Imagine this scenario: A couple goes on a Caribbean cruise with an all-you-can-eat buffet and an open bar. During the trip, they engage in 2 or 3 days of binge-style drinking, which is considered about four drinks in a single sitting. A few weeks after the trip, the woman finds out that she’s pregnant and calls your office wondering if there will be any harm to the fetus.

This is not a theoretical question. I have received many of these calls over the years, and in some cases the fear of adverse effects on the baby has led the couple to terminate the pregnancy. When we consider the general rise in binge drinking in North America and the fact that about half of all pregnancies are unplanned, this is a very real concern.

Dr. Koren is professor of physiology/pharmacology and pediatrics at Western University in Ontario. He is the founder of the Motherisk Program. He reported having no relevant financial disclosures. Email him at [email protected].

Imagine this scenario: A couple goes on a Caribbean cruise with an all-you-can-eat buffet and an open bar. During the trip, they engage in 2 or 3 days of binge-style drinking, which is considered about four drinks in a single sitting. A few weeks after the trip, the woman finds out that she’s pregnant and calls your office wondering if there will be any harm to the fetus.

This is not a theoretical question. I have received many of these calls over the years, and in some cases the fear of adverse effects on the baby has led the couple to terminate the pregnancy. When we consider the general rise in binge drinking in North America and the fact that about half of all pregnancies are unplanned, this is a very real concern.

Dr. Koren is professor of physiology/pharmacology and pediatrics at Western University in Ontario. He is the founder of the Motherisk Program. He reported having no relevant financial disclosures. Email him at [email protected].

Imagine this scenario: A couple goes on a Caribbean cruise with an all-you-can-eat buffet and an open bar. During the trip, they engage in 2 or 3 days of binge-style drinking, which is considered about four drinks in a single sitting. A few weeks after the trip, the woman finds out that she’s pregnant and calls your office wondering if there will be any harm to the fetus.

This is not a theoretical question. I have received many of these calls over the years, and in some cases the fear of adverse effects on the baby has led the couple to terminate the pregnancy. When we consider the general rise in binge drinking in North America and the fact that about half of all pregnancies are unplanned, this is a very real concern.

Dr. Koren is professor of physiology/pharmacology and pediatrics at Western University in Ontario. He is the founder of the Motherisk Program. He reported having no relevant financial disclosures. Email him at [email protected].

Ovarian cancer remains the most deadly gynecologic malignancy in the United States with more than 14,000 deaths in 2016. Yet, the prevalence remains low with approximately 22,000 cases in 2016. Stage at diagnosis is one of the strongest predictors of overall survival. The 5-year overall survival is more than 90% with stage I disease; this drops to 25% for those with distant metastases. Unfortunately, three-quarters of patients have disease spread beyond the ovary at the time ovarian cancer is clinically identified.

In this update, we will review:

• The fundamentals of ovarian cancer screening.

• How to identify patients who would benefit from surveillance.

• The usefulness of tumor markers.

• The results from recent large ovarian cancer screening trials.

Screening is a critical part of secondary prevention through early disease detection, when patients are asymptomatic and treatment can stop progression. Core principles of a good screening test are that the test is noninvasive, tolerable to the patient, and not costly. The disease should pose a major health threat and be detected at a stage at which intervention can impart a survival advantage. Most critically, the test should be sensitive and specific (i.e., detect disease when it is truly present and rarely be positive in the absence of disease).

Screening vs. case finding

A significant distinction should be made between average-risk patients and high-risk patients. Ob.gyns. frequently encounter high-risk patients who would benefit from regular surveillance or case finding (for example, patients with BRCA deleterious mutations or with Lynch syndrome). There are multiple risk factors for ovarian cancer, but the strongest known is family history, which is present in 15% of ovarian cancer patients. Having one relative with ovarian cancer increases the lifetime risk of ovarian cancer up to 5%. When a patient reports having one or more family members with ovarian cancer, it is important to differentiate between a common sporadic presentation and a rare familial cancer syndrome. ACOG Practice Bulletin 103 provides excellent guidance on which patients warrant formal genetic risk assessments by a genetic counselor.²

Tumor markers

During the last 25 years, screening for ovarian cancer in an average-risk population has been evaluated in multiple large prospective studies using serum tumor markers (i.e., CA 125) and ultrasound results.

CA 125 and HE4 tumor markers are frequently elevated in ovarian cancer and have been studied in ovarian cancer screening. However, while having a high sensitivity for detecting disease, they are nonspecific because they are also elevated in numerous benign conditions and therefore have not proven to be a useful screening tool in the average-risk population. There are clinically available tumor marker panels that are not intended for screening. Rather, they clarify the uncertainty of the presurgical adnexal mass evaluation by providing a risk score. High risk scores are generally managed in conjunction with a gynecologic oncology referral.

Multimodal screening

Combined assessment of both ultrasound findings and tumor marker levels shows more promise with respect to prediction of ovarian cancer. However, a systematic review of 25 ovarian cancer screening studies concluded that screening low-risk populations should not be included in clinical practice until randomized trials assessed the effect on mortality and the risk of adverse events. Three large randomized controlled trials have been completed to date.^3,4,5

The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) results appear promising. However, the revealing analysis was post hoc since the original study design did not take into account the inherent delayed effect in screening studies. While these results may provide a basis for future successful screening for ovarian cancer, confirmatory further analysis is pending, using additional data over a period of the next 3 years.

Ultimately, we are all excited about the possibility of effective screening protocols for ovarian cancer and await completed analyses of UKCTOCS. Until their benefits are confirmed, screening and preventive measures should be limited to those at high risk for ovarian cancer.

References

1. Hippokratia. 2007 Apr;11(2):63-6.

2. Obstet Gynecol. 2009 Apr;113(4):957-66.

3. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9.

4. Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20.

5. Lancet. 2016 Mar 5;387(10022):945-56.

Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no relevant financial disclosures.

Ovarian cancer remains the most deadly gynecologic malignancy in the United States with more than 14,000 deaths in 2016. Yet, the prevalence remains low with approximately 22,000 cases in 2016. Stage at diagnosis is one of the strongest predictors of overall survival. The 5-year overall survival is more than 90% with stage I disease; this drops to 25% for those with distant metastases. Unfortunately, three-quarters of patients have disease spread beyond the ovary at the time ovarian cancer is clinically identified.

In this update, we will review:

• The fundamentals of ovarian cancer screening.

• How to identify patients who would benefit from surveillance.

• The usefulness of tumor markers.

• The results from recent large ovarian cancer screening trials.

Screening is a critical part of secondary prevention through early disease detection, when patients are asymptomatic and treatment can stop progression. Core principles of a good screening test are that the test is noninvasive, tolerable to the patient, and not costly. The disease should pose a major health threat and be detected at a stage at which intervention can impart a survival advantage. Most critically, the test should be sensitive and specific (i.e., detect disease when it is truly present and rarely be positive in the absence of disease).

Screening vs. case finding

A significant distinction should be made between average-risk patients and high-risk patients. Ob.gyns. frequently encounter high-risk patients who would benefit from regular surveillance or case finding (for example, patients with BRCA deleterious mutations or with Lynch syndrome). There are multiple risk factors for ovarian cancer, but the strongest known is family history, which is present in 15% of ovarian cancer patients. Having one relative with ovarian cancer increases the lifetime risk of ovarian cancer up to 5%. When a patient reports having one or more family members with ovarian cancer, it is important to differentiate between a common sporadic presentation and a rare familial cancer syndrome. ACOG Practice Bulletin 103 provides excellent guidance on which patients warrant formal genetic risk assessments by a genetic counselor.²

Tumor markers

During the last 25 years, screening for ovarian cancer in an average-risk population has been evaluated in multiple large prospective studies using serum tumor markers (i.e., CA 125) and ultrasound results.

