Neil Osterweil

ORLANDO – The type of regional chemotherapy given to patients with in-transit or intralymphatic melanoma of the extremities appears to make a difference in out-of-field recurrences and time to distant recurrence, reported investigators at a symposium of the Society of Surgical Oncology.

A study of 214 patients who underwent either first-time hyperthermic isolated limb perfusion (HILP) or isolated limb infusion (ILI) for in-transit melanomas showed that HILP was associated with significantly more in-field complete responses (P = .01), and a longer median time to out-of-field recurrences, compared with ILI, said Dr. Ketan Sharma of Duke University Medical Center in Durham, NC.

"We found that perfusion complete response and infusion complete response exhibit similar degrees of in-field disease control," Dr. Sharma said.

However, "recurrent disease after a regional therapy complete response is complex, and requires a multidisciplinary approach to treatment," he added.

The National Cancer Institute defines an in-transit metastasis as a "type of metastasis in which skin cancer spreads through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node."

The investigators used data from a prospective database of patients with in-transit melanomas to take a retrospective look at complete responders to either of the two isolated limb therapies. They compared patterns of recurrence and effects on outcomes between the two modalities. In all, 81 patients had first-time HILP and 133 had first-time ILI.

Among 36 patients with a complete response to HILP, 24 had recurrences. Of these patients, 11 experienced in-field-only recurrences, 12 had out-of-field-only recurrences, and 1 patient had a mixed recurrence pattern.

In comparison, 28 of 37 patients with complete responses to ILI had recurrences (9 had in-field-only, 16 had out-of-field, and 3 had mixed recurrence patterns).

There were no significant differences between the perfusion or infusion therapies in time to in-field recurrence, but time to out-of-field recurrence to regional nodes was significantly longer with HILP (42 months vs. 14 months; P = .02). When the authors looked at distant out-of-field recurrences, however, the difference between the treatment types was not significant.

Overall survival after all procedures (including partial responses, stable disease, and nonresponses) was also similar among the treatment types. The overall survival rate after a complete response was higher with HILP (77% vs. 54%); the investigators described this as clinically significant, although it was not statistically significant (P = .1).

At last follow-up (median, 4.0 years for HILP and 2.5 years for ILI), 12 patients who had a complete response to HILP were alive without recurrence for a median duration of 6.5 years, and 24 had recurrences at a median of 3.3 years after perfusion therapy and received additional therapy. Among the latter group, 2 had no evidence of disease, 9 were alive with disease, and 13 died, at a median of 3.1 years.

Among the complete responders to ILI, 9 had no recurrence at a median of 2.6 years; 28 had recurrences at a median of 2.3 years, and received additional treatment. At last follow-up, 8 of the 28 had no evidence of disease (median, 3.9 years), 7 were alive with disease (median, 1.2 years), and 13 had died (median, 2.1 years).

The investigators concluded that the higher proportion of recurrences among patients with an initial complete response to ILI may be due to more frequent lymph node recurrences (nine vs. one in patients who had a complete response to HILP).

The study was supported by Roche/Schering-Plough. Dr. Sharma had no disclosures.

ORLANDO – The type of regional chemotherapy given to patients with in-transit or intralymphatic melanoma of the extremities appears to make a difference in out-of-field recurrences and time to distant recurrence, reported investigators at a symposium of the Society of Surgical Oncology.

A study of 214 patients who underwent either first-time hyperthermic isolated limb perfusion (HILP) or isolated limb infusion (ILI) for in-transit melanomas showed that HILP was associated with significantly more in-field complete responses (P = .01), and a longer median time to out-of-field recurrences, compared with ILI, said Dr. Ketan Sharma of Duke University Medical Center in Durham, NC.

"We found that perfusion complete response and infusion complete response exhibit similar degrees of in-field disease control," Dr. Sharma said.

However, "recurrent disease after a regional therapy complete response is complex, and requires a multidisciplinary approach to treatment," he added.

The National Cancer Institute defines an in-transit metastasis as a "type of metastasis in which skin cancer spreads through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node."

The investigators used data from a prospective database of patients with in-transit melanomas to take a retrospective look at complete responders to either of the two isolated limb therapies. They compared patterns of recurrence and effects on outcomes between the two modalities. In all, 81 patients had first-time HILP and 133 had first-time ILI.

Among 36 patients with a complete response to HILP, 24 had recurrences. Of these patients, 11 experienced in-field-only recurrences, 12 had out-of-field-only recurrences, and 1 patient had a mixed recurrence pattern.

In comparison, 28 of 37 patients with complete responses to ILI had recurrences (9 had in-field-only, 16 had out-of-field, and 3 had mixed recurrence patterns).

There were no significant differences between the perfusion or infusion therapies in time to in-field recurrence, but time to out-of-field recurrence to regional nodes was significantly longer with HILP (42 months vs. 14 months; P = .02). When the authors looked at distant out-of-field recurrences, however, the difference between the treatment types was not significant.

Overall survival after all procedures (including partial responses, stable disease, and nonresponses) was also similar among the treatment types. The overall survival rate after a complete response was higher with HILP (77% vs. 54%); the investigators described this as clinically significant, although it was not statistically significant (P = .1).

At last follow-up (median, 4.0 years for HILP and 2.5 years for ILI), 12 patients who had a complete response to HILP were alive without recurrence for a median duration of 6.5 years, and 24 had recurrences at a median of 3.3 years after perfusion therapy and received additional therapy. Among the latter group, 2 had no evidence of disease, 9 were alive with disease, and 13 died, at a median of 3.1 years.

Among the complete responders to ILI, 9 had no recurrence at a median of 2.6 years; 28 had recurrences at a median of 2.3 years, and received additional treatment. At last follow-up, 8 of the 28 had no evidence of disease (median, 3.9 years), 7 were alive with disease (median, 1.2 years), and 13 had died (median, 2.1 years).

The investigators concluded that the higher proportion of recurrences among patients with an initial complete response to ILI may be due to more frequent lymph node recurrences (nine vs. one in patients who had a complete response to HILP).

The study was supported by Roche/Schering-Plough. Dr. Sharma had no disclosures.

ORLANDO – The type of regional chemotherapy given to patients with in-transit or intralymphatic melanoma of the extremities appears to make a difference in out-of-field recurrences and time to distant recurrence, reported investigators at a symposium of the Society of Surgical Oncology.

A study of 214 patients who underwent either first-time hyperthermic isolated limb perfusion (HILP) or isolated limb infusion (ILI) for in-transit melanomas showed that HILP was associated with significantly more in-field complete responses (P = .01), and a longer median time to out-of-field recurrences, compared with ILI, said Dr. Ketan Sharma of Duke University Medical Center in Durham, NC.

"We found that perfusion complete response and infusion complete response exhibit similar degrees of in-field disease control," Dr. Sharma said.

However, "recurrent disease after a regional therapy complete response is complex, and requires a multidisciplinary approach to treatment," he added.

The National Cancer Institute defines an in-transit metastasis as a "type of metastasis in which skin cancer spreads through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node."

The investigators used data from a prospective database of patients with in-transit melanomas to take a retrospective look at complete responders to either of the two isolated limb therapies. They compared patterns of recurrence and effects on outcomes between the two modalities. In all, 81 patients had first-time HILP and 133 had first-time ILI.

Among 36 patients with a complete response to HILP, 24 had recurrences. Of these patients, 11 experienced in-field-only recurrences, 12 had out-of-field-only recurrences, and 1 patient had a mixed recurrence pattern.

In comparison, 28 of 37 patients with complete responses to ILI had recurrences (9 had in-field-only, 16 had out-of-field, and 3 had mixed recurrence patterns).

There were no significant differences between the perfusion or infusion therapies in time to in-field recurrence, but time to out-of-field recurrence to regional nodes was significantly longer with HILP (42 months vs. 14 months; P = .02). When the authors looked at distant out-of-field recurrences, however, the difference between the treatment types was not significant.

Overall survival after all procedures (including partial responses, stable disease, and nonresponses) was also similar among the treatment types. The overall survival rate after a complete response was higher with HILP (77% vs. 54%); the investigators described this as clinically significant, although it was not statistically significant (P = .1).

At last follow-up (median, 4.0 years for HILP and 2.5 years for ILI), 12 patients who had a complete response to HILP were alive without recurrence for a median duration of 6.5 years, and 24 had recurrences at a median of 3.3 years after perfusion therapy and received additional therapy. Among the latter group, 2 had no evidence of disease, 9 were alive with disease, and 13 died, at a median of 3.1 years.

Among the complete responders to ILI, 9 had no recurrence at a median of 2.6 years; 28 had recurrences at a median of 2.3 years, and received additional treatment. At last follow-up, 8 of the 28 had no evidence of disease (median, 3.9 years), 7 were alive with disease (median, 1.2 years), and 13 had died (median, 2.1 years).

The investigators concluded that the higher proportion of recurrences among patients with an initial complete response to ILI may be due to more frequent lymph node recurrences (nine vs. one in patients who had a complete response to HILP).

The study was supported by Roche/Schering-Plough. Dr. Sharma had no disclosures.

ORLANDO – Malignant melanomas of the scalp behave differently from melanomas arising at other body sites, and are associated with poor disease-free and overall survival compared with other head and neck melanomas, investigators reported here.

A retrospective study of more than 11,000 patients with malignant melanomas showed that 5-year melanoma-specific survival was 65% for patients with lesions on the scalp, compared with 78% for patients with tumors on the trunk or elsewhere on the head, face, neck, or ear (P = .0003), said Dr. Junko Ozao-Choy, a fellow at the John Wayne Cancer Institute in Santa Monica, Calif.

Five-year overall survival for patients with melanomas of the scalp was 58%, compared with 72% for those with head, face, neck, or ear lesions, 74% for those with trunk lesions, and 77% for those with tumors on an extremity (P less than .0001), Dr. Ozao-Choy reported at a symposium sponsored by the Society of Surgical Oncology.

Melanomas of the scalp may account for the poor prognosis of head and neck melanoma relative to tumors originating at other body sites, Dr. Ozao-Choy and her colleagues suggested.

"Scalp melanomas may warrant further studies to ascertain whether biology or anatomy contributes to their worse clinical course," she said, adding that the results indicate "scalp melanomas may need closer clinical follow-up."

Compared with melanomas originating at other body sites, scalp melanomas tend to occur in older patients, predominantly men, according to the investigators. The lesions tend to have higher Breslow thickness, advanced nodal stage and overall stage, and more ulceration.

Dr. Ozao-Choy and her colleagues based their findings on a database review of 11,396 patients presenting for treatment within 4 months of diagnosis from 1971 through 2010. In univariate analysis controlling for sex, they found that 80% of the 799 patients with melanoma originating on the scalp were men (P = .0001).

The mean age at presentation was 54 years for those with scalp lesions and 55 for those with head, neck, or ear tumors. Taken together, the mean age at diagnosis for patients with scalp and head melanomas was higher than for patients with lesions on the trunk (age 47 years) or extremities (age 51 years, P less than .0001).

Scalp tumors had greater Breslow thickness, at a mean of 2.5 mm compared with 1.7 mm for other head and neck melanomas, 1.8 mm for trunk tumors, and 1.9 mm for lesions on an extremity (P less than .0001).

Looking at 5-year overall survival by stage, the authors found that patients with stage I/II scalp lesions had worse survival than those with stage I/II lesions at other sites (P less than .0001). Similarly, stage III scalp primary tumors were associated with worse survival than other stage III tumors (P = .009).

Multivariate analysis controlling for age, male sex, Breslow thickness, lymph node status, and ulceration revealed that patients with scalp tumors had worse 5-year disease-free survival, at 47%, compared with 61% for other head and neck tumors, 66% for trunk tumors, and 69% for extremity melanomas (hazard ratio, 1.8; P less than .0001).

In the question and answer session, an audience member commented that the worse prognosis for head and neck melanomas may be related to the greater frequency of aggressive NRAS and BRAF mutations in tumors originating at those sites.

The study was internally funded. The authors had no disclosures.

ORLANDO – Malignant melanomas of the scalp behave differently from melanomas arising at other body sites, and are associated with poor disease-free and overall survival compared with other head and neck melanomas, investigators reported here.

A retrospective study of more than 11,000 patients with malignant melanomas showed that 5-year melanoma-specific survival was 65% for patients with lesions on the scalp, compared with 78% for patients with tumors on the trunk or elsewhere on the head, face, neck, or ear (P = .0003), said Dr. Junko Ozao-Choy, a fellow at the John Wayne Cancer Institute in Santa Monica, Calif.

Five-year overall survival for patients with melanomas of the scalp was 58%, compared with 72% for those with head, face, neck, or ear lesions, 74% for those with trunk lesions, and 77% for those with tumors on an extremity (P less than .0001), Dr. Ozao-Choy reported at a symposium sponsored by the Society of Surgical Oncology.

Melanomas of the scalp may account for the poor prognosis of head and neck melanoma relative to tumors originating at other body sites, Dr. Ozao-Choy and her colleagues suggested.

"Scalp melanomas may warrant further studies to ascertain whether biology or anatomy contributes to their worse clinical course," she said, adding that the results indicate "scalp melanomas may need closer clinical follow-up."

Compared with melanomas originating at other body sites, scalp melanomas tend to occur in older patients, predominantly men, according to the investigators. The lesions tend to have higher Breslow thickness, advanced nodal stage and overall stage, and more ulceration.

Dr. Ozao-Choy and her colleagues based their findings on a database review of 11,396 patients presenting for treatment within 4 months of diagnosis from 1971 through 2010. In univariate analysis controlling for sex, they found that 80% of the 799 patients with melanoma originating on the scalp were men (P = .0001).

