Cancer survivorship care plans have been recommended to improve clinical care and patient outcomes. We describe here how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record, and implemented 2 complementary delivery models.

Click on the PDF icon at the top of this introduction to read the full article.

Cancer survivorship care plans have been recommended to improve clinical care and patient outcomes. We describe here how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record, and implemented 2 complementary delivery models.

Click on the PDF icon at the top of this introduction to read the full article.

Cancer survivorship care plans have been recommended to improve clinical care and patient outcomes. We describe here how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record, and implemented 2 complementary delivery models.

Click on the PDF icon at the top of this introduction to read the full article.

The Obama administration suffered another legal judgment against the Affordable Care Act when a district court judge ruled that the government has wrongly spent billions of dollars to repay insurers for health insurance provided to certain low-income patients

Congress never appropriated the money for those payments and “no public money can be spent without [an appropriation],” Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia wrote in her May 12 opinion.

If the ruling stands, the reimbursements could end, making health insurance too expensive for the millions of low-income patients who benefit from the ACA’s cost-sharing subsides, according to Jay Mark Waxman, a Boston-based health law attorney.

“If premiums become too expensive, you have people pulling out, then you have the so-called death spiral,” Mr. Waxman said in an interview. “The law could remain intact, but you could end up with not having very many people taking advantage of the marketplace, particularly the Silver Plan.”

The case in question, U.S. House of Representatives v. Burwell, revolves around two sections of the ACA. Section 1401 provides tax credits to certain patients in order to make insurance premiums more affordable, while Section 1402 requires insurers to reduce copayments, deductibles, and other out-of-pocket costs for certain low-income patients. The health law requires the federal government to reimburse insurers for the cost of these two sections.

While the first section received funding through the congressional appropriations process, the second section did not. In January 2014, HHS started repaying repay cost-sharing subsidies to insurers using federal funds. The House sued, claiming that HHS is illegally spending monies that Congress never appropriated. HHS has argued that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements.

Judge Collyer ruled in the House’s favor, writing that paying out reimbursements without an appropriation violates the Constitution.

House members praised the court decision, calling it a victory for “the rule of law and the American taxpayer.”

“We received vindication of what we have known for quite some time – that the administration does not have the authority to spend over $150 billion for payments to insurance companies without an appropriation from Congress,” House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement. “The court’s message was clear: Complying with Article I of the Constitution is not optional for President Obama.”

White House Press Secretary Josh Earnest countered that the administration has seen its share of lawsuits over the ACA and that such legal challenges generally end in a government victory.

“This is not the first time that we’ve seen opponents of the Affordable Care Act go through the motions to try to win this political fight in the court system,” Mr. Earnest said during a press conference. “And it’s unfortunate that Republicans have resorted to a taxpayer-funded lawsuit to refight a political fight that they keep losing. They’ve been losing this fight for 6 years. And they’ll lose it again.”

It’s too early to predict how the legal case might be resolved, said Katherine Hempstead, who directs health insurance coverage for the Robert Wood Johnson Foundation.

“There’s a lot of potential endings that don’t lead to people losing their cost-sharing reductions,” Ms. Hempstead said in an interview. “There are a lot of twists and turns ahead, and the probability of people losing their reductions is remote.”

The House could lose the case on appeal, she said. Such a ruling could be made on the merits of the case or on procedural grounds. Whether the House has standing to sue HHS has been questioned as well, she noted. HHS continues to argue that the House has not established a concrete or imminent injury and therefore, the suit should be thrown out. In addition, some have suggested that the federal ruling could be interpreted as requiring Congress to appropriate money to pay for the cost-sharing reductions, she said.

The ultimate resolution could come from the U.S. Supreme Court, Mr. Waxman added. Another possibility is that the next administration will decline to pursue the case.

“Depending on the timing, it could just stop in the court of appeals,” he said. “The next administration could say, ‘We’re happy with where it is and not take it up. You don’t know what’s going to happen.”

Mr. Earnest said the U.S. Department of Justice is reviewing the ruling and will make an announcement about the next step after the analysis.

[email protected]

On Twitter @legal_med

The Obama administration suffered another legal judgment against the Affordable Care Act when a district court judge ruled that the government has wrongly spent billions of dollars to repay insurers for health insurance provided to certain low-income patients

Congress never appropriated the money for those payments and “no public money can be spent without [an appropriation],” Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia wrote in her May 12 opinion.

If the ruling stands, the reimbursements could end, making health insurance too expensive for the millions of low-income patients who benefit from the ACA’s cost-sharing subsides, according to Jay Mark Waxman, a Boston-based health law attorney.

“If premiums become too expensive, you have people pulling out, then you have the so-called death spiral,” Mr. Waxman said in an interview. “The law could remain intact, but you could end up with not having very many people taking advantage of the marketplace, particularly the Silver Plan.”

The case in question, U.S. House of Representatives v. Burwell, revolves around two sections of the ACA. Section 1401 provides tax credits to certain patients in order to make insurance premiums more affordable, while Section 1402 requires insurers to reduce copayments, deductibles, and other out-of-pocket costs for certain low-income patients. The health law requires the federal government to reimburse insurers for the cost of these two sections.

While the first section received funding through the congressional appropriations process, the second section did not. In January 2014, HHS started repaying repay cost-sharing subsidies to insurers using federal funds. The House sued, claiming that HHS is illegally spending monies that Congress never appropriated. HHS has argued that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements.

Judge Collyer ruled in the House’s favor, writing that paying out reimbursements without an appropriation violates the Constitution.

House members praised the court decision, calling it a victory for “the rule of law and the American taxpayer.”

“We received vindication of what we have known for quite some time – that the administration does not have the authority to spend over $150 billion for payments to insurance companies without an appropriation from Congress,” House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement. “The court’s message was clear: Complying with Article I of the Constitution is not optional for President Obama.”

White House Press Secretary Josh Earnest countered that the administration has seen its share of lawsuits over the ACA and that such legal challenges generally end in a government victory.

“This is not the first time that we’ve seen opponents of the Affordable Care Act go through the motions to try to win this political fight in the court system,” Mr. Earnest said during a press conference. “And it’s unfortunate that Republicans have resorted to a taxpayer-funded lawsuit to refight a political fight that they keep losing. They’ve been losing this fight for 6 years. And they’ll lose it again.”

It’s too early to predict how the legal case might be resolved, said Katherine Hempstead, who directs health insurance coverage for the Robert Wood Johnson Foundation.

