Andrew D. Bowser

CHICAGO – The investigational drug ivosidenib was associated with durable responses, transfusion independence, and a low rate of serious adverse events in patients with IDH1-mutated relapsed/refractory acute myeloid leukemia (AML), based on results of a phase 1 study presented at the annual meeting of the American Society of Clinical Oncology (ASCO).

Daily oral ivosidenib, which inhibits mutant IDH1 the gene that encodes for isocitrate dehydrogenase 1 and is present in 6%-10% of AML patients, was associated with a complete response rate of nearly 32%. In patients who achieved a complete response, median duration of response was 8.2 months and median overall survival was 18.8 months, Daniel A. Pollyea, MD, University of Colorado School of Medicine, Aurora, reported at the meeting.

A wide variety of study participants achieved transfusion independence, even patients who had lesser and no discernable responses, Dr. Pollyea said. “A significant minority of these patients (with lesser or no response) were able to achieve transfusion independence which is obviously a big achievement with respect to quality of life, and suggestive of the mechanism of action here with respect to differentiation.”

The conclusions of this study are “striking,” with response rates and tolerability “very similar” to results seen with the IDH2 inhibitor enasidenib, said Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, N.Y.

Ivosidenib is “likely to become the new standard of care treatment” for IDH1-mutant patients in the relapsed-refractory setting based on the data presented at ASCO, Dr. Wang said in a presentation commenting on the results.

“Given the development of ivosidenib and enasidenib, I think we should all carefully consider whether testing of IDH1 and IDH2 mutational status should also become standard of care in all relapsed and refractory patients, in order to offer them these novel and highly effective as well as well-tolerated targeted therapies,” she said.

Enasidenib was approved by the U.S. Food and Drug Administration (FDA) in 2017 for relapsed or refractory AML with an IDH2 mutation.

Here at ASCO, Dr. Pollyea reported results based on 179 patients with relapsed/refractory IDH1-mutant AML who received 500 mg of ivosidenib daily.

The overall response rate was 41.9% (75 patients), he said. The rate of complete remission (CR) or CR with partial hematologic recovery (CRh) was 31.8% (57 patients), with a median of 2.0 months to CR/CRh and a median duration of CR/CRh of 8.2 months, he said.

Grade 3 or greater leukocytosis was seen in 8% of patients, and grade 3 or greater QT prolongation was seen in 10% of patients, Dr. Pollyea reported.

IHD differentiation syndrome of any grade was seen in 19 patients (10.6%), and about half of those cases (5%) were grade 3 or greater. However, cases were managed with supportive care, and there were no dose reductions, permanent treatment discontinuations, or deaths due to the condition, Dr. Pollyea said.

Moreover, the majority of those patients (10 out of 19) went on to have a response. “Supportive care and continued treatment can allow for patients ultimately to respond who are experiencing differentiation syndrome,” Dr. Pollyea said.

Results of the phase 1 study were published simultaneously in the New England Journal of Medicine.The trial was sponsored by Agios. Dr. Pollyea reported disclosures related to Agios, as well as Abbvie, argenx, Celgene, Celyad, Curis, Pfizer, and Servier.

SOURCE: Pollyea DA, et al. J Clin Oncol36, 2018 (suppl; abstr 7000).

CHICAGO – The investigational drug ivosidenib was associated with durable responses, transfusion independence, and a low rate of serious adverse events in patients with IDH1-mutated relapsed/refractory acute myeloid leukemia (AML), based on results of a phase 1 study presented at the annual meeting of the American Society of Clinical Oncology (ASCO).

Daily oral ivosidenib, which inhibits mutant IDH1 the gene that encodes for isocitrate dehydrogenase 1 and is present in 6%-10% of AML patients, was associated with a complete response rate of nearly 32%. In patients who achieved a complete response, median duration of response was 8.2 months and median overall survival was 18.8 months, Daniel A. Pollyea, MD, University of Colorado School of Medicine, Aurora, reported at the meeting.

A wide variety of study participants achieved transfusion independence, even patients who had lesser and no discernable responses, Dr. Pollyea said. “A significant minority of these patients (with lesser or no response) were able to achieve transfusion independence which is obviously a big achievement with respect to quality of life, and suggestive of the mechanism of action here with respect to differentiation.”

The conclusions of this study are “striking,” with response rates and tolerability “very similar” to results seen with the IDH2 inhibitor enasidenib, said Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, N.Y.

Ivosidenib is “likely to become the new standard of care treatment” for IDH1-mutant patients in the relapsed-refractory setting based on the data presented at ASCO, Dr. Wang said in a presentation commenting on the results.

“Given the development of ivosidenib and enasidenib, I think we should all carefully consider whether testing of IDH1 and IDH2 mutational status should also become standard of care in all relapsed and refractory patients, in order to offer them these novel and highly effective as well as well-tolerated targeted therapies,” she said.

Enasidenib was approved by the U.S. Food and Drug Administration (FDA) in 2017 for relapsed or refractory AML with an IDH2 mutation.

Here at ASCO, Dr. Pollyea reported results based on 179 patients with relapsed/refractory IDH1-mutant AML who received 500 mg of ivosidenib daily.

