Review the PDF of the fact sheet on drug reactions with board-relevant, easy-to-review material. This month's fact sheet will review common drug reactions including their clinical presentation, associated signs, symptoms and laboratory abnormalities, time of onset, implicated drugs, pathology, and treatment and mortality.

Practice Questions

1. RegiSCAR is a scoring method used for what drug reaction?

a. RegiSCAR is a diagnostic scoring method for DRESS/DIHS
b. RegiSCAR is a diagnostic scoring method for FDE
c. RegiSCAR is a diagnostic scoring method for SJS
d. RegiSCAR predicts mortality rate for AGEP
e. RegiSCAR predicts mortality rate for SJS

2. DRESS/DIHS is associated with what mortality rate?

a. 0%
b. 1%–5%
c. 5%–10%
d. 5%–30%
e. 10%–40%

3. Unlike other drug eruptions that typically develop 1 to 2 weeks after drug initiation, which drug eruption has a relatively late onset, often 3 weeks after drug initiation?

a. AGEP
b. DRESS/DIHS
c. exanthematous/morbilliform drug eruption
d. FDE
e. SJS

4. A patient develops a morbilliform eruption 14 days after starting an anticonvulsant. What additional finding(s) make DRESS/DIHS more likely than a common morbilliform drug rash?

a. hypocalcemia
b. lymphadenopathy
c. prominent facial edema
d. A and C
e. B and C

5. Which drug is commonly implicated in the nonpigmenting variant of FDE?

a. barbiturates
b. carbamazepine
c. NSAIDs
d. pseudoephedrine
e. sulfonamides

Answers to practice questions provided on next page

Practice Question Answers

1. RegiSCAR is a scoring method used for what drug reaction?

a. RegiSCAR is a diagnostic scoring method for DRESS/DIHS
b. RegiSCAR is a diagnostic scoring method for FDE
c. RegiSCAR is a diagnostic scoring method for SJS
d. RegiSCAR predicts mortality rate for AGEP
e. RegiSCAR predicts mortality rate for SJS
 

2. DRESS/DIHS is associated with what mortality rate?

a. 0%
b. 1%–5%
c. 5%–10%
d. 5%–30%
e. 10%–40%
 

3. Unlike other drug eruptions that typically develop 1 to 2 weeks after drug initiation, which drug eruption has a relatively late onset, often 3 weeks after drug initiation?

a. AGEP
b. DRESS/DIHS
c. exanthematous/morbilliform drug eruption
d. FDE
e. SJS
 

4. A patient develops a morbilliform eruption 14 days after starting an anticonvulsant. What additional finding(s) make DRESS/DIHS more likely than a common morbilliform drug rash?

a. hypocalcemia
b. lymphadenopath
c. prominent facial edema
d. A and C
e. B and C
 

5. Which drug is commonly implicated in the nonpigmenting variant of FDE?

a. barbiturates
b. carbamazepine
c. NSAIDs
d. pseudoephedrine
e. sulfonamides

Review the PDF of the fact sheet on drug reactions with board-relevant, easy-to-review material. This month's fact sheet will review common drug reactions including their clinical presentation, associated signs, symptoms and laboratory abnormalities, time of onset, implicated drugs, pathology, and treatment and mortality.

Practice Questions

1. RegiSCAR is a scoring method used for what drug reaction?

a. RegiSCAR is a diagnostic scoring method for DRESS/DIHS
b. RegiSCAR is a diagnostic scoring method for FDE
c. RegiSCAR is a diagnostic scoring method for SJS
d. RegiSCAR predicts mortality rate for AGEP
e. RegiSCAR predicts mortality rate for SJS

2. DRESS/DIHS is associated with what mortality rate?

a. 0%
b. 1%–5%
c. 5%–10%
d. 5%–30%
e. 10%–40%

3. Unlike other drug eruptions that typically develop 1 to 2 weeks after drug initiation, which drug eruption has a relatively late onset, often 3 weeks after drug initiation?

a. AGEP
b. DRESS/DIHS
c. exanthematous/morbilliform drug eruption
d. FDE
e. SJS

4. A patient develops a morbilliform eruption 14 days after starting an anticonvulsant. What additional finding(s) make DRESS/DIHS more likely than a common morbilliform drug rash?

a. hypocalcemia
b. lymphadenopathy
c. prominent facial edema
d. A and C
e. B and C