“There’s a lot of potential endings that don’t lead to people losing their cost-sharing reductions,” Ms. Hempstead said in an interview. “There are a lot of twists and turns ahead, and the probability of people losing their reductions is remote.”

The House could lose the case on appeal, she said. Such a ruling could be made on the merits of the case or on procedural grounds. Whether the House has standing to sue HHS has been questioned as well, she noted. HHS continues to argue that the House has not established a concrete or imminent injury and therefore, the suit should be thrown out. In addition, some have suggested that the federal ruling could be interpreted as requiring Congress to appropriate money to pay for the cost-sharing reductions, she said.

The ultimate resolution could come from the U.S. Supreme Court, Mr. Waxman added. Another possibility is that the next administration will decline to pursue the case.

“Depending on the timing, it could just stop in the court of appeals,” he said. “The next administration could say, ‘We’re happy with where it is and not take it up. You don’t know what’s going to happen.”

Mr. Earnest said the U.S. Department of Justice is reviewing the ruling and will make an announcement about the next step after the analysis.

[email protected]

On Twitter @legal_med

The Obama administration suffered another legal judgment against the Affordable Care Act when a district court judge ruled that the government has wrongly spent billions of dollars to repay insurers for health insurance provided to certain low-income patients

Congress never appropriated the money for those payments and “no public money can be spent without [an appropriation],” Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia wrote in her May 12 opinion.

If the ruling stands, the reimbursements could end, making health insurance too expensive for the millions of low-income patients who benefit from the ACA’s cost-sharing subsides, according to Jay Mark Waxman, a Boston-based health law attorney.

“If premiums become too expensive, you have people pulling out, then you have the so-called death spiral,” Mr. Waxman said in an interview. “The law could remain intact, but you could end up with not having very many people taking advantage of the marketplace, particularly the Silver Plan.”

The case in question, U.S. House of Representatives v. Burwell, revolves around two sections of the ACA. Section 1401 provides tax credits to certain patients in order to make insurance premiums more affordable, while Section 1402 requires insurers to reduce copayments, deductibles, and other out-of-pocket costs for certain low-income patients. The health law requires the federal government to reimburse insurers for the cost of these two sections.

While the first section received funding through the congressional appropriations process, the second section did not. In January 2014, HHS started repaying repay cost-sharing subsidies to insurers using federal funds. The House sued, claiming that HHS is illegally spending monies that Congress never appropriated. HHS has argued that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements.

Judge Collyer ruled in the House’s favor, writing that paying out reimbursements without an appropriation violates the Constitution.

House members praised the court decision, calling it a victory for “the rule of law and the American taxpayer.”

“We received vindication of what we have known for quite some time – that the administration does not have the authority to spend over $150 billion for payments to insurance companies without an appropriation from Congress,” House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement. “The court’s message was clear: Complying with Article I of the Constitution is not optional for President Obama.”

White House Press Secretary Josh Earnest countered that the administration has seen its share of lawsuits over the ACA and that such legal challenges generally end in a government victory.

“This is not the first time that we’ve seen opponents of the Affordable Care Act go through the motions to try to win this political fight in the court system,” Mr. Earnest said during a press conference. “And it’s unfortunate that Republicans have resorted to a taxpayer-funded lawsuit to refight a political fight that they keep losing. They’ve been losing this fight for 6 years. And they’ll lose it again.”

It’s too early to predict how the legal case might be resolved, said Katherine Hempstead, who directs health insurance coverage for the Robert Wood Johnson Foundation.

“There’s a lot of potential endings that don’t lead to people losing their cost-sharing reductions,” Ms. Hempstead said in an interview. “There are a lot of twists and turns ahead, and the probability of people losing their reductions is remote.”

The House could lose the case on appeal, she said. Such a ruling could be made on the merits of the case or on procedural grounds. Whether the House has standing to sue HHS has been questioned as well, she noted. HHS continues to argue that the House has not established a concrete or imminent injury and therefore, the suit should be thrown out. In addition, some have suggested that the federal ruling could be interpreted as requiring Congress to appropriate money to pay for the cost-sharing reductions, she said.

The ultimate resolution could come from the U.S. Supreme Court, Mr. Waxman added. Another possibility is that the next administration will decline to pursue the case.

“Depending on the timing, it could just stop in the court of appeals,” he said. “The next administration could say, ‘We’re happy with where it is and not take it up. You don’t know what’s going to happen.”

Mr. Earnest said the U.S. Department of Justice is reviewing the ruling and will make an announcement about the next step after the analysis.

[email protected]

On Twitter @legal_med

SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.

For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.

Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.

To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).

The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.

Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.

The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).

Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.

Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.

SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.

For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.

Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.

To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).

The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.

Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.

The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).

Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.

Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.

SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.

For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.

Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.

To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).

The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.

Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.

The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).

Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.

Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.

ORLANDO – Sentinel node biopsies may be a useful staging tool for patients with cutaneous squamous cell carcinomas of the head and neck.

These patients – especially those with compromised immune systems – appear to be at sufficiently high risk of metastasis to justify the procedure, Dr. Jonathan Lopez said at the annual meeting of the American College of Mohs Surgery.

“We found that sentinel lymph node biopsy in our clinic had a 91% negative predictive value for local recurrence, nodal recurrence, and disease-specific death. It provides valuable prognostic information for patients at increased risk of nodal metastasis,” said Dr. Lopez, a dermatology resident at the Mayo Clinic, Rochester, Minn.

He and his associates conducted a chart review of 24 patients treated at the Mayo Clinic from 2000 to 2014 for a cutaneous squamous cell carcinoma (SCC) of the head or neck. Of these, 11 patients were immunosuppressed. Five had undergone a kidney transplant and three a lung transplant. One patient had Hodgkin’s lymphoma, one had cutaneous lymphocytic leukemia, and one, metastatic urothelial carcinoma.

Before sentinel node biopsy, eight patients had a wide local excision; 12 were treated with Mohs micrographic surgery only; and four had a Mohs procedure followed by resection for better margins.

The biopsies identified two patients with nodal disease, but failed to identify a third who had it, Dr. Lopez said.

Patient No. 1 had a primary SCC on the nasal tip that was stage 2, according to the American Joint Committee on Cancer (AJCC) staging system, and 2b according to the Brigham and Women’s Hospital (BWH) system. He had undergone a prior double lung transplant and his lymph node dissection showed no nodal metastasis. He declined radiotherapy and died within 2 months of the biopsy, of unclear causes that were not related to his skin cancer.

