LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.

The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.

Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.

For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.

An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.

Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.

In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).

“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.

[email protected]

LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.

The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.

Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.

For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.

An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.

Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.

In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).

“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.

[email protected]

LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.

The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.

Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.

For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.

An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.

Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.

In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).

“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.

[email protected]

Review the PDF of the fact sheet on vulvar diseases with board-relevant, easy-to-review material. This fact sheet is the second of 2 parts covering a wide spectrum of vulvar diseases from lichen sclerosus to vulvodynia.

After, test your knowledge by answering the 5 practice questions.

 

Practice Questions

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 

2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 
2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

Review the PDF of the fact sheet on vulvar diseases with board-relevant, easy-to-review material. This fact sheet is the second of 2 parts covering a wide spectrum of vulvar diseases from lichen sclerosus to vulvodynia.

After, test your knowledge by answering the 5 practice questions.

 

Practice Questions

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 

2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 
2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

Review the PDF of the fact sheet on vulvar diseases with board-relevant, easy-to-review material. This fact sheet is the second of 2 parts covering a wide spectrum of vulvar diseases from lichen sclerosus to vulvodynia.

After, test your knowledge by answering the 5 practice questions.

 

Practice Questions

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 

2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 
2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

 

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

 

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

Patients with bipolar disorder who perceive their overall physical health as poor experience worse disease outcomes, according to Emily E. Bernstein of Harvard University, Cambridge, Mass., and her associates.

Data were collected from the Systematic Treatment Enhancement Program for Bipolar Disorder and were analyzed via the Short Form Health Survey (SF-36). An increased sense of role limitation increased the risk of depressive symptoms, while increased physical pain raised the risk of mania/hypomania. “Reports of specific or concrete physical limitations in daily life showed no associations with psychiatric symptoms at concurrent assessments, but did predict worse course of illness” 1 year later, the researchers wrote.

“Though further research is warranted, changes in subjective physical health–related quality of life, even independent of objective health changes, may offer important insight into global well-being and be targets of psychotherapy treatment,” they concluded.

Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.052).

[email protected]

Patients with bipolar disorder who perceive their overall physical health as poor experience worse disease outcomes, according to Emily E. Bernstein of Harvard University, Cambridge, Mass., and her associates.

Data were collected from the Systematic Treatment Enhancement Program for Bipolar Disorder and were analyzed via the Short Form Health Survey (SF-36). An increased sense of role limitation increased the risk of depressive symptoms, while increased physical pain raised the risk of mania/hypomania. “Reports of specific or concrete physical limitations in daily life showed no associations with psychiatric symptoms at concurrent assessments, but did predict worse course of illness” 1 year later, the researchers wrote.

“Though further research is warranted, changes in subjective physical health–related quality of life, even independent of objective health changes, may offer important insight into global well-being and be targets of psychotherapy treatment,” they concluded.

Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.052).

[email protected]

Patients with bipolar disorder who perceive their overall physical health as poor experience worse disease outcomes, according to Emily E. Bernstein of Harvard University, Cambridge, Mass., and her associates.

Data were collected from the Systematic Treatment Enhancement Program for Bipolar Disorder and were analyzed via the Short Form Health Survey (SF-36). An increased sense of role limitation increased the risk of depressive symptoms, while increased physical pain raised the risk of mania/hypomania. “Reports of specific or concrete physical limitations in daily life showed no associations with psychiatric symptoms at concurrent assessments, but did predict worse course of illness” 1 year later, the researchers wrote.

“Though further research is warranted, changes in subjective physical health–related quality of life, even independent of objective health changes, may offer important insight into global well-being and be targets of psychotherapy treatment,” they concluded.

Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.052).

[email protected]

The U.S. Food and Drug Administration has provided its first approval of a coagulation factor replacement drug specifically for patients with hereditary Factor X deficiency who are aged 12 years or older, the FDA said in a written statement. Typically, patients with this inherited disorder are treated with plasma-derived prothrombin complex concentrates.

Coagadex, the new coagulation factor replacement drug, was effective at controlling bleeding episodes in individuals with moderate to severe hereditary Factor X deficiency, in a 16-patient study. Prior to being treated with the purified Factor X concentrate, the study’s participants had the following types of bleeding episodes: spontaneous; traumatic; or heavy menstrual.

Researchers also conducted a smaller study of the drug’s effectiveness on patients who were undergoing surgery. In this research project, Coagadex was successful at controlling blood loss during and after surgery, in those patients with mild hereditary Factor X deficiency.

“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in the release.

Bio Products Laboratory manufactured the new drug.

[email protected]

The U.S. Food and Drug Administration has provided its first approval of a coagulation factor replacement drug specifically for patients with hereditary Factor X deficiency who are aged 12 years or older, the FDA said in a written statement. Typically, patients with this inherited disorder are treated with plasma-derived prothrombin complex concentrates.

Coagadex, the new coagulation factor replacement drug, was effective at controlling bleeding episodes in individuals with moderate to severe hereditary Factor X deficiency, in a 16-patient study. Prior to being treated with the purified Factor X concentrate, the study’s participants had the following types of bleeding episodes: spontaneous; traumatic; or heavy menstrual.

Researchers also conducted a smaller study of the drug’s effectiveness on patients who were undergoing surgery. In this research project, Coagadex was successful at controlling blood loss during and after surgery, in those patients with mild hereditary Factor X deficiency.

“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in the release.

Bio Products Laboratory manufactured the new drug.

[email protected]

The U.S. Food and Drug Administration has provided its first approval of a coagulation factor replacement drug specifically for patients with hereditary Factor X deficiency who are aged 12 years or older, the FDA said in a written statement. Typically, patients with this inherited disorder are treated with plasma-derived prothrombin complex concentrates.

Coagadex, the new coagulation factor replacement drug, was effective at controlling bleeding episodes in individuals with moderate to severe hereditary Factor X deficiency, in a 16-patient study. Prior to being treated with the purified Factor X concentrate, the study’s participants had the following types of bleeding episodes: spontaneous; traumatic; or heavy menstrual.

Researchers also conducted a smaller study of the drug’s effectiveness on patients who were undergoing surgery. In this research project, Coagadex was successful at controlling blood loss during and after surgery, in those patients with mild hereditary Factor X deficiency.

“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in the release.

Bio Products Laboratory manufactured the new drug.

[email protected]

Lake BUENA VISTA, FLA. – Pazopanib is an effective therapy for advanced thyroid cancer, but at present, there seems to be no way to predict which patients will respond to it.

An investigation into the predictive value of thyroglobulin found that the level during treatment did change, but it did so in parallel with response; there was no way to use the protein to parse out which patients would do well, Dr. Keith Bible said at the International Thyroid Congress.

“We had hoped that it might be a predictor as early as 4 weeks, so we could assign patients into categories of response and perhaps stop treatment earlier,” said Dr. Bible of the Mayo Clinic, Rochester, Minn. “Unfortunately, there was no way to do that.”

Pazopanib (Votrient) is a tyrosine kinase inhibitor of vascular endothelial growth factor receptors. It is approved for advanced soft tissue sarcoma and advanced renal cell carcinoma. The Mayo Clinic Consortium has been investigating pazopanib in phase II trials for advanced differentiated and medullary thyroid cancers. In a 2010 report, it was shown to induce at least a partial response in about half of the patients who received it (Lancet Oncol. 2010 Oct;11[10]:962-72).