The overall response rate was 41.9% (75 patients), he said. The rate of complete remission (CR) or CR with partial hematologic recovery (CRh) was 31.8% (57 patients), with a median of 2.0 months to CR/CRh and a median duration of CR/CRh of 8.2 months, he said.

Grade 3 or greater leukocytosis was seen in 8% of patients, and grade 3 or greater QT prolongation was seen in 10% of patients, Dr. Pollyea reported.

IHD differentiation syndrome of any grade was seen in 19 patients (10.6%), and about half of those cases (5%) were grade 3 or greater. However, cases were managed with supportive care, and there were no dose reductions, permanent treatment discontinuations, or deaths due to the condition, Dr. Pollyea said.

Moreover, the majority of those patients (10 out of 19) went on to have a response. “Supportive care and continued treatment can allow for patients ultimately to respond who are experiencing differentiation syndrome,” Dr. Pollyea said.

Results of the phase 1 study were published simultaneously in the New England Journal of Medicine.The trial was sponsored by Agios. Dr. Pollyea reported disclosures related to Agios, as well as Abbvie, argenx, Celgene, Celyad, Curis, Pfizer, and Servier.

SOURCE: Pollyea DA, et al. J Clin Oncol36, 2018 (suppl; abstr 7000).

CHICAGO – The investigational drug ivosidenib was associated with durable responses, transfusion independence, and a low rate of serious adverse events in patients with IDH1-mutated relapsed/refractory acute myeloid leukemia (AML), based on results of a phase 1 study presented at the annual meeting of the American Society of Clinical Oncology (ASCO).

Daily oral ivosidenib, which inhibits mutant IDH1 the gene that encodes for isocitrate dehydrogenase 1 and is present in 6%-10% of AML patients, was associated with a complete response rate of nearly 32%. In patients who achieved a complete response, median duration of response was 8.2 months and median overall survival was 18.8 months, Daniel A. Pollyea, MD, University of Colorado School of Medicine, Aurora, reported at the meeting.

A wide variety of study participants achieved transfusion independence, even patients who had lesser and no discernable responses, Dr. Pollyea said. “A significant minority of these patients (with lesser or no response) were able to achieve transfusion independence which is obviously a big achievement with respect to quality of life, and suggestive of the mechanism of action here with respect to differentiation.”

The conclusions of this study are “striking,” with response rates and tolerability “very similar” to results seen with the IDH2 inhibitor enasidenib, said Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, N.Y.

Ivosidenib is “likely to become the new standard of care treatment” for IDH1-mutant patients in the relapsed-refractory setting based on the data presented at ASCO, Dr. Wang said in a presentation commenting on the results.

“Given the development of ivosidenib and enasidenib, I think we should all carefully consider whether testing of IDH1 and IDH2 mutational status should also become standard of care in all relapsed and refractory patients, in order to offer them these novel and highly effective as well as well-tolerated targeted therapies,” she said.

Enasidenib was approved by the U.S. Food and Drug Administration (FDA) in 2017 for relapsed or refractory AML with an IDH2 mutation.

Here at ASCO, Dr. Pollyea reported results based on 179 patients with relapsed/refractory IDH1-mutant AML who received 500 mg of ivosidenib daily.

The overall response rate was 41.9% (75 patients), he said. The rate of complete remission (CR) or CR with partial hematologic recovery (CRh) was 31.8% (57 patients), with a median of 2.0 months to CR/CRh and a median duration of CR/CRh of 8.2 months, he said.

Grade 3 or greater leukocytosis was seen in 8% of patients, and grade 3 or greater QT prolongation was seen in 10% of patients, Dr. Pollyea reported.

IHD differentiation syndrome of any grade was seen in 19 patients (10.6%), and about half of those cases (5%) were grade 3 or greater. However, cases were managed with supportive care, and there were no dose reductions, permanent treatment discontinuations, or deaths due to the condition, Dr. Pollyea said.

Moreover, the majority of those patients (10 out of 19) went on to have a response. “Supportive care and continued treatment can allow for patients ultimately to respond who are experiencing differentiation syndrome,” Dr. Pollyea said.

Results of the phase 1 study were published simultaneously in the New England Journal of Medicine.The trial was sponsored by Agios. Dr. Pollyea reported disclosures related to Agios, as well as Abbvie, argenx, Celgene, Celyad, Curis, Pfizer, and Servier.

SOURCE: Pollyea DA, et al. J Clin Oncol36, 2018 (suppl; abstr 7000).

CHICAGO – Adding ibrutinib to rituximab improved progression-free survival in patients with Waldenström’s macroglobulinemia, results of a randomized phase 3 trial show.

The results make ibrutinib plus rituximab “a new standard of care” for the disease, said investigator Meletios A. Dimopoulos, MD, with the Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Greece.

“This is a combination with remarkable activity as far as progression-free survival is concerned, and well tolerated,” Dr. Dimopoulos said in a presentation of the data here at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO).