Patient No. 2 had a primary lesion on the right cheek, and a history of kidney transplant. His cancer was stage 2 by the AJCC system and 2b by the BWH system. His lymph node dissection of the right parotid and neck was negative. At last follow-up of 3.5 years, he was cancer free. However, Dr. Lopez noted, the patient died at 4 years’ follow-up of unknown causes.

The final patient had a primary lesion on the right conchal bowl. It was a stage 2 cancer by the AJCC system and 2a by the BWH system. His sentinel node biopsy was negative. However, the otolaryngologist who performed the biopsy also took seven superficial parotid nodes and one of those was positive. This patient had no recurrence at the last visit, 1.5 years after the biopsy.

The sentinel node biopsies were negative in the 21 other patients. Of these, 14 had no evidence of recurrence at a mean of 3 years’ follow-up after the sentinel lymph node biopsy. Two developed local recurrence and two others, both of whom had a history of multiple squamous cell carcinomas, developed nodal spread and died of metastatic disease. Three have died of causes unrelated to their cancer.

Dr. Lopez had no financial disclosures.

[email protected]

ORLANDO – Sentinel node biopsies may be a useful staging tool for patients with cutaneous squamous cell carcinomas of the head and neck.

These patients – especially those with compromised immune systems – appear to be at sufficiently high risk of metastasis to justify the procedure, Dr. Jonathan Lopez said at the annual meeting of the American College of Mohs Surgery.

“We found that sentinel lymph node biopsy in our clinic had a 91% negative predictive value for local recurrence, nodal recurrence, and disease-specific death. It provides valuable prognostic information for patients at increased risk of nodal metastasis,” said Dr. Lopez, a dermatology resident at the Mayo Clinic, Rochester, Minn.

He and his associates conducted a chart review of 24 patients treated at the Mayo Clinic from 2000 to 2014 for a cutaneous squamous cell carcinoma (SCC) of the head or neck. Of these, 11 patients were immunosuppressed. Five had undergone a kidney transplant and three a lung transplant. One patient had Hodgkin’s lymphoma, one had cutaneous lymphocytic leukemia, and one, metastatic urothelial carcinoma.

Before sentinel node biopsy, eight patients had a wide local excision; 12 were treated with Mohs micrographic surgery only; and four had a Mohs procedure followed by resection for better margins.

The biopsies identified two patients with nodal disease, but failed to identify a third who had it, Dr. Lopez said.

Patient No. 1 had a primary SCC on the nasal tip that was stage 2, according to the American Joint Committee on Cancer (AJCC) staging system, and 2b according to the Brigham and Women’s Hospital (BWH) system. He had undergone a prior double lung transplant and his lymph node dissection showed no nodal metastasis. He declined radiotherapy and died within 2 months of the biopsy, of unclear causes that were not related to his skin cancer.

Patient No. 2 had a primary lesion on the right cheek, and a history of kidney transplant. His cancer was stage 2 by the AJCC system and 2b by the BWH system. His lymph node dissection of the right parotid and neck was negative. At last follow-up of 3.5 years, he was cancer free. However, Dr. Lopez noted, the patient died at 4 years’ follow-up of unknown causes.

The final patient had a primary lesion on the right conchal bowl. It was a stage 2 cancer by the AJCC system and 2a by the BWH system. His sentinel node biopsy was negative. However, the otolaryngologist who performed the biopsy also took seven superficial parotid nodes and one of those was positive. This patient had no recurrence at the last visit, 1.5 years after the biopsy.

The sentinel node biopsies were negative in the 21 other patients. Of these, 14 had no evidence of recurrence at a mean of 3 years’ follow-up after the sentinel lymph node biopsy. Two developed local recurrence and two others, both of whom had a history of multiple squamous cell carcinomas, developed nodal spread and died of metastatic disease. Three have died of causes unrelated to their cancer.

Dr. Lopez had no financial disclosures.

[email protected]

ORLANDO – Sentinel node biopsies may be a useful staging tool for patients with cutaneous squamous cell carcinomas of the head and neck.

These patients – especially those with compromised immune systems – appear to be at sufficiently high risk of metastasis to justify the procedure, Dr. Jonathan Lopez said at the annual meeting of the American College of Mohs Surgery.

“We found that sentinel lymph node biopsy in our clinic had a 91% negative predictive value for local recurrence, nodal recurrence, and disease-specific death. It provides valuable prognostic information for patients at increased risk of nodal metastasis,” said Dr. Lopez, a dermatology resident at the Mayo Clinic, Rochester, Minn.

He and his associates conducted a chart review of 24 patients treated at the Mayo Clinic from 2000 to 2014 for a cutaneous squamous cell carcinoma (SCC) of the head or neck. Of these, 11 patients were immunosuppressed. Five had undergone a kidney transplant and three a lung transplant. One patient had Hodgkin’s lymphoma, one had cutaneous lymphocytic leukemia, and one, metastatic urothelial carcinoma.

Before sentinel node biopsy, eight patients had a wide local excision; 12 were treated with Mohs micrographic surgery only; and four had a Mohs procedure followed by resection for better margins.

The biopsies identified two patients with nodal disease, but failed to identify a third who had it, Dr. Lopez said.

Patient No. 1 had a primary SCC on the nasal tip that was stage 2, according to the American Joint Committee on Cancer (AJCC) staging system, and 2b according to the Brigham and Women’s Hospital (BWH) system. He had undergone a prior double lung transplant and his lymph node dissection showed no nodal metastasis. He declined radiotherapy and died within 2 months of the biopsy, of unclear causes that were not related to his skin cancer.

Patient No. 2 had a primary lesion on the right cheek, and a history of kidney transplant. His cancer was stage 2 by the AJCC system and 2b by the BWH system. His lymph node dissection of the right parotid and neck was negative. At last follow-up of 3.5 years, he was cancer free. However, Dr. Lopez noted, the patient died at 4 years’ follow-up of unknown causes.

The final patient had a primary lesion on the right conchal bowl. It was a stage 2 cancer by the AJCC system and 2a by the BWH system. His sentinel node biopsy was negative. However, the otolaryngologist who performed the biopsy also took seven superficial parotid nodes and one of those was positive. This patient had no recurrence at the last visit, 1.5 years after the biopsy.

The sentinel node biopsies were negative in the 21 other patients. Of these, 14 had no evidence of recurrence at a mean of 3 years’ follow-up after the sentinel lymph node biopsy. Two developed local recurrence and two others, both of whom had a history of multiple squamous cell carcinomas, developed nodal spread and died of metastatic disease. Three have died of causes unrelated to their cancer.