Last year, it was also shown to be effective in advanced medullary thyroid cancer. Five of 35 patients attained partial Response Evaluation Criteria In Solid Tumors (RECIST) responses (14%) (J Clin Endocrinol Metab. 2014 May;99[5]:1687-93).

The drug has not been successful in treating advanced anaplastic thyroid cancer, however.

Because of pazopanib’s proclivity to induce sometimes-severe hypertension, investigators were hoping for some way to stratify potential responders. Thyroglobulin levels could be one marker, Dr. Bible said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

He and the consortium investigators examined how thyroglobulin levels correlated with RECIST scores in 60 patients with metastatic differentiated thyroid cancers. The patients received a median of 10 cycles, but the range was wide (1-53 cycles). Most of them (92%) had already received systemic therapy, including a tyrosine kinase inhibitor and/or radioactive iodine.

The most common side effect was hypertension, which occurred in 75% patients, and was severe in 23%. Of those with a severe reaction, 53% required a new prescription for an antihypertensive medication. No one left the study or required a pazopanib dose reduction because of a blood pressure elevation, however. “We responded with a aggressive treatment, but it was a prominent issue,” Dr. Bible said.

Other adverse events were fatigue (83%; 8% severe); decrease in neutrophils (47%; 8% severe); diarrhea (78%; 7% severe); hand-foot syndrome (17%; 7% severe); and elevations of liver enzymes (53%; 6% severe). There were no deaths related to the study drug.

Partial RECIST responses occurred in 22 patients (37%). Thyroglobulin change did not differ by response after cycle 1, although its nadir was lower among patients who attained a partial response than among those who maintained disease stability (–87% vs. –69%).

“There was this correlation of nadir with maximum RECIST response, but this occurred in parallel with the response, so it was not capable of providing a prediction of response,” Dr. Bible said.

Prior therapy also was not a response predictor, he added.

Genomic profiling was available for 16 patients; of these, 11 had mutations of BRAF, p53, JAK3 or HRAS. Thyroglobulin change and response to treatment was not significantly correlated with any of these mutations. Nor did it correlate with any type of prior tumor therapy.

The finding that pazopanib can benefit patients previously treated with a kinase inhibitor is an interesting one, Dr. Bible noted.

“Most kinase inhibitors are very promiscuous – they work on a number of pathways and have a footprint which is very messy. Most of them seem to have some activity in differentiated thyroid cancer, but we are still struggling to understand how that footprint varies. In theory they are all targeting VEGF receptors, but it’s striking that we can go from one kinase inhibitor to the next and still get a response.”

Dr. Bible had no financial declarations.

[email protected]

On Twitter @Alz_Gal

Lake BUENA VISTA, FLA. – Pazopanib is an effective therapy for advanced thyroid cancer, but at present, there seems to be no way to predict which patients will respond to it.

An investigation into the predictive value of thyroglobulin found that the level during treatment did change, but it did so in parallel with response; there was no way to use the protein to parse out which patients would do well, Dr. Keith Bible said at the International Thyroid Congress.

“We had hoped that it might be a predictor as early as 4 weeks, so we could assign patients into categories of response and perhaps stop treatment earlier,” said Dr. Bible of the Mayo Clinic, Rochester, Minn. “Unfortunately, there was no way to do that.”

Pazopanib (Votrient) is a tyrosine kinase inhibitor of vascular endothelial growth factor receptors. It is approved for advanced soft tissue sarcoma and advanced renal cell carcinoma. The Mayo Clinic Consortium has been investigating pazopanib in phase II trials for advanced differentiated and medullary thyroid cancers. In a 2010 report, it was shown to induce at least a partial response in about half of the patients who received it (Lancet Oncol. 2010 Oct;11[10]:962-72).

Last year, it was also shown to be effective in advanced medullary thyroid cancer. Five of 35 patients attained partial Response Evaluation Criteria In Solid Tumors (RECIST) responses (14%) (J Clin Endocrinol Metab. 2014 May;99[5]:1687-93).

The drug has not been successful in treating advanced anaplastic thyroid cancer, however.

Because of pazopanib’s proclivity to induce sometimes-severe hypertension, investigators were hoping for some way to stratify potential responders. Thyroglobulin levels could be one marker, Dr. Bible said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

He and the consortium investigators examined how thyroglobulin levels correlated with RECIST scores in 60 patients with metastatic differentiated thyroid cancers. The patients received a median of 10 cycles, but the range was wide (1-53 cycles). Most of them (92%) had already received systemic therapy, including a tyrosine kinase inhibitor and/or radioactive iodine.

The most common side effect was hypertension, which occurred in 75% patients, and was severe in 23%. Of those with a severe reaction, 53% required a new prescription for an antihypertensive medication. No one left the study or required a pazopanib dose reduction because of a blood pressure elevation, however. “We responded with a aggressive treatment, but it was a prominent issue,” Dr. Bible said.

Other adverse events were fatigue (83%; 8% severe); decrease in neutrophils (47%; 8% severe); diarrhea (78%; 7% severe); hand-foot syndrome (17%; 7% severe); and elevations of liver enzymes (53%; 6% severe). There were no deaths related to the study drug.

Partial RECIST responses occurred in 22 patients (37%). Thyroglobulin change did not differ by response after cycle 1, although its nadir was lower among patients who attained a partial response than among those who maintained disease stability (–87% vs. –69%).

“There was this correlation of nadir with maximum RECIST response, but this occurred in parallel with the response, so it was not capable of providing a prediction of response,” Dr. Bible said.

Prior therapy also was not a response predictor, he added.

Genomic profiling was available for 16 patients; of these, 11 had mutations of BRAF, p53, JAK3 or HRAS. Thyroglobulin change and response to treatment was not significantly correlated with any of these mutations. Nor did it correlate with any type of prior tumor therapy.

The finding that pazopanib can benefit patients previously treated with a kinase inhibitor is an interesting one, Dr. Bible noted.

“Most kinase inhibitors are very promiscuous – they work on a number of pathways and have a footprint which is very messy. Most of them seem to have some activity in differentiated thyroid cancer, but we are still struggling to understand how that footprint varies. In theory they are all targeting VEGF receptors, but it’s striking that we can go from one kinase inhibitor to the next and still get a response.”

Dr. Bible had no financial declarations.

[email protected]

On Twitter @Alz_Gal

Lake BUENA VISTA, FLA. – Pazopanib is an effective therapy for advanced thyroid cancer, but at present, there seems to be no way to predict which patients will respond to it.

An investigation into the predictive value of thyroglobulin found that the level during treatment did change, but it did so in parallel with response; there was no way to use the protein to parse out which patients would do well, Dr. Keith Bible said at the International Thyroid Congress.

“We had hoped that it might be a predictor as early as 4 weeks, so we could assign patients into categories of response and perhaps stop treatment earlier,” said Dr. Bible of the Mayo Clinic, Rochester, Minn. “Unfortunately, there was no way to do that.”