CA 125 and HE4 tumor markers are frequently elevated in ovarian cancer and have been studied in ovarian cancer screening. However, while having a high sensitivity for detecting disease, they are nonspecific because they are also elevated in numerous benign conditions and therefore have not proven to be a useful screening tool in the average-risk population. There are clinically available tumor marker panels that are not intended for screening. Rather, they clarify the uncertainty of the presurgical adnexal mass evaluation by providing a risk score. High risk scores are generally managed in conjunction with a gynecologic oncology referral.

Multimodal screening

Combined assessment of both ultrasound findings and tumor marker levels shows more promise with respect to prediction of ovarian cancer. However, a systematic review of 25 ovarian cancer screening studies concluded that screening low-risk populations should not be included in clinical practice until randomized trials assessed the effect on mortality and the risk of adverse events. Three large randomized controlled trials have been completed to date.^3,4,5

The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) results appear promising. However, the revealing analysis was post hoc since the original study design did not take into account the inherent delayed effect in screening studies. While these results may provide a basis for future successful screening for ovarian cancer, confirmatory further analysis is pending, using additional data over a period of the next 3 years.

Ultimately, we are all excited about the possibility of effective screening protocols for ovarian cancer and await completed analyses of UKCTOCS. Until their benefits are confirmed, screening and preventive measures should be limited to those at high risk for ovarian cancer.

References

1. Hippokratia. 2007 Apr;11(2):63-6.

2. Obstet Gynecol. 2009 Apr;113(4):957-66.

3. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9.

4. Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20.

5. Lancet. 2016 Mar 5;387(10022):945-56.

Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no relevant financial disclosures.

Ovarian cancer remains the most deadly gynecologic malignancy in the United States with more than 14,000 deaths in 2016. Yet, the prevalence remains low with approximately 22,000 cases in 2016. Stage at diagnosis is one of the strongest predictors of overall survival. The 5-year overall survival is more than 90% with stage I disease; this drops to 25% for those with distant metastases. Unfortunately, three-quarters of patients have disease spread beyond the ovary at the time ovarian cancer is clinically identified.

In this update, we will review:

• The fundamentals of ovarian cancer screening.

• How to identify patients who would benefit from surveillance.

• The usefulness of tumor markers.

• The results from recent large ovarian cancer screening trials.

Screening is a critical part of secondary prevention through early disease detection, when patients are asymptomatic and treatment can stop progression. Core principles of a good screening test are that the test is noninvasive, tolerable to the patient, and not costly. The disease should pose a major health threat and be detected at a stage at which intervention can impart a survival advantage. Most critically, the test should be sensitive and specific (i.e., detect disease when it is truly present and rarely be positive in the absence of disease).

Screening vs. case finding

A significant distinction should be made between average-risk patients and high-risk patients. Ob.gyns. frequently encounter high-risk patients who would benefit from regular surveillance or case finding (for example, patients with BRCA deleterious mutations or with Lynch syndrome). There are multiple risk factors for ovarian cancer, but the strongest known is family history, which is present in 15% of ovarian cancer patients. Having one relative with ovarian cancer increases the lifetime risk of ovarian cancer up to 5%. When a patient reports having one or more family members with ovarian cancer, it is important to differentiate between a common sporadic presentation and a rare familial cancer syndrome. ACOG Practice Bulletin 103 provides excellent guidance on which patients warrant formal genetic risk assessments by a genetic counselor.²

Tumor markers

During the last 25 years, screening for ovarian cancer in an average-risk population has been evaluated in multiple large prospective studies using serum tumor markers (i.e., CA 125) and ultrasound results.

CA 125 and HE4 tumor markers are frequently elevated in ovarian cancer and have been studied in ovarian cancer screening. However, while having a high sensitivity for detecting disease, they are nonspecific because they are also elevated in numerous benign conditions and therefore have not proven to be a useful screening tool in the average-risk population. There are clinically available tumor marker panels that are not intended for screening. Rather, they clarify the uncertainty of the presurgical adnexal mass evaluation by providing a risk score. High risk scores are generally managed in conjunction with a gynecologic oncology referral.

Multimodal screening

Combined assessment of both ultrasound findings and tumor marker levels shows more promise with respect to prediction of ovarian cancer. However, a systematic review of 25 ovarian cancer screening studies concluded that screening low-risk populations should not be included in clinical practice until randomized trials assessed the effect on mortality and the risk of adverse events. Three large randomized controlled trials have been completed to date.^3,4,5

The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) results appear promising. However, the revealing analysis was post hoc since the original study design did not take into account the inherent delayed effect in screening studies. While these results may provide a basis for future successful screening for ovarian cancer, confirmatory further analysis is pending, using additional data over a period of the next 3 years.

Ultimately, we are all excited about the possibility of effective screening protocols for ovarian cancer and await completed analyses of UKCTOCS. Until their benefits are confirmed, screening and preventive measures should be limited to those at high risk for ovarian cancer.

References

1. Hippokratia. 2007 Apr;11(2):63-6.

2. Obstet Gynecol. 2009 Apr;113(4):957-66.

3. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9.

4. Int J Gynecol Cancer. 2008 May-Jun;18(3):414-20.

5. Lancet. 2016 Mar 5;387(10022):945-56.

Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Rossi is an assistant professor in the division of gynecologic oncology at UNC–Chapel Hill. They reported having no relevant financial disclosures.

Frederick Lansigan, MD

Photo by Larry Young

SAN FRANCISCO—Patients with refractory peripheral T-cell lymphoma (PTCL) have significantly worse overall survival (OS) than patients with relapsed PTCL, according to data from the COMPLETE registry.

The data also showed that patients treated with a curative intent had significantly better OS than patients who received palliative care.

However, there was no significant difference in OS according to disease subtype or between patients who received conventional chemotherapy and those who received novel agents.

Frederick Lansigan, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, presented these data at the 9th Annual T-cell Lymphoma Forum. Data were also presented at the 2016 ASH Annual Meeting (abstract 4150).

Dr Lansigan and his colleagues analyzed COMPLETE data on patients with mature T-cell lymphomas, focusing on patients in first relapse and those with primary refractory disease.

Refractory disease was defined as no response to initial treatment or disease progression during or within 1 month of completing front-line therapy.

Relapsed disease was defined as progression more than 1 month after completing induction therapy in patients who initially achieved a complete response (CR) or partial response (PR).

Patients

There were 138 patients in the analysis—58 with relapsed disease and 80 with refractory disease.

The median time from informed consent to diagnosis of relapsed disease was 11.4 months, and the time to diagnosis of refractory disease was 2.2 months.

Disease subtypes included:

• PTCL not otherwise specified (NOS)—35% of relapsed and 28% of refractory patients
• Angioimmunoblastic T-cell lymphoma—22% and 16%
• ALK- anaplastic large-cell lymphoma (ALCL)—10% and 14%
• ALK+ ALCL—3% and 4%
• Natural killer/T-cell lymphoma, nasal type—9% and 8%
• Enteropathy-associated T-cell lymphoma—5% and 3%
• Hepatosplenic T-cell lymphoma—3% and 5%
• Adult T-cell leukemia/lymphoma—2% and 5%
• Transformed mycosis fungoides—0% and 10%
• “Other”—10% and 9%.

Treatment

Most patients received combination regimens as front-line therapy—81% in the relapsed group and 68% in the refractory group. Nineteen and 32%, respectively, received single-agent treatment.