Dr. Lopez had no financial disclosures.

[email protected]

Fecal microbiota transplantation (FMT) was effective in reducing symptoms of ulcerative colitis (UC) and inducing healing of the digestive tract in patients who were resistant to or intolerant of other treatments. The randomized trial, reported at the 2016 Annual Digestive Disease Week, looked at 8 weeks of treatment aimed at inducing remission. Longer-term data are needed to determine the effect of FMT on maintaining remission.

FMT is currently used to treat Clostridium difficile infection. This study extends the potential use of this approach in UC.

“Multi-donor FMT aims to treat the underlying microbial disturbances associated with UC, instead of just the symptoms. This is unlike the usual treatment with immunotherapies,” explained lead author Dr. Sudarshan Paramsothy in a teleconference in advance of the annual Digestive Disease Week.

“This is the first multicenter clinical trial to use an intense therapy of FMT infusions – 40 over 8 weeks – and it has been able to show definitively that FMT is an effective treatment for ulcerative colitis. This is important, because there are millions of people worldwide seeking alternative treatments for their condition,” said Dr. Paramsothy, a gastroenterologist from the University of New South Wales, Australia.

The study enrolled 81 patients with active disease and treatment-resistant or intolerant UC across three different study sites in Australia. Patients were randomized to intense FMT (n = 41) or placebo (n = 40). The first treatment was given through a colonoscope; subsequently, enemas were self-administered 5 days a week for 8 weeks.

Patients in the study were allowed to be on treatment for UC, with the exception of biologics, which had to be suspended at least 12 weeks prior to enrollment in the trial.

Dr. Paramsothy pointed out that patients with UC are accustomed to using enemas as part of treatment, so FMT would be acceptable to them.

“The enemas in this trial were as well tolerated as other types of enemas,” he noted.

After 8 weeks, more than three times as many patients in the FMT group versus placebo reported steroid-free clinical remission (symptom relief) and had endoscopically determined healing/improvement of the digestive tract lining: 11 of 41 patients (27%) in the FMT group versus 3/40 (8%) in the placebo group, a statistically significant difference (P = .02). When steroid-free clinical remission (symptom-free) status was assessed, 44% of the FMT group versus 20% of controls met this endpoint (P = .02).

At week 8, clinical response was seen in 54% of the FMT-treated group versus 23% of the control group (P less than .01).

No difference between the two study arms was seen in the rate of adverse events.

Thirty-seven patients initially assigned to placebo went on to receive open-label FMT; of these, 10 (27%) were both symptom-free and endoscopically improved, 17 (46%) had clinical remission, and 9 (24%) had endoscopic remission.

This study utilized FMT from at three to seven unrelated donors to minimize the potential for a “donor effect,” in which outcomes may be determined by the microbial characteristics of a single donor.

Future studies will look at potential factors in the microbiota that influence response, optimal dosing, and the impact on response of clinical and microbial factors in patients. An important area of research is how best to match patients and donors.

“We are conducting microbial studies to ascertain why some patients respond and others don’t,” he noted. “We are also studying how to optimize selection of donors based on microbial profile. Depending on the recipient, a different microbial profile might be better.”

Studies of the longer-term effect of FMT in UC are needed. It is not known if FMT improves sensitivity to biologics or other treatments.

Another concern is whether FMT changes the microbiome and makes patients more susceptible to infection or other morbidities. “There is a push for registries to follow patients [treated with FMT] long term,” he said.

Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.

Fecal microbiota transplantation (FMT) was effective in reducing symptoms of ulcerative colitis (UC) and inducing healing of the digestive tract in patients who were resistant to or intolerant of other treatments. The randomized trial, reported at the 2016 Annual Digestive Disease Week, looked at 8 weeks of treatment aimed at inducing remission. Longer-term data are needed to determine the effect of FMT on maintaining remission.

FMT is currently used to treat Clostridium difficile infection. This study extends the potential use of this approach in UC.

“Multi-donor FMT aims to treat the underlying microbial disturbances associated with UC, instead of just the symptoms. This is unlike the usual treatment with immunotherapies,” explained lead author Dr. Sudarshan Paramsothy in a teleconference in advance of the annual Digestive Disease Week.

“This is the first multicenter clinical trial to use an intense therapy of FMT infusions – 40 over 8 weeks – and it has been able to show definitively that FMT is an effective treatment for ulcerative colitis. This is important, because there are millions of people worldwide seeking alternative treatments for their condition,” said Dr. Paramsothy, a gastroenterologist from the University of New South Wales, Australia.

The study enrolled 81 patients with active disease and treatment-resistant or intolerant UC across three different study sites in Australia. Patients were randomized to intense FMT (n = 41) or placebo (n = 40). The first treatment was given through a colonoscope; subsequently, enemas were self-administered 5 days a week for 8 weeks.

Patients in the study were allowed to be on treatment for UC, with the exception of biologics, which had to be suspended at least 12 weeks prior to enrollment in the trial.

Dr. Paramsothy pointed out that patients with UC are accustomed to using enemas as part of treatment, so FMT would be acceptable to them.

“The enemas in this trial were as well tolerated as other types of enemas,” he noted.

After 8 weeks, more than three times as many patients in the FMT group versus placebo reported steroid-free clinical remission (symptom relief) and had endoscopically determined healing/improvement of the digestive tract lining: 11 of 41 patients (27%) in the FMT group versus 3/40 (8%) in the placebo group, a statistically significant difference (P = .02). When steroid-free clinical remission (symptom-free) status was assessed, 44% of the FMT group versus 20% of controls met this endpoint (P = .02).

At week 8, clinical response was seen in 54% of the FMT-treated group versus 23% of the control group (P less than .01).

No difference between the two study arms was seen in the rate of adverse events.

Thirty-seven patients initially assigned to placebo went on to receive open-label FMT; of these, 10 (27%) were both symptom-free and endoscopically improved, 17 (46%) had clinical remission, and 9 (24%) had endoscopic remission.

This study utilized FMT from at three to seven unrelated donors to minimize the potential for a “donor effect,” in which outcomes may be determined by the microbial characteristics of a single donor.

Future studies will look at potential factors in the microbiota that influence response, optimal dosing, and the impact on response of clinical and microbial factors in patients. An important area of research is how best to match patients and donors.

“We are conducting microbial studies to ascertain why some patients respond and others don’t,” he noted. “We are also studying how to optimize selection of donors based on microbial profile. Depending on the recipient, a different microbial profile might be better.”

