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Myth of the Month: Vaccinations in patients with Guillain-Barré syndrome
A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.
What do you recommend for her to receive over the next year?
A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.
B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.
C. Influenza vaccine.
D. No vaccines.
Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.1 Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.
Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?
The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.4 They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.
The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).
Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.5 They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.
In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.6
There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.
Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.7 A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.
Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).8 A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.
The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.9
I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).
In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.
References
1. Neuroepidemiology 2011; 36(2):123-33.
2. Am J Epidemiol. 1979 Aug;110(2):105-23.
3. Clin Infect Dis. 2014 Apr;58(8):1149-55.
4. Clin Infect Dis. 2013 Jul;57(2):197-204.
5. Vaccine. 2015 Apr 21;33(17):2045-9.
6. Emerg Infect Dis. 2015 Feb;21(2):224-31.
7. Clin Infect Dis. 2012 Mar;54(6):800-4.
8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.
9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.
What do you recommend for her to receive over the next year?
A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.
B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.
C. Influenza vaccine.
D. No vaccines.
Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.1 Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.
Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?
The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.4 They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.
The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).
Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.5 They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.
In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.6
There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.
Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.7 A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.
Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).8 A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.
The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.9
I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).
In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.
References
1. Neuroepidemiology 2011; 36(2):123-33.
2. Am J Epidemiol. 1979 Aug;110(2):105-23.
3. Clin Infect Dis. 2014 Apr;58(8):1149-55.
4. Clin Infect Dis. 2013 Jul;57(2):197-204.
5. Vaccine. 2015 Apr 21;33(17):2045-9.
6. Emerg Infect Dis. 2015 Feb;21(2):224-31.
7. Clin Infect Dis. 2012 Mar;54(6):800-4.
8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.
9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.
What do you recommend for her to receive over the next year?
A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.
B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.
C. Influenza vaccine.
D. No vaccines.
Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.1 Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.
Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?
The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.4 They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.
The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).
Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.5 They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.
In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.6
There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.
Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.7 A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.
Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).8 A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.
The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.9
I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).
In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.
References
1. Neuroepidemiology 2011; 36(2):123-33.
2. Am J Epidemiol. 1979 Aug;110(2):105-23.
3. Clin Infect Dis. 2014 Apr;58(8):1149-55.
4. Clin Infect Dis. 2013 Jul;57(2):197-204.
5. Vaccine. 2015 Apr 21;33(17):2045-9.
6. Emerg Infect Dis. 2015 Feb;21(2):224-31.
7. Clin Infect Dis. 2012 Mar;54(6):800-4.
8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.
9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
Acetaminophen doesn’t exacerbate asthma in young children
As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.
In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.
The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.
The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).
There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.
Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.
“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.
This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.
The findings of Sheehan et al. should reassure clinicians and parents who care for young children taking asthma-controlling medications that the use of acetaminophen in usual, as-needed doses will not worsen the condition.
Acetaminophen and ibuprofen can be used similarly in situations for which they are indicated.
Augusto A. Litonjua, MD, is in the Channing Division of Network Medicine, Brigham and Women’s Hospital, and at Harvard Medical School, both in Boston. Dr. Litonjua made these remarks in an editorial accompanying Dr. Sheehan’s report (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMe1607629). He reported receiving personal fees from UpToDate, Springer Humana Press, and AstraZeneca outside this editorial.
The findings of Sheehan et al. should reassure clinicians and parents who care for young children taking asthma-controlling medications that the use of acetaminophen in usual, as-needed doses will not worsen the condition.
Acetaminophen and ibuprofen can be used similarly in situations for which they are indicated.
Augusto A. Litonjua, MD, is in the Channing Division of Network Medicine, Brigham and Women’s Hospital, and at Harvard Medical School, both in Boston. Dr. Litonjua made these remarks in an editorial accompanying Dr. Sheehan’s report (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMe1607629). He reported receiving personal fees from UpToDate, Springer Humana Press, and AstraZeneca outside this editorial.
The findings of Sheehan et al. should reassure clinicians and parents who care for young children taking asthma-controlling medications that the use of acetaminophen in usual, as-needed doses will not worsen the condition.
Acetaminophen and ibuprofen can be used similarly in situations for which they are indicated.
Augusto A. Litonjua, MD, is in the Channing Division of Network Medicine, Brigham and Women’s Hospital, and at Harvard Medical School, both in Boston. Dr. Litonjua made these remarks in an editorial accompanying Dr. Sheehan’s report (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMe1607629). He reported receiving personal fees from UpToDate, Springer Humana Press, and AstraZeneca outside this editorial.
As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.
In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.
The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.
The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).
There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.
Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.
“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.
This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.
As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.
In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.
The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.
The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).
There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.
Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.
“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.
This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Using acetaminophen for fever or pain doesn’t exacerbate mild persistent asthma in young children.
Major finding: The mean number of asthma exacerbations was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference.
Data source: A 2-year multicenter, double-blind, randomized clinical trial involving 300 children aged 1-5 years.
Disclosures: This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.
Primary biliary cholangitis: Obeticholic acid reduces biomarkers
Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.
A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.
They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.
The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.
In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.
In the open-label extension phase of the study, treatment efficacy was similar.
The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.
The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.
The results of this phase III clinical trial are encouraging, but we still do not know whether or how obeticholic acid impacts clinical endpoints such as hepatic decompensation, progression to cirrhosis, symptoms, or survival.
Also unknown is whether patients with this chronic disease will be able to take obeticholic acid indefinitely. And we don’t know whether to continue treating those who don’t show a biochemical response to the drug within 1 year, who comprise approximately 50% of patients, according to the results of this trial.
The price of obeticholic acid is also a concern. At present it costs approximately $70,000 per year.
Daniel S. Pratt, MD, is at the Autoimmune and Cholestatic Liver Center at Massachusetts General Hospital and at Harvard Medical School, both in Boston. He reported having no relevant financial disclosures. Dr. Pratt made these remarks in an editorial accompanying Dr. Nevens’ report (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMe1607744).
The results of this phase III clinical trial are encouraging, but we still do not know whether or how obeticholic acid impacts clinical endpoints such as hepatic decompensation, progression to cirrhosis, symptoms, or survival.
Also unknown is whether patients with this chronic disease will be able to take obeticholic acid indefinitely. And we don’t know whether to continue treating those who don’t show a biochemical response to the drug within 1 year, who comprise approximately 50% of patients, according to the results of this trial.
The price of obeticholic acid is also a concern. At present it costs approximately $70,000 per year.
Daniel S. Pratt, MD, is at the Autoimmune and Cholestatic Liver Center at Massachusetts General Hospital and at Harvard Medical School, both in Boston. He reported having no relevant financial disclosures. Dr. Pratt made these remarks in an editorial accompanying Dr. Nevens’ report (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMe1607744).
The results of this phase III clinical trial are encouraging, but we still do not know whether or how obeticholic acid impacts clinical endpoints such as hepatic decompensation, progression to cirrhosis, symptoms, or survival.
Also unknown is whether patients with this chronic disease will be able to take obeticholic acid indefinitely. And we don’t know whether to continue treating those who don’t show a biochemical response to the drug within 1 year, who comprise approximately 50% of patients, according to the results of this trial.
The price of obeticholic acid is also a concern. At present it costs approximately $70,000 per year.
Daniel S. Pratt, MD, is at the Autoimmune and Cholestatic Liver Center at Massachusetts General Hospital and at Harvard Medical School, both in Boston. He reported having no relevant financial disclosures. Dr. Pratt made these remarks in an editorial accompanying Dr. Nevens’ report (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMe1607744).
Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.
A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.
They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.
The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.
In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.
In the open-label extension phase of the study, treatment efficacy was similar.
The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.
The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.
Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.
A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.
They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.
The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.
In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.
In the open-label extension phase of the study, treatment efficacy was similar.