Ibrutinib, a BTK inhibitor, was approved as a single agent in 2015 for the treatment of Waldenström’s macroglobulinemia.* Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) list ibrutinib as an “other” recommended regimen, noting that study data show a “lower overall and absence of major responses” reported for MYD88 wild-type patients.Rituximab alone and in combination with other agents has clinical activity in Waldenström’s. Moreover, preclinical studies have shown that rituximab and ibrutinib have synergistic activity, Dr. Dimopoulos said, presenting data from the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia that was published concurrently in the New England Journal of Medicine.

They initiated a study of 150 symptomatic patients randomized to either ibrutinib plus rituximab or placebo plus rituximab, with a primary end point of progression-free survival.

They also assessed mutational status of MYD88 and CXCR4 in bone marrow samples, given that previous data suggest outcomes of ibrutinib treatment for this disease depend on MYD88 and CXCR4 mutational status, they said in the report.

Progression-free survival at 30 months was 82% for ibrutinib plus rituximab, compared to 28% for placebo plus rituximab (hazard ratio for progression or death, 0.20; P less than 0.001). Further, ibrutinib and rituximab had a benefit that was independent of the MYD88 or CXCR4 genotype, the investigators reported.

“Response rates with ibrutinib–rituximab were similar across different CXCR4 genotypes, but were slightly lower among patients who did not have the activating MYD88 L265P mutation, which triggers the growth of malignant cells through BTK and hematopoietic-cell kinase, both of which are targeted by ibrutinib,” they wrote.

Atrial fibrillation of grade 3 or higher occurred in 12% of the ibrutinib-rituximab and in 1% of placebo-rituximab groups. In the ibrutinib-rituximab group, the majority of these cases occurred in patients older than 75 years of age, Dr. Dimopoulos reported at ASCO.

Grade 3 or greater hypertension occurred in 13% and 4% of the ibrutinib-rituximab and placebo-rituximab groups respectively, while respiratory tract infections occurred in 4% and 0%. Conversely, the ibrutinib-rituximab arm had a lower rate of grade 3 or greater infusion reactions (1% vs. 16%), he said.

Based on this report, ibrutinib plus rituximab is “appealing, primarily in MYD88-mutated patients, which is the vast majority of Waldenström’s patients,” said Craig Hofmeister, MD, MPH, who commented on the study in a ASCO presentation discussing the results of this trial.

Dr. Hofmeister, of Winship Cancer Institute, Emory University, Atlanta, noted the numerically lower response rate in patients without the MYD88 mutation “makes me wonder whether I would want to have ibrutinib if I was MYD88 wild type.”

Atrial fibrillation and infections on the ibrutinib-rituximab regimen may require close monitoring and should be managed appropriately, he added. “Atrial fibrillation seems to be a consistent theme with ibrutinib, certainly in patients who are older and have probably more heart disease.”

The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.

SOURCE: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.

*Correction, 8/27/2018: An earlier version of this story misstated the date of ibrutinib's approval as a single agent in the treatment of Waldenström’s macroglobulinemia.

CHICAGO – Adding ibrutinib to rituximab improved progression-free survival in patients with Waldenström’s macroglobulinemia, results of a randomized phase 3 trial show.

The results make ibrutinib plus rituximab “a new standard of care” for the disease, said investigator Meletios A. Dimopoulos, MD, with the Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Greece.

“This is a combination with remarkable activity as far as progression-free survival is concerned, and well tolerated,” Dr. Dimopoulos said in a presentation of the data here at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO).

Ibrutinib, a BTK inhibitor, was approved as a single agent in 2015 for the treatment of Waldenström’s macroglobulinemia.* Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) list ibrutinib as an “other” recommended regimen, noting that study data show a “lower overall and absence of major responses” reported for MYD88 wild-type patients.Rituximab alone and in combination with other agents has clinical activity in Waldenström’s. Moreover, preclinical studies have shown that rituximab and ibrutinib have synergistic activity, Dr. Dimopoulos said, presenting data from the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia that was published concurrently in the New England Journal of Medicine.

They initiated a study of 150 symptomatic patients randomized to either ibrutinib plus rituximab or placebo plus rituximab, with a primary end point of progression-free survival.

They also assessed mutational status of MYD88 and CXCR4 in bone marrow samples, given that previous data suggest outcomes of ibrutinib treatment for this disease depend on MYD88 and CXCR4 mutational status, they said in the report.

Progression-free survival at 30 months was 82% for ibrutinib plus rituximab, compared to 28% for placebo plus rituximab (hazard ratio for progression or death, 0.20; P less than 0.001). Further, ibrutinib and rituximab had a benefit that was independent of the MYD88 or CXCR4 genotype, the investigators reported.

“Response rates with ibrutinib–rituximab were similar across different CXCR4 genotypes, but were slightly lower among patients who did not have the activating MYD88 L265P mutation, which triggers the growth of malignant cells through BTK and hematopoietic-cell kinase, both of which are targeted by ibrutinib,” they wrote.

Atrial fibrillation of grade 3 or higher occurred in 12% of the ibrutinib-rituximab and in 1% of placebo-rituximab groups. In the ibrutinib-rituximab group, the majority of these cases occurred in patients older than 75 years of age, Dr. Dimopoulos reported at ASCO.