A majority of patients in both groups received chemotherapy or novel agents as second-line therapy—65% in the relapsed group and 71% in the refractory group. (Novel agents include histone deacetylase inhibitors, monoclonal antibodies, immunoconjugates, pralatrexate, bendamustine, denileukin diftitox, alisertib, and lenalidomide.)

Fifteen percent of relapsed patients and 16% of refractory patients received palliative care/best supportive care/observation as second-line therapy. Fifteen percent and 7%, respectively, had a transplant. Four percent and 6%, respectively, received chemotherapy and radiotherapy.

Of the patients who received systemic therapy second-line, 53% of relapsed patients received novel therapies, and 47% received conventional chemotherapy. Twenty-five percent of the refractory patients received novel therapies, and 75% received chemotherapy (P=0.005 for relapsed/refractory comparison of novel vs traditional therapy).

Most patients with relapsed disease received single agents (74%) rather than multi-agent regimens (26%) as second-line therapy. However, single-agent treatment was about as common as multi-agent regimens for refractory patients—53% and 47%, respectively (P=0.03 for relapsed/refractory comparison).

The objective response rates to second-line therapy were 61% for relapsed patients and 37% for refractory patients (P=0.02). The CR rates were 37% and 12%, respectively (P=0.003).

Survival

The median OS was significantly better for patients with relapsed PTCL—15.7 months, compared to 6.1 months for refractory patients (P=0.0237).

OS was also significantly better for patients who achieved a CR. The median OS was not reached for patients with a CR, 14.6 months for those with a PR, 13.7 months for those with stable disease, and 3.2 months for those who progressed (P<0.0001).

There was no significant difference in median OS for patients who received novel agents and those who received traditional chemotherapy—14.6 months and 11.1 months, respectively (P=0.2362).

Disease subtype

There was no significant difference in OS between patients who had PTCL-NOS, ALCL, or another PTCL subtype.

For relapsed patients, the median OS was 26 months for those with ALCL, 34 months for those with PTCL-NOS, and 35 months for those with other subtypes (P=0.82).

For refractory patients, the median OS was 31 months for those with ALCL, 7 months for those with PTCL-NOS, and 11 months for those with other subtypes (P=0.36).

Treatment intent

There was a significant difference in OS according to the intent of treatment.

Among relapsed patients, the median OS was not reached for those treated with curative intent and was 17 months for those who received palliative care (P=0.001).

Among refractory patients, the median OS was 15 months for those treated with curative intent and 5 months for those who received palliative care (P=0.005).

Dr Lansigan noted that the better outcomes in patients treated with curative intent may reflect a host of things, such as performance status, fitness for treatment, and transplant eligibility.

Treatment type

In relapsed patients, there was no significant difference in median OS between patients who underwent a transplant (not reached), those who received chemotherapy (24.4 months), and those who received best supportive care (20.9 months).

In refractory patients, the differences were significant. The median OS was not reached in patients who underwent a transplant, 11.6 months in those who received chemotherapy, and 3.5 months in those who received best supportive care (P=0.001).

In closing, Dr Lansigan noted that, in addition to showing a difference in OS between patients with relapsed and refractory PTCL, the COMPLETE registry highlights differences in practice patterns.

“The refractory group was treated more aggressively with traditional combination salvage regimens, but this does not appear to be better than single-agent chemo,” he said. “Of course, selection bias does play a role here, but this is hypothesis-generating.”

“In the relapsed PTCL group, novel, single-agent chemo was used more often, with good effect, with high response rates and long-term survival outcomes. So novel single agents can be considered as salvage therapy for both relapsed and refractory PTCL. Clinical trials are needed to improve outcomes in this poor-risk subgroup.”

Frederick Lansigan, MD

Photo by Larry Young

SAN FRANCISCO—Patients with refractory peripheral T-cell lymphoma (PTCL) have significantly worse overall survival (OS) than patients with relapsed PTCL, according to data from the COMPLETE registry.

The data also showed that patients treated with a curative intent had significantly better OS than patients who received palliative care.

However, there was no significant difference in OS according to disease subtype or between patients who received conventional chemotherapy and those who received novel agents.

Frederick Lansigan, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, presented these data at the 9th Annual T-cell Lymphoma Forum. Data were also presented at the 2016 ASH Annual Meeting (abstract 4150).

Dr Lansigan and his colleagues analyzed COMPLETE data on patients with mature T-cell lymphomas, focusing on patients in first relapse and those with primary refractory disease.

Refractory disease was defined as no response to initial treatment or disease progression during or within 1 month of completing front-line therapy.

Relapsed disease was defined as progression more than 1 month after completing induction therapy in patients who initially achieved a complete response (CR) or partial response (PR).

Patients

There were 138 patients in the analysis—58 with relapsed disease and 80 with refractory disease.

The median time from informed consent to diagnosis of relapsed disease was 11.4 months, and the time to diagnosis of refractory disease was 2.2 months.

Disease subtypes included:

• PTCL not otherwise specified (NOS)—35% of relapsed and 28% of refractory patients
• Angioimmunoblastic T-cell lymphoma—22% and 16%
• ALK- anaplastic large-cell lymphoma (ALCL)—10% and 14%
• ALK+ ALCL—3% and 4%
• Natural killer/T-cell lymphoma, nasal type—9% and 8%
• Enteropathy-associated T-cell lymphoma—5% and 3%
• Hepatosplenic T-cell lymphoma—3% and 5%
• Adult T-cell leukemia/lymphoma—2% and 5%
• Transformed mycosis fungoides—0% and 10%
• “Other”—10% and 9%.

Treatment

Most patients received combination regimens as front-line therapy—81% in the relapsed group and 68% in the refractory group. Nineteen and 32%, respectively, received single-agent treatment.

A majority of patients in both groups received chemotherapy or novel agents as second-line therapy—65% in the relapsed group and 71% in the refractory group. (Novel agents include histone deacetylase inhibitors, monoclonal antibodies, immunoconjugates, pralatrexate, bendamustine, denileukin diftitox, alisertib, and lenalidomide.)

Fifteen percent of relapsed patients and 16% of refractory patients received palliative care/best supportive care/observation as second-line therapy. Fifteen percent and 7%, respectively, had a transplant. Four percent and 6%, respectively, received chemotherapy and radiotherapy.

Of the patients who received systemic therapy second-line, 53% of relapsed patients received novel therapies, and 47% received conventional chemotherapy. Twenty-five percent of the refractory patients received novel therapies, and 75% received chemotherapy (P=0.005 for relapsed/refractory comparison of novel vs traditional therapy).

Most patients with relapsed disease received single agents (74%) rather than multi-agent regimens (26%) as second-line therapy. However, single-agent treatment was about as common as multi-agent regimens for refractory patients—53% and 47%, respectively (P=0.03 for relapsed/refractory comparison).

The objective response rates to second-line therapy were 61% for relapsed patients and 37% for refractory patients (P=0.02). The CR rates were 37% and 12%, respectively (P=0.003).

Survival

The median OS was significantly better for patients with relapsed PTCL—15.7 months, compared to 6.1 months for refractory patients (P=0.0237).

OS was also significantly better for patients who achieved a CR. The median OS was not reached for patients with a CR, 14.6 months for those with a PR, 13.7 months for those with stable disease, and 3.2 months for those who progressed (P<0.0001).

There was no significant difference in median OS for patients who received novel agents and those who received traditional chemotherapy—14.6 months and 11.1 months, respectively (P=0.2362).

Disease subtype

There was no significant difference in OS between patients who had PTCL-NOS, ALCL, or another PTCL subtype.