The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.
The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Obeticholic acid therapy reduced alkaline phosphatase level, total bilirubin level, and other biomarkers in primary biliary cholangitis.
Major finding: 46% of the 5-mg group and 47% of the 10-mg group achieved the primary end point, compared with only 10% of the placebo group.
Data source: A 1-year international randomized double-blind placebo-controlled phase III clinical trial involving 217 adults with primary biliary cholangitis.
Disclosures: This study was supported by Intercept Pharmaceuticals. Dr. Nevens reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.
A dual Y-shaped stent can improve QOL with airway fistulas
Airway fistula is a rare but life-threatening complication of esophageal surgery, but an innovative technique using two custom-made, Y-shaped metallic stents can preserve airway patency, researchers at Zhengzhou University in China reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:557-63).
The study involved 10 patients who received Y-shaped stents to treat gastrotracheal or gastrobronchial fistulas (GTFs and GBFs, respectively) after esophageal surgery from 2010 through 2014. “Our patients tolerated the stents well and had good palliation of their symptoms,” wrote Teng-Fei Li, MD, and colleagues.
Six patients died within 8 months for unrelated reasons – either tumors (four patients), or hemoptysis or pulmonary infection (one each). In one patient, the carinal fistula enlarged 4 months after stenting, but the researchers successfully placed an additional small Y-shaped stent. At the publication of the paper, this patient and three others had survived, Dr. Li and colleagues said.
After esophagectomy, fistulas can form between the tracheobronchial tree and stomach for a variety of reasons. A metallic stent would seem the logical choice after fistula formation, but it can be problematic, Dr. Li and colleagues pointed out. “Most often the clinician faces a situation in which the esophageal stent should have a larger diameter on the gastric side, making stenting the alimentary side of the fistula insufficient,” they said. The risk of stent migration is high, and the bifurcated structure of the trachea and main bronchi can cause leakage and stent displacement.
The researchers noted that Y-shaped self-expanding stents have been used for sealing airway fistulas, but they don’t always fully seal large GTFs and GBFs. Their primary objective in studying the combined-type Y-shaped covered metallic stent was to determine the safety and feasibility of the technique; the secondary aim was to evaluate long-term patency and complication rates.
They designed a Y-shaped stent delivery system (Micro-Tech) and used a combined bundle-and-push to insert the main body of the stent. In all, they inserted 20 Y-shaped stents in the 10 patients, although two stents did not fully expand and were dilated with a balloon. The researchers reported resolution of coughing during eating, toleration of liquid or semiliquid diet, and no complications after insertion.
Dr. Li and colleagues also developed strategies to avoid complications of Y-shaped stents, which have been known to retain secretions because they hinder cilia function. “To avoid this, we provided sputum suction and administered continuous high-concentration oxygen during the procedure,” they noted. Also, speed and agility in placement are important. “The operation should be performed as rapidly and gently as possible to avoid irritation to the airway,” Dr. Li and colleagues wrote. The postoperative course involved IV expectorants and antiasthma agents and aerosol inhalation of terbutaline. Surveillance bronchoscopes and debridement of granulation tissue helped avoid stent obstruction.
Nonetheless, the researches acknowledged limitations of the retrospective study, namely its small sample size and lack of a control group.
Dr. Li and colleagues had no financial relationships to disclose.
The Zhengzhou University investigators provide an opportunity to “think outside the box” when managing complex airway fistulas, Waël C. Hanna, MDCM, of McMaster University and St. Joseph’s Healthcare in Hamilton, Ontario, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:564).
 |
Dr. Waël Hanna |
Dr. Hanna credited a couple of innovations in their technique to overcome the challenge of Y stents that “remain notoriously difficult to position”: eliminating rigid bronchoscopy and using angiography-guided oral delivery; and developing the hybrid deployment mechanism.
Dr. Hanna also noted two “important nuances” of the technique: The stents are custom-made based on the length and location of the fistula; and the routine placement of two stents, with a limb of the smaller Y stent projecting through a limb of the larger Y stent to seal the entire airway. “This Y-en-Y technique using perfectly fitted stents is likely what caused the excellent outcomes that are reported in this series,” Dr. Hanna said.
But their approach may not be a practical solution to complex airway fistulas soon, he said. “Most of us who see the occasional case are unlikely to be able to commission custom-made Y stents,” he said. What’s more, the deployment mechanism is complicated, and the effect on patient quality of life is unclear.
Dr. Hanna had no financial relationships to disclose.
The Zhengzhou University investigators provide an opportunity to “think outside the box” when managing complex airway fistulas, Waël C. Hanna, MDCM, of McMaster University and St. Joseph’s Healthcare in Hamilton, Ontario, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:564).
|
Dr. Waël Hanna |
Dr. Hanna credited a couple of innovations in their technique to overcome the challenge of Y stents that “remain notoriously difficult to position”: eliminating rigid bronchoscopy and using angiography-guided oral delivery; and developing the hybrid deployment mechanism.
Dr. Hanna also noted two “important nuances” of the technique: The stents are custom-made based on the length and location of the fistula; and the routine placement of two stents, with a limb of the smaller Y stent projecting through a limb of the larger Y stent to seal the entire airway. “This Y-en-Y technique using perfectly fitted stents is likely what caused the excellent outcomes that are reported in this series,” Dr. Hanna said.
But their approach may not be a practical solution to complex airway fistulas soon, he said. “Most of us who see the occasional case are unlikely to be able to commission custom-made Y stents,” he said. What’s more, the deployment mechanism is complicated, and the effect on patient quality of life is unclear.
Dr. Hanna had no financial relationships to disclose.
The Zhengzhou University investigators provide an opportunity to “think outside the box” when managing complex airway fistulas, Waël C. Hanna, MDCM, of McMaster University and St. Joseph’s Healthcare in Hamilton, Ontario, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:564).
|
Dr. Waël Hanna |
Dr. Hanna credited a couple of innovations in their technique to overcome the challenge of Y stents that “remain notoriously difficult to position”: eliminating rigid bronchoscopy and using angiography-guided oral delivery; and developing the hybrid deployment mechanism.
Dr. Hanna also noted two “important nuances” of the technique: The stents are custom-made based on the length and location of the fistula; and the routine placement of two stents, with a limb of the smaller Y stent projecting through a limb of the larger Y stent to seal the entire airway. “This Y-en-Y technique using perfectly fitted stents is likely what caused the excellent outcomes that are reported in this series,” Dr. Hanna said.
But their approach may not be a practical solution to complex airway fistulas soon, he said. “Most of us who see the occasional case are unlikely to be able to commission custom-made Y stents,” he said. What’s more, the deployment mechanism is complicated, and the effect on patient quality of life is unclear.
Dr. Hanna had no financial relationships to disclose.
Airway fistula is a rare but life-threatening complication of esophageal surgery, but an innovative technique using two custom-made, Y-shaped metallic stents can preserve airway patency, researchers at Zhengzhou University in China reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:557-63).
The study involved 10 patients who received Y-shaped stents to treat gastrotracheal or gastrobronchial fistulas (GTFs and GBFs, respectively) after esophageal surgery from 2010 through 2014. “Our patients tolerated the stents well and had good palliation of their symptoms,” wrote Teng-Fei Li, MD, and colleagues.
Six patients died within 8 months for unrelated reasons – either tumors (four patients), or hemoptysis or pulmonary infection (one each). In one patient, the carinal fistula enlarged 4 months after stenting, but the researchers successfully placed an additional small Y-shaped stent. At the publication of the paper, this patient and three others had survived, Dr. Li and colleagues said.