Studies of the longer-term effect of FMT in UC are needed. It is not known if FMT improves sensitivity to biologics or other treatments.

Another concern is whether FMT changes the microbiome and makes patients more susceptible to infection or other morbidities. “There is a push for registries to follow patients [treated with FMT] long term,” he said.

Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.

Fecal microbiota transplantation (FMT) was effective in reducing symptoms of ulcerative colitis (UC) and inducing healing of the digestive tract in patients who were resistant to or intolerant of other treatments. The randomized trial, reported at the 2016 Annual Digestive Disease Week, looked at 8 weeks of treatment aimed at inducing remission. Longer-term data are needed to determine the effect of FMT on maintaining remission.

FMT is currently used to treat Clostridium difficile infection. This study extends the potential use of this approach in UC.

“Multi-donor FMT aims to treat the underlying microbial disturbances associated with UC, instead of just the symptoms. This is unlike the usual treatment with immunotherapies,” explained lead author Dr. Sudarshan Paramsothy in a teleconference in advance of the annual Digestive Disease Week.

“This is the first multicenter clinical trial to use an intense therapy of FMT infusions – 40 over 8 weeks – and it has been able to show definitively that FMT is an effective treatment for ulcerative colitis. This is important, because there are millions of people worldwide seeking alternative treatments for their condition,” said Dr. Paramsothy, a gastroenterologist from the University of New South Wales, Australia.

The study enrolled 81 patients with active disease and treatment-resistant or intolerant UC across three different study sites in Australia. Patients were randomized to intense FMT (n = 41) or placebo (n = 40). The first treatment was given through a colonoscope; subsequently, enemas were self-administered 5 days a week for 8 weeks.

Patients in the study were allowed to be on treatment for UC, with the exception of biologics, which had to be suspended at least 12 weeks prior to enrollment in the trial.

Dr. Paramsothy pointed out that patients with UC are accustomed to using enemas as part of treatment, so FMT would be acceptable to them.

“The enemas in this trial were as well tolerated as other types of enemas,” he noted.

After 8 weeks, more than three times as many patients in the FMT group versus placebo reported steroid-free clinical remission (symptom relief) and had endoscopically determined healing/improvement of the digestive tract lining: 11 of 41 patients (27%) in the FMT group versus 3/40 (8%) in the placebo group, a statistically significant difference (P = .02). When steroid-free clinical remission (symptom-free) status was assessed, 44% of the FMT group versus 20% of controls met this endpoint (P = .02).

At week 8, clinical response was seen in 54% of the FMT-treated group versus 23% of the control group (P less than .01).

No difference between the two study arms was seen in the rate of adverse events.

Thirty-seven patients initially assigned to placebo went on to receive open-label FMT; of these, 10 (27%) were both symptom-free and endoscopically improved, 17 (46%) had clinical remission, and 9 (24%) had endoscopic remission.

This study utilized FMT from at three to seven unrelated donors to minimize the potential for a “donor effect,” in which outcomes may be determined by the microbial characteristics of a single donor.

Future studies will look at potential factors in the microbiota that influence response, optimal dosing, and the impact on response of clinical and microbial factors in patients. An important area of research is how best to match patients and donors.

“We are conducting microbial studies to ascertain why some patients respond and others don’t,” he noted. “We are also studying how to optimize selection of donors based on microbial profile. Depending on the recipient, a different microbial profile might be better.”

Studies of the longer-term effect of FMT in UC are needed. It is not known if FMT improves sensitivity to biologics or other treatments.

Another concern is whether FMT changes the microbiome and makes patients more susceptible to infection or other morbidities. “There is a push for registries to follow patients [treated with FMT] long term,” he said.

Dr. Paramsothy received funding from the Broad Medical Research Program at the Crohn’s & Colitis Foundation of America, the Gastroenterological Society of Australia, and the Mt. Sinai Hospital New York (SUCCESS fund) for this research. Study infusions were supplied by the Centre for Digestive Diseases, Sydney.

SAN DIEGO – Diabetes (not recent onset), obesity, and gallstone disease were associated with the occurrence of sporadic pancreatic neuroendocrine tumors (PNET) in the prospective, case-control European EpiNet study.

Cigarette smoking, first-degree family history of cancer, and alcohol consumption were not significantly associated with PNET in this study, which was reported at the annual Digestive Disease Week.

“This is the first prospective multicenter study investigating risk factors for the occurrence of PNET. We confirmed that diabetes, obesity and gallstone disease are significantly associated with PNET. The role of obesity is confirmed for the first time. However, the study failed to confirm an association with family history of cancer, smoking cigarettes, alcohol consumption, hormonal reproductive factors, or allergies. This is different from pancreatic cancer,” said lead author Dr. Roberto Valente, Sapienza University of Rome, Italy.

Alice Goodman/Frontline Medical News

PNET is a rare tumor, comprising 1% of all pancreatic tumors and 10% of all pancreatic neoplasms.

“The incidence of PNET is rising over time and we don’t know why. Thus far, risk factors for PNET have been poorly investigated. Many factors associated with pancreatic cancer have not been previously studied in PNET, including allergies, use of aspirin, and reproductive/gynecologic factors in women,” he said.

Previous case-control studies in small samples identified diabetes, smoking, alcohol consumption, and a family history of cancer as potential risk factors. Dr. Valente and coinvestigators sought to evaluate risk and protective factors for PNET in a more rigorous study.

Participants were drawn from five European countries. The study included 201 cases of sporadic, histologically proven PNET diagnosed within 24 months of the initiation of the study, and 603 controls matched for age and sex. For both cases and controls, about 50% were male, mean age was 59 years, and 97% were Caucasian. Among cases, 76.6% had nonfunctioning PNET that were equally distributed anatomically.

Participants responded to standardized questionnaires about demographics, and environmental, and familial risk factors using a predefined standard questionnaire.

Obesity (defined as body mass index [BMI] greater than 30) was significantly more prevalent in cases than controls (26.5% versus 19.26%, respectively, P = .03). Diabetes was also significantly more prevalent in cases than controls (18.5% versus 12.5%, respectively P = .003).

No differences were found between cases and controls in family history of any cancer, alcohol consumption, coffee drinking, or cigarette smoking.

Looking at previous medical history, only gallstone disease was strongly associated with PNET, but this was of borderline statistical significance (19.2% versus 13.2%, respectively, P = .06).

The investigators looked at previously uninvestigated potentially protective factors such as allergies (asthma, eczema, hay fever), and use of aspirin. None of these was significantly more prevalent in cases compared with controls.

