underwent surgery with curative intent. Patients who did not undergo surgery tended to have a higher stage of disease, compared with those who did (57% vs. 26%: P = .005). Overall survival at 36 months was similar between the two groups (33.9% in the surgery group vs. 35.8% in the no surgery group; P = .87).
“Unfortunately, it seems from our own experience and from national data that additional research is needed to determine how best to treat these patients and that surgery may not prolong survival in many of these patients,” Dr. Thiels said. “Although additional research is needed to optimize outcomes for these patients, harnessing the power of a national cancer database like the NCDB allows us to improve our understanding of these otherwise extremely rare, and difficult to study, tumors.”
Dr. Thiels reported having no financial disclosures.
AT THE ASCRS ANNUAL MEETING
Key clinical point: Among patients with primary small cell cancer of the anus, survival was 29% at 36 months.
Major finding: Overall survival among patients with primary small cell cancer of the anus was 66% at 12 months and 29% at 36 months.
Data source: A review of National Cancer Data Base records from 174 patients with primary cell cancer of the anus who were treated from 1998-2014.
Disclosures: Dr. Thiels reported having no financial disclosures.
FDG-PET/CT leads pack for small-cell lung cancer staging
For pretreatment staging of small-cell lung cancer (SCLC) the use of positron-emission tomography combined with CT was more sensitive compared with several other tests, according to a new report on a review of studies.
Overall, positron emission tomography using [F]-fluorodeoxyglucose as a radiotracer combined with CT (FDG-PET/CT) had greater sensitivity to detect osseous metastases than did bone scintigraphy or CT alone, according to Dr. Jonathan R. Treadwell, Ph.D., of ECRI Institute–Penn Medicine’s Evidence-based Practice Center in Plymouth Meeting, Pa., and colleagues. In addition, the researchers concluded that adding FDG-PET/CT to the protocol for patients who have undergone standard staging increased the sensitivity for detecting additional metastases. Data on endobronchial ultrasound were insufficient to draw any conclusions.
The findings generally line up with recent guidelines from the American College of Radiology (ACR) and American College of Chest Physicians (ACCP). In 2014, the ACR gave the highest rating of “usually appropriate” (with regard to staging SCLC) to FDG-PET/CT from skull base to mid-thigh, while bone scintigraphy was rated as “may be appropriate” and not necessary if PET/CT had been done, the researchers wrote. The 2013 ACCP guideline “suggested” FDG PET instead of bone scintigraphy for patients with limited disease, they added.
The researchers reviewed data from seven studies to assess the accuracy and effectiveness of several imaging modalities for the pretreatment staging of SCLC. The report was generated for the Agency for Healthcare Research and Quality (AHRQ) as part of its Comparative Effectiveness Review series, and is not an official AHRQ position, the researchers noted.
Combining FDG-PET with CT scanning has demonstrated even greater effectiveness at identifying malignant tumors and metabolically active metastases than has PET alone, because the CT allows for more localized anatomic detail, the researchers explained. “False negative scans usually result from non–metabolically active sites of tumor or from suboptimal quality studies,” they said, while false positives using FDG-PET are usually attributed to inflammation or metabolically active infection.
The meta-analysis included data on endobronchial ultrasound, which involves ultrasound to view structures inside and adjacent to the airway; bone scintigraphy, a less expensive planar molecular imaging technique; and CT alone.
Comparative evidence on pretreatment staging for SCLC is limited, according to the researchers. The data did not allow them to determine how FDG-PET/CT compared to other imaging in terms of specificity, and any type of imaging can yield false positives, they said. However, higher sensitivity alone can benefit patients in terms of improving patient selection for optimal therapy, sparing patients chemotherapy if not needed, and improving the prediction value of ongoing research, they noted.
“Although high-quality evidence may not be voluminous, I think most physicians would agree with the conclusion that a bone scan is not mandatory in the work-up of possible SCLC, if a PET/CT has been done,” Dr. W. Michael Alberts of the Moffitt Cancer Center in Tampa, Fla., said in an interview.