Grade 3 or greater hypertension occurred in 13% and 4% of the ibrutinib-rituximab and placebo-rituximab groups respectively, while respiratory tract infections occurred in 4% and 0%. Conversely, the ibrutinib-rituximab arm had a lower rate of grade 3 or greater infusion reactions (1% vs. 16%), he said.

Based on this report, ibrutinib plus rituximab is “appealing, primarily in MYD88-mutated patients, which is the vast majority of Waldenström’s patients,” said Craig Hofmeister, MD, MPH, who commented on the study in a ASCO presentation discussing the results of this trial.

Dr. Hofmeister, of Winship Cancer Institute, Emory University, Atlanta, noted the numerically lower response rate in patients without the MYD88 mutation “makes me wonder whether I would want to have ibrutinib if I was MYD88 wild type.”

Atrial fibrillation and infections on the ibrutinib-rituximab regimen may require close monitoring and should be managed appropriately, he added. “Atrial fibrillation seems to be a consistent theme with ibrutinib, certainly in patients who are older and have probably more heart disease.”

The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.

SOURCE: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.

*Correction, 8/27/2018: An earlier version of this story misstated the date of ibrutinib's approval as a single agent in the treatment of Waldenström’s macroglobulinemia.

CHICAGO – Adding ibrutinib to rituximab improved progression-free survival in patients with Waldenström’s macroglobulinemia, results of a randomized phase 3 trial show.

The results make ibrutinib plus rituximab “a new standard of care” for the disease, said investigator Meletios A. Dimopoulos, MD, with the Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Greece.

“This is a combination with remarkable activity as far as progression-free survival is concerned, and well tolerated,” Dr. Dimopoulos said in a presentation of the data here at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO).

Ibrutinib, a BTK inhibitor, was approved as a single agent in 2015 for the treatment of Waldenström’s macroglobulinemia.* Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) list ibrutinib as an “other” recommended regimen, noting that study data show a “lower overall and absence of major responses” reported for MYD88 wild-type patients.Rituximab alone and in combination with other agents has clinical activity in Waldenström’s. Moreover, preclinical studies have shown that rituximab and ibrutinib have synergistic activity, Dr. Dimopoulos said, presenting data from the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia that was published concurrently in the New England Journal of Medicine.

They initiated a study of 150 symptomatic patients randomized to either ibrutinib plus rituximab or placebo plus rituximab, with a primary end point of progression-free survival.

They also assessed mutational status of MYD88 and CXCR4 in bone marrow samples, given that previous data suggest outcomes of ibrutinib treatment for this disease depend on MYD88 and CXCR4 mutational status, they said in the report.

Progression-free survival at 30 months was 82% for ibrutinib plus rituximab, compared to 28% for placebo plus rituximab (hazard ratio for progression or death, 0.20; P less than 0.001). Further, ibrutinib and rituximab had a benefit that was independent of the MYD88 or CXCR4 genotype, the investigators reported.

“Response rates with ibrutinib–rituximab were similar across different CXCR4 genotypes, but were slightly lower among patients who did not have the activating MYD88 L265P mutation, which triggers the growth of malignant cells through BTK and hematopoietic-cell kinase, both of which are targeted by ibrutinib,” they wrote.

Atrial fibrillation of grade 3 or higher occurred in 12% of the ibrutinib-rituximab and in 1% of placebo-rituximab groups. In the ibrutinib-rituximab group, the majority of these cases occurred in patients older than 75 years of age, Dr. Dimopoulos reported at ASCO.

Grade 3 or greater hypertension occurred in 13% and 4% of the ibrutinib-rituximab and placebo-rituximab groups respectively, while respiratory tract infections occurred in 4% and 0%. Conversely, the ibrutinib-rituximab arm had a lower rate of grade 3 or greater infusion reactions (1% vs. 16%), he said.

Based on this report, ibrutinib plus rituximab is “appealing, primarily in MYD88-mutated patients, which is the vast majority of Waldenström’s patients,” said Craig Hofmeister, MD, MPH, who commented on the study in a ASCO presentation discussing the results of this trial.

Dr. Hofmeister, of Winship Cancer Institute, Emory University, Atlanta, noted the numerically lower response rate in patients without the MYD88 mutation “makes me wonder whether I would want to have ibrutinib if I was MYD88 wild type.”

Atrial fibrillation and infections on the ibrutinib-rituximab regimen may require close monitoring and should be managed appropriately, he added. “Atrial fibrillation seems to be a consistent theme with ibrutinib, certainly in patients who are older and have probably more heart disease.”

The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.

SOURCE: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.

*Correction, 8/27/2018: An earlier version of this story misstated the date of ibrutinib's approval as a single agent in the treatment of Waldenström’s macroglobulinemia.

Many U.S. hospitals still did not have influenza vaccination requirements for health care personnel as of summer 2017, suggested the results of a national survey.

Nearly two-thirds of hospitals had mandatory influenza vaccination in place in 2017, up from just one-third in 2013, according to survey responses submitted by infection preventionists working at Veterans Affairs (VA) and non-VA hospitals.

Jovanmandic/Thinkstock

By contrast, the proportion of VA hospitals with such requirements increased only slightly, from 1.3% in 2013 to just 4.1% in 2017 (P = .29), the report showed.