After esophagectomy, fistulas can form between the tracheobronchial tree and stomach for a variety of reasons. A metallic stent would seem the logical choice after fistula formation, but it can be problematic, Dr. Li and colleagues pointed out. “Most often the clinician faces a situation in which the esophageal stent should have a larger diameter on the gastric side, making stenting the alimentary side of the fistula insufficient,” they said. The risk of stent migration is high, and the bifurcated structure of the trachea and main bronchi can cause leakage and stent displacement.
The researchers noted that Y-shaped self-expanding stents have been used for sealing airway fistulas, but they don’t always fully seal large GTFs and GBFs. Their primary objective in studying the combined-type Y-shaped covered metallic stent was to determine the safety and feasibility of the technique; the secondary aim was to evaluate long-term patency and complication rates.
They designed a Y-shaped stent delivery system (Micro-Tech) and used a combined bundle-and-push to insert the main body of the stent. In all, they inserted 20 Y-shaped stents in the 10 patients, although two stents did not fully expand and were dilated with a balloon. The researchers reported resolution of coughing during eating, toleration of liquid or semiliquid diet, and no complications after insertion.
Dr. Li and colleagues also developed strategies to avoid complications of Y-shaped stents, which have been known to retain secretions because they hinder cilia function. “To avoid this, we provided sputum suction and administered continuous high-concentration oxygen during the procedure,” they noted. Also, speed and agility in placement are important. “The operation should be performed as rapidly and gently as possible to avoid irritation to the airway,” Dr. Li and colleagues wrote. The postoperative course involved IV expectorants and antiasthma agents and aerosol inhalation of terbutaline. Surveillance bronchoscopes and debridement of granulation tissue helped avoid stent obstruction.
Nonetheless, the researches acknowledged limitations of the retrospective study, namely its small sample size and lack of a control group.
Dr. Li and colleagues had no financial relationships to disclose.
Airway fistula is a rare but life-threatening complication of esophageal surgery, but an innovative technique using two custom-made, Y-shaped metallic stents can preserve airway patency, researchers at Zhengzhou University in China reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:557-63).
The study involved 10 patients who received Y-shaped stents to treat gastrotracheal or gastrobronchial fistulas (GTFs and GBFs, respectively) after esophageal surgery from 2010 through 2014. “Our patients tolerated the stents well and had good palliation of their symptoms,” wrote Teng-Fei Li, MD, and colleagues.
Six patients died within 8 months for unrelated reasons – either tumors (four patients), or hemoptysis or pulmonary infection (one each). In one patient, the carinal fistula enlarged 4 months after stenting, but the researchers successfully placed an additional small Y-shaped stent. At the publication of the paper, this patient and three others had survived, Dr. Li and colleagues said.
After esophagectomy, fistulas can form between the tracheobronchial tree and stomach for a variety of reasons. A metallic stent would seem the logical choice after fistula formation, but it can be problematic, Dr. Li and colleagues pointed out. “Most often the clinician faces a situation in which the esophageal stent should have a larger diameter on the gastric side, making stenting the alimentary side of the fistula insufficient,” they said. The risk of stent migration is high, and the bifurcated structure of the trachea and main bronchi can cause leakage and stent displacement.
The researchers noted that Y-shaped self-expanding stents have been used for sealing airway fistulas, but they don’t always fully seal large GTFs and GBFs. Their primary objective in studying the combined-type Y-shaped covered metallic stent was to determine the safety and feasibility of the technique; the secondary aim was to evaluate long-term patency and complication rates.
They designed a Y-shaped stent delivery system (Micro-Tech) and used a combined bundle-and-push to insert the main body of the stent. In all, they inserted 20 Y-shaped stents in the 10 patients, although two stents did not fully expand and were dilated with a balloon. The researchers reported resolution of coughing during eating, toleration of liquid or semiliquid diet, and no complications after insertion.
Dr. Li and colleagues also developed strategies to avoid complications of Y-shaped stents, which have been known to retain secretions because they hinder cilia function. “To avoid this, we provided sputum suction and administered continuous high-concentration oxygen during the procedure,” they noted. Also, speed and agility in placement are important. “The operation should be performed as rapidly and gently as possible to avoid irritation to the airway,” Dr. Li and colleagues wrote. The postoperative course involved IV expectorants and antiasthma agents and aerosol inhalation of terbutaline. Surveillance bronchoscopes and debridement of granulation tissue helped avoid stent obstruction.
Nonetheless, the researches acknowledged limitations of the retrospective study, namely its small sample size and lack of a control group.
Dr. Li and colleagues had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A combined type Y-shaped self-expandable coated metallic stent is a new approach for treatment of airway fistulas.
Major finding: Ten patients received the stents; all of them reported improved quality of life. Six died within 8 months because of unrelated factors.
Data source: Single-institution retrospective review of 10 patients with gastrotracheal or gastrobronchial fistulas who received the stent to reopen the airway.
Disclosures: Dr. Li and coauthors had no financial relationships to disclose. The study received support from the National High-Tech R&D Program of China.
Guideline recommends 2-mm negative margins for DCIS
Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.
Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?
The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.
“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).
According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.
The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.
Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.
The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.
On Twitter @jessnicolecraig
Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.
Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?
The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.
“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).
According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.
The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.
Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.
The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.
On Twitter @jessnicolecraig
Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.
Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?
The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.
“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).
According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.
The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.
Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.
The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.
On Twitter @jessnicolecraig
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ.
Major finding: Patients with 2-mm clear margins were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
Data source: Meta-analysis of 20 studies and other published literature.
Disclosures: The Susan G. Komen Foundation funded the guideline development process. The panel members had no relevant disclosures.
Pilot program helps children better understand food allergies
Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.
At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.
After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.
The authors stated that they had no financial conflicts of interest.
Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018
Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.
At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.
After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.
The authors stated that they had no financial conflicts of interest.
Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018
Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.
At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.
After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.
The authors stated that they had no financial conflicts of interest.
Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018
FROM ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY
Antipsychotics in pregnancy pose no meaningful malformation risk
Antipsychotic use early in pregnancy does not appear to meaningfully increase the risk of congenital malformations, according to findings from a large Medicaid pregnancy cohort.
A possible exception is with the use of risperidone; a small increase in the risk for malformations seen with the drug should be viewed as “an initial safety signal that will require confirmation in other studies,” Krista F. Huybrechts, PhD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues reported online Aug. 17 in JAMA Psychiatry.
In a nationwide sample of more than 1.3 million pregnant women with a live-born infant between January 1, 2000 and December 31, 2010, the rate of congenital malformations identified within 90 days after delivery was 32.7 per 1,000 births among 1,331,724 women with no antipsychotic (AP) exposure, compared with a rate of 44.5 per 1,000 births among 9,258 women who filled at least one prescription for an atypical AP during their first trimester, and 38.2 per 1,000 in 733 women who filled at least one prescription for a typical AP during their first trimester, the researchers found (JAMA Psychiatry. 2016 Aug 17. doi: 10.1001/jamapsychiatry.2016.1520).
On unadjusted analyses, an overall risk was seen with atypical AP exposure (relative risk, 1.36), but not with typical AP exposure (RR, 1.17). After adjusting for confounding variables, the risk was not statistically significant (RR, 1.05 and 0.90, respectively). The findings were similar for cardiac malformations, the researchers noted.
When agents were analyzed individually, a small increased risk in overall malformations and cardiac malformations was found with risperidone (RR, 1.26 for each).
“The findings for risperidone should be viewed as an initial safety signal that will require confirmation in other studies,” the researchers wrote.
The study was supported by grants from the National Institutes of Health and the Swiss National Science Foundation. Dr. Huybrechts reported having no financial disclosures. Other authors disclosed receiving consulting fees and/or grant support from AstraZeneca, UCB, Alkermes, Bristol-Myers Squibb/Otsuka, Sunovion, Bayer, Ortho-McNeil Janssen, Pfizer, Forest Laboratories, Cephalon, GlaxoSmithKline, Takeda/Lundbeck, the National Institutes of Health, JDS Therapeutics, Noven Pharmaceuticals, and PamLab.