Cost might play a role in why the guidelines are being issued at this time, he noted, because “the initial work-up of the patient with suspected SCLC may prove to be quite expensive, and the elimination of a superfluous test may be a fiscal winner.” However, more research is needed in this area, particularly in the areas of including the order of pretreatment testing and the incorporation of new procedures and imaging modalities, he added. “Perhaps more intellectually challenging, however, might be the question of why SCLC is becoming less common, or why has improvement in treatment been so slow compared to NSCLC,” he added.
The researchers had no financial conflicts to disclose.
For pretreatment staging of small-cell lung cancer (SCLC) the use of positron-emission tomography combined with CT was more sensitive compared with several other tests, according to a new report on a review of studies.
Overall, positron emission tomography using [F]-fluorodeoxyglucose as a radiotracer combined with CT (FDG-PET/CT) had greater sensitivity to detect osseous metastases than did bone scintigraphy or CT alone, according to Dr. Jonathan R. Treadwell, Ph.D., of ECRI Institute–Penn Medicine’s Evidence-based Practice Center in Plymouth Meeting, Pa., and colleagues. In addition, the researchers concluded that adding FDG-PET/CT to the protocol for patients who have undergone standard staging increased the sensitivity for detecting additional metastases. Data on endobronchial ultrasound were insufficient to draw any conclusions.
The findings generally line up with recent guidelines from the American College of Radiology (ACR) and American College of Chest Physicians (ACCP). In 2014, the ACR gave the highest rating of “usually appropriate” (with regard to staging SCLC) to FDG-PET/CT from skull base to mid-thigh, while bone scintigraphy was rated as “may be appropriate” and not necessary if PET/CT had been done, the researchers wrote. The 2013 ACCP guideline “suggested” FDG PET instead of bone scintigraphy for patients with limited disease, they added.
The researchers reviewed data from seven studies to assess the accuracy and effectiveness of several imaging modalities for the pretreatment staging of SCLC. The report was generated for the Agency for Healthcare Research and Quality (AHRQ) as part of its Comparative Effectiveness Review series, and is not an official AHRQ position, the researchers noted.
Combining FDG-PET with CT scanning has demonstrated even greater effectiveness at identifying malignant tumors and metabolically active metastases than has PET alone, because the CT allows for more localized anatomic detail, the researchers explained. “False negative scans usually result from non–metabolically active sites of tumor or from suboptimal quality studies,” they said, while false positives using FDG-PET are usually attributed to inflammation or metabolically active infection.
The meta-analysis included data on endobronchial ultrasound, which involves ultrasound to view structures inside and adjacent to the airway; bone scintigraphy, a less expensive planar molecular imaging technique; and CT alone.
Comparative evidence on pretreatment staging for SCLC is limited, according to the researchers. The data did not allow them to determine how FDG-PET/CT compared to other imaging in terms of specificity, and any type of imaging can yield false positives, they said. However, higher sensitivity alone can benefit patients in terms of improving patient selection for optimal therapy, sparing patients chemotherapy if not needed, and improving the prediction value of ongoing research, they noted.
“Although high-quality evidence may not be voluminous, I think most physicians would agree with the conclusion that a bone scan is not mandatory in the work-up of possible SCLC, if a PET/CT has been done,” Dr. W. Michael Alberts of the Moffitt Cancer Center in Tampa, Fla., said in an interview.
Cost might play a role in why the guidelines are being issued at this time, he noted, because “the initial work-up of the patient with suspected SCLC may prove to be quite expensive, and the elimination of a superfluous test may be a fiscal winner.” However, more research is needed in this area, particularly in the areas of including the order of pretreatment testing and the incorporation of new procedures and imaging modalities, he added. “Perhaps more intellectually challenging, however, might be the question of why SCLC is becoming less common, or why has improvement in treatment been so slow compared to NSCLC,” he added.