The mean age at presentation was 54 years for those with scalp lesions and 55 for those with head, neck, or ear tumors. Taken together, the mean age at diagnosis for patients with scalp and head melanomas was higher than for patients with lesions on the trunk (age 47 years) or extremities (age 51 years, P less than .0001).

Scalp tumors had greater Breslow thickness, at a mean of 2.5 mm compared with 1.7 mm for other head and neck melanomas, 1.8 mm for trunk tumors, and 1.9 mm for lesions on an extremity (P less than .0001).

Looking at 5-year overall survival by stage, the authors found that patients with stage I/II scalp lesions had worse survival than those with stage I/II lesions at other sites (P less than .0001). Similarly, stage III scalp primary tumors were associated with worse survival than other stage III tumors (P = .009).

Multivariate analysis controlling for age, male sex, Breslow thickness, lymph node status, and ulceration revealed that patients with scalp tumors had worse 5-year disease-free survival, at 47%, compared with 61% for other head and neck tumors, 66% for trunk tumors, and 69% for extremity melanomas (hazard ratio, 1.8; P less than .0001).

In the question and answer session, an audience member commented that the worse prognosis for head and neck melanomas may be related to the greater frequency of aggressive NRAS and BRAF mutations in tumors originating at those sites.

The study was internally funded. The authors had no disclosures.

ORLANDO – Malignant melanomas of the scalp behave differently from melanomas arising at other body sites, and are associated with poor disease-free and overall survival compared with other head and neck melanomas, investigators reported here.

A retrospective study of more than 11,000 patients with malignant melanomas showed that 5-year melanoma-specific survival was 65% for patients with lesions on the scalp, compared with 78% for patients with tumors on the trunk or elsewhere on the head, face, neck, or ear (P = .0003), said Dr. Junko Ozao-Choy, a fellow at the John Wayne Cancer Institute in Santa Monica, Calif.

Five-year overall survival for patients with melanomas of the scalp was 58%, compared with 72% for those with head, face, neck, or ear lesions, 74% for those with trunk lesions, and 77% for those with tumors on an extremity (P less than .0001), Dr. Ozao-Choy reported at a symposium sponsored by the Society of Surgical Oncology.

Melanomas of the scalp may account for the poor prognosis of head and neck melanoma relative to tumors originating at other body sites, Dr. Ozao-Choy and her colleagues suggested.

"Scalp melanomas may warrant further studies to ascertain whether biology or anatomy contributes to their worse clinical course," she said, adding that the results indicate "scalp melanomas may need closer clinical follow-up."

Compared with melanomas originating at other body sites, scalp melanomas tend to occur in older patients, predominantly men, according to the investigators. The lesions tend to have higher Breslow thickness, advanced nodal stage and overall stage, and more ulceration.

Dr. Ozao-Choy and her colleagues based their findings on a database review of 11,396 patients presenting for treatment within 4 months of diagnosis from 1971 through 2010. In univariate analysis controlling for sex, they found that 80% of the 799 patients with melanoma originating on the scalp were men (P = .0001).

The mean age at presentation was 54 years for those with scalp lesions and 55 for those with head, neck, or ear tumors. Taken together, the mean age at diagnosis for patients with scalp and head melanomas was higher than for patients with lesions on the trunk (age 47 years) or extremities (age 51 years, P less than .0001).

Scalp tumors had greater Breslow thickness, at a mean of 2.5 mm compared with 1.7 mm for other head and neck melanomas, 1.8 mm for trunk tumors, and 1.9 mm for lesions on an extremity (P less than .0001).

Looking at 5-year overall survival by stage, the authors found that patients with stage I/II scalp lesions had worse survival than those with stage I/II lesions at other sites (P less than .0001). Similarly, stage III scalp primary tumors were associated with worse survival than other stage III tumors (P = .009).

Multivariate analysis controlling for age, male sex, Breslow thickness, lymph node status, and ulceration revealed that patients with scalp tumors had worse 5-year disease-free survival, at 47%, compared with 61% for other head and neck tumors, 66% for trunk tumors, and 69% for extremity melanomas (hazard ratio, 1.8; P less than .0001).

In the question and answer session, an audience member commented that the worse prognosis for head and neck melanomas may be related to the greater frequency of aggressive NRAS and BRAF mutations in tumors originating at those sites.

The study was internally funded. The authors had no disclosures.

ORLANDO – Aspirin sensitivity can be a real headache for patients and clinicians, but a safe and effective aspirin desensitization protocol can bring the analgesic and anti-inflammatory benefits of aspirin therapy to patients with aspirin-exacerbated respiratory disease, reported a clinician at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Patients with AERD who undergo aspirin desensitization have fewer bouts of sinusitis, show improvement in both asthma symptoms and sense of smell, and use less corticosteroid, compared with patients who don’t undergo desensitization, said Dr. Katharine M. Woessner, program director in the division of allergy, asthma, and immunology at the Scripps Clinic in San Diego.

©jimdeli/Fotolia.com

Aspirin desensitization also blunts the response to other NSAIDS like ibuprofen and naproxen, which – like aspirin – inhibit the cyclooxygenase-1 (COX-1) enzyme, Dr. Woessner said. Aspirin and other NSAIDs induce rhinitis and asthma attacks in patients with AERD, and the disease is progressive even when patients are careful to avoid all NSAIDs.

Only 3 of 1,400 consecutive patients with AERD that was treated with aspirin desensitization at Scripps experienced systemic reactions, and all of those responded to a single dose of intramuscular epinephrine, she said.

"I don’t know why aspirin desensitization works, but we clearly have a therapy that’s easy to use and is quite effective in managing these patients," Dr. Woessner said.

Aspirin Challenge

AERD usually begins in patients in their 30s or 40s who have a prior history of tolerance to aspirin and other NSAIDs. It is more than twice as likely to occur in women, and tends to be more severe in women than in men. Patients develop chronic congestion, rhinitis, anosmia, and nasal polyps, often followed by asthma 1-5 years after the onset of rhinitis.

The disease is characterized by chronic eosinophilic rhinosinusitis and nasal polyposis that are initially intermittent but evolve into chronic, hyperplasic eosinophilic sinusitis that often requires surgical intervention, Dr. Woessner said.

The asthma that develops in patients with AERD is persistent, usually moderate to severe, and related to the severity of sinus disease. However, "asthma is not necessarily a prerequisite to make a diagnosis of aspirin-exacerbated respiratory disease," she noted.

The clinical standard for AERD diagnosis is an oral aspirin challenge. Patients typically can experience a 20% or greater decline in FEV₁ (forced expiratory volume in 1 second) and a naso-ocular reaction, but purely upper airway or lower airway reactions can also occur. Patients may also have a partial asthma reaction, with a change in FEV₁ from baseline of –15% to –20% and a naso-ocular reaction or laryngospasm. Patients are considered to be negative for AERD if they have no reactions following a 325-mg oral aspirin challenge.

In those who test positive, treatment consists of avoiding all COX-1–inhibiting NSAIDS. Highly selective COX-2 inhibitors such as celecoxib (Celebrex) are generally well tolerated in patients with AERD, Dr. Woesnner said, noting that more than 200 AERD-proven patients at Scripps who were challenged with a highly selective COX-2 inhibitor had no reaction. However, cross reactivity is possible with higher doses of less-selective COX-2 inhibitors such as nimesulide (Sulide) or meloxicam (Mobic). Acetaminophen at doses up to 1,000 mg are also typically well tolerated in these patients.

"There are several drugs that don’t cross-react with aspirin in patients with AERD. The problem is that they’re not very good analgesics, so if we need something that’s analgesic or anti-inflammatory, patients are not going to get much benefit from these medications," Dr. Woessner said.

Outpatient Precautions

Aspirin challenge and desensitization in the outpatient setting can be safely performed with a few caveats. The patient should have stable asthma within 10% of the best prior value and an FEV₁ of at least 60%-80% of predicted, or an output of at least 1.5 L. The patient should be on inhaled steroids and a long-acting beta-agonist, and 2-4 weeks before desensitization should be started on montelukast or another leukotriene modifier.

The advent of leukotriene inhibitors has made aspirin desensitization a routine outpatient procedure, session moderator Dr. Mariana C. Castells noted in an interview.

"We used to do aspirin desensitization in the intensive care unit, just because the reactions were scary and we didn’t know how to control them. In the last 10 years, since we started to use montelukast [Singulair] and Zyflo [zileuton], less than 1% have been done in an intensive care unit," said Dr. Castells of the division of rheumatology, immunology, and allergy at Brigham and Women’s Hospital in Boston.

Patients are asked to not use antihistamines for 72 hours before the procedure so that their naso-ocular responses can be observed. Patients with nasal polyps may require debulking surgery prior to desensitization.

"We had recommended in the past that intravenous access be available, but we have data now that it may not be necessary," Dr. Woessner said.

On day 1 of sensitization, patients take 20-40 mg of aspirin at 8 a.m., 40-60 mg at 11 a.m., and 60-100 mg at 2 p.m. On day 2, the respective doses at the same times of day are 100-160 mg, 160-325 mg, and 325 mg.

During desensitization, FEV₁ should be measured every hour, and should be at least 1.5 L and greater than 60% of predicted. When a patient has a reaction and that reaction is resolved, the provoking dose should be repeated, and if there is no reaction, the escalating doses can be continued every 3 hours as scheduled. Patients are considered to be densensitized or aspirin tolerant if they can take a 325-mg dose with no reaction. The patient should be instructed to start on 650-mg aspirin that night as the first daily dose, and to continue with up to 650 mg twice daily. About half of all patients can decrease to 325 mg b.i.d. at 1-6 months after the densensitization protocol is completed.

Combining a nasal ketorolac challenge with the oral aspirin challenge can make the desensitization even safer, Dr. Woessner said. The patient is given ketorolac spray at increasing doses every half-hour over 2 hours, followed 1 hour after the last spray with 60-mg aspirin in two doses 1.5 hours apart. The patient is discharged and returns the next day to receive 150-mg aspirin, followed 3 hours later by 325 mg.

No funding source was reported. Dr. Woessner disclosed that she is on the speakers bureaus of Merck and Teva, and has been a speaker for GlaxoSmithKline.

ORLANDO – Aspirin sensitivity can be a real headache for patients and clinicians, but a safe and effective aspirin desensitization protocol can bring the analgesic and anti-inflammatory benefits of aspirin therapy to patients with aspirin-exacerbated respiratory disease, reported a clinician at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Patients with AERD who undergo aspirin desensitization have fewer bouts of sinusitis, show improvement in both asthma symptoms and sense of smell, and use less corticosteroid, compared with patients who don’t undergo desensitization, said Dr. Katharine M. Woessner, program director in the division of allergy, asthma, and immunology at the Scripps Clinic in San Diego.

©jimdeli/Fotolia.com

Aspirin desensitization also blunts the response to other NSAIDS like ibuprofen and naproxen, which – like aspirin – inhibit the cyclooxygenase-1 (COX-1) enzyme, Dr. Woessner said. Aspirin and other NSAIDs induce rhinitis and asthma attacks in patients with AERD, and the disease is progressive even when patients are careful to avoid all NSAIDs.

Only 3 of 1,400 consecutive patients with AERD that was treated with aspirin desensitization at Scripps experienced systemic reactions, and all of those responded to a single dose of intramuscular epinephrine, she said.

"I don’t know why aspirin desensitization works, but we clearly have a therapy that’s easy to use and is quite effective in managing these patients," Dr. Woessner said.

Aspirin Challenge

AERD usually begins in patients in their 30s or 40s who have a prior history of tolerance to aspirin and other NSAIDs. It is more than twice as likely to occur in women, and tends to be more severe in women than in men. Patients develop chronic congestion, rhinitis, anosmia, and nasal polyps, often followed by asthma 1-5 years after the onset of rhinitis.

The disease is characterized by chronic eosinophilic rhinosinusitis and nasal polyposis that are initially intermittent but evolve into chronic, hyperplasic eosinophilic sinusitis that often requires surgical intervention, Dr. Woessner said.

The asthma that develops in patients with AERD is persistent, usually moderate to severe, and related to the severity of sinus disease. However, "asthma is not necessarily a prerequisite to make a diagnosis of aspirin-exacerbated respiratory disease," she noted.

The clinical standard for AERD diagnosis is an oral aspirin challenge. Patients typically can experience a 20% or greater decline in FEV₁ (forced expiratory volume in 1 second) and a naso-ocular reaction, but purely upper airway or lower airway reactions can also occur. Patients may also have a partial asthma reaction, with a change in FEV₁ from baseline of –15% to –20% and a naso-ocular reaction or laryngospasm. Patients are considered to be negative for AERD if they have no reactions following a 325-mg oral aspirin challenge.

In those who test positive, treatment consists of avoiding all COX-1–inhibiting NSAIDS. Highly selective COX-2 inhibitors such as celecoxib (Celebrex) are generally well tolerated in patients with AERD, Dr. Woesnner said, noting that more than 200 AERD-proven patients at Scripps who were challenged with a highly selective COX-2 inhibitor had no reaction. However, cross reactivity is possible with higher doses of less-selective COX-2 inhibitors such as nimesulide (Sulide) or meloxicam (Mobic). Acetaminophen at doses up to 1,000 mg are also typically well tolerated in these patients.

"There are several drugs that don’t cross-react with aspirin in patients with AERD. The problem is that they’re not very good analgesics, so if we need something that’s analgesic or anti-inflammatory, patients are not going to get much benefit from these medications," Dr. Woessner said.