This “landmark report” by Huybrechts et al involves the largest population of women exposed to APs published to date, and addresses a “major source of concern for women and prescribers,” Katherine L. Wisner, MD, and her colleagues wrote in an editorial.
With the exception of risperidone, which was found to be associated with a 26% increase in the risk of overall and cardiac malformations, and possibly even greater risk among those who filled at least two AP prescriptions – and thus merits further exploration – AP use was found in the study to be safe.
“This study increases the field’s appetite for additional high-quality data on other maternal and offspring outcomes to improve the sophistication of risk-benefit decision making,” the authors wrote.
Nowhere in medicine is there a greater need for personalization of care, particularly when it comes to the treatment of serious mental illness with consideration of “pregnancy physiology and the mother’s capacity to provide sustenance for the growing fetus and newborn,” they wrote.
Dr. Wisner is with Northwestern University, Chicago. She reported that her department at Northwestern received contractual fees for her consultation to Quinn Emanuel Urquhart & Sullivan, LLP, who represented Pfizer Pharmaceutical Company in 2015. A coauthor, Christina Chambers, PhD, reported receiving research funding from AbbVie, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Sandoz, and Teva. No other disclosures were reported. Their comments are excerpted from an accompanying editorial (JAMA Psychiatry. 2016 Aug 17. doi: 10.1001/jamapsychiatry.2016.1538).
This “landmark report” by Huybrechts et al involves the largest population of women exposed to APs published to date, and addresses a “major source of concern for women and prescribers,” Katherine L. Wisner, MD, and her colleagues wrote in an editorial.
With the exception of risperidone, which was found to be associated with a 26% increase in the risk of overall and cardiac malformations, and possibly even greater risk among those who filled at least two AP prescriptions – and thus merits further exploration – AP use was found in the study to be safe.
“This study increases the field’s appetite for additional high-quality data on other maternal and offspring outcomes to improve the sophistication of risk-benefit decision making,” the authors wrote.
Nowhere in medicine is there a greater need for personalization of care, particularly when it comes to the treatment of serious mental illness with consideration of “pregnancy physiology and the mother’s capacity to provide sustenance for the growing fetus and newborn,” they wrote.
Dr. Wisner is with Northwestern University, Chicago. She reported that her department at Northwestern received contractual fees for her consultation to Quinn Emanuel Urquhart & Sullivan, LLP, who represented Pfizer Pharmaceutical Company in 2015. A coauthor, Christina Chambers, PhD, reported receiving research funding from AbbVie, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Sandoz, and Teva. No other disclosures were reported. Their comments are excerpted from an accompanying editorial (JAMA Psychiatry. 2016 Aug 17. doi: 10.1001/jamapsychiatry.2016.1538).
This “landmark report” by Huybrechts et al involves the largest population of women exposed to APs published to date, and addresses a “major source of concern for women and prescribers,” Katherine L. Wisner, MD, and her colleagues wrote in an editorial.
With the exception of risperidone, which was found to be associated with a 26% increase in the risk of overall and cardiac malformations, and possibly even greater risk among those who filled at least two AP prescriptions – and thus merits further exploration – AP use was found in the study to be safe.
“This study increases the field’s appetite for additional high-quality data on other maternal and offspring outcomes to improve the sophistication of risk-benefit decision making,” the authors wrote.
Nowhere in medicine is there a greater need for personalization of care, particularly when it comes to the treatment of serious mental illness with consideration of “pregnancy physiology and the mother’s capacity to provide sustenance for the growing fetus and newborn,” they wrote.
Dr. Wisner is with Northwestern University, Chicago. She reported that her department at Northwestern received contractual fees for her consultation to Quinn Emanuel Urquhart & Sullivan, LLP, who represented Pfizer Pharmaceutical Company in 2015. A coauthor, Christina Chambers, PhD, reported receiving research funding from AbbVie, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Sandoz, and Teva. No other disclosures were reported. Their comments are excerpted from an accompanying editorial (JAMA Psychiatry. 2016 Aug 17. doi: 10.1001/jamapsychiatry.2016.1538).
Antipsychotic use early in pregnancy does not appear to meaningfully increase the risk of congenital malformations, according to findings from a large Medicaid pregnancy cohort.
A possible exception is with the use of risperidone; a small increase in the risk for malformations seen with the drug should be viewed as “an initial safety signal that will require confirmation in other studies,” Krista F. Huybrechts, PhD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues reported online Aug. 17 in JAMA Psychiatry.
In a nationwide sample of more than 1.3 million pregnant women with a live-born infant between January 1, 2000 and December 31, 2010, the rate of congenital malformations identified within 90 days after delivery was 32.7 per 1,000 births among 1,331,724 women with no antipsychotic (AP) exposure, compared with a rate of 44.5 per 1,000 births among 9,258 women who filled at least one prescription for an atypical AP during their first trimester, and 38.2 per 1,000 in 733 women who filled at least one prescription for a typical AP during their first trimester, the researchers found (JAMA Psychiatry. 2016 Aug 17. doi: 10.1001/jamapsychiatry.2016.1520).
On unadjusted analyses, an overall risk was seen with atypical AP exposure (relative risk, 1.36), but not with typical AP exposure (RR, 1.17). After adjusting for confounding variables, the risk was not statistically significant (RR, 1.05 and 0.90, respectively). The findings were similar for cardiac malformations, the researchers noted.
When agents were analyzed individually, a small increased risk in overall malformations and cardiac malformations was found with risperidone (RR, 1.26 for each).
“The findings for risperidone should be viewed as an initial safety signal that will require confirmation in other studies,” the researchers wrote.
The study was supported by grants from the National Institutes of Health and the Swiss National Science Foundation. Dr. Huybrechts reported having no financial disclosures. Other authors disclosed receiving consulting fees and/or grant support from AstraZeneca, UCB, Alkermes, Bristol-Myers Squibb/Otsuka, Sunovion, Bayer, Ortho-McNeil Janssen, Pfizer, Forest Laboratories, Cephalon, GlaxoSmithKline, Takeda/Lundbeck, the National Institutes of Health, JDS Therapeutics, Noven Pharmaceuticals, and PamLab.
Antipsychotic use early in pregnancy does not appear to meaningfully increase the risk of congenital malformations, according to findings from a large Medicaid pregnancy cohort.
A possible exception is with the use of risperidone; a small increase in the risk for malformations seen with the drug should be viewed as “an initial safety signal that will require confirmation in other studies,” Krista F. Huybrechts, PhD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues reported online Aug. 17 in JAMA Psychiatry.
In a nationwide sample of more than 1.3 million pregnant women with a live-born infant between January 1, 2000 and December 31, 2010, the rate of congenital malformations identified within 90 days after delivery was 32.7 per 1,000 births among 1,331,724 women with no antipsychotic (AP) exposure, compared with a rate of 44.5 per 1,000 births among 9,258 women who filled at least one prescription for an atypical AP during their first trimester, and 38.2 per 1,000 in 733 women who filled at least one prescription for a typical AP during their first trimester, the researchers found (JAMA Psychiatry. 2016 Aug 17. doi: 10.1001/jamapsychiatry.2016.1520).
On unadjusted analyses, an overall risk was seen with atypical AP exposure (relative risk, 1.36), but not with typical AP exposure (RR, 1.17). After adjusting for confounding variables, the risk was not statistically significant (RR, 1.05 and 0.90, respectively). The findings were similar for cardiac malformations, the researchers noted.
When agents were analyzed individually, a small increased risk in overall malformations and cardiac malformations was found with risperidone (RR, 1.26 for each).
“The findings for risperidone should be viewed as an initial safety signal that will require confirmation in other studies,” the researchers wrote.