Penalties for not complying with the policy were not universal in hospitals with mandates, they added. Only 74% said they had such penalties, and 13% allowed health care personnel to decline influenza vaccination without a specified reason.

After the survey responses were received, the VA issued a directive stating that all health care personnel should receive annual influenza vaccination and should wear masks during influenza season, Dr. Greene noted.

That directive is in line with recommendations from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, which have stated that all health care personnel should receive influenza vaccination each year.

In addition, the U.S. Department of Health & Human Services has set a goal of 90% of health care personnel to be vaccinated by 2020, Dr. Green and his coauthors noted.

Mandating influenza vaccination is just one proven successful strategy for increasing coverage at hospitals, according to the study authors. Other approaches include influenza education, incentives, free and easy access to vaccination, and annual campaigns directed at health care personnel, as well as written policies describing the vaccination goal.

“Regardless of whether an organization has an official mandate for vaccinations, establishing a written policy that states the organizational commitment to increasing vaccination rates is among the recommended strategies for improving vaccination coverage among health care personnel,” they wrote.

Dr. Greene and his coauthors reported receiving grants from the Blue Cross Blue Shield of Michigan Foundation and the U.S. Department of Veterans Affairs Patient Safety Center of Inquiry during the conduct of the study. One study coauthor reported personal fees from Jvion and from Doximity outside the submitted work.

SOURCE: Greene MT et al. JAMA Network Open. 2018;1(2):e180143.

Many U.S. hospitals still did not have influenza vaccination requirements for health care personnel as of summer 2017, suggested the results of a national survey.

Nearly two-thirds of hospitals had mandatory influenza vaccination in place in 2017, up from just one-third in 2013, according to survey responses submitted by infection preventionists working at Veterans Affairs (VA) and non-VA hospitals.

Jovanmandic/Thinkstock

By contrast, the proportion of VA hospitals with such requirements increased only slightly, from 1.3% in 2013 to just 4.1% in 2017 (P = .29), the report showed.

Penalties for not complying with the policy were not universal in hospitals with mandates, they added. Only 74% said they had such penalties, and 13% allowed health care personnel to decline influenza vaccination without a specified reason.

After the survey responses were received, the VA issued a directive stating that all health care personnel should receive annual influenza vaccination and should wear masks during influenza season, Dr. Greene noted.

That directive is in line with recommendations from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, which have stated that all health care personnel should receive influenza vaccination each year.

In addition, the U.S. Department of Health & Human Services has set a goal of 90% of health care personnel to be vaccinated by 2020, Dr. Green and his coauthors noted.

Mandating influenza vaccination is just one proven successful strategy for increasing coverage at hospitals, according to the study authors. Other approaches include influenza education, incentives, free and easy access to vaccination, and annual campaigns directed at health care personnel, as well as written policies describing the vaccination goal.

“Regardless of whether an organization has an official mandate for vaccinations, establishing a written policy that states the organizational commitment to increasing vaccination rates is among the recommended strategies for improving vaccination coverage among health care personnel,” they wrote.

Dr. Greene and his coauthors reported receiving grants from the Blue Cross Blue Shield of Michigan Foundation and the U.S. Department of Veterans Affairs Patient Safety Center of Inquiry during the conduct of the study. One study coauthor reported personal fees from Jvion and from Doximity outside the submitted work.

SOURCE: Greene MT et al. JAMA Network Open. 2018;1(2):e180143.

Many U.S. hospitals still did not have influenza vaccination requirements for health care personnel as of summer 2017, suggested the results of a national survey.

Nearly two-thirds of hospitals had mandatory influenza vaccination in place in 2017, up from just one-third in 2013, according to survey responses submitted by infection preventionists working at Veterans Affairs (VA) and non-VA hospitals.

Jovanmandic/Thinkstock

By contrast, the proportion of VA hospitals with such requirements increased only slightly, from 1.3% in 2013 to just 4.1% in 2017 (P = .29), the report showed.

Penalties for not complying with the policy were not universal in hospitals with mandates, they added. Only 74% said they had such penalties, and 13% allowed health care personnel to decline influenza vaccination without a specified reason.

After the survey responses were received, the VA issued a directive stating that all health care personnel should receive annual influenza vaccination and should wear masks during influenza season, Dr. Greene noted.

That directive is in line with recommendations from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, which have stated that all health care personnel should receive influenza vaccination each year.

In addition, the U.S. Department of Health & Human Services has set a goal of 90% of health care personnel to be vaccinated by 2020, Dr. Green and his coauthors noted.

Mandating influenza vaccination is just one proven successful strategy for increasing coverage at hospitals, according to the study authors. Other approaches include influenza education, incentives, free and easy access to vaccination, and annual campaigns directed at health care personnel, as well as written policies describing the vaccination goal.

“Regardless of whether an organization has an official mandate for vaccinations, establishing a written policy that states the organizational commitment to increasing vaccination rates is among the recommended strategies for improving vaccination coverage among health care personnel,” they wrote.

Dr. Greene and his coauthors reported receiving grants from the Blue Cross Blue Shield of Michigan Foundation and the U.S. Department of Veterans Affairs Patient Safety Center of Inquiry during the conduct of the study. One study coauthor reported personal fees from Jvion and from Doximity outside the submitted work.