Outpatient Precautions

Aspirin challenge and desensitization in the outpatient setting can be safely performed with a few caveats. The patient should have stable asthma within 10% of the best prior value and an FEV₁ of at least 60%-80% of predicted, or an output of at least 1.5 L. The patient should be on inhaled steroids and a long-acting beta-agonist, and 2-4 weeks before desensitization should be started on montelukast or another leukotriene modifier.

The advent of leukotriene inhibitors has made aspirin desensitization a routine outpatient procedure, session moderator Dr. Mariana C. Castells noted in an interview.

"We used to do aspirin desensitization in the intensive care unit, just because the reactions were scary and we didn’t know how to control them. In the last 10 years, since we started to use montelukast [Singulair] and Zyflo [zileuton], less than 1% have been done in an intensive care unit," said Dr. Castells of the division of rheumatology, immunology, and allergy at Brigham and Women’s Hospital in Boston.

Patients are asked to not use antihistamines for 72 hours before the procedure so that their naso-ocular responses can be observed. Patients with nasal polyps may require debulking surgery prior to desensitization.

"We had recommended in the past that intravenous access be available, but we have data now that it may not be necessary," Dr. Woessner said.

On day 1 of sensitization, patients take 20-40 mg of aspirin at 8 a.m., 40-60 mg at 11 a.m., and 60-100 mg at 2 p.m. On day 2, the respective doses at the same times of day are 100-160 mg, 160-325 mg, and 325 mg.

During desensitization, FEV₁ should be measured every hour, and should be at least 1.5 L and greater than 60% of predicted. When a patient has a reaction and that reaction is resolved, the provoking dose should be repeated, and if there is no reaction, the escalating doses can be continued every 3 hours as scheduled. Patients are considered to be densensitized or aspirin tolerant if they can take a 325-mg dose with no reaction. The patient should be instructed to start on 650-mg aspirin that night as the first daily dose, and to continue with up to 650 mg twice daily. About half of all patients can decrease to 325 mg b.i.d. at 1-6 months after the densensitization protocol is completed.

Combining a nasal ketorolac challenge with the oral aspirin challenge can make the desensitization even safer, Dr. Woessner said. The patient is given ketorolac spray at increasing doses every half-hour over 2 hours, followed 1 hour after the last spray with 60-mg aspirin in two doses 1.5 hours apart. The patient is discharged and returns the next day to receive 150-mg aspirin, followed 3 hours later by 325 mg.

No funding source was reported. Dr. Woessner disclosed that she is on the speakers bureaus of Merck and Teva, and has been a speaker for GlaxoSmithKline.

ORLANDO – Aspirin sensitivity can be a real headache for patients and clinicians, but a safe and effective aspirin desensitization protocol can bring the analgesic and anti-inflammatory benefits of aspirin therapy to patients with aspirin-exacerbated respiratory disease, reported a clinician at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Patients with AERD who undergo aspirin desensitization have fewer bouts of sinusitis, show improvement in both asthma symptoms and sense of smell, and use less corticosteroid, compared with patients who don’t undergo desensitization, said Dr. Katharine M. Woessner, program director in the division of allergy, asthma, and immunology at the Scripps Clinic in San Diego.

©jimdeli/Fotolia.com

Aspirin desensitization also blunts the response to other NSAIDS like ibuprofen and naproxen, which – like aspirin – inhibit the cyclooxygenase-1 (COX-1) enzyme, Dr. Woessner said. Aspirin and other NSAIDs induce rhinitis and asthma attacks in patients with AERD, and the disease is progressive even when patients are careful to avoid all NSAIDs.

Only 3 of 1,400 consecutive patients with AERD that was treated with aspirin desensitization at Scripps experienced systemic reactions, and all of those responded to a single dose of intramuscular epinephrine, she said.

"I don’t know why aspirin desensitization works, but we clearly have a therapy that’s easy to use and is quite effective in managing these patients," Dr. Woessner said.

Aspirin Challenge

AERD usually begins in patients in their 30s or 40s who have a prior history of tolerance to aspirin and other NSAIDs. It is more than twice as likely to occur in women, and tends to be more severe in women than in men. Patients develop chronic congestion, rhinitis, anosmia, and nasal polyps, often followed by asthma 1-5 years after the onset of rhinitis.

The disease is characterized by chronic eosinophilic rhinosinusitis and nasal polyposis that are initially intermittent but evolve into chronic, hyperplasic eosinophilic sinusitis that often requires surgical intervention, Dr. Woessner said.

The asthma that develops in patients with AERD is persistent, usually moderate to severe, and related to the severity of sinus disease. However, "asthma is not necessarily a prerequisite to make a diagnosis of aspirin-exacerbated respiratory disease," she noted.

The clinical standard for AERD diagnosis is an oral aspirin challenge. Patients typically can experience a 20% or greater decline in FEV₁ (forced expiratory volume in 1 second) and a naso-ocular reaction, but purely upper airway or lower airway reactions can also occur. Patients may also have a partial asthma reaction, with a change in FEV₁ from baseline of –15% to –20% and a naso-ocular reaction or laryngospasm. Patients are considered to be negative for AERD if they have no reactions following a 325-mg oral aspirin challenge.

In those who test positive, treatment consists of avoiding all COX-1–inhibiting NSAIDS. Highly selective COX-2 inhibitors such as celecoxib (Celebrex) are generally well tolerated in patients with AERD, Dr. Woesnner said, noting that more than 200 AERD-proven patients at Scripps who were challenged with a highly selective COX-2 inhibitor had no reaction. However, cross reactivity is possible with higher doses of less-selective COX-2 inhibitors such as nimesulide (Sulide) or meloxicam (Mobic). Acetaminophen at doses up to 1,000 mg are also typically well tolerated in these patients.

"There are several drugs that don’t cross-react with aspirin in patients with AERD. The problem is that they’re not very good analgesics, so if we need something that’s analgesic or anti-inflammatory, patients are not going to get much benefit from these medications," Dr. Woessner said.

Outpatient Precautions

Aspirin challenge and desensitization in the outpatient setting can be safely performed with a few caveats. The patient should have stable asthma within 10% of the best prior value and an FEV₁ of at least 60%-80% of predicted, or an output of at least 1.5 L. The patient should be on inhaled steroids and a long-acting beta-agonist, and 2-4 weeks before desensitization should be started on montelukast or another leukotriene modifier.

The advent of leukotriene inhibitors has made aspirin desensitization a routine outpatient procedure, session moderator Dr. Mariana C. Castells noted in an interview.

"We used to do aspirin desensitization in the intensive care unit, just because the reactions were scary and we didn’t know how to control them. In the last 10 years, since we started to use montelukast [Singulair] and Zyflo [zileuton], less than 1% have been done in an intensive care unit," said Dr. Castells of the division of rheumatology, immunology, and allergy at Brigham and Women’s Hospital in Boston.

Patients are asked to not use antihistamines for 72 hours before the procedure so that their naso-ocular responses can be observed. Patients with nasal polyps may require debulking surgery prior to desensitization.

"We had recommended in the past that intravenous access be available, but we have data now that it may not be necessary," Dr. Woessner said.

On day 1 of sensitization, patients take 20-40 mg of aspirin at 8 a.m., 40-60 mg at 11 a.m., and 60-100 mg at 2 p.m. On day 2, the respective doses at the same times of day are 100-160 mg, 160-325 mg, and 325 mg.

During desensitization, FEV₁ should be measured every hour, and should be at least 1.5 L and greater than 60% of predicted. When a patient has a reaction and that reaction is resolved, the provoking dose should be repeated, and if there is no reaction, the escalating doses can be continued every 3 hours as scheduled. Patients are considered to be densensitized or aspirin tolerant if they can take a 325-mg dose with no reaction. The patient should be instructed to start on 650-mg aspirin that night as the first daily dose, and to continue with up to 650 mg twice daily. About half of all patients can decrease to 325 mg b.i.d. at 1-6 months after the densensitization protocol is completed.

Combining a nasal ketorolac challenge with the oral aspirin challenge can make the desensitization even safer, Dr. Woessner said. The patient is given ketorolac spray at increasing doses every half-hour over 2 hours, followed 1 hour after the last spray with 60-mg aspirin in two doses 1.5 hours apart. The patient is discharged and returns the next day to receive 150-mg aspirin, followed 3 hours later by 325 mg.

No funding source was reported. Dr. Woessner disclosed that she is on the speakers bureaus of Merck and Teva, and has been a speaker for GlaxoSmithKline.

ORLANDO  – Triple-negative breast tumors are notorious for their ability to evade hormonal agents and targeted therapies. But a subset of these intractable tumors expresses androgen receptors, and may be vulnerable to antiandrogen drugs, investigators suggested at the symposium of the Society of Surgical Oncology.

An evaluation of cancerous and normal breast tissues from 94 patients with triple-negative breast tumors (lacking estrogen-, progesterone-, and HER2-receptor expression), showed that the androgen receptor (AR) was expressed in 23% of tumors, reported Dr. Barbara Pockaj of the Mayo Clinic in Scottsdale, Ariz., and colleagues.

AR–positive cancers occurred more frequently in older patients and were significantly associated with lymph node metastases, compared with AR-negative, triple-negative breast cancers in this small study, she said.

There was a trend toward higher tumor stage at diagnosis among patients with AR-positive tumors, but AR-positive and AR-negative patients did not differ significantly in overall or recurrence-free survival, said Dr. Pockaj.

Previous studies have suggested that 10%-43% of triple-negative breast cancers bear the androgen receptor, but the antibodies and methods used for characterizing the presence of the receptor varied significantly, making it difficult to nail down actual numbers, Dr. Pockaj said.

The investigators examined 177 tissue biopsy cores from 94 patients with triple-negative breast cancer to see whether AR-receptor expression correlated with patient and tumor factors and survival, and where expression of the receptors in different tissues from the same patients correlated with tumor progression.

The receptor was expressed in 88% of normal breast tissues in the samples, a proportion identical to that of the estrogen receptor in normal tissues from the same patients.

AR expression was detected in all 6 of 6 adjacent DCIS (ductal carcinoma in situ) samples from AR-positive patients, and in 9 of 15 DCIS samples from patients with AR-negative cancer.

All lymph node metastases from AR-positive patients were also positive, whereas no lymph node metastases from AR-negative patients were found to express the androgen receptor.

There were no significant differences between AR-positive and -negative patients in tumor grade, angiolymphatic invasion, TNM (tumor, node, metastasis) stage, or tumor size. In contrast, 16 of the 72 (22%) of the AR-negative patients had lymph node metastases, compared with 10 of 22 (46%) AR-positive patients (P = .033).

There were no significant differences in locoregional recurrences, overall survival, or disease-specific survival between positive and negative patients.

Among all 94 patients, however, the presence of lymph node metastases was associated with a significantly worse recurrence-free survival (hazard ratio, 5.502; P = .017). Chemotherapy significantly reduced that risk (HR, 0.099; P = .0004).

In multivariate analysis, the investigators found that AR expression was associated with older age (63 years vs. 57 years; P = .051) and with the presence of lymph nodes metastases (P = .033).

Although larger studies are needed, the data suggest that AR-positive, triple-negative breast cancer "has unique clinical behavior and may need different treatment," Dr. Pockaj said.

A phase II, open-label trial of the antiandrogen bicalutamide (Casodex) in patients with AR-positive, estrogen- and progesterone-receptor–negative, metastatic breast cancer is currently underway in eight U.S. cancer centers.

The current study was supported by the Translational Genomics Research Institute, Phoenix, and the Mayo Clinic, Scottsdale, Ariz. Dr. Pockaj is an employee of the Mayo Clinic.

ORLANDO  – Triple-negative breast tumors are notorious for their ability to evade hormonal agents and targeted therapies. But a subset of these intractable tumors expresses androgen receptors, and may be vulnerable to antiandrogen drugs, investigators suggested at the symposium of the Society of Surgical Oncology.

An evaluation of cancerous and normal breast tissues from 94 patients with triple-negative breast tumors (lacking estrogen-, progesterone-, and HER2-receptor expression), showed that the androgen receptor (AR) was expressed in 23% of tumors, reported Dr. Barbara Pockaj of the Mayo Clinic in Scottsdale, Ariz., and colleagues.

AR–positive cancers occurred more frequently in older patients and were significantly associated with lymph node metastases, compared with AR-negative, triple-negative breast cancers in this small study, she said.

There was a trend toward higher tumor stage at diagnosis among patients with AR-positive tumors, but AR-positive and AR-negative patients did not differ significantly in overall or recurrence-free survival, said Dr. Pockaj.

Previous studies have suggested that 10%-43% of triple-negative breast cancers bear the androgen receptor, but the antibodies and methods used for characterizing the presence of the receptor varied significantly, making it difficult to nail down actual numbers, Dr. Pockaj said.

The investigators examined 177 tissue biopsy cores from 94 patients with triple-negative breast cancer to see whether AR-receptor expression correlated with patient and tumor factors and survival, and where expression of the receptors in different tissues from the same patients correlated with tumor progression.

The receptor was expressed in 88% of normal breast tissues in the samples, a proportion identical to that of the estrogen receptor in normal tissues from the same patients.

AR expression was detected in all 6 of 6 adjacent DCIS (ductal carcinoma in situ) samples from AR-positive patients, and in 9 of 15 DCIS samples from patients with AR-negative cancer.

All lymph node metastases from AR-positive patients were also positive, whereas no lymph node metastases from AR-negative patients were found to express the androgen receptor.

There were no significant differences between AR-positive and -negative patients in tumor grade, angiolymphatic invasion, TNM (tumor, node, metastasis) stage, or tumor size. In contrast, 16 of the 72 (22%) of the AR-negative patients had lymph node metastases, compared with 10 of 22 (46%) AR-positive patients (P = .033).