The study was supported by grants from the National Institutes of Health and the Swiss National Science Foundation. Dr. Huybrechts reported having no financial disclosures. Other authors disclosed receiving consulting fees and/or grant support from AstraZeneca, UCB, Alkermes, Bristol-Myers Squibb/Otsuka, Sunovion, Bayer, Ortho-McNeil Janssen, Pfizer, Forest Laboratories, Cephalon, GlaxoSmithKline, Takeda/Lundbeck, the National Institutes of Health, JDS Therapeutics, Noven Pharmaceuticals, and PamLab.
FROM JAMA PSYCHIATRY
Key clinical point: Antipsychotic use in the first trimester does not appear to meaningfully increase the risk of congenital malformations.
Major finding: The adjusted relative risk for malformations is 1.05 and 0.90 with atypical and typical antipsychotic drug exposure, respectively.
Data source: A total of 1,341,715 pregnancies from the Medicaid Analytic Extract database pregnancy cohort.
Disclosures: The study was supported by grants from the National Institutes of Health and the Swiss National Science Foundation. Dr. Huybrechts reported having no financial disclosures. Other authors disclosed receiving consulting fees and/or grant support from AstraZeneca, UCB, Alkermes, Bristol-Myers Squibb/Otsuka, Sunovion, Bayer, Ortho-McNeil Janssen, Pfizer, Forest Laboratories, Cephalon, GlaxoSmithKline, Takeda/Lundbeck, the National Institutes of Health, JDS Therapeutics, Noven Pharmaceuticals, and PamLab.
Cancer trends shifting in HIV-positive patients
DURBAN, SOUTH AFRICA – The rates of the AIDS-defining cancers Kaposi’s sarcoma and non-Hodgkin’s lymphoma have plummeted in the antiretroviral era, yet they are still the two top cancers in terms of cumulative incidence in HIV-infected patients by age 75, Benigno Rodriguez, MD, said at the 21st International AIDS Conference.
Lung cancer also remains a major concern in the HIV-infected population. Each of these three cancers carries about a 1 in 25 lifetime risk to age 75, the estimated lifespan of HIV-positive patients on combination antiretroviral therapy (ART), according to Dr. Rodriguez of Case Western Reserve University in Cleveland.
ART has resulted in a marked change in cancer trends among HIV-infected patients. The incidence of AIDS-defining cancers has decreased “massively,” Dr. Rodriguez observed; but because ART has extended the lifespan, patients are now living long enough to get other cancers. And they do so at a higher rate than that of the general population because of their impaired immune function, higher rate of risk factors such as smoking, and greater prevalence of oncogenic viral coinfections such as hepatitis B and C and Epstein-Barr virus.
The increase in the incidence and risk of colorectal, liver, and anal cancers among HIV-positive individuals since the introduction of combination ART can largely be explained by the population’s longer exposure to risk due to increasing survival, he said.
Dr. Rodriguez presented highlights of an analysis of cancer trends in North America during 1996-2009. The study was based on 86,620 HIV-infected persons with 475,660 person-years of follow-up and 196,987 subjects without HIV infection and with more than 1.8 million person-years of follow-up. Trends over time were assessed for nine cancers: Kaposi’s sarcoma, non-Hodgkin’s lymphoma, Hodgkin’s lymphoma, and melanoma, as well as anal, lung, colorectal, liver, and oropharyngeal cancers (Ann Intern Med. 2015;163:507-18).
Examining trends in three periods – 1996-1999, 2000-2004, and 2005-2009 – the investigators looked at the impact of ART over time on rates of AIDS-related and non–AIDS-related cancers in HIV-infected patients and compared them to results in the general HIV-uninfected population.
By conducting a competing risk analysis, Dr. Rodriguez and his coworkers were able to estimate the cumulative lifetime risk of the various cancers by age 75, a metric that provides readily understandable information for counseling HIV-infected patients about their long-term cancer risk.
The measure “is more intuitive than using incidence rates,” Dr. Rodriguez said. In a study of 1,578 HIV-infected patients who received the hepatitis B vaccine, for example, those patients whose immune function did not to respond to the vaccine were more likely to be among the 6% of patients who subsequently developed cancer during up to 20 years of follow-up.
The findings on cancer trends in the ART era have clinical implications for cancer screening and prevention in HIV-infected patients. The high rates of smoking and lung cancer in this population make HIV-positive smokers a logical target for lung cancer screening. The rising risk of colorectal cancer – the cumulative lifetime risk to age 75 was 0.4% in 1996-1999, 0.7% in 2000-2004, and 1.3% in 2005-2009 – suggests a need for increased colorectal cancer screening in the older HIV-positive population.
Early and sustained HIV suppression with combination ART remains the only known method of preventing AIDS-defining cancers. Dr. Rodriguez and his coinvestigators in the Centers for AIDS Research Network of Integrated Clinical Systems demonstrated the crucial role of suppressing HIV in a study of 6,036 HIV-infected patients who started on ART and were followed for more than 21,000 person-years. Compared with HIV-infected patients with a 3-month lagged HIV viremia of no more than 50 copies/mL, patients’ risk of developing non-Hodgkin’s lymphoma was 2.1-fold greater if their 3-month lagged HIV viremia was 51-500 copies/mL and 3.56-fold greater if it exceeded 500 copies/mL (Clin Infect Dis. 2014 Jun;58[11]:1599-606).
The study on cancer trends over time was funded by the National Institutes of Health. Dr. Rodriguez reported receiving honoraria from Gilead Sciences.
DURBAN, SOUTH AFRICA – The rates of the AIDS-defining cancers Kaposi’s sarcoma and non-Hodgkin’s lymphoma have plummeted in the antiretroviral era, yet they are still the two top cancers in terms of cumulative incidence in HIV-infected patients by age 75, Benigno Rodriguez, MD, said at the 21st International AIDS Conference.
Lung cancer also remains a major concern in the HIV-infected population. Each of these three cancers carries about a 1 in 25 lifetime risk to age 75, the estimated lifespan of HIV-positive patients on combination antiretroviral therapy (ART), according to Dr. Rodriguez of Case Western Reserve University in Cleveland.
ART has resulted in a marked change in cancer trends among HIV-infected patients. The incidence of AIDS-defining cancers has decreased “massively,” Dr. Rodriguez observed; but because ART has extended the lifespan, patients are now living long enough to get other cancers. And they do so at a higher rate than that of the general population because of their impaired immune function, higher rate of risk factors such as smoking, and greater prevalence of oncogenic viral coinfections such as hepatitis B and C and Epstein-Barr virus.
The increase in the incidence and risk of colorectal, liver, and anal cancers among HIV-positive individuals since the introduction of combination ART can largely be explained by the population’s longer exposure to risk due to increasing survival, he said.
Dr. Rodriguez presented highlights of an analysis of cancer trends in North America during 1996-2009. The study was based on 86,620 HIV-infected persons with 475,660 person-years of follow-up and 196,987 subjects without HIV infection and with more than 1.8 million person-years of follow-up. Trends over time were assessed for nine cancers: Kaposi’s sarcoma, non-Hodgkin’s lymphoma, Hodgkin’s lymphoma, and melanoma, as well as anal, lung, colorectal, liver, and oropharyngeal cancers (Ann Intern Med. 2015;163:507-18).
Examining trends in three periods – 1996-1999, 2000-2004, and 2005-2009 – the investigators looked at the impact of ART over time on rates of AIDS-related and non–AIDS-related cancers in HIV-infected patients and compared them to results in the general HIV-uninfected population.
By conducting a competing risk analysis, Dr. Rodriguez and his coworkers were able to estimate the cumulative lifetime risk of the various cancers by age 75, a metric that provides readily understandable information for counseling HIV-infected patients about their long-term cancer risk.