The researchers had no financial conflicts to disclose.
For pretreatment staging of small-cell lung cancer (SCLC) the use of positron-emission tomography combined with CT was more sensitive compared with several other tests, according to a new report on a review of studies.
Overall, positron emission tomography using [F]-fluorodeoxyglucose as a radiotracer combined with CT (FDG-PET/CT) had greater sensitivity to detect osseous metastases than did bone scintigraphy or CT alone, according to Dr. Jonathan R. Treadwell, Ph.D., of ECRI Institute–Penn Medicine’s Evidence-based Practice Center in Plymouth Meeting, Pa., and colleagues. In addition, the researchers concluded that adding FDG-PET/CT to the protocol for patients who have undergone standard staging increased the sensitivity for detecting additional metastases. Data on endobronchial ultrasound were insufficient to draw any conclusions.
The findings generally line up with recent guidelines from the American College of Radiology (ACR) and American College of Chest Physicians (ACCP). In 2014, the ACR gave the highest rating of “usually appropriate” (with regard to staging SCLC) to FDG-PET/CT from skull base to mid-thigh, while bone scintigraphy was rated as “may be appropriate” and not necessary if PET/CT had been done, the researchers wrote. The 2013 ACCP guideline “suggested” FDG PET instead of bone scintigraphy for patients with limited disease, they added.
The researchers reviewed data from seven studies to assess the accuracy and effectiveness of several imaging modalities for the pretreatment staging of SCLC. The report was generated for the Agency for Healthcare Research and Quality (AHRQ) as part of its Comparative Effectiveness Review series, and is not an official AHRQ position, the researchers noted.
Combining FDG-PET with CT scanning has demonstrated even greater effectiveness at identifying malignant tumors and metabolically active metastases than has PET alone, because the CT allows for more localized anatomic detail, the researchers explained. “False negative scans usually result from non–metabolically active sites of tumor or from suboptimal quality studies,” they said, while false positives using FDG-PET are usually attributed to inflammation or metabolically active infection.
The meta-analysis included data on endobronchial ultrasound, which involves ultrasound to view structures inside and adjacent to the airway; bone scintigraphy, a less expensive planar molecular imaging technique; and CT alone.
Comparative evidence on pretreatment staging for SCLC is limited, according to the researchers. The data did not allow them to determine how FDG-PET/CT compared to other imaging in terms of specificity, and any type of imaging can yield false positives, they said. However, higher sensitivity alone can benefit patients in terms of improving patient selection for optimal therapy, sparing patients chemotherapy if not needed, and improving the prediction value of ongoing research, they noted.
“Although high-quality evidence may not be voluminous, I think most physicians would agree with the conclusion that a bone scan is not mandatory in the work-up of possible SCLC, if a PET/CT has been done,” Dr. W. Michael Alberts of the Moffitt Cancer Center in Tampa, Fla., said in an interview.
Cost might play a role in why the guidelines are being issued at this time, he noted, because “the initial work-up of the patient with suspected SCLC may prove to be quite expensive, and the elimination of a superfluous test may be a fiscal winner.” However, more research is needed in this area, particularly in the areas of including the order of pretreatment testing and the incorporation of new procedures and imaging modalities, he added. “Perhaps more intellectually challenging, however, might be the question of why SCLC is becoming less common, or why has improvement in treatment been so slow compared to NSCLC,” he added.
The researchers had no financial conflicts to disclose.
Anal cancer cases continue to rise, with disproportionately poorer outcomes for blacks
LOS ANGELES – Overall 5-year survival rates for anal cancer in the United States have steadily improved since the 1970s, but the incidence of disease continues to rise. In addition, African Americans with anal cancer have significantly and disproportionally lower 5-year survival rates, compared with whites.
Those are key findings from an analysis of Surveillance, Epidemiology and End Results (SEER) data that primary study author Dr. Marco Ferrara presented at the annual meeting of the American Society of Colon and Rectal Surgeons.