There were no significant differences in locoregional recurrences, overall survival, or disease-specific survival between positive and negative patients.

Among all 94 patients, however, the presence of lymph node metastases was associated with a significantly worse recurrence-free survival (hazard ratio, 5.502; P = .017). Chemotherapy significantly reduced that risk (HR, 0.099; P = .0004).

In multivariate analysis, the investigators found that AR expression was associated with older age (63 years vs. 57 years; P = .051) and with the presence of lymph nodes metastases (P = .033).

Although larger studies are needed, the data suggest that AR-positive, triple-negative breast cancer "has unique clinical behavior and may need different treatment," Dr. Pockaj said.

A phase II, open-label trial of the antiandrogen bicalutamide (Casodex) in patients with AR-positive, estrogen- and progesterone-receptor–negative, metastatic breast cancer is currently underway in eight U.S. cancer centers.

The current study was supported by the Translational Genomics Research Institute, Phoenix, and the Mayo Clinic, Scottsdale, Ariz. Dr. Pockaj is an employee of the Mayo Clinic.

ORLANDO  – Triple-negative breast tumors are notorious for their ability to evade hormonal agents and targeted therapies. But a subset of these intractable tumors expresses androgen receptors, and may be vulnerable to antiandrogen drugs, investigators suggested at the symposium of the Society of Surgical Oncology.

An evaluation of cancerous and normal breast tissues from 94 patients with triple-negative breast tumors (lacking estrogen-, progesterone-, and HER2-receptor expression), showed that the androgen receptor (AR) was expressed in 23% of tumors, reported Dr. Barbara Pockaj of the Mayo Clinic in Scottsdale, Ariz., and colleagues.

AR–positive cancers occurred more frequently in older patients and were significantly associated with lymph node metastases, compared with AR-negative, triple-negative breast cancers in this small study, she said.

There was a trend toward higher tumor stage at diagnosis among patients with AR-positive tumors, but AR-positive and AR-negative patients did not differ significantly in overall or recurrence-free survival, said Dr. Pockaj.

Previous studies have suggested that 10%-43% of triple-negative breast cancers bear the androgen receptor, but the antibodies and methods used for characterizing the presence of the receptor varied significantly, making it difficult to nail down actual numbers, Dr. Pockaj said.

The investigators examined 177 tissue biopsy cores from 94 patients with triple-negative breast cancer to see whether AR-receptor expression correlated with patient and tumor factors and survival, and where expression of the receptors in different tissues from the same patients correlated with tumor progression.

The receptor was expressed in 88% of normal breast tissues in the samples, a proportion identical to that of the estrogen receptor in normal tissues from the same patients.

AR expression was detected in all 6 of 6 adjacent DCIS (ductal carcinoma in situ) samples from AR-positive patients, and in 9 of 15 DCIS samples from patients with AR-negative cancer.

All lymph node metastases from AR-positive patients were also positive, whereas no lymph node metastases from AR-negative patients were found to express the androgen receptor.

There were no significant differences between AR-positive and -negative patients in tumor grade, angiolymphatic invasion, TNM (tumor, node, metastasis) stage, or tumor size. In contrast, 16 of the 72 (22%) of the AR-negative patients had lymph node metastases, compared with 10 of 22 (46%) AR-positive patients (P = .033).

There were no significant differences in locoregional recurrences, overall survival, or disease-specific survival between positive and negative patients.

Among all 94 patients, however, the presence of lymph node metastases was associated with a significantly worse recurrence-free survival (hazard ratio, 5.502; P = .017). Chemotherapy significantly reduced that risk (HR, 0.099; P = .0004).

In multivariate analysis, the investigators found that AR expression was associated with older age (63 years vs. 57 years; P = .051) and with the presence of lymph nodes metastases (P = .033).

Although larger studies are needed, the data suggest that AR-positive, triple-negative breast cancer "has unique clinical behavior and may need different treatment," Dr. Pockaj said.

A phase II, open-label trial of the antiandrogen bicalutamide (Casodex) in patients with AR-positive, estrogen- and progesterone-receptor–negative, metastatic breast cancer is currently underway in eight U.S. cancer centers.

The current study was supported by the Translational Genomics Research Institute, Phoenix, and the Mayo Clinic, Scottsdale, Ariz. Dr. Pockaj is an employee of the Mayo Clinic.

ORLANDO – Anastrozole led the pack in a new analysis of a clinical trial that found neoadjuvant aromatase inhibitor therapies can shrink large, endocrine-rich tumors in postmenopausal women scheduled for mastectomy.

Half of these women were able to have successful breast-conserving surgery instead, lead author Dr. John A. Olson Jr. reported at a symposium sponsored by the Society of Surgical Oncology. Conversion rates ranged from 25% to 70.4%, based on tumor stage and the aromatase inhibitor (AI) that was used.

"Even in the absence of a randomized clinical trial, we feel it’s reasonable to consider neoadjuvant endocrine therapy for selected women who desire breast-conserving surgery," said Dr. Olson, who recently joined the University of Maryland, Baltimore, as chief of its division of general and oncologic surgery. He had been at Duke University in Durham, N.C.

Among all patients initially considered inoperable or mastectomy candidates, breast-conserving surgery was made possible in 48.2% of those on exemestane (Aromasin), 43.1% of those on letrozole (Femara), and 64.7% of those on anastrozole (Arimidex), reported Dr. Olson. The differences between these AIs were not statistically significant, however, and he noted that the study was not powered to detect differences among the individual drugs by surgical assignment.

The phase III American College of Surgeons Oncology Group (ACOSOG) Z1031 trial randomized 377 women with stage II or III estrogen-receptor (ER)-positive breast cancer. This analysis addressed 163 women who were considered to have inoperable disease or were scheduled for mastectomy. Treatment-naïve women with stage T2 through T4c with any nodal involvement but not metastases and palpable tumors greater than 2 cm were enrolled.

Women in the trial received 16-18 weeks of neoadjuvant exemestane 25 mg daily, letrozole 2.5 mg, or anastrozole 1 mg. Following surgery, they continued on AI therapy where possible, and received adjuvant radiotherapy and chemotherapy at the treating physician’s discretion. The overall clinical tumor response rate to neoadjuvant AI therapy was 69% (258 of 374 patients).

At the end of AI therapy, 91 (56%) of the 163 women classified as having inoperable disease or requiring a mastectomy at baseline were considered to be suitable candidates for a breast-conserving procedure. The remaining 72 were assigned to mastectomy. One-third of women who underwent breast-conserving surgery after AI therapy required additional surgery to ensure adequate resection margins, Dr. Olson noted.

Eleven of the women assigned to breast conservation eventually had a mastectomy, for a total mastectomy-to-breast-conserving surgery conversion rate of 51%. Conversely, 4 (5%) of the women scheduled for mastectomy at the end of neoadjuvant therapy went on to a breast-conserving procedure.

Among 189 considered eligible for breast-conserving surgery before treatment, 17 were recommended for mastectomy following AI therapy, and 16 went on to undergo it, while 1 had a breast-conserving procedure instead.

Of the 172 recommended for conservation surgery after neoadjuvant treatment, 16 went on to mastectomy, and 156 had the recommended conservation surgery. In all, 64 of the 172 patients (37%) required re-excision for inadequate margins on the first go-round.

In a breakdown by drug and tumor type, 70.4% of women with T2 tumors on either exemestane or anastrozole had successful conversion to breast conservation, compared with 55.2% of patients on letrozole. Among patients with T3 tumors, 25% of those on exemestane went on to breast-conserving surgery, compared with 28.6% of those on letrozole and 60% of those on anastrozole. Of those with higher tumor stages (T4a-c), exemestane accounted for 28.6% of conversions, compared with 37.5% for letrozole and 50% for anastrozole.

The investigators performed a multivariate analysis controlling for clinical T and N stage, surgical impression, assigned treatment arm, tumor size, and tumor response to therapy. This analysis revealed that the factors significantly predicting conversion to breast-conserving operations were clinical stage T2 (odds ratio, 2.11; P = .0364) and smaller vs. larger tumors (OR, 4.03; P = .006) for those not larger than 2.0 cm in their largest dimension prior to surgery compared with tumors 5.1 cm or greater. Intermediate-size tumors (2.1-5.0 cm) trended toward but did not reach significance.

"Importantly, there was no tumor feature or clinical factor that predicted the change in surgical plan. This shows that biological response to the aromatase inhibitor was the driver of the final surgical procedure chosen," Dr. Olson said.

The overall incidence of pathologic stage 1 disease following surgery was 24.3% among mastectomy patients and 44.8% in conservation surgery patients; this difference was not significant.

"The relatively high incidence of stage I disease following AI therapy suggests significant downstaging of this group of patients who presented with clinical stage II or III disease," Dr. Olson said.

However, the high rate of T1 tumors in women who had a mastectomy suggests that presurgical staging for women who have neoadjuvant therapy could stand improvement, he noted.

Following the presentation, Dr. Monica Morrow, chief of the breast surgical service at Memorial Sloan-Kettering Cancer Center in New York suggested that the study may not be considering the appropriate duration of neoadjuvant therapy.

"We give this like it’s chemotherapy for 4 months, when we know that it takes a long time to achieve maximum benefit in the adjuvant setting, so would it make more sense to treat people to response plateau, if your goal was downstaging to breast conservation?" she said.

Dr. Morrow was not involved in the study, but she moderated the session in which it was presented.

The study was supported by the National Cancer Institute, the Breast Cancer Research Foundation, Pfizer, AstraZeneca, and Novartis. Dr. Olson and Dr. Morrow reported that they had no relevant financial disclosures.

ORLANDO – Anastrozole led the pack in a new analysis of a clinical trial that found neoadjuvant aromatase inhibitor therapies can shrink large, endocrine-rich tumors in postmenopausal women scheduled for mastectomy.

Half of these women were able to have successful breast-conserving surgery instead, lead author Dr. John A. Olson Jr. reported at a symposium sponsored by the Society of Surgical Oncology. Conversion rates ranged from 25% to 70.4%, based on tumor stage and the aromatase inhibitor (AI) that was used.

"Even in the absence of a randomized clinical trial, we feel it’s reasonable to consider neoadjuvant endocrine therapy for selected women who desire breast-conserving surgery," said Dr. Olson, who recently joined the University of Maryland, Baltimore, as chief of its division of general and oncologic surgery. He had been at Duke University in Durham, N.C.

Among all patients initially considered inoperable or mastectomy candidates, breast-conserving surgery was made possible in 48.2% of those on exemestane (Aromasin), 43.1% of those on letrozole (Femara), and 64.7% of those on anastrozole (Arimidex), reported Dr. Olson. The differences between these AIs were not statistically significant, however, and he noted that the study was not powered to detect differences among the individual drugs by surgical assignment.

The phase III American College of Surgeons Oncology Group (ACOSOG) Z1031 trial randomized 377 women with stage II or III estrogen-receptor (ER)-positive breast cancer. This analysis addressed 163 women who were considered to have inoperable disease or were scheduled for mastectomy. Treatment-naïve women with stage T2 through T4c with any nodal involvement but not metastases and palpable tumors greater than 2 cm were enrolled.

Women in the trial received 16-18 weeks of neoadjuvant exemestane 25 mg daily, letrozole 2.5 mg, or anastrozole 1 mg. Following surgery, they continued on AI therapy where possible, and received adjuvant radiotherapy and chemotherapy at the treating physician’s discretion. The overall clinical tumor response rate to neoadjuvant AI therapy was 69% (258 of 374 patients).

At the end of AI therapy, 91 (56%) of the 163 women classified as having inoperable disease or requiring a mastectomy at baseline were considered to be suitable candidates for a breast-conserving procedure. The remaining 72 were assigned to mastectomy. One-third of women who underwent breast-conserving surgery after AI therapy required additional surgery to ensure adequate resection margins, Dr. Olson noted.

Eleven of the women assigned to breast conservation eventually had a mastectomy, for a total mastectomy-to-breast-conserving surgery conversion rate of 51%. Conversely, 4 (5%) of the women scheduled for mastectomy at the end of neoadjuvant therapy went on to a breast-conserving procedure.

Among 189 considered eligible for breast-conserving surgery before treatment, 17 were recommended for mastectomy following AI therapy, and 16 went on to undergo it, while 1 had a breast-conserving procedure instead.

Of the 172 recommended for conservation surgery after neoadjuvant treatment, 16 went on to mastectomy, and 156 had the recommended conservation surgery. In all, 64 of the 172 patients (37%) required re-excision for inadequate margins on the first go-round.

In a breakdown by drug and tumor type, 70.4% of women with T2 tumors on either exemestane or anastrozole had successful conversion to breast conservation, compared with 55.2% of patients on letrozole. Among patients with T3 tumors, 25% of those on exemestane went on to breast-conserving surgery, compared with 28.6% of those on letrozole and 60% of those on anastrozole. Of those with higher tumor stages (T4a-c), exemestane accounted for 28.6% of conversions, compared with 37.5% for letrozole and 50% for anastrozole.

The investigators performed a multivariate analysis controlling for clinical T and N stage, surgical impression, assigned treatment arm, tumor size, and tumor response to therapy. This analysis revealed that the factors significantly predicting conversion to breast-conserving operations were clinical stage T2 (odds ratio, 2.11; P = .0364) and smaller vs. larger tumors (OR, 4.03; P = .006) for those not larger than 2.0 cm in their largest dimension prior to surgery compared with tumors 5.1 cm or greater. Intermediate-size tumors (2.1-5.0 cm) trended toward but did not reach significance.