The measure “is more intuitive than using incidence rates,” Dr. Rodriguez said. In a study of 1,578 HIV-infected patients who received the hepatitis B vaccine, for example, those patients whose immune function did not to respond to the vaccine were more likely to be among the 6% of patients who subsequently developed cancer during up to 20 years of follow-up.
The findings on cancer trends in the ART era have clinical implications for cancer screening and prevention in HIV-infected patients. The high rates of smoking and lung cancer in this population make HIV-positive smokers a logical target for lung cancer screening. The rising risk of colorectal cancer – the cumulative lifetime risk to age 75 was 0.4% in 1996-1999, 0.7% in 2000-2004, and 1.3% in 2005-2009 – suggests a need for increased colorectal cancer screening in the older HIV-positive population.
Early and sustained HIV suppression with combination ART remains the only known method of preventing AIDS-defining cancers. Dr. Rodriguez and his coinvestigators in the Centers for AIDS Research Network of Integrated Clinical Systems demonstrated the crucial role of suppressing HIV in a study of 6,036 HIV-infected patients who started on ART and were followed for more than 21,000 person-years. Compared with HIV-infected patients with a 3-month lagged HIV viremia of no more than 50 copies/mL, patients’ risk of developing non-Hodgkin’s lymphoma was 2.1-fold greater if their 3-month lagged HIV viremia was 51-500 copies/mL and 3.56-fold greater if it exceeded 500 copies/mL (Clin Infect Dis. 2014 Jun;58[11]:1599-606).
The study on cancer trends over time was funded by the National Institutes of Health. Dr. Rodriguez reported receiving honoraria from Gilead Sciences.
DURBAN, SOUTH AFRICA – The rates of the AIDS-defining cancers Kaposi’s sarcoma and non-Hodgkin’s lymphoma have plummeted in the antiretroviral era, yet they are still the two top cancers in terms of cumulative incidence in HIV-infected patients by age 75, Benigno Rodriguez, MD, said at the 21st International AIDS Conference.
Lung cancer also remains a major concern in the HIV-infected population. Each of these three cancers carries about a 1 in 25 lifetime risk to age 75, the estimated lifespan of HIV-positive patients on combination antiretroviral therapy (ART), according to Dr. Rodriguez of Case Western Reserve University in Cleveland.
ART has resulted in a marked change in cancer trends among HIV-infected patients. The incidence of AIDS-defining cancers has decreased “massively,” Dr. Rodriguez observed; but because ART has extended the lifespan, patients are now living long enough to get other cancers. And they do so at a higher rate than that of the general population because of their impaired immune function, higher rate of risk factors such as smoking, and greater prevalence of oncogenic viral coinfections such as hepatitis B and C and Epstein-Barr virus.
The increase in the incidence and risk of colorectal, liver, and anal cancers among HIV-positive individuals since the introduction of combination ART can largely be explained by the population’s longer exposure to risk due to increasing survival, he said.
Dr. Rodriguez presented highlights of an analysis of cancer trends in North America during 1996-2009. The study was based on 86,620 HIV-infected persons with 475,660 person-years of follow-up and 196,987 subjects without HIV infection and with more than 1.8 million person-years of follow-up. Trends over time were assessed for nine cancers: Kaposi’s sarcoma, non-Hodgkin’s lymphoma, Hodgkin’s lymphoma, and melanoma, as well as anal, lung, colorectal, liver, and oropharyngeal cancers (Ann Intern Med. 2015;163:507-18).
Examining trends in three periods – 1996-1999, 2000-2004, and 2005-2009 – the investigators looked at the impact of ART over time on rates of AIDS-related and non–AIDS-related cancers in HIV-infected patients and compared them to results in the general HIV-uninfected population.
By conducting a competing risk analysis, Dr. Rodriguez and his coworkers were able to estimate the cumulative lifetime risk of the various cancers by age 75, a metric that provides readily understandable information for counseling HIV-infected patients about their long-term cancer risk.
The measure “is more intuitive than using incidence rates,” Dr. Rodriguez said. In a study of 1,578 HIV-infected patients who received the hepatitis B vaccine, for example, those patients whose immune function did not to respond to the vaccine were more likely to be among the 6% of patients who subsequently developed cancer during up to 20 years of follow-up.
The findings on cancer trends in the ART era have clinical implications for cancer screening and prevention in HIV-infected patients. The high rates of smoking and lung cancer in this population make HIV-positive smokers a logical target for lung cancer screening. The rising risk of colorectal cancer – the cumulative lifetime risk to age 75 was 0.4% in 1996-1999, 0.7% in 2000-2004, and 1.3% in 2005-2009 – suggests a need for increased colorectal cancer screening in the older HIV-positive population.
Early and sustained HIV suppression with combination ART remains the only known method of preventing AIDS-defining cancers. Dr. Rodriguez and his coinvestigators in the Centers for AIDS Research Network of Integrated Clinical Systems demonstrated the crucial role of suppressing HIV in a study of 6,036 HIV-infected patients who started on ART and were followed for more than 21,000 person-years. Compared with HIV-infected patients with a 3-month lagged HIV viremia of no more than 50 copies/mL, patients’ risk of developing non-Hodgkin’s lymphoma was 2.1-fold greater if their 3-month lagged HIV viremia was 51-500 copies/mL and 3.56-fold greater if it exceeded 500 copies/mL (Clin Infect Dis. 2014 Jun;58[11]:1599-606).
The study on cancer trends over time was funded by the National Institutes of Health. Dr. Rodriguez reported receiving honoraria from Gilead Sciences.
AT AIDS 2016
Key clinical point: HIV-infected persons in North America have roughly a 1 in 25 cumulative lifetime risk of developing lung cancer, Kaposi’s sarcoma, or non-Hodgkin’s lymphoma.
Major finding: The cumulative lifetime risk of developing non-Hodgkin’s lymphoma in HIV-infected patients on combination antiretroviral therapy is sevenfold greater than the risk in the general population.
Data source: A competing risk analysis for nine cancers based upon 86,620 HIV-infected persons followed for 475,660 person-years and 196,987 subjects not infected with HIV and with more than 1.8 million person-years of follow-up.
Disclosures: The National Institutes of Health funded the study. The presenter reported receiving honoraria from Gilead Sciences.
Ankylosing spondylitis patients develop multiple comorbidities after diagnosis
DENVER – Evidence continues to mount that ankylosing spondylitis patients are at increased risk for developing various comorbidities, compared with the general adult population.
Patients newly diagnosed with ankylosing spondylitis (AS) had twice the rate of new-onset depression during the first 3 years following diagnosis, compared with matched people from the general population in a study of more than 21,000 American adults. Patients with newly diagnosed AS also had a 60% higher rate of developing a new cardiovascular disease, compared with the matched general population, Jessica A. Walsh, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.
“We need to figure out what to do about all the comorbidities. Rheumatologists need to either screen their AS patients for comorbidities, or they need to be sure their patients are plugged in with another physician who will screen them,” said Dr. Walsh, director of the spondyloarthritis clinic at the University of Utah in Salt Lake City.
Her analysis used data from the Truven Health MarketScan databases for U.S. patients covered by Medicare or commercial health insurance, and included 6,370 patients with newly diagnosed AS and 14,988 adults matched by age and sex. The analysis only included AS patients who were free from comorbidities during the 2 years prior to their AS diagnosis. The average age of the people in the study was 52 years, and 54% were men.
During an average follow-up of 2.9 years following initial AS diagnosis, the most common comorbidity among the AS patients was uveitis, which occurred nearly 15-fold more frequently among the AS patients than in the controls. Other common incident comorbidities included inflammatory bowel disease, nearly sixfold more common among the AS patients, and osteoporosis, which was nearly threefold more common during follow-up after AS diagnosis, compared with the controls.