5. Which drug is commonly implicated in the nonpigmenting variant of FDE?

a. barbiturates
b. carbamazepine
c. NSAIDs
d. pseudoephedrine
e. sulfonamides

Answers to practice questions provided on next page

Practice Question Answers

1. RegiSCAR is a scoring method used for what drug reaction?

a. RegiSCAR is a diagnostic scoring method for DRESS/DIHS
b. RegiSCAR is a diagnostic scoring method for FDE
c. RegiSCAR is a diagnostic scoring method for SJS
d. RegiSCAR predicts mortality rate for AGEP
e. RegiSCAR predicts mortality rate for SJS
 

2. DRESS/DIHS is associated with what mortality rate?

a. 0%
b. 1%–5%
c. 5%–10%
d. 5%–30%
e. 10%–40%
 

3. Unlike other drug eruptions that typically develop 1 to 2 weeks after drug initiation, which drug eruption has a relatively late onset, often 3 weeks after drug initiation?

a. AGEP
b. DRESS/DIHS
c. exanthematous/morbilliform drug eruption
d. FDE
e. SJS
 

4. A patient develops a morbilliform eruption 14 days after starting an anticonvulsant. What additional finding(s) make DRESS/DIHS more likely than a common morbilliform drug rash?

a. hypocalcemia
b. lymphadenopath
c. prominent facial edema
d. A and C
e. B and C
 

5. Which drug is commonly implicated in the nonpigmenting variant of FDE?

a. barbiturates
b. carbamazepine
c. NSAIDs
d. pseudoephedrine
e. sulfonamides

Review the PDF of the fact sheet on drug reactions with board-relevant, easy-to-review material. This month's fact sheet will review common drug reactions including their clinical presentation, associated signs, symptoms and laboratory abnormalities, time of onset, implicated drugs, pathology, and treatment and mortality.

Practice Questions

1. RegiSCAR is a scoring method used for what drug reaction?

a. RegiSCAR is a diagnostic scoring method for DRESS/DIHS
b. RegiSCAR is a diagnostic scoring method for FDE
c. RegiSCAR is a diagnostic scoring method for SJS
d. RegiSCAR predicts mortality rate for AGEP
e. RegiSCAR predicts mortality rate for SJS

2. DRESS/DIHS is associated with what mortality rate?

a. 0%
b. 1%–5%
c. 5%–10%
d. 5%–30%
e. 10%–40%

3. Unlike other drug eruptions that typically develop 1 to 2 weeks after drug initiation, which drug eruption has a relatively late onset, often 3 weeks after drug initiation?

a. AGEP
b. DRESS/DIHS
c. exanthematous/morbilliform drug eruption
d. FDE
e. SJS

4. A patient develops a morbilliform eruption 14 days after starting an anticonvulsant. What additional finding(s) make DRESS/DIHS more likely than a common morbilliform drug rash?

a. hypocalcemia
b. lymphadenopathy
c. prominent facial edema
d. A and C
e. B and C

5. Which drug is commonly implicated in the nonpigmenting variant of FDE?

a. barbiturates
b. carbamazepine
c. NSAIDs
d. pseudoephedrine
e. sulfonamides

Answers to practice questions provided on next page

Practice Question Answers

1. RegiSCAR is a scoring method used for what drug reaction?

a. RegiSCAR is a diagnostic scoring method for DRESS/DIHS
b. RegiSCAR is a diagnostic scoring method for FDE
c. RegiSCAR is a diagnostic scoring method for SJS
d. RegiSCAR predicts mortality rate for AGEP
e. RegiSCAR predicts mortality rate for SJS
 

2. DRESS/DIHS is associated with what mortality rate?

a. 0%
b. 1%–5%
c. 5%–10%
d. 5%–30%
e. 10%–40%
 

3. Unlike other drug eruptions that typically develop 1 to 2 weeks after drug initiation, which drug eruption has a relatively late onset, often 3 weeks after drug initiation?

a. AGEP
b. DRESS/DIHS
c. exanthematous/morbilliform drug eruption
d. FDE
e. SJS
 

4. A patient develops a morbilliform eruption 14 days after starting an anticonvulsant. What additional finding(s) make DRESS/DIHS more likely than a common morbilliform drug rash?

a. hypocalcemia
b. lymphadenopath
c. prominent facial edema
d. A and C
e. B and C
 

5. Which drug is commonly implicated in the nonpigmenting variant of FDE?

a. barbiturates
b. carbamazepine
c. NSAIDs
d. pseudoephedrine
e. sulfonamides

Overall survival and progression-free survival were similar at 5 years in chronic myeloid leukemia patients receiving dasatinib or imatinib, but those given dasatinib had higher major molecular response rates and complete cytogenic response rates without a higher rate of adverse events, based on an extension study of previously published data from the DASISION trial.