Reproductive/hormonal factors were analyzed in 98 cases and 294 controls. None of these factors was significantly different in cases or controls.

Univariate regression analysis adjusted for age found that diabetes (P = .02), diabetes for more than 1 year (P = .002), obesity (P = .02), and previous gallstone disease (P = .04) were significant risk factors for PNET.

Multivariate logistic regression analysis confirmed diabetes as a significant risk factor (P = .009), and obesity and gallstone disease were of borderline significance (P = .09 and P = .07, respectively).

“The reported risk factors partially overlap with those reported for pancreatic adenocarcinoma, thus suggesting a possible organ-specific carcinogenic effect,” Dr Valente noted.

SAN DIEGO – Diabetes (not recent onset), obesity, and gallstone disease were associated with the occurrence of sporadic pancreatic neuroendocrine tumors (PNET) in the prospective, case-control European EpiNet study.

Cigarette smoking, first-degree family history of cancer, and alcohol consumption were not significantly associated with PNET in this study, which was reported at the annual Digestive Disease Week.

“This is the first prospective multicenter study investigating risk factors for the occurrence of PNET. We confirmed that diabetes, obesity and gallstone disease are significantly associated with PNET. The role of obesity is confirmed for the first time. However, the study failed to confirm an association with family history of cancer, smoking cigarettes, alcohol consumption, hormonal reproductive factors, or allergies. This is different from pancreatic cancer,” said lead author Dr. Roberto Valente, Sapienza University of Rome, Italy.

Alice Goodman/Frontline Medical News

PNET is a rare tumor, comprising 1% of all pancreatic tumors and 10% of all pancreatic neoplasms.

“The incidence of PNET is rising over time and we don’t know why. Thus far, risk factors for PNET have been poorly investigated. Many factors associated with pancreatic cancer have not been previously studied in PNET, including allergies, use of aspirin, and reproductive/gynecologic factors in women,” he said.

Previous case-control studies in small samples identified diabetes, smoking, alcohol consumption, and a family history of cancer as potential risk factors. Dr. Valente and coinvestigators sought to evaluate risk and protective factors for PNET in a more rigorous study.

Participants were drawn from five European countries. The study included 201 cases of sporadic, histologically proven PNET diagnosed within 24 months of the initiation of the study, and 603 controls matched for age and sex. For both cases and controls, about 50% were male, mean age was 59 years, and 97% were Caucasian. Among cases, 76.6% had nonfunctioning PNET that were equally distributed anatomically.

Participants responded to standardized questionnaires about demographics, and environmental, and familial risk factors using a predefined standard questionnaire.

Obesity (defined as body mass index [BMI] greater than 30) was significantly more prevalent in cases than controls (26.5% versus 19.26%, respectively, P = .03). Diabetes was also significantly more prevalent in cases than controls (18.5% versus 12.5%, respectively P = .003).

No differences were found between cases and controls in family history of any cancer, alcohol consumption, coffee drinking, or cigarette smoking.

Looking at previous medical history, only gallstone disease was strongly associated with PNET, but this was of borderline statistical significance (19.2% versus 13.2%, respectively, P = .06).

The investigators looked at previously uninvestigated potentially protective factors such as allergies (asthma, eczema, hay fever), and use of aspirin. None of these was significantly more prevalent in cases compared with controls.

Reproductive/hormonal factors were analyzed in 98 cases and 294 controls. None of these factors was significantly different in cases or controls.

Univariate regression analysis adjusted for age found that diabetes (P = .02), diabetes for more than 1 year (P = .002), obesity (P = .02), and previous gallstone disease (P = .04) were significant risk factors for PNET.

Multivariate logistic regression analysis confirmed diabetes as a significant risk factor (P = .009), and obesity and gallstone disease were of borderline significance (P = .09 and P = .07, respectively).

“The reported risk factors partially overlap with those reported for pancreatic adenocarcinoma, thus suggesting a possible organ-specific carcinogenic effect,” Dr Valente noted.

SAN DIEGO – Diabetes (not recent onset), obesity, and gallstone disease were associated with the occurrence of sporadic pancreatic neuroendocrine tumors (PNET) in the prospective, case-control European EpiNet study.

Cigarette smoking, first-degree family history of cancer, and alcohol consumption were not significantly associated with PNET in this study, which was reported at the annual Digestive Disease Week.

“This is the first prospective multicenter study investigating risk factors for the occurrence of PNET. We confirmed that diabetes, obesity and gallstone disease are significantly associated with PNET. The role of obesity is confirmed for the first time. However, the study failed to confirm an association with family history of cancer, smoking cigarettes, alcohol consumption, hormonal reproductive factors, or allergies. This is different from pancreatic cancer,” said lead author Dr. Roberto Valente, Sapienza University of Rome, Italy.

Alice Goodman/Frontline Medical News

PNET is a rare tumor, comprising 1% of all pancreatic tumors and 10% of all pancreatic neoplasms.

“The incidence of PNET is rising over time and we don’t know why. Thus far, risk factors for PNET have been poorly investigated. Many factors associated with pancreatic cancer have not been previously studied in PNET, including allergies, use of aspirin, and reproductive/gynecologic factors in women,” he said.

Previous case-control studies in small samples identified diabetes, smoking, alcohol consumption, and a family history of cancer as potential risk factors. Dr. Valente and coinvestigators sought to evaluate risk and protective factors for PNET in a more rigorous study.

Participants were drawn from five European countries. The study included 201 cases of sporadic, histologically proven PNET diagnosed within 24 months of the initiation of the study, and 603 controls matched for age and sex. For both cases and controls, about 50% were male, mean age was 59 years, and 97% were Caucasian. Among cases, 76.6% had nonfunctioning PNET that were equally distributed anatomically.

Participants responded to standardized questionnaires about demographics, and environmental, and familial risk factors using a predefined standard questionnaire.

Obesity (defined as body mass index [BMI] greater than 30) was significantly more prevalent in cases than controls (26.5% versus 19.26%, respectively, P = .03). Diabetes was also significantly more prevalent in cases than controls (18.5% versus 12.5%, respectively P = .003).

No differences were found between cases and controls in family history of any cancer, alcohol consumption, coffee drinking, or cigarette smoking.

Looking at previous medical history, only gallstone disease was strongly associated with PNET, but this was of borderline statistical significance (19.2% versus 13.2%, respectively, P = .06).

The investigators looked at previously uninvestigated potentially protective factors such as allergies (asthma, eczema, hay fever), and use of aspirin. None of these was significantly more prevalent in cases compared with controls.