Other comorbidities with increased incidence in the AS patients included sleep apnea (80% more common among the AS patients during follow-up), asthma (50% more often), hypertension (44% more common), malignancy (23% more common), diabetes (20% more common), and dyslipidemia (11% more common). All these incidence rates represented statistically significant increases in the AS patients, compared with the controls.
A related analysis reported by Dr. Walsh also used data from the Truven Health databases for a somewhat larger group of AS patients, 6,679 followed for 1 year after their AS diagnosis, and 19,951 matched controls. The AS patients had a significantly higher rate of hospital admissions – 12%, compared with 6% among the controls – and a significantly higher rate of emergency department visits, at 23%, compared with 15% among the controls. The AS patients also had double the rate of physician office visits and prescribed medications.
“Obviously, the AS patients are not as healthy,” Dr. Walsh said in an interview. “We adjusted for their comorbidities, but that did not affect the hospitalization rates. We need to look into this more; I don’t know why the AS patients are being hospitalized. Typically AS itself does not lead to hospitalization, so I suspect it’s because of comorbidities, or perhaps because of adverse events from treatment.”
Dr. Walsh is a consultant to AbbVie and Novartis.
On Twitter @mitchelzoler
DENVER – Evidence continues to mount that ankylosing spondylitis patients are at increased risk for developing various comorbidities, compared with the general adult population.
Patients newly diagnosed with ankylosing spondylitis (AS) had twice the rate of new-onset depression during the first 3 years following diagnosis, compared with matched people from the general population in a study of more than 21,000 American adults. Patients with newly diagnosed AS also had a 60% higher rate of developing a new cardiovascular disease, compared with the matched general population, Jessica A. Walsh, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.
“We need to figure out what to do about all the comorbidities. Rheumatologists need to either screen their AS patients for comorbidities, or they need to be sure their patients are plugged in with another physician who will screen them,” said Dr. Walsh, director of the spondyloarthritis clinic at the University of Utah in Salt Lake City.
Her analysis used data from the Truven Health MarketScan databases for U.S. patients covered by Medicare or commercial health insurance, and included 6,370 patients with newly diagnosed AS and 14,988 adults matched by age and sex. The analysis only included AS patients who were free from comorbidities during the 2 years prior to their AS diagnosis. The average age of the people in the study was 52 years, and 54% were men.
During an average follow-up of 2.9 years following initial AS diagnosis, the most common comorbidity among the AS patients was uveitis, which occurred nearly 15-fold more frequently among the AS patients than in the controls. Other common incident comorbidities included inflammatory bowel disease, nearly sixfold more common among the AS patients, and osteoporosis, which was nearly threefold more common during follow-up after AS diagnosis, compared with the controls.
Other comorbidities with increased incidence in the AS patients included sleep apnea (80% more common among the AS patients during follow-up), asthma (50% more often), hypertension (44% more common), malignancy (23% more common), diabetes (20% more common), and dyslipidemia (11% more common). All these incidence rates represented statistically significant increases in the AS patients, compared with the controls.
A related analysis reported by Dr. Walsh also used data from the Truven Health databases for a somewhat larger group of AS patients, 6,679 followed for 1 year after their AS diagnosis, and 19,951 matched controls. The AS patients had a significantly higher rate of hospital admissions – 12%, compared with 6% among the controls – and a significantly higher rate of emergency department visits, at 23%, compared with 15% among the controls. The AS patients also had double the rate of physician office visits and prescribed medications.
“Obviously, the AS patients are not as healthy,” Dr. Walsh said in an interview. “We adjusted for their comorbidities, but that did not affect the hospitalization rates. We need to look into this more; I don’t know why the AS patients are being hospitalized. Typically AS itself does not lead to hospitalization, so I suspect it’s because of comorbidities, or perhaps because of adverse events from treatment.”
Dr. Walsh is a consultant to AbbVie and Novartis.
On Twitter @mitchelzoler
DENVER – Evidence continues to mount that ankylosing spondylitis patients are at increased risk for developing various comorbidities, compared with the general adult population.
Patients newly diagnosed with ankylosing spondylitis (AS) had twice the rate of new-onset depression during the first 3 years following diagnosis, compared with matched people from the general population in a study of more than 21,000 American adults. Patients with newly diagnosed AS also had a 60% higher rate of developing a new cardiovascular disease, compared with the matched general population, Jessica A. Walsh, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.
“We need to figure out what to do about all the comorbidities. Rheumatologists need to either screen their AS patients for comorbidities, or they need to be sure their patients are plugged in with another physician who will screen them,” said Dr. Walsh, director of the spondyloarthritis clinic at the University of Utah in Salt Lake City.
Her analysis used data from the Truven Health MarketScan databases for U.S. patients covered by Medicare or commercial health insurance, and included 6,370 patients with newly diagnosed AS and 14,988 adults matched by age and sex. The analysis only included AS patients who were free from comorbidities during the 2 years prior to their AS diagnosis. The average age of the people in the study was 52 years, and 54% were men.
During an average follow-up of 2.9 years following initial AS diagnosis, the most common comorbidity among the AS patients was uveitis, which occurred nearly 15-fold more frequently among the AS patients than in the controls. Other common incident comorbidities included inflammatory bowel disease, nearly sixfold more common among the AS patients, and osteoporosis, which was nearly threefold more common during follow-up after AS diagnosis, compared with the controls.
Other comorbidities with increased incidence in the AS patients included sleep apnea (80% more common among the AS patients during follow-up), asthma (50% more often), hypertension (44% more common), malignancy (23% more common), diabetes (20% more common), and dyslipidemia (11% more common). All these incidence rates represented statistically significant increases in the AS patients, compared with the controls.
A related analysis reported by Dr. Walsh also used data from the Truven Health databases for a somewhat larger group of AS patients, 6,679 followed for 1 year after their AS diagnosis, and 19,951 matched controls. The AS patients had a significantly higher rate of hospital admissions – 12%, compared with 6% among the controls – and a significantly higher rate of emergency department visits, at 23%, compared with 15% among the controls. The AS patients also had double the rate of physician office visits and prescribed medications.
“Obviously, the AS patients are not as healthy,” Dr. Walsh said in an interview. “We adjusted for their comorbidities, but that did not affect the hospitalization rates. We need to look into this more; I don’t know why the AS patients are being hospitalized. Typically AS itself does not lead to hospitalization, so I suspect it’s because of comorbidities, or perhaps because of adverse events from treatment.”
Dr. Walsh is a consultant to AbbVie and Novartis.
On Twitter @mitchelzoler
AT THE 2016 SPARTAN ANNUAL MEETING
Key clinical point: In the 3 years after initial ankylosing spondylitis diagnosis, the incidence of several comorbidities rises significantly above those in the general population.
Major finding: The incidence of new-onset depression among newly diagnosed ankylosing spondylitis patients was twice as high as it was among matched controls.
Data source: Observational data collected by Truven Health MarketScan, with a total of 21,358 patients and controls.
Disclosures: Dr. Walsh is a consultant to AbbVie and Novartis.
BM transplants provide better quality of life
Photo by Chad McNeeley
Patients receiving hematopoietic stem cell transplants from unrelated donors have better quality of life if they receive cells derived from bone marrow (BM) rather than peripheral blood (PB), according to a large study.
Recipients of BM transplants reported better psychological well-being, had fewer symptoms of graft-versus-host disease (GVHD), and were more likely to be back at work 5 years after their transplant.
However, there was no significant difference in overall survival, treatment-related death, or relapse between patients who received BM grafts and those who received PB transplants.
Stephanie Lee, MD, of Fred Hutchinson Cancer Research Center in Seattle, Washington, and her colleagues reported these results in JAMA Oncology.
“We’re hoping that, once we provide information about long-term quality of life and recovery, patients and their doctors can take this into account when they’re planning their transplants,” Dr Lee said.
She noted, however, that the results would only be applicable to transplant patients who are similar to those enrolled in this study.