The DASISION phase III clinical trial included 519 patients with newly diagnosed and treatment-naive chronic myeloid leukemia. Participants were randomly assigned to receive either 100 mg of dasatinib daily (259 patients) or 400 mg of imatinib daily (260 patients). Dosage was altered on a per-patient basis if adverse events or suboptimal responses were observed. The median average daily dose was 99 mg for dasatinib and 400 mg for imatinib after 5 years.

Courtesy Wikimedia Commons/Difu Wu/Creative Commons License

“Initial results showed that dasatinib had met its primary end point of superior efficacy compared with imatinib and had an acceptable safety profile, leading to its approval for first-line use,” reported Dr. Jorge Cortes of the University of Texas MD Anderson Cancer Center, Houston, and his associates (J Clin Oncol. 2016 May 23. doi: 10.1200/JCO.2015.64.8899). Given the faster and deeper molecular responses seen in patients taking dasatinib, “dasatinib should continue to be considered a standard first-line therapy for patients with newly diagnosed” chronic myeloid leukemia, they wrote.

In DASISION (Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients), complete cytogenic response, major molecular response, overall survival, and progression-free survival were measured.

The major molecular response rate was significantly higher for patients receiving dasatinib, compared with patients receiving imatinib (76% vs. 64%, P = .0022).

The rate of complete cytogenic response was 28% for dasatinib and 26% for imatinib.

The 5-year overall survival for patients receiving dasatinib was 91% and was not significantly different than the overall survival rate for patients receiving imatinib (90%, P = .1192). Five-year progression-free survival was 85% for patients receiving dasatinib and 86% for patients receiving imatinib.

Grade 3 or 4 adverse events were seen in 15% of patients receiving dasatinib and 11% of patients receiving imatinib. After 5 years, 26 patients had died in each experimental group.

This study was supported by Bristol-Myers Squibb. Eleven investigators reported serving in advisory roles or receiving financial compensation from multiple companies. One investigator had no disclosures to report.

[email protected]

On Twitter @JessCraig_OP

Overall survival and progression-free survival were similar at 5 years in chronic myeloid leukemia patients receiving dasatinib or imatinib, but those given dasatinib had higher major molecular response rates and complete cytogenic response rates without a higher rate of adverse events, based on an extension study of previously published data from the DASISION trial.

The DASISION phase III clinical trial included 519 patients with newly diagnosed and treatment-naive chronic myeloid leukemia. Participants were randomly assigned to receive either 100 mg of dasatinib daily (259 patients) or 400 mg of imatinib daily (260 patients). Dosage was altered on a per-patient basis if adverse events or suboptimal responses were observed. The median average daily dose was 99 mg for dasatinib and 400 mg for imatinib after 5 years.

Courtesy Wikimedia Commons/Difu Wu/Creative Commons License

“Initial results showed that dasatinib had met its primary end point of superior efficacy compared with imatinib and had an acceptable safety profile, leading to its approval for first-line use,” reported Dr. Jorge Cortes of the University of Texas MD Anderson Cancer Center, Houston, and his associates (J Clin Oncol. 2016 May 23. doi: 10.1200/JCO.2015.64.8899). Given the faster and deeper molecular responses seen in patients taking dasatinib, “dasatinib should continue to be considered a standard first-line therapy for patients with newly diagnosed” chronic myeloid leukemia, they wrote.

In DASISION (Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients), complete cytogenic response, major molecular response, overall survival, and progression-free survival were measured.

The major molecular response rate was significantly higher for patients receiving dasatinib, compared with patients receiving imatinib (76% vs. 64%, P = .0022).

The rate of complete cytogenic response was 28% for dasatinib and 26% for imatinib.

The 5-year overall survival for patients receiving dasatinib was 91% and was not significantly different than the overall survival rate for patients receiving imatinib (90%, P = .1192). Five-year progression-free survival was 85% for patients receiving dasatinib and 86% for patients receiving imatinib.

Grade 3 or 4 adverse events were seen in 15% of patients receiving dasatinib and 11% of patients receiving imatinib. After 5 years, 26 patients had died in each experimental group.

This study was supported by Bristol-Myers Squibb. Eleven investigators reported serving in advisory roles or receiving financial compensation from multiple companies. One investigator had no disclosures to report.

[email protected]

On Twitter @JessCraig_OP

Overall survival and progression-free survival were similar at 5 years in chronic myeloid leukemia patients receiving dasatinib or imatinib, but those given dasatinib had higher major molecular response rates and complete cytogenic response rates without a higher rate of adverse events, based on an extension study of previously published data from the DASISION trial.