For relapsed patients, the median OS was 26 months for those with ALCL, 34 months for those with PTCL-NOS, and 35 months for those with other subtypes (P=0.82).

For refractory patients, the median OS was 31 months for those with ALCL, 7 months for those with PTCL-NOS, and 11 months for those with other subtypes (P=0.36).

Treatment intent

There was a significant difference in OS according to the intent of treatment.

Among relapsed patients, the median OS was not reached for those treated with curative intent and was 17 months for those who received palliative care (P=0.001).

Among refractory patients, the median OS was 15 months for those treated with curative intent and 5 months for those who received palliative care (P=0.005).

Dr Lansigan noted that the better outcomes in patients treated with curative intent may reflect a host of things, such as performance status, fitness for treatment, and transplant eligibility.

Treatment type

In relapsed patients, there was no significant difference in median OS between patients who underwent a transplant (not reached), those who received chemotherapy (24.4 months), and those who received best supportive care (20.9 months).

In refractory patients, the differences were significant. The median OS was not reached in patients who underwent a transplant, 11.6 months in those who received chemotherapy, and 3.5 months in those who received best supportive care (P=0.001).

In closing, Dr Lansigan noted that, in addition to showing a difference in OS between patients with relapsed and refractory PTCL, the COMPLETE registry highlights differences in practice patterns.

“The refractory group was treated more aggressively with traditional combination salvage regimens, but this does not appear to be better than single-agent chemo,” he said. “Of course, selection bias does play a role here, but this is hypothesis-generating.”

“In the relapsed PTCL group, novel, single-agent chemo was used more often, with good effect, with high response rates and long-term survival outcomes. So novel single agents can be considered as salvage therapy for both relapsed and refractory PTCL. Clinical trials are needed to improve outcomes in this poor-risk subgroup.”

Frederick Lansigan, MD

Photo by Larry Young

SAN FRANCISCO—Patients with refractory peripheral T-cell lymphoma (PTCL) have significantly worse overall survival (OS) than patients with relapsed PTCL, according to data from the COMPLETE registry.

The data also showed that patients treated with a curative intent had significantly better OS than patients who received palliative care.

However, there was no significant difference in OS according to disease subtype or between patients who received conventional chemotherapy and those who received novel agents.

Frederick Lansigan, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, presented these data at the 9th Annual T-cell Lymphoma Forum. Data were also presented at the 2016 ASH Annual Meeting (abstract 4150).

Dr Lansigan and his colleagues analyzed COMPLETE data on patients with mature T-cell lymphomas, focusing on patients in first relapse and those with primary refractory disease.

Refractory disease was defined as no response to initial treatment or disease progression during or within 1 month of completing front-line therapy.

Relapsed disease was defined as progression more than 1 month after completing induction therapy in patients who initially achieved a complete response (CR) or partial response (PR).

Patients

There were 138 patients in the analysis—58 with relapsed disease and 80 with refractory disease.

The median time from informed consent to diagnosis of relapsed disease was 11.4 months, and the time to diagnosis of refractory disease was 2.2 months.

Disease subtypes included:

• PTCL not otherwise specified (NOS)—35% of relapsed and 28% of refractory patients
• Angioimmunoblastic T-cell lymphoma—22% and 16%
• ALK- anaplastic large-cell lymphoma (ALCL)—10% and 14%
• ALK+ ALCL—3% and 4%
• Natural killer/T-cell lymphoma, nasal type—9% and 8%
• Enteropathy-associated T-cell lymphoma—5% and 3%
• Hepatosplenic T-cell lymphoma—3% and 5%
• Adult T-cell leukemia/lymphoma—2% and 5%
• Transformed mycosis fungoides—0% and 10%
• “Other”—10% and 9%.

Treatment

Most patients received combination regimens as front-line therapy—81% in the relapsed group and 68% in the refractory group. Nineteen and 32%, respectively, received single-agent treatment.

A majority of patients in both groups received chemotherapy or novel agents as second-line therapy—65% in the relapsed group and 71% in the refractory group. (Novel agents include histone deacetylase inhibitors, monoclonal antibodies, immunoconjugates, pralatrexate, bendamustine, denileukin diftitox, alisertib, and lenalidomide.)

Fifteen percent of relapsed patients and 16% of refractory patients received palliative care/best supportive care/observation as second-line therapy. Fifteen percent and 7%, respectively, had a transplant. Four percent and 6%, respectively, received chemotherapy and radiotherapy.

Of the patients who received systemic therapy second-line, 53% of relapsed patients received novel therapies, and 47% received conventional chemotherapy. Twenty-five percent of the refractory patients received novel therapies, and 75% received chemotherapy (P=0.005 for relapsed/refractory comparison of novel vs traditional therapy).

Most patients with relapsed disease received single agents (74%) rather than multi-agent regimens (26%) as second-line therapy. However, single-agent treatment was about as common as multi-agent regimens for refractory patients—53% and 47%, respectively (P=0.03 for relapsed/refractory comparison).

The objective response rates to second-line therapy were 61% for relapsed patients and 37% for refractory patients (P=0.02). The CR rates were 37% and 12%, respectively (P=0.003).

Survival

The median OS was significantly better for patients with relapsed PTCL—15.7 months, compared to 6.1 months for refractory patients (P=0.0237).

OS was also significantly better for patients who achieved a CR. The median OS was not reached for patients with a CR, 14.6 months for those with a PR, 13.7 months for those with stable disease, and 3.2 months for those who progressed (P<0.0001).

There was no significant difference in median OS for patients who received novel agents and those who received traditional chemotherapy—14.6 months and 11.1 months, respectively (P=0.2362).

Disease subtype

There was no significant difference in OS between patients who had PTCL-NOS, ALCL, or another PTCL subtype.

For relapsed patients, the median OS was 26 months for those with ALCL, 34 months for those with PTCL-NOS, and 35 months for those with other subtypes (P=0.82).

For refractory patients, the median OS was 31 months for those with ALCL, 7 months for those with PTCL-NOS, and 11 months for those with other subtypes (P=0.36).

Treatment intent

There was a significant difference in OS according to the intent of treatment.

Among relapsed patients, the median OS was not reached for those treated with curative intent and was 17 months for those who received palliative care (P=0.001).

Among refractory patients, the median OS was 15 months for those treated with curative intent and 5 months for those who received palliative care (P=0.005).

Dr Lansigan noted that the better outcomes in patients treated with curative intent may reflect a host of things, such as performance status, fitness for treatment, and transplant eligibility.

Treatment type

In relapsed patients, there was no significant difference in median OS between patients who underwent a transplant (not reached), those who received chemotherapy (24.4 months), and those who received best supportive care (20.9 months).

In refractory patients, the differences were significant. The median OS was not reached in patients who underwent a transplant, 11.6 months in those who received chemotherapy, and 3.5 months in those who received best supportive care (P=0.001).

In closing, Dr Lansigan noted that, in addition to showing a difference in OS between patients with relapsed and refractory PTCL, the COMPLETE registry highlights differences in practice patterns.

“The refractory group was treated more aggressively with traditional combination salvage regimens, but this does not appear to be better than single-agent chemo,” he said. “Of course, selection bias does play a role here, but this is hypothesis-generating.”

“In the relapsed PTCL group, novel, single-agent chemo was used more often, with good effect, with high response rates and long-term survival outcomes. So novel single agents can be considered as salvage therapy for both relapsed and refractory PTCL. Clinical trials are needed to improve outcomes in this poor-risk subgroup.”