The study included 551 patients, ages 16 to 66, who were receiving transplants from unrelated donors to treat hematologic neoplasms. The patients were randomly assigned to receive PB or BM grafts.
From 6 months to 5 years after transplant, researchers called the patients periodically to assess how they were doing.
At the 5-year mark, 102 BM recipients and 93 PB recipients were still alive and eligible for assessment.
At a median follow-up of 73 months (range, 30-121 months), there was no significant difference in survival rate, relapse incidence, or treatment-related mortality between BM and PB recipients.
The survival rate was 40% for BM recipients and 39% for PB recipients (P=0.84). The relapse rates were 32% and 29%, respectively (P=0.47). And the treatment-related mortality rates were 29% and 32%, respectively (P=0.44).
However, BM recipients were more likely to report better psychological well-being, earning higher Mental Health Inventory Psychological Well-Being scores than PB recipients. The mean scores were 78.9 and 72.2, respectively (P=0.01).
In addition, BM recipients had fewer symptoms of GVHD, earning lower Lee Chronic GVHD symptom scores than PB recipients. The mean scores were 13.1 and 19.3, respectively (P=0.004).
The researchers suspected, but could not confirm, that BM recipients had better psychological well-being because they experienced fewer self-reported symptoms of chronic GVHD.
The researchers also found that BM recipients were more likely than PB recipients to be working full-time or part-time 5 years after transplant. When the team adjusted for work status before transplant, the odds ratio was 1.5 (P=0.002).
“Results of this study set bone marrow as the standard source of stem cells for transplantation from unrelated donors,” said study author Claudio Anasetti, MD, of Moffitt Cancer Center in Tampa, Florida.
“When both your disease and the recommended treatment are life-threatening, I don’t think people are necessarily asking, ‘Which treatment is going to give me better quality of life years from now?’” Dr Lee added.
“Yet, if you’re going to make it through, as many patients do, you want to do it with good quality of life. That’s the whole point of having the transplant. It’s not just to cure your disease but also to try to get back to as normal a lifestyle as you can.” 
Photo by Chad McNeeley
Patients receiving hematopoietic stem cell transplants from unrelated donors have better quality of life if they receive cells derived from bone marrow (BM) rather than peripheral blood (PB), according to a large study.
Recipients of BM transplants reported better psychological well-being, had fewer symptoms of graft-versus-host disease (GVHD), and were more likely to be back at work 5 years after their transplant.
However, there was no significant difference in overall survival, treatment-related death, or relapse between patients who received BM grafts and those who received PB transplants.
Stephanie Lee, MD, of Fred Hutchinson Cancer Research Center in Seattle, Washington, and her colleagues reported these results in JAMA Oncology.
“We’re hoping that, once we provide information about long-term quality of life and recovery, patients and their doctors can take this into account when they’re planning their transplants,” Dr Lee said.
She noted, however, that the results would only be applicable to transplant patients who are similar to those enrolled in this study.
The study included 551 patients, ages 16 to 66, who were receiving transplants from unrelated donors to treat hematologic neoplasms. The patients were randomly assigned to receive PB or BM grafts.
From 6 months to 5 years after transplant, researchers called the patients periodically to assess how they were doing.
At the 5-year mark, 102 BM recipients and 93 PB recipients were still alive and eligible for assessment.
At a median follow-up of 73 months (range, 30-121 months), there was no significant difference in survival rate, relapse incidence, or treatment-related mortality between BM and PB recipients.
The survival rate was 40% for BM recipients and 39% for PB recipients (P=0.84). The relapse rates were 32% and 29%, respectively (P=0.47). And the treatment-related mortality rates were 29% and 32%, respectively (P=0.44).
However, BM recipients were more likely to report better psychological well-being, earning higher Mental Health Inventory Psychological Well-Being scores than PB recipients. The mean scores were 78.9 and 72.2, respectively (P=0.01).
In addition, BM recipients had fewer symptoms of GVHD, earning lower Lee Chronic GVHD symptom scores than PB recipients. The mean scores were 13.1 and 19.3, respectively (P=0.004).
The researchers suspected, but could not confirm, that BM recipients had better psychological well-being because they experienced fewer self-reported symptoms of chronic GVHD.
The researchers also found that BM recipients were more likely than PB recipients to be working full-time or part-time 5 years after transplant. When the team adjusted for work status before transplant, the odds ratio was 1.5 (P=0.002).
“Results of this study set bone marrow as the standard source of stem cells for transplantation from unrelated donors,” said study author Claudio Anasetti, MD, of Moffitt Cancer Center in Tampa, Florida.
“When both your disease and the recommended treatment are life-threatening, I don’t think people are necessarily asking, ‘Which treatment is going to give me better quality of life years from now?’” Dr Lee added.
“Yet, if you’re going to make it through, as many patients do, you want to do it with good quality of life. That’s the whole point of having the transplant. It’s not just to cure your disease but also to try to get back to as normal a lifestyle as you can.”
Photo by Chad McNeeley
Patients receiving hematopoietic stem cell transplants from unrelated donors have better quality of life if they receive cells derived from bone marrow (BM) rather than peripheral blood (PB), according to a large study.
Recipients of BM transplants reported better psychological well-being, had fewer symptoms of graft-versus-host disease (GVHD), and were more likely to be back at work 5 years after their transplant.
However, there was no significant difference in overall survival, treatment-related death, or relapse between patients who received BM grafts and those who received PB transplants.
Stephanie Lee, MD, of Fred Hutchinson Cancer Research Center in Seattle, Washington, and her colleagues reported these results in JAMA Oncology.
“We’re hoping that, once we provide information about long-term quality of life and recovery, patients and their doctors can take this into account when they’re planning their transplants,” Dr Lee said.
She noted, however, that the results would only be applicable to transplant patients who are similar to those enrolled in this study.
The study included 551 patients, ages 16 to 66, who were receiving transplants from unrelated donors to treat hematologic neoplasms. The patients were randomly assigned to receive PB or BM grafts.
From 6 months to 5 years after transplant, researchers called the patients periodically to assess how they were doing.
At the 5-year mark, 102 BM recipients and 93 PB recipients were still alive and eligible for assessment.
At a median follow-up of 73 months (range, 30-121 months), there was no significant difference in survival rate, relapse incidence, or treatment-related mortality between BM and PB recipients.
The survival rate was 40% for BM recipients and 39% for PB recipients (P=0.84). The relapse rates were 32% and 29%, respectively (P=0.47). And the treatment-related mortality rates were 29% and 32%, respectively (P=0.44).
However, BM recipients were more likely to report better psychological well-being, earning higher Mental Health Inventory Psychological Well-Being scores than PB recipients. The mean scores were 78.9 and 72.2, respectively (P=0.01).
In addition, BM recipients had fewer symptoms of GVHD, earning lower Lee Chronic GVHD symptom scores than PB recipients. The mean scores were 13.1 and 19.3, respectively (P=0.004).
The researchers suspected, but could not confirm, that BM recipients had better psychological well-being because they experienced fewer self-reported symptoms of chronic GVHD.
The researchers also found that BM recipients were more likely than PB recipients to be working full-time or part-time 5 years after transplant. When the team adjusted for work status before transplant, the odds ratio was 1.5 (P=0.002).
“Results of this study set bone marrow as the standard source of stem cells for transplantation from unrelated donors,” said study author Claudio Anasetti, MD, of Moffitt Cancer Center in Tampa, Florida.
“When both your disease and the recommended treatment are life-threatening, I don’t think people are necessarily asking, ‘Which treatment is going to give me better quality of life years from now?’” Dr Lee added.
“Yet, if you’re going to make it through, as many patients do, you want to do it with good quality of life. That’s the whole point of having the transplant. It’s not just to cure your disease but also to try to get back to as normal a lifestyle as you can.”