Pazopanib (Votrient) is a tyrosine kinase inhibitor of vascular endothelial growth factor receptors. It is approved for advanced soft tissue sarcoma and advanced renal cell carcinoma. The Mayo Clinic Consortium has been investigating pazopanib in phase II trials for advanced differentiated and medullary thyroid cancers. In a 2010 report, it was shown to induce at least a partial response in about half of the patients who received it (Lancet Oncol. 2010 Oct;11[10]:962-72).

Last year, it was also shown to be effective in advanced medullary thyroid cancer. Five of 35 patients attained partial Response Evaluation Criteria In Solid Tumors (RECIST) responses (14%) (J Clin Endocrinol Metab. 2014 May;99[5]:1687-93).

The drug has not been successful in treating advanced anaplastic thyroid cancer, however.

Because of pazopanib’s proclivity to induce sometimes-severe hypertension, investigators were hoping for some way to stratify potential responders. Thyroglobulin levels could be one marker, Dr. Bible said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

He and the consortium investigators examined how thyroglobulin levels correlated with RECIST scores in 60 patients with metastatic differentiated thyroid cancers. The patients received a median of 10 cycles, but the range was wide (1-53 cycles). Most of them (92%) had already received systemic therapy, including a tyrosine kinase inhibitor and/or radioactive iodine.

The most common side effect was hypertension, which occurred in 75% patients, and was severe in 23%. Of those with a severe reaction, 53% required a new prescription for an antihypertensive medication. No one left the study or required a pazopanib dose reduction because of a blood pressure elevation, however. “We responded with a aggressive treatment, but it was a prominent issue,” Dr. Bible said.

Other adverse events were fatigue (83%; 8% severe); decrease in neutrophils (47%; 8% severe); diarrhea (78%; 7% severe); hand-foot syndrome (17%; 7% severe); and elevations of liver enzymes (53%; 6% severe). There were no deaths related to the study drug.

Partial RECIST responses occurred in 22 patients (37%). Thyroglobulin change did not differ by response after cycle 1, although its nadir was lower among patients who attained a partial response than among those who maintained disease stability (–87% vs. –69%).

“There was this correlation of nadir with maximum RECIST response, but this occurred in parallel with the response, so it was not capable of providing a prediction of response,” Dr. Bible said.

Prior therapy also was not a response predictor, he added.

Genomic profiling was available for 16 patients; of these, 11 had mutations of BRAF, p53, JAK3 or HRAS. Thyroglobulin change and response to treatment was not significantly correlated with any of these mutations. Nor did it correlate with any type of prior tumor therapy.

The finding that pazopanib can benefit patients previously treated with a kinase inhibitor is an interesting one, Dr. Bible noted.

“Most kinase inhibitors are very promiscuous – they work on a number of pathways and have a footprint which is very messy. Most of them seem to have some activity in differentiated thyroid cancer, but we are still struggling to understand how that footprint varies. In theory they are all targeting VEGF receptors, but it’s striking that we can go from one kinase inhibitor to the next and still get a response.”

Dr. Bible had no financial declarations.

[email protected]

On Twitter @Alz_Gal

LAKE BUENA VISTA, FLA. – Most patients with differentiated thyroid cancer who had shown progression on previous courses of targeted chemotherapy either maintained stable disease or responded to the oral multikinase inhibitor cabozantinib (Cometriq), according to a small multicenter phase II trial presented at the International Thyroid Congress.

This is important, according to Dr. Manisha H. Shah, because there has been no standard of care for patients with differentiated thyroid cancer whose cancer progresses on first- or second-line vascular endothelial growth factor receptor (VEGFR) inhibitors.

Nine of the 25 enrolled patients (36%; 95% confidence interval, 18%-57%) showed confirmed partial response, 12 patients (48%) had stable disease, and one patient had disease progression, according to Dr. Shah, director of the neuroendocrine tumor program at Ohio State University’s Wexner Medical Center. The trial enrolled patients with radioiodine–refractory differentiated thyroid cancer who had progression of their disease after one or two previous VEGFR agents.

©SciePro/Science Source

Cabozantinib targets VEGFR and MET and is approved as first-line treatment for medullary thyroid cancer. The majority of the response to cabozantinib occurs in the first several months of treatment, so the study used a Simon minimax two-stage design, enrolling an initial 16 patients, then opening enrollment to an additional 9 when at least 2 of the initial cohort showed partial or complete response within the first 6 months.

The primary outcome measure was the number of patients showing objective response (partial or complete response) within the first 6 months of therapy.

Median patient age was 64 years, and 64% of patients were male. Just over half of the patients previously had been treated with sorafenib, and just over a quarter had received pazopanib. Five patients had received two previous VEGFR-targeted therapies, while the remaining 20 had received one.

Nine patients (36%) had papillary thyroid cancer, seven (28%) had poorly differentiated thyroid cancer, five (20%) had Hurthle cell cancer, and four (16%) had follicular thyroid cancer. The most common metastasis sites were lymph node, bone, and lung.

Patients received continuous treatment until they showed disease progression, had an unacceptable adverse event or an illness precluding further treatment, or withdrew consent.

Disease progression was measured by serum tumor markers and CT or MRI scan every 8 weeks while in the study; patients also received bone scans and ¹⁸F-FDG and ¹⁸F-fluoride PET scans before the study and while in the study.

Side effects were common and generally mild, with two instances each of grade 3 events related to fatigue, hand-foot skin reactions, and diarrhea. One death occurred and was adjudicated as possibly study related; there were no grade 4 events, and no grade 3 bleeding events.

Dr. Shah noted that the starting cabozantinib dose of 60 mg/day was considerably lower than that used in previous trials for thyroid cancer. With time, investigators have learned that the sometimes debilitating side effects of cabozantinib are somewhat dose dependent, she noted. The study design permitted dose escalation to 80 mg for nonresponders to the lower dose, and permitted a decrease to 40 or 20 mg/day as needed to manage side effects. Investigators were able to tell the patients what to expect, and to be proactive in anticipating side effects. “We have learned to manage these drugs much better with time,” she said.

“Cabozantinib was effective in inducing a durable partial response,” said Dr. Shah. Future directions, in addition to phase III clinical trials, may include combining cabozantinib with immune checkpoint–targeted therapies such as lenvatinib, a strategy that has been effective for other cancers, she said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The multisite study was sponsored by the National Cancer Institute with participation by eight International Thyroid Oncology Group centers. Dr. Shah reported being on the advisory board for Exelixis and Eisai, and receiving research funding from those two organizations and Bayer.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Most patients with differentiated thyroid cancer who had shown progression on previous courses of targeted chemotherapy either maintained stable disease or responded to the oral multikinase inhibitor cabozantinib (Cometriq), according to a small multicenter phase II trial presented at the International Thyroid Congress.

This is important, according to Dr. Manisha H. Shah, because there has been no standard of care for patients with differentiated thyroid cancer whose cancer progresses on first- or second-line vascular endothelial growth factor receptor (VEGFR) inhibitors.

Nine of the 25 enrolled patients (36%; 95% confidence interval, 18%-57%) showed confirmed partial response, 12 patients (48%) had stable disease, and one patient had disease progression, according to Dr. Shah, director of the neuroendocrine tumor program at Ohio State University’s Wexner Medical Center. The trial enrolled patients with radioiodine–refractory differentiated thyroid cancer who had progression of their disease after one or two previous VEGFR agents.