Micrograph showing
mycosis fungoides

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted SGX301 (synthetic hypericin) Promising Innovative Medicine (PIM) designation for the treatment of cutaneous T-cell lymphoma (CTCL).

The PIM designation is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS). 

EAMS provides early access to new medicines for patients with life-threatening and seriously debilitating conditions.

PIM status is awarded following an assessment of early nonclinical and clinical data by the MHRA.

PIM designation has been created as an early signal to companies that a product’s development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme once further development work has been conducted. 

In the second phase, the product is made available to UK patients before a marketing authorization is approved.

The requirements for PIM designation are:

1. The condition should be life-threatening or seriously debilitating with a high unmet medical need (ie, there is no method of treatment, diagnosis, or prevention available, or existing methods have serious limitations).
2. The medicinal product is likely to offer a major advantage over methods currently used in the UK.
3. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit-risk balance. A positive benefit-risk balance should be based on preliminary scientific evidence, as justified by the applicant.

About SGX301

SGX301 is a photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a photosensitizer that is applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 

Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated, normal human lymphoid cells and inhibited the growth of malignant T cells isolated from CTCL patients. Topical hypericin has also proven safe in a phase 1 study of healthy volunteers.

In a phase 2 trial of patients with CTCL (mycosis fungoides only) or psoriasis, topical hypericin conferred a significant improvement over placebo. Among CTCL patients, the treatment prompted a response rate of 58.3%, compared to an 8.3% response rate for placebo (P≤0.04).

Topical hypericin was also well tolerated in this trial. There were no deaths or serious adverse events related to the treatment. However, there were reports of mild to moderate burning, itching, erythema, and pruritus at the application site.

A phase 3 trial of SGX301 is currently recruiting patients. SGX301 is under development by Soligenix, Inc.

Micrograph showing
mycosis fungoides

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted SGX301 (synthetic hypericin) Promising Innovative Medicine (PIM) designation for the treatment of cutaneous T-cell lymphoma (CTCL).

The PIM designation is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS). 

EAMS provides early access to new medicines for patients with life-threatening and seriously debilitating conditions.

PIM status is awarded following an assessment of early nonclinical and clinical data by the MHRA.

PIM designation has been created as an early signal to companies that a product’s development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme once further development work has been conducted. 

In the second phase, the product is made available to UK patients before a marketing authorization is approved.

The requirements for PIM designation are:

1. The condition should be life-threatening or seriously debilitating with a high unmet medical need (ie, there is no method of treatment, diagnosis, or prevention available, or existing methods have serious limitations).
2. The medicinal product is likely to offer a major advantage over methods currently used in the UK.
3. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit-risk balance. A positive benefit-risk balance should be based on preliminary scientific evidence, as justified by the applicant.

About SGX301

SGX301 is a photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a photosensitizer that is applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 

Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated, normal human lymphoid cells and inhibited the growth of malignant T cells isolated from CTCL patients. Topical hypericin has also proven safe in a phase 1 study of healthy volunteers.

In a phase 2 trial of patients with CTCL (mycosis fungoides only) or psoriasis, topical hypericin conferred a significant improvement over placebo. Among CTCL patients, the treatment prompted a response rate of 58.3%, compared to an 8.3% response rate for placebo (P≤0.04).

Topical hypericin was also well tolerated in this trial. There were no deaths or serious adverse events related to the treatment. However, there were reports of mild to moderate burning, itching, erythema, and pruritus at the application site.

A phase 3 trial of SGX301 is currently recruiting patients. SGX301 is under development by Soligenix, Inc.

Micrograph showing
mycosis fungoides

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted SGX301 (synthetic hypericin) Promising Innovative Medicine (PIM) designation for the treatment of cutaneous T-cell lymphoma (CTCL).

The PIM designation is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS). 

EAMS provides early access to new medicines for patients with life-threatening and seriously debilitating conditions.

PIM status is awarded following an assessment of early nonclinical and clinical data by the MHRA.

PIM designation has been created as an early signal to companies that a product’s development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme once further development work has been conducted. 

In the second phase, the product is made available to UK patients before a marketing authorization is approved.

The requirements for PIM designation are:

1. The condition should be life-threatening or seriously debilitating with a high unmet medical need (ie, there is no method of treatment, diagnosis, or prevention available, or existing methods have serious limitations).
2. The medicinal product is likely to offer a major advantage over methods currently used in the UK.
3. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit-risk balance. A positive benefit-risk balance should be based on preliminary scientific evidence, as justified by the applicant.

About SGX301

SGX301 is a photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a photosensitizer that is applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 

Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated, normal human lymphoid cells and inhibited the growth of malignant T cells isolated from CTCL patients. Topical hypericin has also proven safe in a phase 1 study of healthy volunteers.

In a phase 2 trial of patients with CTCL (mycosis fungoides only) or psoriasis, topical hypericin conferred a significant improvement over placebo. Among CTCL patients, the treatment prompted a response rate of 58.3%, compared to an 8.3% response rate for placebo (P≤0.04).

Topical hypericin was also well tolerated in this trial. There were no deaths or serious adverse events related to the treatment. However, there were reports of mild to moderate burning, itching, erythema, and pruritus at the application site.

A phase 3 trial of SGX301 is currently recruiting patients. SGX301 is under development by Soligenix, Inc.

Antihemophilic factor

In a survey of 200 adults with hemophilia A, most were not aware that factor VIII (FVIII) products can be stored at room temperature.

A majority of patients surveyed thought FVIII products must be stored in the refrigerator at all times.

The minority of

patients who did store FVIII at room temperature felt significantly

more satisfied with their treatment and less restricted in their daily

lives than patients who refrigerated FVIII.

“People living with hemophilia A can feel restricted in their daily life based on the misconception that all FVIII treatments must be stored in the refrigerator,” said Mariasanta Napolitano, MD, of the University of Palermo in Italy.

“It is important that healthcare professionals communicate to patients that some FVIII products can be used portably and at room temperature, to enable them to go about their daily lives as actively as they wish.”

Dr Napolitano and her colleagues presented the results of this survey at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD, poster P024).

The researchers conducted the survey in adults with hemophilia A in 7 countries. Face-to-face surveys were conducted with 90 people in the European Union (France, Italy, and UK) and 90 people in Latin America (Argentina, Brazil, and Mexico). Online surveys were conducted with 20 people in Japan.

The questionnaire covered current use of FVIII products, patient satisfaction, and restrictions in daily life using verbalized rating scales (eg, “not restricted at all / somewhat restricted / restricted / strongly restricted”).

Seventy-four percent of patients used FVII as prophylaxis, and 26% used on-demand treatment. Sixty-seven percent used recombinant FVIII, and 33% used plasma-derived FVIII.

Storage

Most patients—85%—stored their FVIII product in the refrigerator, with 15% storing their treatment at room temperature.

Of those storing FVIII in the refrigerator, 88% said FVIII must be stored in the refrigerator at all times. Seventy-nine percent of patients said they worry about the temperature at which FVIII is stored.

Seventy-four percent said they wait for their FVIII product to reach room temperature before mixing and injecting it. The median wait time was 10 minutes.

Sixty-two percent of patients said an injection with cold FVIII is more unpleasant than an injection with room temperature FVIII.

Satisfaction

Patients storing FVIII at room temperature were significantly more likely than those storing FVIII in the refrigerator to report overall satisfaction with their FVIII product (52% vs 28%, P<0.05).