“Disparities in health-related outcomes for diseases such as cancer are unfortunately commonly observed,” Dr. Ferrara’s mentor and the senior study author Dr. Daniel I. Chu said in an interview in advance of the meeting. “African Americans in particular have higher cancer-specific death rates, higher rates of advanced cancer on initial diagnosis, and less frequent use of cancer screening tests. While our understanding of disparities continues to progress for the more common cancers (lung, breast, prostate, colorectal), comparatively fewer data are available for anal cancer. This gap in knowledge is important because anal cancer incidence has actually been increasing in the U.S. population over the past decades. While effective treatment is available, we asked if disparities exist in anal cancer.”
To find out, the researchers used the national SEER database to identify all patients with cancer of the anus, anal canal, and anorectum from 1973 to 1999 (Period 1; a total of 6,755 cases) and 2000 to 2012 (Period 2; a total of 18,027 cases) and stratified them by race. They determined the incidence, staging, and treatment provided for each group and used 2000 Census data to calculate the age-adjusted annual incidence of anal cancer. The primary outcome was 5-year survival.
More than half of patients (61%) were female, 86% were white, 10% were African American, and the remaining 4% were from other ethnic groups. Dr. Ferrara, who is a fourth-year surgery resident at Baptist Health System in Birmingham, Ala., reported that between Periods 1 and 2, the overall incidence of anal cancer increased from 1.1 to 1.8 cases per 100,000 individuals. The overall incidence was higher among African Americans, compared with whites (1.6 vs. 1.3 cases per 100,000 individuals, respectively). The incidence among African-American males was slightly higher, at 1.9 cases per 100,000 individuals.
The researchers found that nearly half of patients (48%) presented with localized disease, while 31% had regional disease. Between Periods 1 and 2 the proportion of patients who received any treatment for anal cancer increased from 63% to 74%. The use of radiation therapy increased from 61% to 72%, while the use of local excisions and abdominoperineal resections decreased from 60% to 45%. Overall, African Americans were more likely than whites to not undergo recommended surgery (9.8% vs. 8.7%, respectively) or to refuse recommended surgery (1.8% vs. 1.1%; P less than .05 for both associations).
Overall 5-year survival for anal cancer improved from 63% in Period 1 to 70% in Period 2 (P less than .05). However, African Americans had significantly lower 5-year survival rates, compared with whites in both time periods (53% vs. 64% in Period 1, and 62% vs. 71% in Period 2; P less than .05 for both associations).
“Health disparities exist in anal cancer with African Americans faring worse than Caucasian patients,” said Dr. Chu, who is a gastrointestinal surgeon at the University of Alabama at Birmingham. “While the etiologies for these disparities are unclear, anal cancer is a very treatable disease when caught early, regardless of race. Screening should be done for those at higher risk, such as patients with a family history of anal cancer, HIV, or HPV [human papillomavirus]. Ultimately, more research is needed to understand the factors driving these disparities at the patient, provider, and health care system level.”
He acknowledged certain limitations of the study, including its retrospective nature, the inability to assess the potential impact of education status and other social factors, and the generalizability of its findings, since SEER is limited to major cancer hospitals.
The researchers reported having no financial disclosures.
LOS ANGELES – Overall 5-year survival rates for anal cancer in the United States have steadily improved since the 1970s, but the incidence of disease continues to rise. In addition, African Americans with anal cancer have significantly and disproportionally lower 5-year survival rates, compared with whites.
Those are key findings from an analysis of Surveillance, Epidemiology and End Results (SEER) data that primary study author Dr. Marco Ferrara presented at the annual meeting of the American Society of Colon and Rectal Surgeons.