©SciePro/Science Source

Cabozantinib targets VEGFR and MET and is approved as first-line treatment for medullary thyroid cancer. The majority of the response to cabozantinib occurs in the first several months of treatment, so the study used a Simon minimax two-stage design, enrolling an initial 16 patients, then opening enrollment to an additional 9 when at least 2 of the initial cohort showed partial or complete response within the first 6 months.

The primary outcome measure was the number of patients showing objective response (partial or complete response) within the first 6 months of therapy.

Median patient age was 64 years, and 64% of patients were male. Just over half of the patients previously had been treated with sorafenib, and just over a quarter had received pazopanib. Five patients had received two previous VEGFR-targeted therapies, while the remaining 20 had received one.

Nine patients (36%) had papillary thyroid cancer, seven (28%) had poorly differentiated thyroid cancer, five (20%) had Hurthle cell cancer, and four (16%) had follicular thyroid cancer. The most common metastasis sites were lymph node, bone, and lung.

Patients received continuous treatment until they showed disease progression, had an unacceptable adverse event or an illness precluding further treatment, or withdrew consent.

Disease progression was measured by serum tumor markers and CT or MRI scan every 8 weeks while in the study; patients also received bone scans and ¹⁸F-FDG and ¹⁸F-fluoride PET scans before the study and while in the study.

Side effects were common and generally mild, with two instances each of grade 3 events related to fatigue, hand-foot skin reactions, and diarrhea. One death occurred and was adjudicated as possibly study related; there were no grade 4 events, and no grade 3 bleeding events.

Dr. Shah noted that the starting cabozantinib dose of 60 mg/day was considerably lower than that used in previous trials for thyroid cancer. With time, investigators have learned that the sometimes debilitating side effects of cabozantinib are somewhat dose dependent, she noted. The study design permitted dose escalation to 80 mg for nonresponders to the lower dose, and permitted a decrease to 40 or 20 mg/day as needed to manage side effects. Investigators were able to tell the patients what to expect, and to be proactive in anticipating side effects. “We have learned to manage these drugs much better with time,” she said.

“Cabozantinib was effective in inducing a durable partial response,” said Dr. Shah. Future directions, in addition to phase III clinical trials, may include combining cabozantinib with immune checkpoint–targeted therapies such as lenvatinib, a strategy that has been effective for other cancers, she said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The multisite study was sponsored by the National Cancer Institute with participation by eight International Thyroid Oncology Group centers. Dr. Shah reported being on the advisory board for Exelixis and Eisai, and receiving research funding from those two organizations and Bayer.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Most patients with differentiated thyroid cancer who had shown progression on previous courses of targeted chemotherapy either maintained stable disease or responded to the oral multikinase inhibitor cabozantinib (Cometriq), according to a small multicenter phase II trial presented at the International Thyroid Congress.

This is important, according to Dr. Manisha H. Shah, because there has been no standard of care for patients with differentiated thyroid cancer whose cancer progresses on first- or second-line vascular endothelial growth factor receptor (VEGFR) inhibitors.

Nine of the 25 enrolled patients (36%; 95% confidence interval, 18%-57%) showed confirmed partial response, 12 patients (48%) had stable disease, and one patient had disease progression, according to Dr. Shah, director of the neuroendocrine tumor program at Ohio State University’s Wexner Medical Center. The trial enrolled patients with radioiodine–refractory differentiated thyroid cancer who had progression of their disease after one or two previous VEGFR agents.

©SciePro/Science Source

Cabozantinib targets VEGFR and MET and is approved as first-line treatment for medullary thyroid cancer. The majority of the response to cabozantinib occurs in the first several months of treatment, so the study used a Simon minimax two-stage design, enrolling an initial 16 patients, then opening enrollment to an additional 9 when at least 2 of the initial cohort showed partial or complete response within the first 6 months.

The primary outcome measure was the number of patients showing objective response (partial or complete response) within the first 6 months of therapy.

Median patient age was 64 years, and 64% of patients were male. Just over half of the patients previously had been treated with sorafenib, and just over a quarter had received pazopanib. Five patients had received two previous VEGFR-targeted therapies, while the remaining 20 had received one.

Nine patients (36%) had papillary thyroid cancer, seven (28%) had poorly differentiated thyroid cancer, five (20%) had Hurthle cell cancer, and four (16%) had follicular thyroid cancer. The most common metastasis sites were lymph node, bone, and lung.

Patients received continuous treatment until they showed disease progression, had an unacceptable adverse event or an illness precluding further treatment, or withdrew consent.

Disease progression was measured by serum tumor markers and CT or MRI scan every 8 weeks while in the study; patients also received bone scans and ¹⁸F-FDG and ¹⁸F-fluoride PET scans before the study and while in the study.

Side effects were common and generally mild, with two instances each of grade 3 events related to fatigue, hand-foot skin reactions, and diarrhea. One death occurred and was adjudicated as possibly study related; there were no grade 4 events, and no grade 3 bleeding events.

Dr. Shah noted that the starting cabozantinib dose of 60 mg/day was considerably lower than that used in previous trials for thyroid cancer. With time, investigators have learned that the sometimes debilitating side effects of cabozantinib are somewhat dose dependent, she noted. The study design permitted dose escalation to 80 mg for nonresponders to the lower dose, and permitted a decrease to 40 or 20 mg/day as needed to manage side effects. Investigators were able to tell the patients what to expect, and to be proactive in anticipating side effects. “We have learned to manage these drugs much better with time,” she said.

“Cabozantinib was effective in inducing a durable partial response,” said Dr. Shah. Future directions, in addition to phase III clinical trials, may include combining cabozantinib with immune checkpoint–targeted therapies such as lenvatinib, a strategy that has been effective for other cancers, she said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The multisite study was sponsored by the National Cancer Institute with participation by eight International Thyroid Oncology Group centers. Dr. Shah reported being on the advisory board for Exelixis and Eisai, and receiving research funding from those two organizations and Bayer.

[email protected]

On Twitter @karioakes

HONOLULU – Obese patients who develop an upper GI bleed receive more treatment, are more likely to develop hemorrhagic shock, and are more likely to require admission to an intensive care unit than those who are not obese, but they do not have higher in-hospital mortality, according to analysis of a large national database that was presented at the annual meeting of the American College of Gastroenterology.

The significantly greater odds ratio of most major complications from upper GI bleeds in patients with obesity relative to those who are not obese was expected but so was an increased rate of in-hospital mortality, according to the first author of the study, Dr. Marwan S. Abou Gergi of Catalyst Medical Consulting, Baltimore.

Courtesy Wikimedia Commons/Med Chaos/Creative Commons 1.0

“In this study, patients with obesity received more frequent endoscopic interventions, which could explain why mortality rates were not significantly higher,” Dr. Abou Gergi reported.

In the analysis, characterized as the first study to evaluate the impact of obesity on outcomes in upper GI hemorrhage, data were drawn from the 2012 Nationwide Inpatient Sample database, which is considered to provide a representative sample of U.S. hospital experience. Drawn from more than 7 million hospitalizations, the study focused on patients 18 or over with a primary ICD-9 code for upper GI hemorrhage. The primary outcome was mortality. Secondary outcomes included interventions, ICU admissions, and length of stay.