Patients storing FVIII at room temperature were also significantly more likely to report satisfaction with:

• Product efficacy (61% vs 43%, P<0.05)
• The procedure of mixing the product before injection (39% vs 22%, P<0.05)
• The flexibility of storage depending on the patients’ needs (55% vs 18%, P<0.05)
• The length of time the product can be stored outside the refrigerator (45% vs 19%, P<0.05)
• The size of vials (42% vs 18%, P<0.05)
• Storage temperature (39% vs 15%, P<0.05).

Daily life

Patients storing FVIII at room temperature travelled significantly more often—16 times per year vs 9 times per year (P<0.01).

Nineteen percent of these patients felt that storing, preparing, and mixing FVIII is disruptive to the normal course of the day, compared to 35% of patients who store FVIII in the refrigerator (P<0.05).

Significantly fewer patients in the room-temperature group said they feel restricted when it comes to sports activities, traveling, and their evening routine (P<0.05).

Forty-eight percent of patients storing FVIII at room temperature said they feel relaxed using FVIII in their daily life, compared to 20% of patients storing FVIII in the refrigerator (P<0.05).

Antihemophilic factor

In a survey of 200 adults with hemophilia A, most were not aware that factor VIII (FVIII) products can be stored at room temperature.

A majority of patients surveyed thought FVIII products must be stored in the refrigerator at all times.

The minority of

patients who did store FVIII at room temperature felt significantly

more satisfied with their treatment and less restricted in their daily

lives than patients who refrigerated FVIII.

“People living with hemophilia A can feel restricted in their daily life based on the misconception that all FVIII treatments must be stored in the refrigerator,” said Mariasanta Napolitano, MD, of the University of Palermo in Italy.

“It is important that healthcare professionals communicate to patients that some FVIII products can be used portably and at room temperature, to enable them to go about their daily lives as actively as they wish.”

Dr Napolitano and her colleagues presented the results of this survey at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD, poster P024).

The researchers conducted the survey in adults with hemophilia A in 7 countries. Face-to-face surveys were conducted with 90 people in the European Union (France, Italy, and UK) and 90 people in Latin America (Argentina, Brazil, and Mexico). Online surveys were conducted with 20 people in Japan.

The questionnaire covered current use of FVIII products, patient satisfaction, and restrictions in daily life using verbalized rating scales (eg, “not restricted at all / somewhat restricted / restricted / strongly restricted”).

Seventy-four percent of patients used FVII as prophylaxis, and 26% used on-demand treatment. Sixty-seven percent used recombinant FVIII, and 33% used plasma-derived FVIII.

Storage

Most patients—85%—stored their FVIII product in the refrigerator, with 15% storing their treatment at room temperature.

Of those storing FVIII in the refrigerator, 88% said FVIII must be stored in the refrigerator at all times. Seventy-nine percent of patients said they worry about the temperature at which FVIII is stored.

Seventy-four percent said they wait for their FVIII product to reach room temperature before mixing and injecting it. The median wait time was 10 minutes.

Sixty-two percent of patients said an injection with cold FVIII is more unpleasant than an injection with room temperature FVIII.

Satisfaction

Patients storing FVIII at room temperature were significantly more likely than those storing FVIII in the refrigerator to report overall satisfaction with their FVIII product (52% vs 28%, P<0.05).

Patients storing FVIII at room temperature were also significantly more likely to report satisfaction with:

• Product efficacy (61% vs 43%, P<0.05)
• The procedure of mixing the product before injection (39% vs 22%, P<0.05)
• The flexibility of storage depending on the patients’ needs (55% vs 18%, P<0.05)
• The length of time the product can be stored outside the refrigerator (45% vs 19%, P<0.05)
• The size of vials (42% vs 18%, P<0.05)
• Storage temperature (39% vs 15%, P<0.05).

Daily life

Patients storing FVIII at room temperature travelled significantly more often—16 times per year vs 9 times per year (P<0.01).

Nineteen percent of these patients felt that storing, preparing, and mixing FVIII is disruptive to the normal course of the day, compared to 35% of patients who store FVIII in the refrigerator (P<0.05).

Significantly fewer patients in the room-temperature group said they feel restricted when it comes to sports activities, traveling, and their evening routine (P<0.05).

Forty-eight percent of patients storing FVIII at room temperature said they feel relaxed using FVIII in their daily life, compared to 20% of patients storing FVIII in the refrigerator (P<0.05).

Antihemophilic factor

In a survey of 200 adults with hemophilia A, most were not aware that factor VIII (FVIII) products can be stored at room temperature.

A majority of patients surveyed thought FVIII products must be stored in the refrigerator at all times.

The minority of

patients who did store FVIII at room temperature felt significantly

more satisfied with their treatment and less restricted in their daily

lives than patients who refrigerated FVIII.

“People living with hemophilia A can feel restricted in their daily life based on the misconception that all FVIII treatments must be stored in the refrigerator,” said Mariasanta Napolitano, MD, of the University of Palermo in Italy.

“It is important that healthcare professionals communicate to patients that some FVIII products can be used portably and at room temperature, to enable them to go about their daily lives as actively as they wish.”

Dr Napolitano and her colleagues presented the results of this survey at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD, poster P024).

The researchers conducted the survey in adults with hemophilia A in 7 countries. Face-to-face surveys were conducted with 90 people in the European Union (France, Italy, and UK) and 90 people in Latin America (Argentina, Brazil, and Mexico). Online surveys were conducted with 20 people in Japan.

The questionnaire covered current use of FVIII products, patient satisfaction, and restrictions in daily life using verbalized rating scales (eg, “not restricted at all / somewhat restricted / restricted / strongly restricted”).

Seventy-four percent of patients used FVII as prophylaxis, and 26% used on-demand treatment. Sixty-seven percent used recombinant FVIII, and 33% used plasma-derived FVIII.

Storage

Most patients—85%—stored their FVIII product in the refrigerator, with 15% storing their treatment at room temperature.

Of those storing FVIII in the refrigerator, 88% said FVIII must be stored in the refrigerator at all times. Seventy-nine percent of patients said they worry about the temperature at which FVIII is stored.

Seventy-four percent said they wait for their FVIII product to reach room temperature before mixing and injecting it. The median wait time was 10 minutes.

Sixty-two percent of patients said an injection with cold FVIII is more unpleasant than an injection with room temperature FVIII.

Satisfaction

Patients storing FVIII at room temperature were significantly more likely than those storing FVIII in the refrigerator to report overall satisfaction with their FVIII product (52% vs 28%, P<0.05).

Patients storing FVIII at room temperature were also significantly more likely to report satisfaction with:

• Product efficacy (61% vs 43%, P<0.05)
• The procedure of mixing the product before injection (39% vs 22%, P<0.05)
• The flexibility of storage depending on the patients’ needs (55% vs 18%, P<0.05)
• The length of time the product can be stored outside the refrigerator (45% vs 19%, P<0.05)
• The size of vials (42% vs 18%, P<0.05)
• Storage temperature (39% vs 15%, P<0.05).

Daily life

Patients storing FVIII at room temperature travelled significantly more often—16 times per year vs 9 times per year (P<0.01).

Nineteen percent of these patients felt that storing, preparing, and mixing FVIII is disruptive to the normal course of the day, compared to 35% of patients who store FVIII in the refrigerator (P<0.05).

Significantly fewer patients in the room-temperature group said they feel restricted when it comes to sports activities, traveling, and their evening routine (P<0.05).

Forty-eight percent of patients storing FVIII at room temperature said they feel relaxed using FVIII in their daily life, compared to 20% of patients storing FVIII in the refrigerator (P<0.05).

Prescription pills

New research published in Blood suggests young patients with acute lymphoblastic leukemia (ALL)—and their parents—are likely to over-report treatment adherence.