Reproductive/hormonal factors were analyzed in 98 cases and 294 controls. None of these factors was significantly different in cases or controls.

Univariate regression analysis adjusted for age found that diabetes (P = .02), diabetes for more than 1 year (P = .002), obesity (P = .02), and previous gallstone disease (P = .04) were significant risk factors for PNET.

Multivariate logistic regression analysis confirmed diabetes as a significant risk factor (P = .009), and obesity and gallstone disease were of borderline significance (P = .09 and P = .07, respectively).

“The reported risk factors partially overlap with those reported for pancreatic adenocarcinoma, thus suggesting a possible organ-specific carcinogenic effect,” Dr Valente noted.

ORLANDO – Matrilin-2 – a matrix protein found in peritumoral stroma – reliably distinguished invasive basal cell carcinoma from the often difficult-to-distinguish basaloid follicular hamartoma (BFH), in a study that evaluated the protein as a marker in this setting.

The protein marked 41 of 42 cancers and none of the hamartomas, Dr. Renato Goreshi reported at the annual meeting of the American College of Mohs Surgery. The one cancer it failed to identify was a superficial basal cell tumor – a finding that makes sense, since dermal fibroblasts appear to secrete matrilin-2 as a response to invasive skin tumors, said Dr. Goreshi of the Roger Williams Cancer Center, Providence, R.I.

Mohs surgery typically employs hematoxylin and eosin staining to delineate tumor boundary. But, Dr. Goreshi said, that stain doesn’t always reliably differentiate adnexal tumors from basal cell carcinomas. “Basaloid follicular hamartoma can be particularly difficult to distinguish from basal cell carcinoma,” he said.

BFH typically presents as individual or linearly arranged, small skin-colored to brown papules or plaques, or as multiple lesions in a generalized distribution on the face, scalp, and occasionally, the trunk (Arch Pathol Lab Med. 2010 Aug;134[8]:1215-9). These are often stable for many years. The differential diagnosis includes basal cell carcinoma and trichoepithelioma.

BFH sometimes occurs near a BCC, although there are no data on how often this happens.

Dr. Goreshi cited a 2007 case report of a young woman that illustrates this problem. The patient presented with a basal cell carcinoma on the side of her nose. The adjacent BFH was unrecognized, however. She underwent a multiple-stage Mohs that was unnecessarily extended because tumor margins included sections of the BFH.

“The lesion was interpreted as malignancy by both the Mohs surgeon and the dermatopathologist, but was later determined to have been a hamartoma. This highlights the importance of finding an effective marker,” Dr. Goreshi said.

He and his fellowship director, Dr. Satori Iwamoto, chief of Mohs micrographic surgery at Roger Williams, looked for a reliable way to differentiate these tumors, capitalizing on the invasive nature of BCC. The peritumoral stroma plays a role in tumor growth and invasion. It involves fibroblasts, inflammatory and endothelial cells, and extracellular matrix proteins. Matrilin-2, which is involved in the formation of filamentous networks, was a promising candidate and the initial investigations looked good, said Dr. Goreshi said.

Their confirmatory study comprised 42 BCC and seven BFH sections that were obtained during Mohs surgery. All were stained for matrilin-2 and scored for location and intensity of staining by two reviewers. The investigators also conducted flow cytometry to determine the source of the protein.

The BCC set consisted of 11 morpheaform/infiltrative BCCs, 25 nodular BCCs, and 6 superficial BCCs. With the exception of one superficial lesion, all of these stained positive for matrilin-2 in the peritumoral stroma. None of the BFH sections stained positive for the protein, however. Flow cytometry determined that the protein was coming from dermal fibroblasts in the stroma.

This is actually a key point, Dr. Goreshi noted. “Matrilin-2 is not acting as a conventional tumor marker would, but as a marker of invasion.”

This was again played out in the variation of staining intensity in the tumor subtypes. It was most intense around the infiltrative subtypes. There was also adnexal staining, but it was significantly less than what was seen in the peritumoral stroma. There was virtually no staining in or around the hamartoma.

Staining was not as intense around the superficial BCC subtypes. In fact, it was not significantly different from what was seen in the adnexal structures. Again, however, there was no staining in or around the hamartoma.

“Now we are looking at the staining patterns of other lesions, including melanoma and squamous cell carcinoma, and trying to figure out why the dermal fibroblasts are secreting matrilin-2,” Dr. Goreshi said.

The study was the winner of the 2016 Theodore Tromovitch Award, presented for original research conducted by a fellow-in-training during his or her year of training.

Neither Dr. Goreshi nor Dr. Iwamoto had any relevant financial disclosures.

[email protected]

ORLANDO – Matrilin-2 – a matrix protein found in peritumoral stroma – reliably distinguished invasive basal cell carcinoma from the often difficult-to-distinguish basaloid follicular hamartoma (BFH), in a study that evaluated the protein as a marker in this setting.

The protein marked 41 of 42 cancers and none of the hamartomas, Dr. Renato Goreshi reported at the annual meeting of the American College of Mohs Surgery. The one cancer it failed to identify was a superficial basal cell tumor – a finding that makes sense, since dermal fibroblasts appear to secrete matrilin-2 as a response to invasive skin tumors, said Dr. Goreshi of the Roger Williams Cancer Center, Providence, R.I.

Mohs surgery typically employs hematoxylin and eosin staining to delineate tumor boundary. But, Dr. Goreshi said, that stain doesn’t always reliably differentiate adnexal tumors from basal cell carcinomas. “Basaloid follicular hamartoma can be particularly difficult to distinguish from basal cell carcinoma,” he said.

BFH typically presents as individual or linearly arranged, small skin-colored to brown papules or plaques, or as multiple lesions in a generalized distribution on the face, scalp, and occasionally, the trunk (Arch Pathol Lab Med. 2010 Aug;134[8]:1215-9). These are often stable for many years. The differential diagnosis includes basal cell carcinoma and trichoepithelioma.

BFH sometimes occurs near a BCC, although there are no data on how often this happens.

Dr. Goreshi cited a 2007 case report of a young woman that illustrates this problem. The patient presented with a basal cell carcinoma on the side of her nose. The adjacent BFH was unrecognized, however. She underwent a multiple-stage Mohs that was unnecessarily extended because tumor margins included sections of the BFH.

“The lesion was interpreted as malignancy by both the Mohs surgeon and the dermatopathologist, but was later determined to have been a hamartoma. This highlights the importance of finding an effective marker,” Dr. Goreshi said.