“Disparities in health-related outcomes for diseases such as cancer are unfortunately commonly observed,” Dr. Ferrara’s mentor and the senior study author Dr. Daniel I. Chu said in an interview in advance of the meeting. “African Americans in particular have higher cancer-specific death rates, higher rates of advanced cancer on initial diagnosis, and less frequent use of cancer screening tests. While our understanding of disparities continues to progress for the more common cancers (lung, breast, prostate, colorectal), comparatively fewer data are available for anal cancer. This gap in knowledge is important because anal cancer incidence has actually been increasing in the U.S. population over the past decades. While effective treatment is available, we asked if disparities exist in anal cancer.”
To find out, the researchers used the national SEER database to identify all patients with cancer of the anus, anal canal, and anorectum from 1973 to 1999 (Period 1; a total of 6,755 cases) and 2000 to 2012 (Period 2; a total of 18,027 cases) and stratified them by race. They determined the incidence, staging, and treatment provided for each group and used 2000 Census data to calculate the age-adjusted annual incidence of anal cancer. The primary outcome was 5-year survival.
More than half of patients (61%) were female, 86% were white, 10% were African American, and the remaining 4% were from other ethnic groups. Dr. Ferrara, who is a fourth-year surgery resident at Baptist Health System in Birmingham, Ala., reported that between Periods 1 and 2, the overall incidence of anal cancer increased from 1.1 to 1.8 cases per 100,000 individuals. The overall incidence was higher among African Americans, compared with whites (1.6 vs. 1.3 cases per 100,000 individuals, respectively). The incidence among African-American males was slightly higher, at 1.9 cases per 100,000 individuals.
The researchers found that nearly half of patients (48%) presented with localized disease, while 31% had regional disease. Between Periods 1 and 2 the proportion of patients who received any treatment for anal cancer increased from 63% to 74%. The use of radiation therapy increased from 61% to 72%, while the use of local excisions and abdominoperineal resections decreased from 60% to 45%. Overall, African Americans were more likely than whites to not undergo recommended surgery (9.8% vs. 8.7%, respectively) or to refuse recommended surgery (1.8% vs. 1.1%; P less than .05 for both associations).
Overall 5-year survival for anal cancer improved from 63% in Period 1 to 70% in Period 2 (P less than .05). However, African Americans had significantly lower 5-year survival rates, compared with whites in both time periods (53% vs. 64% in Period 1, and 62% vs. 71% in Period 2; P less than .05 for both associations).
“Health disparities exist in anal cancer with African Americans faring worse than Caucasian patients,” said Dr. Chu, who is a gastrointestinal surgeon at the University of Alabama at Birmingham. “While the etiologies for these disparities are unclear, anal cancer is a very treatable disease when caught early, regardless of race. Screening should be done for those at higher risk, such as patients with a family history of anal cancer, HIV, or HPV [human papillomavirus]. Ultimately, more research is needed to understand the factors driving these disparities at the patient, provider, and health care system level.”
He acknowledged certain limitations of the study, including its retrospective nature, the inability to assess the potential impact of education status and other social factors, and the generalizability of its findings, since SEER is limited to major cancer hospitals.
The researchers reported having no financial disclosures.
LOS ANGELES – Overall 5-year survival rates for anal cancer in the United States have steadily improved since the 1970s, but the incidence of disease continues to rise. In addition, African Americans with anal cancer have significantly and disproportionally lower 5-year survival rates, compared with whites.
Those are key findings from an analysis of Surveillance, Epidemiology and End Results (SEER) data that primary study author Dr. Marco Ferrara presented at the annual meeting of the American Society of Colon and Rectal Surgeons.
“Disparities in health-related outcomes for diseases such as cancer are unfortunately commonly observed,” Dr. Ferrara’s mentor and the senior study author Dr. Daniel I. Chu said in an interview in advance of the meeting. “African Americans in particular have higher cancer-specific death rates, higher rates of advanced cancer on initial diagnosis, and less frequent use of cancer screening tests. While our understanding of disparities continues to progress for the more common cancers (lung, breast, prostate, colorectal), comparatively fewer data are available for anal cancer. This gap in knowledge is important because anal cancer incidence has actually been increasing in the U.S. population over the past decades. While effective treatment is available, we asked if disparities exist in anal cancer.”