The DASISION phase III clinical trial included 519 patients with newly diagnosed and treatment-naive chronic myeloid leukemia. Participants were randomly assigned to receive either 100 mg of dasatinib daily (259 patients) or 400 mg of imatinib daily (260 patients). Dosage was altered on a per-patient basis if adverse events or suboptimal responses were observed. The median average daily dose was 99 mg for dasatinib and 400 mg for imatinib after 5 years.

Courtesy Wikimedia Commons/Difu Wu/Creative Commons License

“Initial results showed that dasatinib had met its primary end point of superior efficacy compared with imatinib and had an acceptable safety profile, leading to its approval for first-line use,” reported Dr. Jorge Cortes of the University of Texas MD Anderson Cancer Center, Houston, and his associates (J Clin Oncol. 2016 May 23. doi: 10.1200/JCO.2015.64.8899). Given the faster and deeper molecular responses seen in patients taking dasatinib, “dasatinib should continue to be considered a standard first-line therapy for patients with newly diagnosed” chronic myeloid leukemia, they wrote.

In DASISION (Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients), complete cytogenic response, major molecular response, overall survival, and progression-free survival were measured.

The major molecular response rate was significantly higher for patients receiving dasatinib, compared with patients receiving imatinib (76% vs. 64%, P = .0022).

The rate of complete cytogenic response was 28% for dasatinib and 26% for imatinib.

The 5-year overall survival for patients receiving dasatinib was 91% and was not significantly different than the overall survival rate for patients receiving imatinib (90%, P = .1192). Five-year progression-free survival was 85% for patients receiving dasatinib and 86% for patients receiving imatinib.

Grade 3 or 4 adverse events were seen in 15% of patients receiving dasatinib and 11% of patients receiving imatinib. After 5 years, 26 patients had died in each experimental group.

This study was supported by Bristol-Myers Squibb. Eleven investigators reported serving in advisory roles or receiving financial compensation from multiple companies. One investigator had no disclosures to report.

[email protected]

On Twitter @JessCraig_OP

Maintenance therapy with enzastaurin, an experimental agent directed against B-cell malignancies, did not improve disease-free survival among patients with high-risk diffuse large B-cell lymphomas following complete responses to chemotherapy with rituximab.

In a randomized, double-blind trial, after a median follow-up of 48 months, the hazard ratio for disease-free survival with enzastaurin vs. placebo, the primary endpoint, was 0.92 (P = .541), reported Dr. Michael Crump of Princess Margaret Cancer Centre in Toronto, and colleagues.

WikimediaCommons/Copyright © 2011 Michael Bonert.

“The risk of treatment failure, however defined, is likely to be different in the subpopulation of patients who achieve remission after that treatment. Furthermore, identifying the value of specific biomarkers in predicting therapeutic response to novel targeted agents may be necessary in guiding future trials within defined subgroups of patients with DLBCL,” they wrote in the study, published online May 23 in Journal of Clinical Oncology.

Enzastaurin is a selective inhibitor of the protein kinase C-beta isoform (PKC-beta) expressed in both normal and malignant B cells. It has been shown to decrease tumor proliferation and induced apoptosis in cancer cells, and has been shown to have activity against relapsed or refractory DLBCL, mantle cell lymphoma, and follicular lymphoma, the authors explained.

Dr. Crump and colleagues conducted a phase III study to determine whether enzastaurin could be effective as maintenance therapy in patients with DLBCL at high risk for relapse after having had complete responses to first-line therapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

They enrolled 758 patients with stage II bulky DLBCL or stage III-IV disease who had three or more International Prognostic Index risk factors at diagnosis, and who had achieved either a confirmed or unconfirmed complete response after six to eight cycles of R-CHOP.

The patients were randomly assigned on a 2:1 basis to receive either oral enzastaurin 500 mg daily or placebo for 3 years, or until disease progression or unacceptable toxicity,

As noted, there was no significant difference in DFS with the active drug vs. placebo. In addition, in correlative analyses looking for biomarkers of response by cell of origin (i.e., germinal-center or non–germinal-center B cell) or by PKC-beta protein expression, the authors found no significant associations with either DFS or overall survival.

Enzastaurin was generally safe, with minor and manageable adverse events. More patients in the enzastaurin arm had episodes of QTc prolongation, but these did not require discontinuation of the drug.

Dr. Crump and coauthors disclosed consulting, advising, research funding and other relationships with various companies, including Eli Lilly. Five coauthors are Lilly employees.

Maintenance therapy with enzastaurin, an experimental agent directed against B-cell malignancies, did not improve disease-free survival among patients with high-risk diffuse large B-cell lymphomas following complete responses to chemotherapy with rituximab.