Of the 132,545 discharges with upper GI hemorrhage, 11,220 (8.5%) were identified as obese. The in-hospital mortality overall was 1.97%, but the proportion of those who died was slightly lower among patients identified as obese, producing a nonsignificant adjusted odds ratio (OR) of 0.87 (P greater than .1). Yet the rates of hemorrhage shock (OR 1.31; P = .02) and admission to the ICU (OR 1.35; P less than .02) were greater in the obese. The median length of stay of 0.35 days for obese patients was also significantly longer.

One reason for the lower rate of mortality may be more aggressive treatment. In particular, repeat endoscopy therapy was more common in those who were obese (P less than .01), suggesting, “Our treatments are working,” Dr. Abou Gergi said.

The proportion of patients with a score of 3 or greater on the Charlson comorbidity index was higher in the obese than in those not identified as obese (49% vs. 39%; P less than .01). This along with previously published evidence that obese patients take more anticoagulants, take more antiplatelets, and may face delays in endoscopy due to greater difficulty in administering sedation, were among considerations predicting a higher mortality, according to Dr. Abou Gergi.

However, there are several potential explanations for these unexpected findings. One is that mortality rates overall were low, making it difficult to show differences on this outcome. In addition, ICD-9 codes may be effective for isolating a group with obesity but not in identifying a control group without obesity.

“It is likely that not all patients who are obese received this code, so we may be seeing a population of obese patients be compared to another population that includes at least some patients who also have obesity,” explained Dr. John R. Saltzman, director of endoscopy, Brigham and Women’s Hospital, Boston. A coauthor of this study, Dr. Saltzman noted that despite a comparable rate of in-hospital mortality, most of the findings in the study argued that patients who develop upper GI bleeding have a more difficult course. He noted that this is reflected in the cost of care, which was significantly higher in those who were obese.

Although he acknowledged that he was surprised that this was “essentially a negative study,” he believes that mortality may have been “too tough” as a primary endpoint for demonstrating a difference. However, he also believes that it may be appropriate to give credit for effective treatments.

“I think that may be the key. We are just getting better at taking care of these patients,” Dr. Saltzman said.

Dr. Abou Gergi reported he has no relevant financial relationships.

HONOLULU – Obese patients who develop an upper GI bleed receive more treatment, are more likely to develop hemorrhagic shock, and are more likely to require admission to an intensive care unit than those who are not obese, but they do not have higher in-hospital mortality, according to analysis of a large national database that was presented at the annual meeting of the American College of Gastroenterology.

The significantly greater odds ratio of most major complications from upper GI bleeds in patients with obesity relative to those who are not obese was expected but so was an increased rate of in-hospital mortality, according to the first author of the study, Dr. Marwan S. Abou Gergi of Catalyst Medical Consulting, Baltimore.

Courtesy Wikimedia Commons/Med Chaos/Creative Commons 1.0

“In this study, patients with obesity received more frequent endoscopic interventions, which could explain why mortality rates were not significantly higher,” Dr. Abou Gergi reported.

In the analysis, characterized as the first study to evaluate the impact of obesity on outcomes in upper GI hemorrhage, data were drawn from the 2012 Nationwide Inpatient Sample database, which is considered to provide a representative sample of U.S. hospital experience. Drawn from more than 7 million hospitalizations, the study focused on patients 18 or over with a primary ICD-9 code for upper GI hemorrhage. The primary outcome was mortality. Secondary outcomes included interventions, ICU admissions, and length of stay.

Of the 132,545 discharges with upper GI hemorrhage, 11,220 (8.5%) were identified as obese. The in-hospital mortality overall was 1.97%, but the proportion of those who died was slightly lower among patients identified as obese, producing a nonsignificant adjusted odds ratio (OR) of 0.87 (P greater than .1). Yet the rates of hemorrhage shock (OR 1.31; P = .02) and admission to the ICU (OR 1.35; P less than .02) were greater in the obese. The median length of stay of 0.35 days for obese patients was also significantly longer.

One reason for the lower rate of mortality may be more aggressive treatment. In particular, repeat endoscopy therapy was more common in those who were obese (P less than .01), suggesting, “Our treatments are working,” Dr. Abou Gergi said.

The proportion of patients with a score of 3 or greater on the Charlson comorbidity index was higher in the obese than in those not identified as obese (49% vs. 39%; P less than .01). This along with previously published evidence that obese patients take more anticoagulants, take more antiplatelets, and may face delays in endoscopy due to greater difficulty in administering sedation, were among considerations predicting a higher mortality, according to Dr. Abou Gergi.

However, there are several potential explanations for these unexpected findings. One is that mortality rates overall were low, making it difficult to show differences on this outcome. In addition, ICD-9 codes may be effective for isolating a group with obesity but not in identifying a control group without obesity.

“It is likely that not all patients who are obese received this code, so we may be seeing a population of obese patients be compared to another population that includes at least some patients who also have obesity,” explained Dr. John R. Saltzman, director of endoscopy, Brigham and Women’s Hospital, Boston. A coauthor of this study, Dr. Saltzman noted that despite a comparable rate of in-hospital mortality, most of the findings in the study argued that patients who develop upper GI bleeding have a more difficult course. He noted that this is reflected in the cost of care, which was significantly higher in those who were obese.

Although he acknowledged that he was surprised that this was “essentially a negative study,” he believes that mortality may have been “too tough” as a primary endpoint for demonstrating a difference. However, he also believes that it may be appropriate to give credit for effective treatments.

“I think that may be the key. We are just getting better at taking care of these patients,” Dr. Saltzman said.

Dr. Abou Gergi reported he has no relevant financial relationships.

HONOLULU – Obese patients who develop an upper GI bleed receive more treatment, are more likely to develop hemorrhagic shock, and are more likely to require admission to an intensive care unit than those who are not obese, but they do not have higher in-hospital mortality, according to analysis of a large national database that was presented at the annual meeting of the American College of Gastroenterology.

The significantly greater odds ratio of most major complications from upper GI bleeds in patients with obesity relative to those who are not obese was expected but so was an increased rate of in-hospital mortality, according to the first author of the study, Dr. Marwan S. Abou Gergi of Catalyst Medical Consulting, Baltimore.

Courtesy Wikimedia Commons/Med Chaos/Creative Commons 1.0

“In this study, patients with obesity received more frequent endoscopic interventions, which could explain why mortality rates were not significantly higher,” Dr. Abou Gergi reported.

In the analysis, characterized as the first study to evaluate the impact of obesity on outcomes in upper GI hemorrhage, data were drawn from the 2012 Nationwide Inpatient Sample database, which is considered to provide a representative sample of U.S. hospital experience. Drawn from more than 7 million hospitalizations, the study focused on patients 18 or over with a primary ICD-9 code for upper GI hemorrhage. The primary outcome was mortality. Secondary outcomes included interventions, ICU admissions, and length of stay.

Of the 132,545 discharges with upper GI hemorrhage, 11,220 (8.5%) were identified as obese. The in-hospital mortality overall was 1.97%, but the proportion of those who died was slightly lower among patients identified as obese, producing a nonsignificant adjusted odds ratio (OR) of 0.87 (P greater than .1). Yet the rates of hemorrhage shock (OR 1.31; P = .02) and admission to the ICU (OR 1.35; P less than .02) were greater in the obese. The median length of stay of 0.35 days for obese patients was also significantly longer.