To find out, the researchers used the national SEER database to identify all patients with cancer of the anus, anal canal, and anorectum from 1973 to 1999 (Period 1; a total of 6,755 cases) and 2000 to 2012 (Period 2; a total of 18,027 cases) and stratified them by race. They determined the incidence, staging, and treatment provided for each group and used 2000 Census data to calculate the age-adjusted annual incidence of anal cancer. The primary outcome was 5-year survival.
More than half of patients (61%) were female, 86% were white, 10% were African American, and the remaining 4% were from other ethnic groups. Dr. Ferrara, who is a fourth-year surgery resident at Baptist Health System in Birmingham, Ala., reported that between Periods 1 and 2, the overall incidence of anal cancer increased from 1.1 to 1.8 cases per 100,000 individuals. The overall incidence was higher among African Americans, compared with whites (1.6 vs. 1.3 cases per 100,000 individuals, respectively). The incidence among African-American males was slightly higher, at 1.9 cases per 100,000 individuals.
The researchers found that nearly half of patients (48%) presented with localized disease, while 31% had regional disease. Between Periods 1 and 2 the proportion of patients who received any treatment for anal cancer increased from 63% to 74%. The use of radiation therapy increased from 61% to 72%, while the use of local excisions and abdominoperineal resections decreased from 60% to 45%. Overall, African Americans were more likely than whites to not undergo recommended surgery (9.8% vs. 8.7%, respectively) or to refuse recommended surgery (1.8% vs. 1.1%; P less than .05 for both associations).
Overall 5-year survival for anal cancer improved from 63% in Period 1 to 70% in Period 2 (P less than .05). However, African Americans had significantly lower 5-year survival rates, compared with whites in both time periods (53% vs. 64% in Period 1, and 62% vs. 71% in Period 2; P less than .05 for both associations).
“Health disparities exist in anal cancer with African Americans faring worse than Caucasian patients,” said Dr. Chu, who is a gastrointestinal surgeon at the University of Alabama at Birmingham. “While the etiologies for these disparities are unclear, anal cancer is a very treatable disease when caught early, regardless of race. Screening should be done for those at higher risk, such as patients with a family history of anal cancer, HIV, or HPV [human papillomavirus]. Ultimately, more research is needed to understand the factors driving these disparities at the patient, provider, and health care system level.”
He acknowledged certain limitations of the study, including its retrospective nature, the inability to assess the potential impact of education status and other social factors, and the generalizability of its findings, since SEER is limited to major cancer hospitals.
The researchers reported having no financial disclosures.
AT THE ASCRS ANNUAL MEETING
Key clinical point: The incidence of anal cancer in the United States continues to rise.
Major finding: Over the past 43 years, the overall incidence of anal cancer increased from 1.1 to 1.8 cases per 100,000 individuals.
Data source: A retrospective study of the SEER database to identify all patients with cancer of the anus, anal canal, and anorectum from 1973 to 1999 (Period 1; a total of 6,755 cases) and 2000 to 2012 (Period 2; a total of 18,027 cases).
Disclosures: The researchers reported having no financial disclosures.
Plasma microRNA assay differentiates colorectal neoplasia
CHICAGO – A novel plasma microRNA assay and prediction model appears to successfully differentiate colorectal neoplasia from other neoplasms and from controls.
The assay includes seven microRNAs that were selected, based on P value, area under the curve (AUC), fold change, and biological plausibility, from among 380 microRNAs screened using microfluidic array technology from a “training” cohort of 60 patients. The training cohort included groups of patients, 10 each, with colorectal cancer, advanced adenoma, breast cancer, pancreatic cancer, and lung cancer – cancers chosen because they frequently develop at similar ages as colon cancer – and 10 controls.