SOURCE: Greene MT et al. JAMA Network Open. 2018;1(2):e180143.

Compared with men, women receiving fluorouracil-based chemotherapy for colorectal cancer had higher rates of treatment-emergent adverse events, a retrospective analysis shows.

Women had statistically significant and clinically relevant increased risks of multiple hematologic and nonhematologic toxicities in the analysis, which was based on data from the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.

The findings suggest that drug targets may be different between women and men, as may be the optimal doses needed to hit those targets with acceptable levels of adverse events, said Valerie Cristina, MD, of Lausanne (Switzerland) University Hospital, and her coinvestigators.

“In an age of personalized medicine, and also considering growing knowledge about sex-related differences in molecular profiles and disease biology, the potential effect of sex on efficacy and toxic effects of systemic treatments in oncology deserves more awareness and further investigation,” the researchers wrote. The report was published in JAMA Oncology.

Patients in this retrospective study had stage II-III colorectal cancer and had received treatment with either adjuvant fluorouracil/leucovorin or leucovorin, fluorouracil, and irinotecan (FOLFIRI). Of 2,974 patients, 1,656 (55.7%) were men and 1,318 (44.3%) were women.

The primary analysis in the study was a comparison by sex of treatment-emergent adverse events of any grade. The investigators found women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.

Significant differences were reported for hematologic adverse events such as leukopenia of any grade, which was seen in 49.6% of women and 38.9% of men (P less than .001), and nonhematologic adverse events, such as nausea of any grade, seen in 61.8% of women and 53.7% of men (P less than .001).

SOURCE: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.

Compared with men, women receiving fluorouracil-based chemotherapy for colorectal cancer had higher rates of treatment-emergent adverse events, a retrospective analysis shows.

Women had statistically significant and clinically relevant increased risks of multiple hematologic and nonhematologic toxicities in the analysis, which was based on data from the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.

The findings suggest that drug targets may be different between women and men, as may be the optimal doses needed to hit those targets with acceptable levels of adverse events, said Valerie Cristina, MD, of Lausanne (Switzerland) University Hospital, and her coinvestigators.

“In an age of personalized medicine, and also considering growing knowledge about sex-related differences in molecular profiles and disease biology, the potential effect of sex on efficacy and toxic effects of systemic treatments in oncology deserves more awareness and further investigation,” the researchers wrote. The report was published in JAMA Oncology.

Patients in this retrospective study had stage II-III colorectal cancer and had received treatment with either adjuvant fluorouracil/leucovorin or leucovorin, fluorouracil, and irinotecan (FOLFIRI). Of 2,974 patients, 1,656 (55.7%) were men and 1,318 (44.3%) were women.

The primary analysis in the study was a comparison by sex of treatment-emergent adverse events of any grade. The investigators found women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.

Significant differences were reported for hematologic adverse events such as leukopenia of any grade, which was seen in 49.6% of women and 38.9% of men (P less than .001), and nonhematologic adverse events, such as nausea of any grade, seen in 61.8% of women and 53.7% of men (P less than .001).

SOURCE: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.

Compared with men, women receiving fluorouracil-based chemotherapy for colorectal cancer had higher rates of treatment-emergent adverse events, a retrospective analysis shows.

Women had statistically significant and clinically relevant increased risks of multiple hematologic and nonhematologic toxicities in the analysis, which was based on data from the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.

The findings suggest that drug targets may be different between women and men, as may be the optimal doses needed to hit those targets with acceptable levels of adverse events, said Valerie Cristina, MD, of Lausanne (Switzerland) University Hospital, and her coinvestigators.

“In an age of personalized medicine, and also considering growing knowledge about sex-related differences in molecular profiles and disease biology, the potential effect of sex on efficacy and toxic effects of systemic treatments in oncology deserves more awareness and further investigation,” the researchers wrote. The report was published in JAMA Oncology.

Patients in this retrospective study had stage II-III colorectal cancer and had received treatment with either adjuvant fluorouracil/leucovorin or leucovorin, fluorouracil, and irinotecan (FOLFIRI). Of 2,974 patients, 1,656 (55.7%) were men and 1,318 (44.3%) were women.

The primary analysis in the study was a comparison by sex of treatment-emergent adverse events of any grade. The investigators found women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.

Significant differences were reported for hematologic adverse events such as leukopenia of any grade, which was seen in 49.6% of women and 38.9% of men (P less than .001), and nonhematologic adverse events, such as nausea of any grade, seen in 61.8% of women and 53.7% of men (P less than .001).

SOURCE: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.

Patients with sepsis-associated coagulopathy appear to be at heightened risk of death, according to results of a large retrospective cohort study.

The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.

Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.

“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.

Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.

Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).

Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.

Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.

These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.

“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.

Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.

SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.

Patients with sepsis-associated coagulopathy appear to be at heightened risk of death, according to results of a large retrospective cohort study.

The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.

Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.

“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.

Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.

Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).

Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.

Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.

These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.

“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.

Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.

SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.

Patients with sepsis-associated coagulopathy appear to be at heightened risk of death, according to results of a large retrospective cohort study.

The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.

Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.

“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.

Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.

Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).

Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.

Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.

These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.