One reason for the lower rate of mortality may be more aggressive treatment. In particular, repeat endoscopy therapy was more common in those who were obese (P less than .01), suggesting, “Our treatments are working,” Dr. Abou Gergi said.

The proportion of patients with a score of 3 or greater on the Charlson comorbidity index was higher in the obese than in those not identified as obese (49% vs. 39%; P less than .01). This along with previously published evidence that obese patients take more anticoagulants, take more antiplatelets, and may face delays in endoscopy due to greater difficulty in administering sedation, were among considerations predicting a higher mortality, according to Dr. Abou Gergi.

However, there are several potential explanations for these unexpected findings. One is that mortality rates overall were low, making it difficult to show differences on this outcome. In addition, ICD-9 codes may be effective for isolating a group with obesity but not in identifying a control group without obesity.

“It is likely that not all patients who are obese received this code, so we may be seeing a population of obese patients be compared to another population that includes at least some patients who also have obesity,” explained Dr. John R. Saltzman, director of endoscopy, Brigham and Women’s Hospital, Boston. A coauthor of this study, Dr. Saltzman noted that despite a comparable rate of in-hospital mortality, most of the findings in the study argued that patients who develop upper GI bleeding have a more difficult course. He noted that this is reflected in the cost of care, which was significantly higher in those who were obese.

Although he acknowledged that he was surprised that this was “essentially a negative study,” he believes that mortality may have been “too tough” as a primary endpoint for demonstrating a difference. However, he also believes that it may be appropriate to give credit for effective treatments.

“I think that may be the key. We are just getting better at taking care of these patients,” Dr. Saltzman said.

Dr. Abou Gergi reported he has no relevant financial relationships.

The UK’s National Institute for Health and Care Excellence (NICE) is asking for views on its plans to recommend a device that automatically replaces sickled red blood cells (RBCs) with healthy RBCs in patients with sickle cell disease (SCD).

NICE has issued a draft medical technology guidance supporting use of the Spectra Optia Apheresis System for automated RBC exchange in patients with SCD who need regular transfusions.

The guidance is open for comment until November 16.

The Spectra Optia system is made up of 3 components: the apheresis machine, embedded software, and a single-use disposable blood tubing set. The system is manufactured by Terumo.

NICE said the evidence examined indicates that the Spectra Optia system speeds up the process of RBC exchange compared to manual RBC exchange.

The evidence also suggests that patients require RBC exchange less frequently when using this system than they do with manual RBC exchange.

Furthermore, the Spectra Optia system is estimated to provide cost savings for most patients, when compared to manual RBC exchange or top-up transfusion.

Potential savings depend on the patient’s clinical circumstance and if devices already owned by the National Health Service can also be used to treat SCD.

However, NICE’s draft guidance also highlights a need for additional data on treatment outcomes, as there is limited clinical evidence for some outcomes.

“In particular, the independent Medical Technologies Advisory Committee would like to see long-term data on how manual and automated cell exchange affects the amount of iron in the body and the need to treat this complication,” said Carole Longson, director of the NICE Centre for Health Technology Evaluation. “We welcome comments on the draft guidance as part of this consultation.”

The UK’s National Institute for Health and Care Excellence (NICE) is asking for views on its plans to recommend a device that automatically replaces sickled red blood cells (RBCs) with healthy RBCs in patients with sickle cell disease (SCD).

NICE has issued a draft medical technology guidance supporting use of the Spectra Optia Apheresis System for automated RBC exchange in patients with SCD who need regular transfusions.

The guidance is open for comment until November 16.

The Spectra Optia system is made up of 3 components: the apheresis machine, embedded software, and a single-use disposable blood tubing set. The system is manufactured by Terumo.

NICE said the evidence examined indicates that the Spectra Optia system speeds up the process of RBC exchange compared to manual RBC exchange.

The evidence also suggests that patients require RBC exchange less frequently when using this system than they do with manual RBC exchange.

Furthermore, the Spectra Optia system is estimated to provide cost savings for most patients, when compared to manual RBC exchange or top-up transfusion.

Potential savings depend on the patient’s clinical circumstance and if devices already owned by the National Health Service can also be used to treat SCD.

However, NICE’s draft guidance also highlights a need for additional data on treatment outcomes, as there is limited clinical evidence for some outcomes.

“In particular, the independent Medical Technologies Advisory Committee would like to see long-term data on how manual and automated cell exchange affects the amount of iron in the body and the need to treat this complication,” said Carole Longson, director of the NICE Centre for Health Technology Evaluation. “We welcome comments on the draft guidance as part of this consultation.”

The UK’s National Institute for Health and Care Excellence (NICE) is asking for views on its plans to recommend a device that automatically replaces sickled red blood cells (RBCs) with healthy RBCs in patients with sickle cell disease (SCD).

NICE has issued a draft medical technology guidance supporting use of the Spectra Optia Apheresis System for automated RBC exchange in patients with SCD who need regular transfusions.

The guidance is open for comment until November 16.

The Spectra Optia system is made up of 3 components: the apheresis machine, embedded software, and a single-use disposable blood tubing set. The system is manufactured by Terumo.

NICE said the evidence examined indicates that the Spectra Optia system speeds up the process of RBC exchange compared to manual RBC exchange.

The evidence also suggests that patients require RBC exchange less frequently when using this system than they do with manual RBC exchange.

Furthermore, the Spectra Optia system is estimated to provide cost savings for most patients, when compared to manual RBC exchange or top-up transfusion.

Potential savings depend on the patient’s clinical circumstance and if devices already owned by the National Health Service can also be used to treat SCD.

However, NICE’s draft guidance also highlights a need for additional data on treatment outcomes, as there is limited clinical evidence for some outcomes.

“In particular, the independent Medical Technologies Advisory Committee would like to see long-term data on how manual and automated cell exchange affects the amount of iron in the body and the need to treat this complication,” said Carole Longson, director of the NICE Centre for Health Technology Evaluation. “We welcome comments on the draft guidance as part of this consultation.”

New research indicates that drug-resistant forms of the malaria parasite Plasmodium falciparum can infect the Anopheles coluzzii mosquito (formerly Anopheles gambiae M form), which is the main transmitter of malaria in Africa.

The discovery suggests that Africa is more at risk for drug-resistant malaria infections than researchers previously thought, and this could further compromise efforts to prevent and eliminate the disease.

Rick Fairhurst, MD, PhD, of the National Institute of Allergy and Infectious Diseases in Rockville, Maryland, and his colleagues reported the discovery in Nature Communications.

The team noted that P falciparum parasites that are resistant to artemisinin, the main drug used to treat malaria, have been rapidly spreading in parts of Southeast Asia.

Malaria experts are concerned that artemisinin-resistant parasites could spread to Africa. However, there were no scientific indications to suggest these parasites could infect A coluzzii mosquitoes—until now.

Dr Fairhurst and his colleagues investigated the transmission potential of these parasites in 3 mosquito species—A coluzzii and the Southeast Asian mosquito species Anopheles dirus and Anopheles minimus.