A panel of seven “uniquely dysregulated” microRNAs specific for colorectal neoplasia was evaluated using single assays in a “test” cohort of 120 patients. A mathematical model was developed to predict sample identity in a 150-patient blinded “validation” cohort using repeat-subsampling validation of the testing dataset with 1,000 iterations each to assess model detection accuracy, Dr. Jane V. Carter of the University of Louisville (Ky.) explained at the annual meeting of the American Surgical Association.
The area under the curve for test cohort comparisons with the assay was 0.91, 0.79, and 0.98 for comparison No. 1 (comparing any neoplasia vs. controls), comparison No. 2 (comparing colorectal neoplasia with other cancers) and comparison No. 3 (comparing colorectal cancer with colorectal adenomas) respectively, Dr. Carter reported.
“Our prediction model identified blinded sample identity with 69%-77% accuracy in comparison No. 1, 66%-76% accuracy in comparison No. 2, and 86%-90% accuracy in comparison No. 3,” she said, noting that the sensitivity and specificity of the assay compare very well with current clinical standards.
Colorectal neoplasms frequently develop in individuals at ages when other common cancers also occur. Current screening methods, including endoscopic and imaging studies and fecal testing have poor patient compliance. Fecal and blood tests lack sensitivity and specificity for the detection of adenomas, limiting their use as screening methods, she said.
But this novel assay, which builds on the earlier work identifying miR-21 as a potential marker for colorectal cancer, provides a useful tool for identifying colorectal neoplasms, she said.
Efforts are underway to confirm the findings in a larger study population. If the findings are confirmed, the assay may have other potential uses such as monitoring therapy by comparing microRNA expression before and after treatment, and also for predicting response to treatment such as following preoperative neoadjuvant chemoradiation, Dr. Carter suggested.
The current findings have significant implications for the development of a noninvasive, reliable, and reproducible screening test for detection of colorectal neoplasia.
“If we can improve early-stage detection, we can improve survival,” she said.
Dr. Carter reported having no relevant disclosures.
The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.
CHICAGO – A novel plasma microRNA assay and prediction model appears to successfully differentiate colorectal neoplasia from other neoplasms and from controls.
The assay includes seven microRNAs that were selected, based on P value, area under the curve (AUC), fold change, and biological plausibility, from among 380 microRNAs screened using microfluidic array technology from a “training” cohort of 60 patients. The training cohort included groups of patients, 10 each, with colorectal cancer, advanced adenoma, breast cancer, pancreatic cancer, and lung cancer – cancers chosen because they frequently develop at similar ages as colon cancer – and 10 controls.
A panel of seven “uniquely dysregulated” microRNAs specific for colorectal neoplasia was evaluated using single assays in a “test” cohort of 120 patients. A mathematical model was developed to predict sample identity in a 150-patient blinded “validation” cohort using repeat-subsampling validation of the testing dataset with 1,000 iterations each to assess model detection accuracy, Dr. Jane V. Carter of the University of Louisville (Ky.) explained at the annual meeting of the American Surgical Association.
The area under the curve for test cohort comparisons with the assay was 0.91, 0.79, and 0.98 for comparison No. 1 (comparing any neoplasia vs. controls), comparison No. 2 (comparing colorectal neoplasia with other cancers) and comparison No. 3 (comparing colorectal cancer with colorectal adenomas) respectively, Dr. Carter reported.
“Our prediction model identified blinded sample identity with 69%-77% accuracy in comparison No. 1, 66%-76% accuracy in comparison No. 2, and 86%-90% accuracy in comparison No. 3,” she said, noting that the sensitivity and specificity of the assay compare very well with current clinical standards.
Colorectal neoplasms frequently develop in individuals at ages when other common cancers also occur. Current screening methods, including endoscopic and imaging studies and fecal testing have poor patient compliance. Fecal and blood tests lack sensitivity and specificity for the detection of adenomas, limiting their use as screening methods, she said.