“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.

Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.

SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.

In light of changing clinical practice guidelines and changing provider attitudes, endocrinologists have the opportunity to step up and become community experts on transgender health care, according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.

“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

MDedge News

For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.

A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.

Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.

It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.

“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”

In light of changing clinical practice guidelines and changing provider attitudes, endocrinologists have the opportunity to step up and become community experts on transgender health care, according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.

“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

MDedge News

For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.

A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.

Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.

It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.

“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”

In light of changing clinical practice guidelines and changing provider attitudes, endocrinologists have the opportunity to step up and become community experts on transgender health care, according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.

“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

MDedge News

For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.

A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.

Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.

It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.

“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”

For patients with sepsis who have initial abnormal lactates, delays in lactate measurement were associated with delayed treatment and progressive mortality increases, findings of a retrospective study show.

Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest^®.

In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.

The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.

They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.

In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.

For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.

The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.

“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.

These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.

“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.

They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.

SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.

For patients with sepsis who have initial abnormal lactates, delays in lactate measurement were associated with delayed treatment and progressive mortality increases, findings of a retrospective study show.

Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest^®.

In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.

The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.

They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.

In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.

For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.

The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.

“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.

These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.

“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.

They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.

SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.

For patients with sepsis who have initial abnormal lactates, delays in lactate measurement were associated with delayed treatment and progressive mortality increases, findings of a retrospective study show.

Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest^®.

In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.

The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.

They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.

In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.

For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.

The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.

“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.

These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.

“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.

They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.

SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.

In postmenopausal women, a higher level of testosterone in comparison to estrogen may increase the cardiovascular disease risk later in life, results of a recent analysis suggest.

A higher ratio of testosterone to estradiol was associated with the development of cardiovascular disease, coronary heart disease, and heart failure in postmenopausal women, according to results from an analysis based on 2,834 postmenopausal women in MESA (Multi-Ethnic Study of Atherosclerosis).

In addition, total testosterone levels were associated with increased cardiovascular disease and coronary heart disease, while estradiol is associated with a reduced risk of coronary heart disease and heart failure with reduced ejection fraction, investigators reported in the Journal of the American College of Cardiology.

Without any interventional studies as guidance, it’s not clear what the “best strategy” would be to modify sex hormone levels and reduce cardiovascular disease risk, wrote investigator Di Zhao, PhD, of the department of epidemiology at Johns Hopkins University Bloomberg School of Public Health, Baltimore, and her study coauthors.

“Nonetheless, a more androgenic sex hormone profile may identify a woman at higher risk for cardiovascular disease who may benefit from other risk-reducing strategies,” Dr. Zhao and her colleagues wrote in their report.

The postmenopausal women included in this analysis all had baseline measurements of testosterone, estradiol, dehydroepiandrosterone, and sex hormone–binding globulin levels between 2000 and 2002, according to the report.

After more than 12 years of follow-up, investigators found that a higher total testosterone to estradiol ratio was independently associated with an increased risk of incident cardiovascular disease (hazard ratio, 1.19; 95% confidence interval, 1.02-1.40), coronary heart disease (HR, 1.45; 95% CI, 1.19-1.78), and heart failure (HR, 1.31; 95% CI, 1.01-1.70).

Investigators also reported a statistically significant association between total testosterone levels and risk of cardiovascular disease and coronary heart disease but not risk of heart failure.

In a subgroup analysis of postmenopausal women with heart failure, investigators found a significant positive association with the testosterone to estradiol ratio (HR, 1.65; 95% CI, 1.07-2.54) and inverse associations for estradiol (HR, 0.60; 95% CI, 0.39-0.93) and for dehydroepiandrosterone (HR, 0.59; 95% CI, 0.44-0.78).

On their own, estradiol levels had no association with cardiovascular disease events overall, but they were associated with lower coronary heart disease risk, according to investigators. Estradiol also was associated with a lower heart failure risk, though the trend did not reach statistical significance.

The study was partially funded by the American Heart Association’s Go Red for Women Research Network. Study authors reported disclosures related to Cordex Systems, Siemens Diagnostics, and other entities.

SOURCE: Zhao D et al. J Am Coll Cardiol. 2018 Jun 5; 71:2555-66.

In postmenopausal women, a higher level of testosterone in comparison to estrogen may increase the cardiovascular disease risk later in life, results of a recent analysis suggest.

A higher ratio of testosterone to estradiol was associated with the development of cardiovascular disease, coronary heart disease, and heart failure in postmenopausal women, according to results from an analysis based on 2,834 postmenopausal women in MESA (Multi-Ethnic Study of Atherosclerosis).

In addition, total testosterone levels were associated with increased cardiovascular disease and coronary heart disease, while estradiol is associated with a reduced risk of coronary heart disease and heart failure with reduced ejection fraction, investigators reported in the Journal of the American College of Cardiology.

Without any interventional studies as guidance, it’s not clear what the “best strategy” would be to modify sex hormone levels and reduce cardiovascular disease risk, wrote investigator Di Zhao, PhD, of the department of epidemiology at Johns Hopkins University Bloomberg School of Public Health, Baltimore, and her study coauthors.