"Importantly, there was no tumor feature or clinical factor that predicted the change in surgical plan. This shows that biological response to the aromatase inhibitor was the driver of the final surgical procedure chosen," Dr. Olson said.

The overall incidence of pathologic stage 1 disease following surgery was 24.3% among mastectomy patients and 44.8% in conservation surgery patients; this difference was not significant.

"The relatively high incidence of stage I disease following AI therapy suggests significant downstaging of this group of patients who presented with clinical stage II or III disease," Dr. Olson said.

However, the high rate of T1 tumors in women who had a mastectomy suggests that presurgical staging for women who have neoadjuvant therapy could stand improvement, he noted.

Following the presentation, Dr. Monica Morrow, chief of the breast surgical service at Memorial Sloan-Kettering Cancer Center in New York suggested that the study may not be considering the appropriate duration of neoadjuvant therapy.

"We give this like it’s chemotherapy for 4 months, when we know that it takes a long time to achieve maximum benefit in the adjuvant setting, so would it make more sense to treat people to response plateau, if your goal was downstaging to breast conservation?" she said.

Dr. Morrow was not involved in the study, but she moderated the session in which it was presented.

The study was supported by the National Cancer Institute, the Breast Cancer Research Foundation, Pfizer, AstraZeneca, and Novartis. Dr. Olson and Dr. Morrow reported that they had no relevant financial disclosures.

ORLANDO – Anastrozole led the pack in a new analysis of a clinical trial that found neoadjuvant aromatase inhibitor therapies can shrink large, endocrine-rich tumors in postmenopausal women scheduled for mastectomy.

Half of these women were able to have successful breast-conserving surgery instead, lead author Dr. John A. Olson Jr. reported at a symposium sponsored by the Society of Surgical Oncology. Conversion rates ranged from 25% to 70.4%, based on tumor stage and the aromatase inhibitor (AI) that was used.

"Even in the absence of a randomized clinical trial, we feel it’s reasonable to consider neoadjuvant endocrine therapy for selected women who desire breast-conserving surgery," said Dr. Olson, who recently joined the University of Maryland, Baltimore, as chief of its division of general and oncologic surgery. He had been at Duke University in Durham, N.C.

Among all patients initially considered inoperable or mastectomy candidates, breast-conserving surgery was made possible in 48.2% of those on exemestane (Aromasin), 43.1% of those on letrozole (Femara), and 64.7% of those on anastrozole (Arimidex), reported Dr. Olson. The differences between these AIs were not statistically significant, however, and he noted that the study was not powered to detect differences among the individual drugs by surgical assignment.

The phase III American College of Surgeons Oncology Group (ACOSOG) Z1031 trial randomized 377 women with stage II or III estrogen-receptor (ER)-positive breast cancer. This analysis addressed 163 women who were considered to have inoperable disease or were scheduled for mastectomy. Treatment-naïve women with stage T2 through T4c with any nodal involvement but not metastases and palpable tumors greater than 2 cm were enrolled.

Women in the trial received 16-18 weeks of neoadjuvant exemestane 25 mg daily, letrozole 2.5 mg, or anastrozole 1 mg. Following surgery, they continued on AI therapy where possible, and received adjuvant radiotherapy and chemotherapy at the treating physician’s discretion. The overall clinical tumor response rate to neoadjuvant AI therapy was 69% (258 of 374 patients).

At the end of AI therapy, 91 (56%) of the 163 women classified as having inoperable disease or requiring a mastectomy at baseline were considered to be suitable candidates for a breast-conserving procedure. The remaining 72 were assigned to mastectomy. One-third of women who underwent breast-conserving surgery after AI therapy required additional surgery to ensure adequate resection margins, Dr. Olson noted.

Eleven of the women assigned to breast conservation eventually had a mastectomy, for a total mastectomy-to-breast-conserving surgery conversion rate of 51%. Conversely, 4 (5%) of the women scheduled for mastectomy at the end of neoadjuvant therapy went on to a breast-conserving procedure.

Among 189 considered eligible for breast-conserving surgery before treatment, 17 were recommended for mastectomy following AI therapy, and 16 went on to undergo it, while 1 had a breast-conserving procedure instead.

Of the 172 recommended for conservation surgery after neoadjuvant treatment, 16 went on to mastectomy, and 156 had the recommended conservation surgery. In all, 64 of the 172 patients (37%) required re-excision for inadequate margins on the first go-round.

In a breakdown by drug and tumor type, 70.4% of women with T2 tumors on either exemestane or anastrozole had successful conversion to breast conservation, compared with 55.2% of patients on letrozole. Among patients with T3 tumors, 25% of those on exemestane went on to breast-conserving surgery, compared with 28.6% of those on letrozole and 60% of those on anastrozole. Of those with higher tumor stages (T4a-c), exemestane accounted for 28.6% of conversions, compared with 37.5% for letrozole and 50% for anastrozole.

The investigators performed a multivariate analysis controlling for clinical T and N stage, surgical impression, assigned treatment arm, tumor size, and tumor response to therapy. This analysis revealed that the factors significantly predicting conversion to breast-conserving operations were clinical stage T2 (odds ratio, 2.11; P = .0364) and smaller vs. larger tumors (OR, 4.03; P = .006) for those not larger than 2.0 cm in their largest dimension prior to surgery compared with tumors 5.1 cm or greater. Intermediate-size tumors (2.1-5.0 cm) trended toward but did not reach significance.

"Importantly, there was no tumor feature or clinical factor that predicted the change in surgical plan. This shows that biological response to the aromatase inhibitor was the driver of the final surgical procedure chosen," Dr. Olson said.

The overall incidence of pathologic stage 1 disease following surgery was 24.3% among mastectomy patients and 44.8% in conservation surgery patients; this difference was not significant.

"The relatively high incidence of stage I disease following AI therapy suggests significant downstaging of this group of patients who presented with clinical stage II or III disease," Dr. Olson said.

However, the high rate of T1 tumors in women who had a mastectomy suggests that presurgical staging for women who have neoadjuvant therapy could stand improvement, he noted.

Following the presentation, Dr. Monica Morrow, chief of the breast surgical service at Memorial Sloan-Kettering Cancer Center in New York suggested that the study may not be considering the appropriate duration of neoadjuvant therapy.

"We give this like it’s chemotherapy for 4 months, when we know that it takes a long time to achieve maximum benefit in the adjuvant setting, so would it make more sense to treat people to response plateau, if your goal was downstaging to breast conservation?" she said.

Dr. Morrow was not involved in the study, but she moderated the session in which it was presented.

The study was supported by the National Cancer Institute, the Breast Cancer Research Foundation, Pfizer, AstraZeneca, and Novartis. Dr. Olson and Dr. Morrow reported that they had no relevant financial disclosures.

ORLANDO – Elevated levels of soluble CD14 in umbilical cord blood appear to be highly predictive of wheeze and cough in the first year of an infant’s life, Taiwanese investigators reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children with elevated cord-blood soluble CD14 (sCD14) had nearly an eightfold risk for wheezing and a sixfold risk for cough in the first year, compared with children with low levels, said Dr. Yu-Lin Huang from the department of pediatrics at the Chang Gung Memorial Hospital and Chang Gung University in Keelung, Taiwan.

The finding lends credence to the hypothesis that prenatal factors play a role in the pathogenesis of asthma.

Soluble CD14 is a pathogen pattern receptor molecule that works with other receptors to recognize bacterial lipopolysaccharides (LPS) and mediate LPS-induced inflammation. Evidence for its utility as a biomarker for allergy and asthma has been decidedly mixed, however, said Dr. Huang.

One study, for example, showed that lower sCD14 levels at birth were associated with increased risk of wheeze at age 1 (Am. J. Respir. Crit. Care Med. 2004;169:70-6), whereas a different study showed that sCD14 levels are higher during acute asthma episodes (Am. J. Respir. Care Crit. Med. 2006;173:617-22).

Because allergic diseases have been steadily rising in Taiwan since the 1970s, the investigators hoped to clarify whether sCD14 level at birth and/or the urine leukotriene E4 to creatinine (LC) ratio at 1 month could be useful predictors of an individual child’s risk for future atopic diseases and asthma.

They recruited newborns delivered at the Chang Chung Memorial Hospital from October 2007 through September 2009, recording sCD14 levels at birth and collecting questionnaires from the mothers asking about parental medical and allergic histories. The questionnaires were repeated at 1, 6, 12, and 18 months.

At 1 month they collected and examined urine for the LC ratio, and followed with child blood and urine samples at 6 and 12 months, and mother’s blood sample at 6 months.

They defined outcomes at age 1 as parental report of wheezing, cough persisting for more than 3 weeks, rhinitis (runny or blocked nose in the absence of a cold or flu), rhinoconjunctivitis, rash (intermittent for at least 3 months), and atopy (positive specific immunoglobulin E to Dermatophagoides pteronyssinus, D.farinae, egg white, milk, Cladosporium herbarum, and wheat).

Of the 206 children available for follow-up at 1 year, wheeze was prevalent in 14%), and sCD14 levels in these children were significantly higher than in the 177 children with no reported wheeze (583 plus or minus 127 vs. 491 plus or minus 162 ng/mL, P = .001).

Similarly, prolonged cough was reported in 7% at 1 year, and these children also had significantly higher sCD14 levels in cord blood (615 plus or minus 170 vs. 496 plus or minus 157, P = .008).

There were no other significant associations with sCD14 and other outcomes. LC ratio at 1 month was not significantly associated with any of the outcomes.

In multiple logistic regression analysis, they found that factors significantly predictive for wheeze at 1 year included sCD14 (P = .002), duration of day care attendance (P = .005), and parental smoking, with each pack per day of cigarettes associated with a doubling of risk (P = .016).

Significant risk factors for prolonged cough include sCD14 (P = .008) and number of older siblings (P = .015).

In a comparison of high vs. low sCD14, the adjusted odds ratio for wheeze with high levels was 7.74 (P less than .001). The adjusted OR for prolonged cough was 5.99 (P = .021).

The study was supported by a Chang Gung Research project grant. Dr. Huang reported that he had no relevant disclosures.

ORLANDO – Elevated levels of soluble CD14 in umbilical cord blood appear to be highly predictive of wheeze and cough in the first year of an infant’s life, Taiwanese investigators reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children with elevated cord-blood soluble CD14 (sCD14) had nearly an eightfold risk for wheezing and a sixfold risk for cough in the first year, compared with children with low levels, said Dr. Yu-Lin Huang from the department of pediatrics at the Chang Gung Memorial Hospital and Chang Gung University in Keelung, Taiwan.

The finding lends credence to the hypothesis that prenatal factors play a role in the pathogenesis of asthma.

Soluble CD14 is a pathogen pattern receptor molecule that works with other receptors to recognize bacterial lipopolysaccharides (LPS) and mediate LPS-induced inflammation. Evidence for its utility as a biomarker for allergy and asthma has been decidedly mixed, however, said Dr. Huang.

One study, for example, showed that lower sCD14 levels at birth were associated with increased risk of wheeze at age 1 (Am. J. Respir. Crit. Care Med. 2004;169:70-6), whereas a different study showed that sCD14 levels are higher during acute asthma episodes (Am. J. Respir. Care Crit. Med. 2006;173:617-22).

Because allergic diseases have been steadily rising in Taiwan since the 1970s, the investigators hoped to clarify whether sCD14 level at birth and/or the urine leukotriene E4 to creatinine (LC) ratio at 1 month could be useful predictors of an individual child’s risk for future atopic diseases and asthma.

They recruited newborns delivered at the Chang Chung Memorial Hospital from October 2007 through September 2009, recording sCD14 levels at birth and collecting questionnaires from the mothers asking about parental medical and allergic histories. The questionnaires were repeated at 1, 6, 12, and 18 months.

At 1 month they collected and examined urine for the LC ratio, and followed with child blood and urine samples at 6 and 12 months, and mother’s blood sample at 6 months.

They defined outcomes at age 1 as parental report of wheezing, cough persisting for more than 3 weeks, rhinitis (runny or blocked nose in the absence of a cold or flu), rhinoconjunctivitis, rash (intermittent for at least 3 months), and atopy (positive specific immunoglobulin E to Dermatophagoides pteronyssinus, D.farinae, egg white, milk, Cladosporium herbarum, and wheat).

Of the 206 children available for follow-up at 1 year, wheeze was prevalent in 14%), and sCD14 levels in these children were significantly higher than in the 177 children with no reported wheeze (583 plus or minus 127 vs. 491 plus or minus 162 ng/mL, P = .001).

Similarly, prolonged cough was reported in 7% at 1 year, and these children also had significantly higher sCD14 levels in cord blood (615 plus or minus 170 vs. 496 plus or minus 157, P = .008).

There were no other significant associations with sCD14 and other outcomes. LC ratio at 1 month was not significantly associated with any of the outcomes.

In multiple logistic regression analysis, they found that factors significantly predictive for wheeze at 1 year included sCD14 (P = .002), duration of day care attendance (P = .005), and parental smoking, with each pack per day of cigarettes associated with a doubling of risk (P = .016).

Significant risk factors for prolonged cough include sCD14 (P = .008) and number of older siblings (P = .015).

In a comparison of high vs. low sCD14, the adjusted odds ratio for wheeze with high levels was 7.74 (P less than .001). The adjusted OR for prolonged cough was 5.99 (P = .021).

The study was supported by a Chang Gung Research project grant. Dr. Huang reported that he had no relevant disclosures.