He and his fellowship director, Dr. Satori Iwamoto, chief of Mohs micrographic surgery at Roger Williams, looked for a reliable way to differentiate these tumors, capitalizing on the invasive nature of BCC. The peritumoral stroma plays a role in tumor growth and invasion. It involves fibroblasts, inflammatory and endothelial cells, and extracellular matrix proteins. Matrilin-2, which is involved in the formation of filamentous networks, was a promising candidate and the initial investigations looked good, said Dr. Goreshi said.

Their confirmatory study comprised 42 BCC and seven BFH sections that were obtained during Mohs surgery. All were stained for matrilin-2 and scored for location and intensity of staining by two reviewers. The investigators also conducted flow cytometry to determine the source of the protein.

The BCC set consisted of 11 morpheaform/infiltrative BCCs, 25 nodular BCCs, and 6 superficial BCCs. With the exception of one superficial lesion, all of these stained positive for matrilin-2 in the peritumoral stroma. None of the BFH sections stained positive for the protein, however. Flow cytometry determined that the protein was coming from dermal fibroblasts in the stroma.

This is actually a key point, Dr. Goreshi noted. “Matrilin-2 is not acting as a conventional tumor marker would, but as a marker of invasion.”

This was again played out in the variation of staining intensity in the tumor subtypes. It was most intense around the infiltrative subtypes. There was also adnexal staining, but it was significantly less than what was seen in the peritumoral stroma. There was virtually no staining in or around the hamartoma.

Staining was not as intense around the superficial BCC subtypes. In fact, it was not significantly different from what was seen in the adnexal structures. Again, however, there was no staining in or around the hamartoma.

“Now we are looking at the staining patterns of other lesions, including melanoma and squamous cell carcinoma, and trying to figure out why the dermal fibroblasts are secreting matrilin-2,” Dr. Goreshi said.

The study was the winner of the 2016 Theodore Tromovitch Award, presented for original research conducted by a fellow-in-training during his or her year of training.

Neither Dr. Goreshi nor Dr. Iwamoto had any relevant financial disclosures.

[email protected]

ORLANDO – Matrilin-2 – a matrix protein found in peritumoral stroma – reliably distinguished invasive basal cell carcinoma from the often difficult-to-distinguish basaloid follicular hamartoma (BFH), in a study that evaluated the protein as a marker in this setting.

The protein marked 41 of 42 cancers and none of the hamartomas, Dr. Renato Goreshi reported at the annual meeting of the American College of Mohs Surgery. The one cancer it failed to identify was a superficial basal cell tumor – a finding that makes sense, since dermal fibroblasts appear to secrete matrilin-2 as a response to invasive skin tumors, said Dr. Goreshi of the Roger Williams Cancer Center, Providence, R.I.

Mohs surgery typically employs hematoxylin and eosin staining to delineate tumor boundary. But, Dr. Goreshi said, that stain doesn’t always reliably differentiate adnexal tumors from basal cell carcinomas. “Basaloid follicular hamartoma can be particularly difficult to distinguish from basal cell carcinoma,” he said.

BFH typically presents as individual or linearly arranged, small skin-colored to brown papules or plaques, or as multiple lesions in a generalized distribution on the face, scalp, and occasionally, the trunk (Arch Pathol Lab Med. 2010 Aug;134[8]:1215-9). These are often stable for many years. The differential diagnosis includes basal cell carcinoma and trichoepithelioma.

BFH sometimes occurs near a BCC, although there are no data on how often this happens.

Dr. Goreshi cited a 2007 case report of a young woman that illustrates this problem. The patient presented with a basal cell carcinoma on the side of her nose. The adjacent BFH was unrecognized, however. She underwent a multiple-stage Mohs that was unnecessarily extended because tumor margins included sections of the BFH.

“The lesion was interpreted as malignancy by both the Mohs surgeon and the dermatopathologist, but was later determined to have been a hamartoma. This highlights the importance of finding an effective marker,” Dr. Goreshi said.

He and his fellowship director, Dr. Satori Iwamoto, chief of Mohs micrographic surgery at Roger Williams, looked for a reliable way to differentiate these tumors, capitalizing on the invasive nature of BCC. The peritumoral stroma plays a role in tumor growth and invasion. It involves fibroblasts, inflammatory and endothelial cells, and extracellular matrix proteins. Matrilin-2, which is involved in the formation of filamentous networks, was a promising candidate and the initial investigations looked good, said Dr. Goreshi said.

Their confirmatory study comprised 42 BCC and seven BFH sections that were obtained during Mohs surgery. All were stained for matrilin-2 and scored for location and intensity of staining by two reviewers. The investigators also conducted flow cytometry to determine the source of the protein.

The BCC set consisted of 11 morpheaform/infiltrative BCCs, 25 nodular BCCs, and 6 superficial BCCs. With the exception of one superficial lesion, all of these stained positive for matrilin-2 in the peritumoral stroma. None of the BFH sections stained positive for the protein, however. Flow cytometry determined that the protein was coming from dermal fibroblasts in the stroma.

This is actually a key point, Dr. Goreshi noted. “Matrilin-2 is not acting as a conventional tumor marker would, but as a marker of invasion.”

This was again played out in the variation of staining intensity in the tumor subtypes. It was most intense around the infiltrative subtypes. There was also adnexal staining, but it was significantly less than what was seen in the peritumoral stroma. There was virtually no staining in or around the hamartoma.

Staining was not as intense around the superficial BCC subtypes. In fact, it was not significantly different from what was seen in the adnexal structures. Again, however, there was no staining in or around the hamartoma.

“Now we are looking at the staining patterns of other lesions, including melanoma and squamous cell carcinoma, and trying to figure out why the dermal fibroblasts are secreting matrilin-2,” Dr. Goreshi said.

The study was the winner of the 2016 Theodore Tromovitch Award, presented for original research conducted by a fellow-in-training during his or her year of training.

Neither Dr. Goreshi nor Dr. Iwamoto had any relevant financial disclosures.

[email protected]

Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.

Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.

“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.

“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.

The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.

Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.

An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”

After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.

“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.

Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.

Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.

One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.

“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”

Dr. Jones had no relevant financial disclosures.

Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.

Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.

“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.

“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.

The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.

Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.

An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”

After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.

“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.

Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.

Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.

One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.

“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”

Dr. Jones had no relevant financial disclosures.

Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.

Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.

“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.

“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.

The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.

Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.

An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”

After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.

“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.

Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.

Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.

One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.

“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”

Dr. Jones had no relevant financial disclosures.