The researchers evaluated whether these mosquitoes became infected after feeding on blood containing any of 6 artemisinin-resistant parasite strains and 3 artemisinin-sensitive parasite strains previously isolated from malaria patients in Cambodia.

The team found parasites in the mosquitoes’ midguts and salivary glands in almost all cases, showing that the artemisinin-resistant and artemisinin-sensitive Cambodian parasites can infect a variety of mosquito species.

The researchers also discovered a shared genetic background among artemisinin-resistant parasites that may enable them to infect diverse mosquito species by evading the insects’ immune systems.

This study did not show that infected mosquitoes can effectively transmit the disease to humans. However, the results support the idea that artemisinin-resistant parasites could potentially spread beyond Cambodia and to Africa, the researchers said.

They plan to investigate other potential genetic determinants of parasite infection in mosquitoes and further examine which Anopheles species from Cambodia are naturally transmitting artemisinin-resistant parasites in the wild.

New research indicates that drug-resistant forms of the malaria parasite Plasmodium falciparum can infect the Anopheles coluzzii mosquito (formerly Anopheles gambiae M form), which is the main transmitter of malaria in Africa.

The discovery suggests that Africa is more at risk for drug-resistant malaria infections than researchers previously thought, and this could further compromise efforts to prevent and eliminate the disease.

Rick Fairhurst, MD, PhD, of the National Institute of Allergy and Infectious Diseases in Rockville, Maryland, and his colleagues reported the discovery in Nature Communications.

The team noted that P falciparum parasites that are resistant to artemisinin, the main drug used to treat malaria, have been rapidly spreading in parts of Southeast Asia.

Malaria experts are concerned that artemisinin-resistant parasites could spread to Africa. However, there were no scientific indications to suggest these parasites could infect A coluzzii mosquitoes—until now.

Dr Fairhurst and his colleagues investigated the transmission potential of these parasites in 3 mosquito species—A coluzzii and the Southeast Asian mosquito species Anopheles dirus and Anopheles minimus.

The researchers evaluated whether these mosquitoes became infected after feeding on blood containing any of 6 artemisinin-resistant parasite strains and 3 artemisinin-sensitive parasite strains previously isolated from malaria patients in Cambodia.

The team found parasites in the mosquitoes’ midguts and salivary glands in almost all cases, showing that the artemisinin-resistant and artemisinin-sensitive Cambodian parasites can infect a variety of mosquito species.

The researchers also discovered a shared genetic background among artemisinin-resistant parasites that may enable them to infect diverse mosquito species by evading the insects’ immune systems.

This study did not show that infected mosquitoes can effectively transmit the disease to humans. However, the results support the idea that artemisinin-resistant parasites could potentially spread beyond Cambodia and to Africa, the researchers said.

They plan to investigate other potential genetic determinants of parasite infection in mosquitoes and further examine which Anopheles species from Cambodia are naturally transmitting artemisinin-resistant parasites in the wild.

New research indicates that drug-resistant forms of the malaria parasite Plasmodium falciparum can infect the Anopheles coluzzii mosquito (formerly Anopheles gambiae M form), which is the main transmitter of malaria in Africa.

The discovery suggests that Africa is more at risk for drug-resistant malaria infections than researchers previously thought, and this could further compromise efforts to prevent and eliminate the disease.

Rick Fairhurst, MD, PhD, of the National Institute of Allergy and Infectious Diseases in Rockville, Maryland, and his colleagues reported the discovery in Nature Communications.

The team noted that P falciparum parasites that are resistant to artemisinin, the main drug used to treat malaria, have been rapidly spreading in parts of Southeast Asia.

Malaria experts are concerned that artemisinin-resistant parasites could spread to Africa. However, there were no scientific indications to suggest these parasites could infect A coluzzii mosquitoes—until now.

Dr Fairhurst and his colleagues investigated the transmission potential of these parasites in 3 mosquito species—A coluzzii and the Southeast Asian mosquito species Anopheles dirus and Anopheles minimus.

The researchers evaluated whether these mosquitoes became infected after feeding on blood containing any of 6 artemisinin-resistant parasite strains and 3 artemisinin-sensitive parasite strains previously isolated from malaria patients in Cambodia.

The team found parasites in the mosquitoes’ midguts and salivary glands in almost all cases, showing that the artemisinin-resistant and artemisinin-sensitive Cambodian parasites can infect a variety of mosquito species.

The researchers also discovered a shared genetic background among artemisinin-resistant parasites that may enable them to infect diverse mosquito species by evading the insects’ immune systems.

This study did not show that infected mosquitoes can effectively transmit the disease to humans. However, the results support the idea that artemisinin-resistant parasites could potentially spread beyond Cambodia and to Africa, the researchers said.

They plan to investigate other potential genetic determinants of parasite infection in mosquitoes and further examine which Anopheles species from Cambodia are naturally transmitting artemisinin-resistant parasites in the wild.

Patients undergoing cardiac surgery can safely receive transfusions with older red blood cells (RBCs), according to new research.

In many countries, RBCs can be stored for as long as 6 weeks before transfusion.

But a study published in 2008 suggested that transfusing RBCs stored for more than 2 weeks could increase the risk of serious complications.

Results of subsequent studies both supported and contradicted that finding.

The new study, published in JAMA, adds to the debate. The results suggest the duration of RBC storage does not affect the risk of death or serious complications after transfusion.

“There have literally been hundreds of studies conducted on this topic the past 5 or 6 years, none of which have been able to provide a definitive answer,” said Gustaf Edgren, MD, PhD, of Karolinska Institutet in Stockholm, Sweden.

In an attempt to change that, Dr Edgren and his colleagues conducted a large-scale study of transfusions among cardiac surgery patients in Sweden. National guidelines there require that the oldest available blood unit is allocated first.

The researchers analyzed registry data on patients who underwent coronary artery bypass graft surgery, heart valve surgery, or both between 1997 and 2012.

There were 47,071 patients who received transfusions at 9 different hospitals. Of these patients, 36.6% received RBCs stored for less than 14 days, 26.8%

received RBCs stored 14 to 27 days, 8.9% received RBCs stored 28 to 42

days, and 27.8% received RBCs of mixed age.

The researchers compared these patient groups, looking at the incidence of serious complications at 30 days and mortality at 30 days, 2 years, and 10 years.

They adjusted their analyses for potential confounding factors such as sex, age, blood group, and hospital. And they found no association between RBC storage duration and mortality or serious complications.

RBC storage duration and adverse outcomes at 30 days
	RBCs stored 1-13 days (n=17,224)		14-27 days (n=12,602)		28-42 days (n=4173)
Adverse outcome	No. of events	Adjusted odds ratio (OR)	No. of events	Adjusted OR	No. of events	Adjusted OR
Acute kidney injury	202	1 (reference)	121	0.94	38	0.97
ARDS/respiratory failure	228	1 (ref)	157	1.16	42	1.00
Serious infection	524	1 (ref)	351	0.99	133	1.13
Stroke	403	1 (ref)	295	1.04	106	1.13
Thrombosis/embolism	70	1 (ref)	49	1.01	17	1.09
Composite adverse outcome (including death)	1670	1 (ref)	1151	1.02	371	1.03

 

RBC storage duration and mortality
Storage age	Patient No.	Deaths at 30 days	Adjusted hazard ratio (HR)	Deaths at 2 years	2-year HR	Deaths at 10 years	2-year HR
1-13 days	17,224	615	1 (ref)	1593	1 (ref)	5897	1 (ref)
14-27 days	12,602	410	1.06	1074	1.02	4358	1.02
28-42 days	4173	103	0.90	325	0.98	1403	0.99
mixed age	13,072	911	0.86	1954	0.94	5655	0.99

“This study is by far the largest investigation focusing on the issue of blood storage in this very sensitive patient group, and we find absolutely no hint of negative health effects associated with stored blood,”  said Ulrik Sartipy, MD, PhD, of Karolinska University Hospital.