“Nonetheless, a more androgenic sex hormone profile may identify a woman at higher risk for cardiovascular disease who may benefit from other risk-reducing strategies,” Dr. Zhao and her colleagues wrote in their report.

The postmenopausal women included in this analysis all had baseline measurements of testosterone, estradiol, dehydroepiandrosterone, and sex hormone–binding globulin levels between 2000 and 2002, according to the report.

After more than 12 years of follow-up, investigators found that a higher total testosterone to estradiol ratio was independently associated with an increased risk of incident cardiovascular disease (hazard ratio, 1.19; 95% confidence interval, 1.02-1.40), coronary heart disease (HR, 1.45; 95% CI, 1.19-1.78), and heart failure (HR, 1.31; 95% CI, 1.01-1.70).

Investigators also reported a statistically significant association between total testosterone levels and risk of cardiovascular disease and coronary heart disease but not risk of heart failure.

In a subgroup analysis of postmenopausal women with heart failure, investigators found a significant positive association with the testosterone to estradiol ratio (HR, 1.65; 95% CI, 1.07-2.54) and inverse associations for estradiol (HR, 0.60; 95% CI, 0.39-0.93) and for dehydroepiandrosterone (HR, 0.59; 95% CI, 0.44-0.78).

On their own, estradiol levels had no association with cardiovascular disease events overall, but they were associated with lower coronary heart disease risk, according to investigators. Estradiol also was associated with a lower heart failure risk, though the trend did not reach statistical significance.

The study was partially funded by the American Heart Association’s Go Red for Women Research Network. Study authors reported disclosures related to Cordex Systems, Siemens Diagnostics, and other entities.

SOURCE: Zhao D et al. J Am Coll Cardiol. 2018 Jun 5; 71:2555-66.

In postmenopausal women, a higher level of testosterone in comparison to estrogen may increase the cardiovascular disease risk later in life, results of a recent analysis suggest.

A higher ratio of testosterone to estradiol was associated with the development of cardiovascular disease, coronary heart disease, and heart failure in postmenopausal women, according to results from an analysis based on 2,834 postmenopausal women in MESA (Multi-Ethnic Study of Atherosclerosis).

In addition, total testosterone levels were associated with increased cardiovascular disease and coronary heart disease, while estradiol is associated with a reduced risk of coronary heart disease and heart failure with reduced ejection fraction, investigators reported in the Journal of the American College of Cardiology.

Without any interventional studies as guidance, it’s not clear what the “best strategy” would be to modify sex hormone levels and reduce cardiovascular disease risk, wrote investigator Di Zhao, PhD, of the department of epidemiology at Johns Hopkins University Bloomberg School of Public Health, Baltimore, and her study coauthors.

“Nonetheless, a more androgenic sex hormone profile may identify a woman at higher risk for cardiovascular disease who may benefit from other risk-reducing strategies,” Dr. Zhao and her colleagues wrote in their report.

The postmenopausal women included in this analysis all had baseline measurements of testosterone, estradiol, dehydroepiandrosterone, and sex hormone–binding globulin levels between 2000 and 2002, according to the report.

After more than 12 years of follow-up, investigators found that a higher total testosterone to estradiol ratio was independently associated with an increased risk of incident cardiovascular disease (hazard ratio, 1.19; 95% confidence interval, 1.02-1.40), coronary heart disease (HR, 1.45; 95% CI, 1.19-1.78), and heart failure (HR, 1.31; 95% CI, 1.01-1.70).

Investigators also reported a statistically significant association between total testosterone levels and risk of cardiovascular disease and coronary heart disease but not risk of heart failure.

In a subgroup analysis of postmenopausal women with heart failure, investigators found a significant positive association with the testosterone to estradiol ratio (HR, 1.65; 95% CI, 1.07-2.54) and inverse associations for estradiol (HR, 0.60; 95% CI, 0.39-0.93) and for dehydroepiandrosterone (HR, 0.59; 95% CI, 0.44-0.78).

On their own, estradiol levels had no association with cardiovascular disease events overall, but they were associated with lower coronary heart disease risk, according to investigators. Estradiol also was associated with a lower heart failure risk, though the trend did not reach statistical significance.

The study was partially funded by the American Heart Association’s Go Red for Women Research Network. Study authors reported disclosures related to Cordex Systems, Siemens Diagnostics, and other entities.

SOURCE: Zhao D et al. J Am Coll Cardiol. 2018 Jun 5; 71:2555-66.

Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.

That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.

“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.

In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.

Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.

In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).

Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).

“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.

The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.

A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.

“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.

Dr. Rudy and her coauthors had no conflicts of interest to disclose.

SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.

Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.

That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.

“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.

In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.

Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.

In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).

Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).

“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.

The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.

A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.

“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.

Dr. Rudy and her coauthors had no conflicts of interest to disclose.

SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.

Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.

That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.

“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.

In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.

Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.

In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).

Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).

“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.

The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.

A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.

“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.

Dr. Rudy and her coauthors had no conflicts of interest to disclose.

SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.

Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.

Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.

That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.

The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.

The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.

Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.

Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.

SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.

Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.

Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.

That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.

The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.

The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.

Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.

Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.

SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.

Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.

Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.

That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.

The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.

The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.

Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.

Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.

SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.