In a study of 416 pediatric ALL patients, 84% of patients or their parents said the patients took more 6-mercaptopurine (6MP) than they actually did.

6MP is prescribed for 2 years after chemotherapy with the goal of producing durable remissions, but studies show that over 95% of the prescribed doses must be taken for the medication to be effective.

“Because this therapy is administered orally every day, we cannot supervise our patients to make sure they are taking their pills,” said study author Smita Bhatia, MD, of the University of Alabama at Birmingham.

“Findings from this study suggest that we need better ways to monitor intake of medications as prescribed.”

This study included 416 pediatric ALL patients followed over 4 months. Patients received prescription pill bottles for their 6MP that contained a microprocessor chip in the cap to log the date and time the bottle was opened.

The logs were compared to self-report questionnaires completed by patients or their parents and provided to physicians at monthly check-ups.

Patients were classified as:

• Perfect reporters—self-report corresponded to data from the Medication Event Monitoring System (MEMS)
• Over-reporters—self-report was greater than MEMS data by more than 5 days per month for more than 50% of the study months
• Others—all patients not meeting criteria for perfect- or over-reporter.

Twelve percent of patients were classified as perfect reporters, 23.6% were over-reporters, 0.5% were under-reporters, and 63.9% were classified as “others.”

Self-reported 6MP intake exceeded MEMS data at least some of the time in 84% of patients.

“We observed that there was an inverse relationship between over-reporting and the extent of non-adherence,” Dr Bhatia noted.

Of the patients who adhered to their regimens (defined as taking their prescribed dose 95% of the time), a small percentage (8%) over-reported their intake.

However, among those found to be non-adherent, a substantially larger percent (47%) over-reported.

In order to find out why patients were not taking their prescribed medication, study author Wendy Landier, PhD, RN, also of the University of Alabama at Birmingham, organized interviews with patients and their parents.

In these interviews, Dr Landier noted that forgetfulness was the primary reason for non-adherence.

“We found that partnering with a parent was very conducive to our patients’ adherence, playing a key role in combatting forgetfulness,” she said.

Recognizing the importance of parental involvement in patient adherence, the researchers were inspired to conduct further research to make parents more involved.

In a trial that builds on this study, physicians send personalized text messages to both patients and their parents at a prescribed time reminding them to take their medicine. Both patient and parent then report back, via text, that the indicated dose was taken.

“Our first study showed that non-adherence was prevalent, increasing the risk of relapse,” Dr Bhatia said. “We then found that parental vigilance was an important facilitator to adherence, while forgetting to take the medication was the most commonly reported barrier.”

“We used these findings to inform the intervention trial to help families improve adherence to treatment. We hope that this will be a real step in improving outcomes in children with leukemia.”

Prescription pills

New research published in Blood suggests young patients with acute lymphoblastic leukemia (ALL)—and their parents—are likely to over-report treatment adherence.

In a study of 416 pediatric ALL patients, 84% of patients or their parents said the patients took more 6-mercaptopurine (6MP) than they actually did.

6MP is prescribed for 2 years after chemotherapy with the goal of producing durable remissions, but studies show that over 95% of the prescribed doses must be taken for the medication to be effective.

“Because this therapy is administered orally every day, we cannot supervise our patients to make sure they are taking their pills,” said study author Smita Bhatia, MD, of the University of Alabama at Birmingham.

“Findings from this study suggest that we need better ways to monitor intake of medications as prescribed.”

This study included 416 pediatric ALL patients followed over 4 months. Patients received prescription pill bottles for their 6MP that contained a microprocessor chip in the cap to log the date and time the bottle was opened.

The logs were compared to self-report questionnaires completed by patients or their parents and provided to physicians at monthly check-ups.

Patients were classified as:

• Perfect reporters—self-report corresponded to data from the Medication Event Monitoring System (MEMS)
• Over-reporters—self-report was greater than MEMS data by more than 5 days per month for more than 50% of the study months
• Others—all patients not meeting criteria for perfect- or over-reporter.

Twelve percent of patients were classified as perfect reporters, 23.6% were over-reporters, 0.5% were under-reporters, and 63.9% were classified as “others.”

Self-reported 6MP intake exceeded MEMS data at least some of the time in 84% of patients.

“We observed that there was an inverse relationship between over-reporting and the extent of non-adherence,” Dr Bhatia noted.

Of the patients who adhered to their regimens (defined as taking their prescribed dose 95% of the time), a small percentage (8%) over-reported their intake.

However, among those found to be non-adherent, a substantially larger percent (47%) over-reported.

In order to find out why patients were not taking their prescribed medication, study author Wendy Landier, PhD, RN, also of the University of Alabama at Birmingham, organized interviews with patients and their parents.

In these interviews, Dr Landier noted that forgetfulness was the primary reason for non-adherence.

“We found that partnering with a parent was very conducive to our patients’ adherence, playing a key role in combatting forgetfulness,” she said.

Recognizing the importance of parental involvement in patient adherence, the researchers were inspired to conduct further research to make parents more involved.

In a trial that builds on this study, physicians send personalized text messages to both patients and their parents at a prescribed time reminding them to take their medicine. Both patient and parent then report back, via text, that the indicated dose was taken.

“Our first study showed that non-adherence was prevalent, increasing the risk of relapse,” Dr Bhatia said. “We then found that parental vigilance was an important facilitator to adherence, while forgetting to take the medication was the most commonly reported barrier.”

“We used these findings to inform the intervention trial to help families improve adherence to treatment. We hope that this will be a real step in improving outcomes in children with leukemia.”

Prescription pills

New research published in Blood suggests young patients with acute lymphoblastic leukemia (ALL)—and their parents—are likely to over-report treatment adherence.

In a study of 416 pediatric ALL patients, 84% of patients or their parents said the patients took more 6-mercaptopurine (6MP) than they actually did.

6MP is prescribed for 2 years after chemotherapy with the goal of producing durable remissions, but studies show that over 95% of the prescribed doses must be taken for the medication to be effective.

“Because this therapy is administered orally every day, we cannot supervise our patients to make sure they are taking their pills,” said study author Smita Bhatia, MD, of the University of Alabama at Birmingham.

“Findings from this study suggest that we need better ways to monitor intake of medications as prescribed.”

This study included 416 pediatric ALL patients followed over 4 months. Patients received prescription pill bottles for their 6MP that contained a microprocessor chip in the cap to log the date and time the bottle was opened.

The logs were compared to self-report questionnaires completed by patients or their parents and provided to physicians at monthly check-ups.

Patients were classified as:

• Perfect reporters—self-report corresponded to data from the Medication Event Monitoring System (MEMS)
• Over-reporters—self-report was greater than MEMS data by more than 5 days per month for more than 50% of the study months
• Others—all patients not meeting criteria for perfect- or over-reporter.

Twelve percent of patients were classified as perfect reporters, 23.6% were over-reporters, 0.5% were under-reporters, and 63.9% were classified as “others.”

Self-reported 6MP intake exceeded MEMS data at least some of the time in 84% of patients.

“We observed that there was an inverse relationship between over-reporting and the extent of non-adherence,” Dr Bhatia noted.

Of the patients who adhered to their regimens (defined as taking their prescribed dose 95% of the time), a small percentage (8%) over-reported their intake.

However, among those found to be non-adherent, a substantially larger percent (47%) over-reported.

In order to find out why patients were not taking their prescribed medication, study author Wendy Landier, PhD, RN, also of the University of Alabama at Birmingham, organized interviews with patients and their parents.

In these interviews, Dr Landier noted that forgetfulness was the primary reason for non-adherence.