But this novel assay, which builds on the earlier work identifying miR-21 as a potential marker for colorectal cancer, provides a useful tool for identifying colorectal neoplasms, she said.
Efforts are underway to confirm the findings in a larger study population. If the findings are confirmed, the assay may have other potential uses such as monitoring therapy by comparing microRNA expression before and after treatment, and also for predicting response to treatment such as following preoperative neoadjuvant chemoradiation, Dr. Carter suggested.
The current findings have significant implications for the development of a noninvasive, reliable, and reproducible screening test for detection of colorectal neoplasia.
“If we can improve early-stage detection, we can improve survival,” she said.
Dr. Carter reported having no relevant disclosures.
The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.
CHICAGO – A novel plasma microRNA assay and prediction model appears to successfully differentiate colorectal neoplasia from other neoplasms and from controls.
The assay includes seven microRNAs that were selected, based on P value, area under the curve (AUC), fold change, and biological plausibility, from among 380 microRNAs screened using microfluidic array technology from a “training” cohort of 60 patients. The training cohort included groups of patients, 10 each, with colorectal cancer, advanced adenoma, breast cancer, pancreatic cancer, and lung cancer – cancers chosen because they frequently develop at similar ages as colon cancer – and 10 controls.
A panel of seven “uniquely dysregulated” microRNAs specific for colorectal neoplasia was evaluated using single assays in a “test” cohort of 120 patients. A mathematical model was developed to predict sample identity in a 150-patient blinded “validation” cohort using repeat-subsampling validation of the testing dataset with 1,000 iterations each to assess model detection accuracy, Dr. Jane V. Carter of the University of Louisville (Ky.) explained at the annual meeting of the American Surgical Association.
The area under the curve for test cohort comparisons with the assay was 0.91, 0.79, and 0.98 for comparison No. 1 (comparing any neoplasia vs. controls), comparison No. 2 (comparing colorectal neoplasia with other cancers) and comparison No. 3 (comparing colorectal cancer with colorectal adenomas) respectively, Dr. Carter reported.
“Our prediction model identified blinded sample identity with 69%-77% accuracy in comparison No. 1, 66%-76% accuracy in comparison No. 2, and 86%-90% accuracy in comparison No. 3,” she said, noting that the sensitivity and specificity of the assay compare very well with current clinical standards.
Colorectal neoplasms frequently develop in individuals at ages when other common cancers also occur. Current screening methods, including endoscopic and imaging studies and fecal testing have poor patient compliance. Fecal and blood tests lack sensitivity and specificity for the detection of adenomas, limiting their use as screening methods, she said.
But this novel assay, which builds on the earlier work identifying miR-21 as a potential marker for colorectal cancer, provides a useful tool for identifying colorectal neoplasms, she said.
Efforts are underway to confirm the findings in a larger study population. If the findings are confirmed, the assay may have other potential uses such as monitoring therapy by comparing microRNA expression before and after treatment, and also for predicting response to treatment such as following preoperative neoadjuvant chemoradiation, Dr. Carter suggested.
The current findings have significant implications for the development of a noninvasive, reliable, and reproducible screening test for detection of colorectal neoplasia.
“If we can improve early-stage detection, we can improve survival,” she said.
Dr. Carter reported having no relevant disclosures.
The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: A novel plasma microRNA assay and prediction model appears to successfully differentiate colorectal neoplasia from other neoplasms and from controls.
Major finding: The prediction model identified sample identity with 69%-77% accuracy when comparing any neoplasia vs. controls, 66%-76% accuracy when comparing colorectal neoplasia with other cancers, and 86%-90% accuracy when comparing colorectal cancer with colorectal adenomas.
Data source: A prediction model used in a 60-person training cohort, a 120-person testing cohort, and a 150-person validation cohort.
Disclosures: Dr. Carter reported having no relevant disclosures.