“[W]e have been able to provide very firm reassurance that the current blood storage practices are safe,” Dr Edgren added.

Patients undergoing cardiac surgery can safely receive transfusions with older red blood cells (RBCs), according to new research.

In many countries, RBCs can be stored for as long as 6 weeks before transfusion.

But a study published in 2008 suggested that transfusing RBCs stored for more than 2 weeks could increase the risk of serious complications.

Results of subsequent studies both supported and contradicted that finding.

The new study, published in JAMA, adds to the debate. The results suggest the duration of RBC storage does not affect the risk of death or serious complications after transfusion.

“There have literally been hundreds of studies conducted on this topic the past 5 or 6 years, none of which have been able to provide a definitive answer,” said Gustaf Edgren, MD, PhD, of Karolinska Institutet in Stockholm, Sweden.

In an attempt to change that, Dr Edgren and his colleagues conducted a large-scale study of transfusions among cardiac surgery patients in Sweden. National guidelines there require that the oldest available blood unit is allocated first.

The researchers analyzed registry data on patients who underwent coronary artery bypass graft surgery, heart valve surgery, or both between 1997 and 2012.

There were 47,071 patients who received transfusions at 9 different hospitals. Of these patients, 36.6% received RBCs stored for less than 14 days, 26.8%

received RBCs stored 14 to 27 days, 8.9% received RBCs stored 28 to 42

days, and 27.8% received RBCs of mixed age.

The researchers compared these patient groups, looking at the incidence of serious complications at 30 days and mortality at 30 days, 2 years, and 10 years.

They adjusted their analyses for potential confounding factors such as sex, age, blood group, and hospital. And they found no association between RBC storage duration and mortality or serious complications.

RBC storage duration and adverse outcomes at 30 days
	RBCs stored 1-13 days (n=17,224)		14-27 days (n=12,602)		28-42 days (n=4173)
Adverse outcome	No. of events	Adjusted odds ratio (OR)	No. of events	Adjusted OR	No. of events	Adjusted OR
Acute kidney injury	202	1 (reference)	121	0.94	38	0.97
ARDS/respiratory failure	228	1 (ref)	157	1.16	42	1.00
Serious infection	524	1 (ref)	351	0.99	133	1.13
Stroke	403	1 (ref)	295	1.04	106	1.13
Thrombosis/embolism	70	1 (ref)	49	1.01	17	1.09
Composite adverse outcome (including death)	1670	1 (ref)	1151	1.02	371	1.03

 

RBC storage duration and mortality
Storage age	Patient No.	Deaths at 30 days	Adjusted hazard ratio (HR)	Deaths at 2 years	2-year HR	Deaths at 10 years	2-year HR
1-13 days	17,224	615	1 (ref)	1593	1 (ref)	5897	1 (ref)
14-27 days	12,602	410	1.06	1074	1.02	4358	1.02
28-42 days	4173	103	0.90	325	0.98	1403	0.99
mixed age	13,072	911	0.86	1954	0.94	5655	0.99

“This study is by far the largest investigation focusing on the issue of blood storage in this very sensitive patient group, and we find absolutely no hint of negative health effects associated with stored blood,”  said Ulrik Sartipy, MD, PhD, of Karolinska University Hospital.

“[W]e have been able to provide very firm reassurance that the current blood storage practices are safe,” Dr Edgren added.

Patients undergoing cardiac surgery can safely receive transfusions with older red blood cells (RBCs), according to new research.

In many countries, RBCs can be stored for as long as 6 weeks before transfusion.

But a study published in 2008 suggested that transfusing RBCs stored for more than 2 weeks could increase the risk of serious complications.

Results of subsequent studies both supported and contradicted that finding.

The new study, published in JAMA, adds to the debate. The results suggest the duration of RBC storage does not affect the risk of death or serious complications after transfusion.

“There have literally been hundreds of studies conducted on this topic the past 5 or 6 years, none of which have been able to provide a definitive answer,” said Gustaf Edgren, MD, PhD, of Karolinska Institutet in Stockholm, Sweden.

In an attempt to change that, Dr Edgren and his colleagues conducted a large-scale study of transfusions among cardiac surgery patients in Sweden. National guidelines there require that the oldest available blood unit is allocated first.

The researchers analyzed registry data on patients who underwent coronary artery bypass graft surgery, heart valve surgery, or both between 1997 and 2012.

There were 47,071 patients who received transfusions at 9 different hospitals. Of these patients, 36.6% received RBCs stored for less than 14 days, 26.8%

received RBCs stored 14 to 27 days, 8.9% received RBCs stored 28 to 42

days, and 27.8% received RBCs of mixed age.

The researchers compared these patient groups, looking at the incidence of serious complications at 30 days and mortality at 30 days, 2 years, and 10 years.

They adjusted their analyses for potential confounding factors such as sex, age, blood group, and hospital. And they found no association between RBC storage duration and mortality or serious complications.

RBC storage duration and adverse outcomes at 30 days
	RBCs stored 1-13 days (n=17,224)		14-27 days (n=12,602)		28-42 days (n=4173)
Adverse outcome	No. of events	Adjusted odds ratio (OR)	No. of events	Adjusted OR	No. of events	Adjusted OR
Acute kidney injury	202	1 (reference)	121	0.94	38	0.97
ARDS/respiratory failure	228	1 (ref)	157	1.16	42	1.00
Serious infection	524	1 (ref)	351	0.99	133	1.13
Stroke	403	1 (ref)	295	1.04	106	1.13
Thrombosis/embolism	70	1 (ref)	49	1.01	17	1.09
Composite adverse outcome (including death)	1670	1 (ref)	1151	1.02	371	1.03

 

RBC storage duration and mortality
Storage age	Patient No.	Deaths at 30 days	Adjusted hazard ratio (HR)	Deaths at 2 years	2-year HR	Deaths at 10 years	2-year HR
1-13 days	17,224	615	1 (ref)	1593	1 (ref)	5897	1 (ref)
14-27 days	12,602	410	1.06	1074	1.02	4358	1.02
28-42 days	4173	103	0.90	325	0.98	1403	0.99
mixed age	13,072	911	0.86	1954	0.94	5655	0.99

“This study is by far the largest investigation focusing on the issue of blood storage in this very sensitive patient group, and we find absolutely no hint of negative health effects associated with stored blood,”  said Ulrik Sartipy, MD, PhD, of Karolinska University Hospital.

“[W]e have been able to provide very firm reassurance that the current blood storage practices are safe,” Dr Edgren added.