ORLANDO – Elevated levels of soluble CD14 in umbilical cord blood appear to be highly predictive of wheeze and cough in the first year of an infant’s life, Taiwanese investigators reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children with elevated cord-blood soluble CD14 (sCD14) had nearly an eightfold risk for wheezing and a sixfold risk for cough in the first year, compared with children with low levels, said Dr. Yu-Lin Huang from the department of pediatrics at the Chang Gung Memorial Hospital and Chang Gung University in Keelung, Taiwan.

The finding lends credence to the hypothesis that prenatal factors play a role in the pathogenesis of asthma.

Soluble CD14 is a pathogen pattern receptor molecule that works with other receptors to recognize bacterial lipopolysaccharides (LPS) and mediate LPS-induced inflammation. Evidence for its utility as a biomarker for allergy and asthma has been decidedly mixed, however, said Dr. Huang.

One study, for example, showed that lower sCD14 levels at birth were associated with increased risk of wheeze at age 1 (Am. J. Respir. Crit. Care Med. 2004;169:70-6), whereas a different study showed that sCD14 levels are higher during acute asthma episodes (Am. J. Respir. Care Crit. Med. 2006;173:617-22).

Because allergic diseases have been steadily rising in Taiwan since the 1970s, the investigators hoped to clarify whether sCD14 level at birth and/or the urine leukotriene E4 to creatinine (LC) ratio at 1 month could be useful predictors of an individual child’s risk for future atopic diseases and asthma.

They recruited newborns delivered at the Chang Chung Memorial Hospital from October 2007 through September 2009, recording sCD14 levels at birth and collecting questionnaires from the mothers asking about parental medical and allergic histories. The questionnaires were repeated at 1, 6, 12, and 18 months.

At 1 month they collected and examined urine for the LC ratio, and followed with child blood and urine samples at 6 and 12 months, and mother’s blood sample at 6 months.

They defined outcomes at age 1 as parental report of wheezing, cough persisting for more than 3 weeks, rhinitis (runny or blocked nose in the absence of a cold or flu), rhinoconjunctivitis, rash (intermittent for at least 3 months), and atopy (positive specific immunoglobulin E to Dermatophagoides pteronyssinus, D.farinae, egg white, milk, Cladosporium herbarum, and wheat).

Of the 206 children available for follow-up at 1 year, wheeze was prevalent in 14%), and sCD14 levels in these children were significantly higher than in the 177 children with no reported wheeze (583 plus or minus 127 vs. 491 plus or minus 162 ng/mL, P = .001).

Similarly, prolonged cough was reported in 7% at 1 year, and these children also had significantly higher sCD14 levels in cord blood (615 plus or minus 170 vs. 496 plus or minus 157, P = .008).

There were no other significant associations with sCD14 and other outcomes. LC ratio at 1 month was not significantly associated with any of the outcomes.

In multiple logistic regression analysis, they found that factors significantly predictive for wheeze at 1 year included sCD14 (P = .002), duration of day care attendance (P = .005), and parental smoking, with each pack per day of cigarettes associated with a doubling of risk (P = .016).

Significant risk factors for prolonged cough include sCD14 (P = .008) and number of older siblings (P = .015).

In a comparison of high vs. low sCD14, the adjusted odds ratio for wheeze with high levels was 7.74 (P less than .001). The adjusted OR for prolonged cough was 5.99 (P = .021).

The study was supported by a Chang Gung Research project grant. Dr. Huang reported that he had no relevant disclosures.

ORLANDO – A chart notation of "lost to follow-up" can mean loss of life for children with severe asthma, suggest the results of a retrospective study reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of 14 children who died from asthma at a children’s hospital over a 10-year period, 11 (79%) evidently never received follow-up care in the asthma clinic, despite having prior asthma-related hospitalizations and clinic appointments made at the time of discharge, reported Dr. Sahar Faghih, a second-year fellow in allergy and immunology at Children’s Hospital of Michigan in Detroit.

"Deaths of high-risk asthmatics were decreased by a combination of a multidisciplinary team clinic and a social service liaison for increased family support. This further emphasizes that barriers to care and clinic attendance necessitate further attention," Dr. Faghih and her colleagues wrote in a poster.

The investigators reviewed a decade of charts on children aged 1-18 years who died from asthma in the period spanning 3 years before to 7 years after the multidisciplinary Children’s Hospital Asthma Management Program (CHAMP) clinic opened in 2004. The social service component of the multidisciplinary team was phased out after 3 years due to lack of funding.

"Deaths of high-risk asthmatics were decreased by a combination of a multi-disciplinary team clinic and a social service liaison for increased family support."

Five of the 14 deaths occurred before the CHAMP clinic model was implemented, and none of these children were enrolled in a health plan. No deaths occurred during the 3 years that a social worker was present in the clinic.

"With the children who died in the care of the asthma clinic, there were some issues of adherence, and two out of five deaths that occurred between 2007 and 2010 occurred in patients who were previously enrolled in CHAMP. Both of those children had a history of medical neglect cases on file with the state," Dr. Faghih said in an interview.

"Perhaps if this clinic still had in place the social service intervention, we may have been able to prevent those deaths from happening," she added.

Although the multidisciplinary model was developed in a specialty children’s hospital, it can be replicated in community practices. Other studies have shown that programs coordinated by trained clinical nurses or nurse practitioners that include asthma education, emphasis on adherence, home visits, and telephone contacts can reduce asthma hospitalizations and emergency department visits by 71%-85%, Dr. Faghih said.

Team-based asthma education and case management programs can save money as well as lives, the investigators noted. They cited a randomized study showing that such programs reduced emergency department visits by 57%, hospitalizations by 75%, and expenditures by 71%. The same study estimated that for every dollar spent on a dedicated asthma nurse, $7.69-$11.76 was saved (J. Allergy Clin. Immunol. 1999;103:436-40).

"Based on 2008 CDC [Centers for Disease Control and Prevention] reporting, there have been a total of 200 pediatric asthma deaths. Perhaps, with the implementation of a multiteam approach, this number can be rectified," Dr. Faghih and her colleagues wrote.

The study was internally funded. The authors reported that they had no conflicts of interest.

ORLANDO – A chart notation of "lost to follow-up" can mean loss of life for children with severe asthma, suggest the results of a retrospective study reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of 14 children who died from asthma at a children’s hospital over a 10-year period, 11 (79%) evidently never received follow-up care in the asthma clinic, despite having prior asthma-related hospitalizations and clinic appointments made at the time of discharge, reported Dr. Sahar Faghih, a second-year fellow in allergy and immunology at Children’s Hospital of Michigan in Detroit.

"Deaths of high-risk asthmatics were decreased by a combination of a multidisciplinary team clinic and a social service liaison for increased family support. This further emphasizes that barriers to care and clinic attendance necessitate further attention," Dr. Faghih and her colleagues wrote in a poster.

The investigators reviewed a decade of charts on children aged 1-18 years who died from asthma in the period spanning 3 years before to 7 years after the multidisciplinary Children’s Hospital Asthma Management Program (CHAMP) clinic opened in 2004. The social service component of the multidisciplinary team was phased out after 3 years due to lack of funding.

"Deaths of high-risk asthmatics were decreased by a combination of a multi-disciplinary team clinic and a social service liaison for increased family support."

Five of the 14 deaths occurred before the CHAMP clinic model was implemented, and none of these children were enrolled in a health plan. No deaths occurred during the 3 years that a social worker was present in the clinic.

"With the children who died in the care of the asthma clinic, there were some issues of adherence, and two out of five deaths that occurred between 2007 and 2010 occurred in patients who were previously enrolled in CHAMP. Both of those children had a history of medical neglect cases on file with the state," Dr. Faghih said in an interview.

"Perhaps if this clinic still had in place the social service intervention, we may have been able to prevent those deaths from happening," she added.

Although the multidisciplinary model was developed in a specialty children’s hospital, it can be replicated in community practices. Other studies have shown that programs coordinated by trained clinical nurses or nurse practitioners that include asthma education, emphasis on adherence, home visits, and telephone contacts can reduce asthma hospitalizations and emergency department visits by 71%-85%, Dr. Faghih said.

Team-based asthma education and case management programs can save money as well as lives, the investigators noted. They cited a randomized study showing that such programs reduced emergency department visits by 57%, hospitalizations by 75%, and expenditures by 71%. The same study estimated that for every dollar spent on a dedicated asthma nurse, $7.69-$11.76 was saved (J. Allergy Clin. Immunol. 1999;103:436-40).

"Based on 2008 CDC [Centers for Disease Control and Prevention] reporting, there have been a total of 200 pediatric asthma deaths. Perhaps, with the implementation of a multiteam approach, this number can be rectified," Dr. Faghih and her colleagues wrote.

The study was internally funded. The authors reported that they had no conflicts of interest.

ORLANDO – A chart notation of "lost to follow-up" can mean loss of life for children with severe asthma, suggest the results of a retrospective study reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of 14 children who died from asthma at a children’s hospital over a 10-year period, 11 (79%) evidently never received follow-up care in the asthma clinic, despite having prior asthma-related hospitalizations and clinic appointments made at the time of discharge, reported Dr. Sahar Faghih, a second-year fellow in allergy and immunology at Children’s Hospital of Michigan in Detroit.

"Deaths of high-risk asthmatics were decreased by a combination of a multidisciplinary team clinic and a social service liaison for increased family support. This further emphasizes that barriers to care and clinic attendance necessitate further attention," Dr. Faghih and her colleagues wrote in a poster.

The investigators reviewed a decade of charts on children aged 1-18 years who died from asthma in the period spanning 3 years before to 7 years after the multidisciplinary Children’s Hospital Asthma Management Program (CHAMP) clinic opened in 2004. The social service component of the multidisciplinary team was phased out after 3 years due to lack of funding.

"Deaths of high-risk asthmatics were decreased by a combination of a multi-disciplinary team clinic and a social service liaison for increased family support."

Five of the 14 deaths occurred before the CHAMP clinic model was implemented, and none of these children were enrolled in a health plan. No deaths occurred during the 3 years that a social worker was present in the clinic.

"With the children who died in the care of the asthma clinic, there were some issues of adherence, and two out of five deaths that occurred between 2007 and 2010 occurred in patients who were previously enrolled in CHAMP. Both of those children had a history of medical neglect cases on file with the state," Dr. Faghih said in an interview.

"Perhaps if this clinic still had in place the social service intervention, we may have been able to prevent those deaths from happening," she added.

Although the multidisciplinary model was developed in a specialty children’s hospital, it can be replicated in community practices. Other studies have shown that programs coordinated by trained clinical nurses or nurse practitioners that include asthma education, emphasis on adherence, home visits, and telephone contacts can reduce asthma hospitalizations and emergency department visits by 71%-85%, Dr. Faghih said.

Team-based asthma education and case management programs can save money as well as lives, the investigators noted. They cited a randomized study showing that such programs reduced emergency department visits by 57%, hospitalizations by 75%, and expenditures by 71%. The same study estimated that for every dollar spent on a dedicated asthma nurse, $7.69-$11.76 was saved (J. Allergy Clin. Immunol. 1999;103:436-40).

"Based on 2008 CDC [Centers for Disease Control and Prevention] reporting, there have been a total of 200 pediatric asthma deaths. Perhaps, with the implementation of a multiteam approach, this number can be rectified," Dr. Faghih and her colleagues wrote.

The study was internally funded. The authors reported that they had no conflicts of interest.

Men who are circumcised before their first sexual intercourse have a significantly lower risk for prostate cancer than do uncircumcised men or those who are circumcised after their first sexual encounter, according to an analysis of data on 3,399 men.

The finding of a 15% reduction in relative risk points to sexually transmitted infections and inflammation as possible risk factors for prostate cancer, the authors suggested in a study published online in the journal Cancer.

"These findings are consistent with research showing that an infectious/inflammatory pathway may be involved in prostate carcinogenesis," wrote Dr. Jonathan L. Wright and colleagues at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle (Cancer 2012 March 12 [doi:10.1002/cncr.26653]).

The authors had hypothesized that circumcision reduces the risk for transmission of a sexually transmitted infection (STI), "and that if a [prostate cancer] develops as a result of the STI, only circumcision prior to first sexual intercourse can potentially alter risk" of prostate cancer.

They borrowed data from two population-based, case-control studies of men with prostate cancer, identifying a total of 1,754 cases in the Seattle–Puget Sound SEER (Surveillance, Epidemiology, and End Results) cancer registry. For the 1,645 controls, they used random-digit dialing to identify men from the same area with no prostate cancer, age-matched in 5-year groups.

In all, 68.8% of cases and 71.5% of controls were circumcised. Among all men who reported being circumcised, 91% had the procedure shortly after birth. Circumcision was performed after first sexual intercourse in 3.9% of cases and 2.5% of controls. Circumcision was also more commonly reported in white men (69%) than in black men (43%).

In multivariate regression analysis, the investigators controlled for age, race, prostate-specific antigen (PSA) test within 5 years of diagnosis or reference data, family history of prostate cancer, history of STIs, prior prostatitis, and number of female and male sexual partners. They found that the overall odds ratio for prostate cancer among men who were circumcised before their first sexual intercourse was 0.88 (95% confidence interval, 0.73-0.99).

The researchers also looked at prostate cancer and circumcision status by aggressiveness of disease, with "aggressive" defined as a composite of Gleason score of 7 (4 + 3) or greater; nonlocalized stage; or PSA level greater than 20 ng/mL at the time of diagnosis.

They saw that preintercourse circumcision had borderline associations with lower risk for both less-aggressive (OR, 0.88; 95% CI, 0.74-1.04) and more-aggressive cancers (OR, 0.82; 95% CI, 0.66-1.00).

The reduction in prostate cancer risk with circumcision before first intercourse was observed in whites (OR, 0.87; 95% CI, 0.73-1.02); and blacks (OR, 0.64; 95% CI, 0.39-1.08).