In a randomized, double-blind trial, after a median follow-up of 48 months, the hazard ratio for disease-free survival with enzastaurin vs. placebo, the primary endpoint, was 0.92 (P = .541), reported Dr. Michael Crump of Princess Margaret Cancer Centre in Toronto, and colleagues.

WikimediaCommons/Copyright © 2011 Michael Bonert.

“The risk of treatment failure, however defined, is likely to be different in the subpopulation of patients who achieve remission after that treatment. Furthermore, identifying the value of specific biomarkers in predicting therapeutic response to novel targeted agents may be necessary in guiding future trials within defined subgroups of patients with DLBCL,” they wrote in the study, published online May 23 in Journal of Clinical Oncology.

Enzastaurin is a selective inhibitor of the protein kinase C-beta isoform (PKC-beta) expressed in both normal and malignant B cells. It has been shown to decrease tumor proliferation and induced apoptosis in cancer cells, and has been shown to have activity against relapsed or refractory DLBCL, mantle cell lymphoma, and follicular lymphoma, the authors explained.

Dr. Crump and colleagues conducted a phase III study to determine whether enzastaurin could be effective as maintenance therapy in patients with DLBCL at high risk for relapse after having had complete responses to first-line therapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

They enrolled 758 patients with stage II bulky DLBCL or stage III-IV disease who had three or more International Prognostic Index risk factors at diagnosis, and who had achieved either a confirmed or unconfirmed complete response after six to eight cycles of R-CHOP.

The patients were randomly assigned on a 2:1 basis to receive either oral enzastaurin 500 mg daily or placebo for 3 years, or until disease progression or unacceptable toxicity,

As noted, there was no significant difference in DFS with the active drug vs. placebo. In addition, in correlative analyses looking for biomarkers of response by cell of origin (i.e., germinal-center or non–germinal-center B cell) or by PKC-beta protein expression, the authors found no significant associations with either DFS or overall survival.

Enzastaurin was generally safe, with minor and manageable adverse events. More patients in the enzastaurin arm had episodes of QTc prolongation, but these did not require discontinuation of the drug.

Dr. Crump and coauthors disclosed consulting, advising, research funding and other relationships with various companies, including Eli Lilly. Five coauthors are Lilly employees.

Maintenance therapy with enzastaurin, an experimental agent directed against B-cell malignancies, did not improve disease-free survival among patients with high-risk diffuse large B-cell lymphomas following complete responses to chemotherapy with rituximab.

In a randomized, double-blind trial, after a median follow-up of 48 months, the hazard ratio for disease-free survival with enzastaurin vs. placebo, the primary endpoint, was 0.92 (P = .541), reported Dr. Michael Crump of Princess Margaret Cancer Centre in Toronto, and colleagues.

WikimediaCommons/Copyright © 2011 Michael Bonert.

“The risk of treatment failure, however defined, is likely to be different in the subpopulation of patients who achieve remission after that treatment. Furthermore, identifying the value of specific biomarkers in predicting therapeutic response to novel targeted agents may be necessary in guiding future trials within defined subgroups of patients with DLBCL,” they wrote in the study, published online May 23 in Journal of Clinical Oncology.

Enzastaurin is a selective inhibitor of the protein kinase C-beta isoform (PKC-beta) expressed in both normal and malignant B cells. It has been shown to decrease tumor proliferation and induced apoptosis in cancer cells, and has been shown to have activity against relapsed or refractory DLBCL, mantle cell lymphoma, and follicular lymphoma, the authors explained.

Dr. Crump and colleagues conducted a phase III study to determine whether enzastaurin could be effective as maintenance therapy in patients with DLBCL at high risk for relapse after having had complete responses to first-line therapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

They enrolled 758 patients with stage II bulky DLBCL or stage III-IV disease who had three or more International Prognostic Index risk factors at diagnosis, and who had achieved either a confirmed or unconfirmed complete response after six to eight cycles of R-CHOP.

The patients were randomly assigned on a 2:1 basis to receive either oral enzastaurin 500 mg daily or placebo for 3 years, or until disease progression or unacceptable toxicity,

As noted, there was no significant difference in DFS with the active drug vs. placebo. In addition, in correlative analyses looking for biomarkers of response by cell of origin (i.e., germinal-center or non–germinal-center B cell) or by PKC-beta protein expression, the authors found no significant associations with either DFS or overall survival.

Enzastaurin was generally safe, with minor and manageable adverse events. More patients in the enzastaurin arm had episodes of QTc prolongation, but these did not require discontinuation of the drug.

Dr. Crump and coauthors disclosed consulting, advising, research funding and other relationships with various companies, including Eli Lilly. Five coauthors are Lilly employees.

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.