Circumcision has been shown in other studies to be linked to lower rates of STIs, including HIV/AIDS, herpes simplex, syphilis, and chancroid, the authors noted. They suggested that the mucosal lining of the prepuce, which is thin, may develop small tears that provide pathogens with a route to the bloodstream.

"Circumcision may reduce these injuries due to the significant keratinization that occurs following the procedure," they speculated. "In addition, the moist environment under the preputial skin may help pathogens survive for extended periods prior to direct infection. Circumcision removes this protective environment."

The authors pointed to other studies linking circumcision to reduced prostate cancer risk, including a 1987 case-control study in which circumcision was associated with a 50% reduction in relative risk among whites, and a near 40% reduction in blacks (J Natl Cancer Inst. 1987;78:869-74).

The study was supported by National Institute of Health grants and the Fred Hutchinson Cancer Research Center. The authors reported no conflicts of interest. Dr. Freedland said that he had no conflicts of interest.

Men who are circumcised before their first sexual intercourse have a significantly lower risk for prostate cancer than do uncircumcised men or those who are circumcised after their first sexual encounter, according to an analysis of data on 3,399 men.

The finding of a 15% reduction in relative risk points to sexually transmitted infections and inflammation as possible risk factors for prostate cancer, the authors suggested in a study published online in the journal Cancer.

"These findings are consistent with research showing that an infectious/inflammatory pathway may be involved in prostate carcinogenesis," wrote Dr. Jonathan L. Wright and colleagues at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle (Cancer 2012 March 12 [doi:10.1002/cncr.26653]).

The authors had hypothesized that circumcision reduces the risk for transmission of a sexually transmitted infection (STI), "and that if a [prostate cancer] develops as a result of the STI, only circumcision prior to first sexual intercourse can potentially alter risk" of prostate cancer.

They borrowed data from two population-based, case-control studies of men with prostate cancer, identifying a total of 1,754 cases in the Seattle–Puget Sound SEER (Surveillance, Epidemiology, and End Results) cancer registry. For the 1,645 controls, they used random-digit dialing to identify men from the same area with no prostate cancer, age-matched in 5-year groups.

In all, 68.8% of cases and 71.5% of controls were circumcised. Among all men who reported being circumcised, 91% had the procedure shortly after birth. Circumcision was performed after first sexual intercourse in 3.9% of cases and 2.5% of controls. Circumcision was also more commonly reported in white men (69%) than in black men (43%).

In multivariate regression analysis, the investigators controlled for age, race, prostate-specific antigen (PSA) test within 5 years of diagnosis or reference data, family history of prostate cancer, history of STIs, prior prostatitis, and number of female and male sexual partners. They found that the overall odds ratio for prostate cancer among men who were circumcised before their first sexual intercourse was 0.88 (95% confidence interval, 0.73-0.99).

The researchers also looked at prostate cancer and circumcision status by aggressiveness of disease, with "aggressive" defined as a composite of Gleason score of 7 (4 + 3) or greater; nonlocalized stage; or PSA level greater than 20 ng/mL at the time of diagnosis.

They saw that preintercourse circumcision had borderline associations with lower risk for both less-aggressive (OR, 0.88; 95% CI, 0.74-1.04) and more-aggressive cancers (OR, 0.82; 95% CI, 0.66-1.00).

The reduction in prostate cancer risk with circumcision before first intercourse was observed in whites (OR, 0.87; 95% CI, 0.73-1.02); and blacks (OR, 0.64; 95% CI, 0.39-1.08).

Circumcision has been shown in other studies to be linked to lower rates of STIs, including HIV/AIDS, herpes simplex, syphilis, and chancroid, the authors noted. They suggested that the mucosal lining of the prepuce, which is thin, may develop small tears that provide pathogens with a route to the bloodstream.

"Circumcision may reduce these injuries due to the significant keratinization that occurs following the procedure," they speculated. "In addition, the moist environment under the preputial skin may help pathogens survive for extended periods prior to direct infection. Circumcision removes this protective environment."

The authors pointed to other studies linking circumcision to reduced prostate cancer risk, including a 1987 case-control study in which circumcision was associated with a 50% reduction in relative risk among whites, and a near 40% reduction in blacks (J Natl Cancer Inst. 1987;78:869-74).

The study was supported by National Institute of Health grants and the Fred Hutchinson Cancer Research Center. The authors reported no conflicts of interest. Dr. Freedland said that he had no conflicts of interest.

Men who are circumcised before their first sexual intercourse have a significantly lower risk for prostate cancer than do uncircumcised men or those who are circumcised after their first sexual encounter, according to an analysis of data on 3,399 men.

The finding of a 15% reduction in relative risk points to sexually transmitted infections and inflammation as possible risk factors for prostate cancer, the authors suggested in a study published online in the journal Cancer.

"These findings are consistent with research showing that an infectious/inflammatory pathway may be involved in prostate carcinogenesis," wrote Dr. Jonathan L. Wright and colleagues at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle (Cancer 2012 March 12 [doi:10.1002/cncr.26653]).

The authors had hypothesized that circumcision reduces the risk for transmission of a sexually transmitted infection (STI), "and that if a [prostate cancer] develops as a result of the STI, only circumcision prior to first sexual intercourse can potentially alter risk" of prostate cancer.

They borrowed data from two population-based, case-control studies of men with prostate cancer, identifying a total of 1,754 cases in the Seattle–Puget Sound SEER (Surveillance, Epidemiology, and End Results) cancer registry. For the 1,645 controls, they used random-digit dialing to identify men from the same area with no prostate cancer, age-matched in 5-year groups.

In all, 68.8% of cases and 71.5% of controls were circumcised. Among all men who reported being circumcised, 91% had the procedure shortly after birth. Circumcision was performed after first sexual intercourse in 3.9% of cases and 2.5% of controls. Circumcision was also more commonly reported in white men (69%) than in black men (43%).

In multivariate regression analysis, the investigators controlled for age, race, prostate-specific antigen (PSA) test within 5 years of diagnosis or reference data, family history of prostate cancer, history of STIs, prior prostatitis, and number of female and male sexual partners. They found that the overall odds ratio for prostate cancer among men who were circumcised before their first sexual intercourse was 0.88 (95% confidence interval, 0.73-0.99).

The researchers also looked at prostate cancer and circumcision status by aggressiveness of disease, with "aggressive" defined as a composite of Gleason score of 7 (4 + 3) or greater; nonlocalized stage; or PSA level greater than 20 ng/mL at the time of diagnosis.

They saw that preintercourse circumcision had borderline associations with lower risk for both less-aggressive (OR, 0.88; 95% CI, 0.74-1.04) and more-aggressive cancers (OR, 0.82; 95% CI, 0.66-1.00).

The reduction in prostate cancer risk with circumcision before first intercourse was observed in whites (OR, 0.87; 95% CI, 0.73-1.02); and blacks (OR, 0.64; 95% CI, 0.39-1.08).

Circumcision has been shown in other studies to be linked to lower rates of STIs, including HIV/AIDS, herpes simplex, syphilis, and chancroid, the authors noted. They suggested that the mucosal lining of the prepuce, which is thin, may develop small tears that provide pathogens with a route to the bloodstream.

"Circumcision may reduce these injuries due to the significant keratinization that occurs following the procedure," they speculated. "In addition, the moist environment under the preputial skin may help pathogens survive for extended periods prior to direct infection. Circumcision removes this protective environment."

The authors pointed to other studies linking circumcision to reduced prostate cancer risk, including a 1987 case-control study in which circumcision was associated with a 50% reduction in relative risk among whites, and a near 40% reduction in blacks (J Natl Cancer Inst. 1987;78:869-74).

The study was supported by National Institute of Health grants and the Fred Hutchinson Cancer Research Center. The authors reported no conflicts of interest. Dr. Freedland said that he had no conflicts of interest.

ORLANDO – People with asthma who engaged in a structured exercise program had sustained quality-of-life improvements, a small study has shown.

Although exercise is often anathema to people with asthma, previously sedentary people with asthma who were randomized in a small study to engage in three exercise sessions per week reported a twofold greater improvement in their symptom-related quality of life, compared with those who did not increase their routine exercise, reported Dr. Thomas Platts-Mills, professor of medicine, allergy, and clinical immunology at the University of Virginia in Charlottesville.

Neil Osterweil/Elsevier Global Medical News

The preliminary study was designed to convince health insurers to fund structured exercise programs in commercial gyms for patients with asthma, Dr. Platts-Mills said.

"You’ve got three obstacles to overcome: one is that the patients think that it’s a problem having to do exercise, because it will make their asthma worse," he noted. "Secondly, the gym may be resistant, because they think they’ll have asthma attacks to deal with; and third, the insurance companies are resistant, period."

The investigators recruited from a local commercial health plan 13 patients with persistent asthma as defined by National Asthma Education and Prevention Program guidelines. The participants were all treated with inhaled corticosteroids (ICS) and leukotriene agents that were on the health plan’s formulary.

All 13 patients were identified as engaging in no or little exercise (fewer than two sessions of aerobic activity per week over the past 6 months). Patients who participated more than 3 hours per week in any kind of moderate-level physical activity were excluded, as were patients with active pulmonary infections, cardiovascular disease, musculoskeletal disease, or other conditions that might impair their ability to exercise.

The authors convinced the insurer to pay a gym to enroll plan members with asthma, and they helped gym staff establish an asthma protocol that included monitoring asthmatics for symptoms and providing access to nebulizers.

"The gyms, we hope, will want to do this, and it’s very much in the insurance company’s favor to do it," Dr. Platts-Mills said. "But it’s still very difficult to get people to do regular exercise."

The seven participants assigned to the exercise group kept an exercise log recording the duration, type, and perceived exertion of all physical activities, including the three assigned exercise sessions each week. They also kept a log of medication use, asthma symptoms, unplanned medical visits, and unplanned asthma-related absences from work or school. Participants also answered a telephone-based asthma quality of life questionnaire at the end of weeks 4, 8, 12 and 16 (the study’s end).

Six participants assigned to be controls were given educational materials on exercise, participated in the telephone survey, and kept logs recording the same information as that of the exercise group. Researchers crossed over those participants to the exercise arm at 4 months.

At week 8, scores on the symptom domain of the quality-of-life questionnaire were significantly higher among exercisers, with 78.3% of responses indicating improvement, compared with 39.5% of responses by participants in the delayed-exercise group (P = .05).

Similarly, on the activity limitations domain, 78.3% of responding exercisers said they saw improvement, compared with 37.2% of delayed exercisers (P = .036). There were trends favoring exercise, but no significant differences, in the emotional function and environmental stimuli domains of the quality-of-life questionnaire.

"We have established that you can get an insurance company to pay a gym to enroll people and establish a protocol in the gym for asthmatics," Dr. Platts-Mills said. "I think this would be far more important for children with asthma if this could be achieved."

The study was supported by Southern Health Services Inc. Dr. Platts-Mills and colleagues reported that they had no conflicts of interest.

ORLANDO – People with asthma who engaged in a structured exercise program had sustained quality-of-life improvements, a small study has shown.

Although exercise is often anathema to people with asthma, previously sedentary people with asthma who were randomized in a small study to engage in three exercise sessions per week reported a twofold greater improvement in their symptom-related quality of life, compared with those who did not increase their routine exercise, reported Dr. Thomas Platts-Mills, professor of medicine, allergy, and clinical immunology at the University of Virginia in Charlottesville.

Neil Osterweil/Elsevier Global Medical News

The preliminary study was designed to convince health insurers to fund structured exercise programs in commercial gyms for patients with asthma, Dr. Platts-Mills said.

"You’ve got three obstacles to overcome: one is that the patients think that it’s a problem having to do exercise, because it will make their asthma worse," he noted. "Secondly, the gym may be resistant, because they think they’ll have asthma attacks to deal with; and third, the insurance companies are resistant, period."

The investigators recruited from a local commercial health plan 13 patients with persistent asthma as defined by National Asthma Education and Prevention Program guidelines. The participants were all treated with inhaled corticosteroids (ICS) and leukotriene agents that were on the health plan’s formulary.

All 13 patients were identified as engaging in no or little exercise (fewer than two sessions of aerobic activity per week over the past 6 months). Patients who participated more than 3 hours per week in any kind of moderate-level physical activity were excluded, as were patients with active pulmonary infections, cardiovascular disease, musculoskeletal disease, or other conditions that might impair their ability to exercise.

The authors convinced the insurer to pay a gym to enroll plan members with asthma, and they helped gym staff establish an asthma protocol that included monitoring asthmatics for symptoms and providing access to nebulizers.

"The gyms, we hope, will want to do this, and it’s very much in the insurance company’s favor to do it," Dr. Platts-Mills said. "But it’s still very difficult to get people to do regular exercise."

The seven participants assigned to the exercise group kept an exercise log recording the duration, type, and perceived exertion of all physical activities, including the three assigned exercise sessions each week. They also kept a log of medication use, asthma symptoms, unplanned medical visits, and unplanned asthma-related absences from work or school. Participants also answered a telephone-based asthma quality of life questionnaire at the end of weeks 4, 8, 12 and 16 (the study’s end).

Six participants assigned to be controls were given educational materials on exercise, participated in the telephone survey, and kept logs recording the same information as that of the exercise group. Researchers crossed over those participants to the exercise arm at 4 months.

At week 8, scores on the symptom domain of the quality-of-life questionnaire were significantly higher among exercisers, with 78.3% of responses indicating improvement, compared with 39.5% of responses by participants in the delayed-exercise group (P = .05).

Similarly, on the activity limitations domain, 78.3% of responding exercisers said they saw improvement, compared with 37.2% of delayed exercisers (P = .036). There were trends favoring exercise, but no significant differences, in the emotional function and environmental stimuli domains of the quality-of-life questionnaire.

"We have established that you can get an insurance company to pay a gym to enroll people and establish a protocol in the gym for asthmatics," Dr. Platts-Mills said. "I think this would be far more important for children with asthma if this could be achieved."

The study was supported by Southern Health Services Inc. Dr. Platts-Mills and colleagues reported that they had no conflicts of interest.

ORLANDO – People with asthma who engaged in a structured exercise program had sustained quality-of-life improvements, a small study has shown.

Although exercise is often anathema to people with asthma, previously sedentary people with asthma who were randomized in a small study to engage in three exercise sessions per week reported a twofold greater improvement in their symptom-related quality of life, compared with those who did not increase their routine exercise, reported Dr. Thomas Platts-Mills, professor of medicine, allergy, and clinical immunology at the University of Virginia in Charlottesville.

Neil Osterweil/Elsevier Global Medical News

The preliminary study was designed to convince health insurers to fund structured exercise programs in commercial gyms for patients with asthma, Dr. Platts-Mills said.

"You’ve got three obstacles to overcome: one is that the patients think that it’s a problem having to do exercise, because it will make their asthma worse," he noted. "Secondly, the gym may be resistant, because they think they’ll have asthma attacks to deal with; and third, the insurance companies are resistant, period."

The investigators recruited from a local commercial health plan 13 patients with persistent asthma as defined by National Asthma Education and Prevention Program guidelines. The participants were all treated with inhaled corticosteroids (ICS) and leukotriene agents that were on the health plan’s formulary.

All 13 patients were identified as engaging in no or little exercise (fewer than two sessions of aerobic activity per week over the past 6 months). Patients who participated more than 3 hours per week in any kind of moderate-level physical activity were excluded, as were patients with active pulmonary infections, cardiovascular disease, musculoskeletal disease, or other conditions that might impair their ability to exercise.

The authors convinced the insurer to pay a gym to enroll plan members with asthma, and they helped gym staff establish an asthma protocol that included monitoring asthmatics for symptoms and providing access to nebulizers.

"The gyms, we hope, will want to do this, and it’s very much in the insurance company’s favor to do it," Dr. Platts-Mills said. "But it’s still very difficult to get people to do regular exercise."

The seven participants assigned to the exercise group kept an exercise log recording the duration, type, and perceived exertion of all physical activities, including the three assigned exercise sessions each week. They also kept a log of medication use, asthma symptoms, unplanned medical visits, and unplanned asthma-related absences from work or school. Participants also answered a telephone-based asthma quality of life questionnaire at the end of weeks 4, 8, 12 and 16 (the study’s end).

Six participants assigned to be controls were given educational materials on exercise, participated in the telephone survey, and kept logs recording the same information as that of the exercise group. Researchers crossed over those participants to the exercise arm at 4 months.

At week 8, scores on the symptom domain of the quality-of-life questionnaire were significantly higher among exercisers, with 78.3% of responses indicating improvement, compared with 39.5% of responses by participants in the delayed-exercise group (P = .05).

Similarly, on the activity limitations domain, 78.3% of responding exercisers said they saw improvement, compared with 37.2% of delayed exercisers (P = .036). There were trends favoring exercise, but no significant differences, in the emotional function and environmental stimuli domains of the quality-of-life questionnaire.

"We have established that you can get an insurance company to pay a gym to enroll people and establish a protocol in the gym for asthmatics," Dr. Platts-Mills said. "I think this would be far more important for children with asthma if this could be achieved."

The study was supported by Southern Health Services Inc. Dr. Platts-Mills and colleagues reported that they had no conflicts of interest.

ORLANDO – Adding asthma education to reading, writing, and arithmetic in public schools resulted in significant improvements in asthma control measures among at-risk children, researchers reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the intervention group also had fewer urgent-care visits, suggesting better asthma control, the authors found.

In a pilot study aimed at reducing socioeconomic disparities in asthma control, at-risk children from schools assigned to implement the American Lung Association’s Open Airways for Schools (OAS) program had significantly better activity quality-of-life (QoL) scores and demonstrated significantly greater improvements in the use of metered-dose inhalers (MDI) than did their peers in schools that did not receive the intervention, reported Dr. Summer Monforte, a second-year fellow at National Jewish Health in Denver.

The study’s senior author was Dr. Stanley J. Szefler, head of pediatric clinical pharmacology at National Jewish Health.

The improvement in MDI use is an indicator that such programs can help to improve the health of children who are at risk for poor asthma outcomes, Dr. Monforte said in an interview.

"Every single time a child comes in, you have to make sure that they take their inhaler correctly; so it’s nice when the medicine gets where it’s supposed to go," she said.

The overall asthma prevalence rate in Colorado is 8.5% – but in some inner-city schools, the rate is nearly three times higher (22.8%). School-based asthma-education programs can help children improve their asthma control and avoid or reduce exacerbations, but such programs are not always available in poorer urban districts, the investigators noted.

They conducted a randomized, controlled study to see whether the evidence-based OAS intervention would work in schools where children were at risk for health care disparities. At-risk schools were defined as those in which more than 75% of children qualified for free lunch programs, or those with a greater than 50% Hispanic or African American student population.

Four of the schools (with a total of 49 children with asthma, plus their parents or guardians) were randomized to receive the intervention, and four other schools (total of 43 asthmatic children) were assigned as controls. All participants had a visit at baseline and at 3 months’ follow-up.

The children in the intervention groups attended a 40-minute OAS session once weekly for 6 weeks, while controls received their usual care.

At baseline, children in both groups were evaluated with the Health Risk Assessment instrument. Children in both groups also were assessed at baseline and follow-up with the Asthma Control Test (ACT) or Childhood ACT, asthma history questionnaires, Juniper’s Pediatric Asthma Quality of Life Questionnaire and Caregiver Quality of Life tools, spirometry, and observation and assessment of inhaler technique.

At 3-month follow-up, children in the intervention group had a mean improvement of 0.8 (plus or minus .22) points on the activity subscale of the QoL scale, which is scored from 1 (worst) to 7 (best). In comparison, controls had a mean improvement of only 0.2 (plus or minus 1.7) points (P = .05).

Assessments of MDI technique showed that children in the intervention group improved by a mean of 2.3 points on a 5-point scale, compared with just 0.7 for controls (P less than .0001).

The authors noted that this was a pilot study of short duration, with limited enrollment attributable to insufficient funding.

Nonetheless, the results indicate that a proven intervention "can be implemented with minor modifications in populations, such as the Denver Public Schools, that differ from the population where it was originally developed," the researchers noted in a poster presentation at the meeting.

The Step Up asthma program, a collaboration between National Jewish Health and the Denver Public Schools, was designed based on the needs identified in the pilot study, and is currently in place. The investigators plan to evaluate its ability to improve asthma control over a 5-year period.

GlaxoSmithKline supported the study. Dr. Monforte reported that she had no relevant disclosures.

ORLANDO – Adding asthma education to reading, writing, and arithmetic in public schools resulted in significant improvements in asthma control measures among at-risk children, researchers reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the intervention group also had fewer urgent-care visits, suggesting better asthma control, the authors found.

In a pilot study aimed at reducing socioeconomic disparities in asthma control, at-risk children from schools assigned to implement the American Lung Association’s Open Airways for Schools (OAS) program had significantly better activity quality-of-life (QoL) scores and demonstrated significantly greater improvements in the use of metered-dose inhalers (MDI) than did their peers in schools that did not receive the intervention, reported Dr. Summer Monforte, a second-year fellow at National Jewish Health in Denver.

The study’s senior author was Dr. Stanley J. Szefler, head of pediatric clinical pharmacology at National Jewish Health.

The improvement in MDI use is an indicator that such programs can help to improve the health of children who are at risk for poor asthma outcomes, Dr. Monforte said in an interview.

"Every single time a child comes in, you have to make sure that they take their inhaler correctly; so it’s nice when the medicine gets where it’s supposed to go," she said.

The overall asthma prevalence rate in Colorado is 8.5% – but in some inner-city schools, the rate is nearly three times higher (22.8%). School-based asthma-education programs can help children improve their asthma control and avoid or reduce exacerbations, but such programs are not always available in poorer urban districts, the investigators noted.

They conducted a randomized, controlled study to see whether the evidence-based OAS intervention would work in schools where children were at risk for health care disparities. At-risk schools were defined as those in which more than 75% of children qualified for free lunch programs, or those with a greater than 50% Hispanic or African American student population.

Four of the schools (with a total of 49 children with asthma, plus their parents or guardians) were randomized to receive the intervention, and four other schools (total of 43 asthmatic children) were assigned as controls. All participants had a visit at baseline and at 3 months’ follow-up.

The children in the intervention groups attended a 40-minute OAS session once weekly for 6 weeks, while controls received their usual care.

At baseline, children in both groups were evaluated with the Health Risk Assessment instrument. Children in both groups also were assessed at baseline and follow-up with the Asthma Control Test (ACT) or Childhood ACT, asthma history questionnaires, Juniper’s Pediatric Asthma Quality of Life Questionnaire and Caregiver Quality of Life tools, spirometry, and observation and assessment of inhaler technique.

At 3-month follow-up, children in the intervention group had a mean improvement of 0.8 (plus or minus .22) points on the activity subscale of the QoL scale, which is scored from 1 (worst) to 7 (best). In comparison, controls had a mean improvement of only 0.2 (plus or minus 1.7) points (P = .05).

Assessments of MDI technique showed that children in the intervention group improved by a mean of 2.3 points on a 5-point scale, compared with just 0.7 for controls (P less than .0001).

The authors noted that this was a pilot study of short duration, with limited enrollment attributable to insufficient funding.

Nonetheless, the results indicate that a proven intervention "can be implemented with minor modifications in populations, such as the Denver Public Schools, that differ from the population where it was originally developed," the researchers noted in a poster presentation at the meeting.

The Step Up asthma program, a collaboration between National Jewish Health and the Denver Public Schools, was designed based on the needs identified in the pilot study, and is currently in place. The investigators plan to evaluate its ability to improve asthma control over a 5-year period.

GlaxoSmithKline supported the study. Dr. Monforte reported that she had no relevant disclosures.

ORLANDO – Adding asthma education to reading, writing, and arithmetic in public schools resulted in significant improvements in asthma control measures among at-risk children, researchers reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the intervention group also had fewer urgent-care visits, suggesting better asthma control, the authors found.

In a pilot study aimed at reducing socioeconomic disparities in asthma control, at-risk children from schools assigned to implement the American Lung Association’s Open Airways for Schools (OAS) program had significantly better activity quality-of-life (QoL) scores and demonstrated significantly greater improvements in the use of metered-dose inhalers (MDI) than did their peers in schools that did not receive the intervention, reported Dr. Summer Monforte, a second-year fellow at National Jewish Health in Denver.

The study’s senior author was Dr. Stanley J. Szefler, head of pediatric clinical pharmacology at National Jewish Health.

The improvement in MDI use is an indicator that such programs can help to improve the health of children who are at risk for poor asthma outcomes, Dr. Monforte said in an interview.

"Every single time a child comes in, you have to make sure that they take their inhaler correctly; so it’s nice when the medicine gets where it’s supposed to go," she said.

The overall asthma prevalence rate in Colorado is 8.5% – but in some inner-city schools, the rate is nearly three times higher (22.8%). School-based asthma-education programs can help children improve their asthma control and avoid or reduce exacerbations, but such programs are not always available in poorer urban districts, the investigators noted.

They conducted a randomized, controlled study to see whether the evidence-based OAS intervention would work in schools where children were at risk for health care disparities. At-risk schools were defined as those in which more than 75% of children qualified for free lunch programs, or those with a greater than 50% Hispanic or African American student population.

Four of the schools (with a total of 49 children with asthma, plus their parents or guardians) were randomized to receive the intervention, and four other schools (total of 43 asthmatic children) were assigned as controls. All participants had a visit at baseline and at 3 months’ follow-up.

The children in the intervention groups attended a 40-minute OAS session once weekly for 6 weeks, while controls received their usual care.

At baseline, children in both groups were evaluated with the Health Risk Assessment instrument. Children in both groups also were assessed at baseline and follow-up with the Asthma Control Test (ACT) or Childhood ACT, asthma history questionnaires, Juniper’s Pediatric Asthma Quality of Life Questionnaire and Caregiver Quality of Life tools, spirometry, and observation and assessment of inhaler technique.

At 3-month follow-up, children in the intervention group had a mean improvement of 0.8 (plus or minus .22) points on the activity subscale of the QoL scale, which is scored from 1 (worst) to 7 (best). In comparison, controls had a mean improvement of only 0.2 (plus or minus 1.7) points (P = .05).

Assessments of MDI technique showed that children in the intervention group improved by a mean of 2.3 points on a 5-point scale, compared with just 0.7 for controls (P less than .0001).

The authors noted that this was a pilot study of short duration, with limited enrollment attributable to insufficient funding.

Nonetheless, the results indicate that a proven intervention "can be implemented with minor modifications in populations, such as the Denver Public Schools, that differ from the population where it was originally developed," the researchers noted in a poster presentation at the meeting.

The Step Up asthma program, a collaboration between National Jewish Health and the Denver Public Schools, was designed based on the needs identified in the pilot study, and is currently in place. The investigators plan to evaluate its ability to improve asthma control over a 5-year period.

GlaxoSmithKline supported the study. Dr. Monforte reported that she had no relevant disclosures.