“We found that partnering with a parent was very conducive to our patients’ adherence, playing a key role in combatting forgetfulness,” she said.

Recognizing the importance of parental involvement in patient adherence, the researchers were inspired to conduct further research to make parents more involved.

In a trial that builds on this study, physicians send personalized text messages to both patients and their parents at a prescribed time reminding them to take their medicine. Both patient and parent then report back, via text, that the indicated dose was taken.

“Our first study showed that non-adherence was prevalent, increasing the risk of relapse,” Dr Bhatia said. “We then found that parental vigilance was an important facilitator to adherence, while forgetting to take the medication was the most commonly reported barrier.”

“We used these findings to inform the intervention trial to help families improve adherence to treatment. We hope that this will be a real step in improving outcomes in children with leukemia.”

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.”¹ Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.² In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.^3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.⁵ Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.⁶

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.⁷ Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”⁸ Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.⁹ But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.¹⁰ Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.¹¹

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.¹² This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.¹³

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.¹⁴ And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.¹⁵ This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.¹⁶

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.”¹ Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.² In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.^3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.⁵ Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.⁶

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.⁷ Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”⁸ Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.⁹ But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.¹⁰ Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.¹¹

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.¹² This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.¹³

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.¹⁴ And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.¹⁵ This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.¹⁶

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.”¹ Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.² In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.^3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.⁵ Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.⁶

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.⁷ Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”⁸ Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.⁹ But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.¹⁰ Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.¹¹

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.¹² This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.¹³

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.¹⁴ And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.¹⁵ This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.¹⁶

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

Veterans are 40% more likely than nonveterans to experience severe pain, according to the 2010-2014 National Health Interview Survey. Epidemiologists from the National Center for Complementary and Integrative Health analyzed data on 6,647 veterans and 61,049 nonveterans who were asked about the persistence and intensity of self-reported pain during the previous 3 months.

Veterans were more likely to report having pain (65.5% vs 56.4%) and more likely to describe severe pain—that is, pain that occurred “most days” or “every day” and bothered the respondent “a lot” (9.1% vs 6.3%). Younger veterans in particular were more than 2 times as likely to report severe pain (7.8% vs 3.2%), even when researchers controlled for underlying demographic characteristics. Veterans aged 18 to 39 years and 50 to 59 years were more likely than nonveterans of the same ages to have any pain, but veterans aged ≥ 70 years were less likely to have severe pain than were similarly aged nonveterans.

Back pain and joint pain topped the list for veterans compared with jaw pain and migraines for nonveterans.

The majority of veteran participants were men (92.5%), whereas the majority of nonveteran participants were women (56.5%). The survey data did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

The survey also didn’t collect information on pain treatment, so it isn’t clear whether differences in treatment would explain the differences in pain experiences. Nor did the survey reveal whether younger veterans with severe pain were in pain despite treatment or because they weren’t getting any treatment.

 “These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities,” the lead researcher said.

Veterans are 40% more likely than nonveterans to experience severe pain, according to the 2010-2014 National Health Interview Survey. Epidemiologists from the National Center for Complementary and Integrative Health analyzed data on 6,647 veterans and 61,049 nonveterans who were asked about the persistence and intensity of self-reported pain during the previous 3 months.

Veterans were more likely to report having pain (65.5% vs 56.4%) and more likely to describe severe pain—that is, pain that occurred “most days” or “every day” and bothered the respondent “a lot” (9.1% vs 6.3%). Younger veterans in particular were more than 2 times as likely to report severe pain (7.8% vs 3.2%), even when researchers controlled for underlying demographic characteristics. Veterans aged 18 to 39 years and 50 to 59 years were more likely than nonveterans of the same ages to have any pain, but veterans aged ≥ 70 years were less likely to have severe pain than were similarly aged nonveterans.

Back pain and joint pain topped the list for veterans compared with jaw pain and migraines for nonveterans.

The majority of veteran participants were men (92.5%), whereas the majority of nonveteran participants were women (56.5%). The survey data did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

The survey also didn’t collect information on pain treatment, so it isn’t clear whether differences in treatment would explain the differences in pain experiences. Nor did the survey reveal whether younger veterans with severe pain were in pain despite treatment or because they weren’t getting any treatment.

 “These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities,” the lead researcher said.

Veterans are 40% more likely than nonveterans to experience severe pain, according to the 2010-2014 National Health Interview Survey. Epidemiologists from the National Center for Complementary and Integrative Health analyzed data on 6,647 veterans and 61,049 nonveterans who were asked about the persistence and intensity of self-reported pain during the previous 3 months.

Veterans were more likely to report having pain (65.5% vs 56.4%) and more likely to describe severe pain—that is, pain that occurred “most days” or “every day” and bothered the respondent “a lot” (9.1% vs 6.3%). Younger veterans in particular were more than 2 times as likely to report severe pain (7.8% vs 3.2%), even when researchers controlled for underlying demographic characteristics. Veterans aged 18 to 39 years and 50 to 59 years were more likely than nonveterans of the same ages to have any pain, but veterans aged ≥ 70 years were less likely to have severe pain than were similarly aged nonveterans.

Back pain and joint pain topped the list for veterans compared with jaw pain and migraines for nonveterans.

The majority of veteran participants were men (92.5%), whereas the majority of nonveteran participants were women (56.5%). The survey data did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

The survey also didn’t collect information on pain treatment, so it isn’t clear whether differences in treatment would explain the differences in pain experiences. Nor did the survey reveal whether younger veterans with severe pain were in pain despite treatment or because they weren’t getting any treatment.

 “These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities,” the lead researcher said.

MIAMI – Pinch grafting can accelerate the healing of chronic, treatment-resistant wounds such as leg ulcers, while at the same time reducing morbidity to the donor skin site. A new epidermal harvesting device also is showing promise, as is a new tool that minces autologous skin grafts prior to application to promote wound healing.

These and other advances in wound healing were presented at the Orlando Dermatology Aesthetic and Clinical Conference. The pinch grafts and minced grafts each rely on the newly added skin to stimulate cytokines. Interestingly, there is evidence that grafts taken from hair-bearing donor sites could be superior for stimulating cytokines and accelerating wound healing, said Robert Kirsner, MD, PhD, of the University of Miami Health System.
 

Islands of regrowth

Physicians perform pinch grafting by taking small punches of skin from a donor site on the thigh, abdomen, or elsewhere, and then transferring the grafts to serve as islands of regrowth in a wound. Pinch grafting can be faster and less expensive than techniques typically performed in an operating room, such as meshed auto-grafting. In contrast, pinch grafting can be accomplished in an office setting “and patients can do quite well.” Dr. Kirsner said. In terms of outcomes, “our data is typical,” he added. “About 50% of refractory ulcers heal, 25% improve, and a percentage recur.”

Spreadable skin grafts

Another autologous grafting technique that can be performed at the bedside uses the Xpansion Micro-Autografting Kit, which minces autologous, split thickness skin grafts. “Then you apply them like peanut butter to bread,” Dr. Kirsner said.

The micro-autografts can help heal both acute and chronic wounds, including full thickness wounds from trauma, some burn wounds, diabetic foot ulcers, and venous ulcers, according to the manufacturer’s website.
 

Epidermal harvesting (without anesthesia)

Epidermal grafting can make sense because the epidermis regenerates. “You can lift off just the epidermis with heat or suction, “ Dr. Kirsner said. For the first time, he added, a new tool allows epidermal grafting without the need for anesthesia (Cellutome Epidermal Harvesting System). The device raises little microdomes of epidermis down to the basal layer, including basal keratinocytes and melanocytes, and a dermatologist can use a sterile dressing to transfer them to the wound. Confocal microscopy shows the dermoepidermal junction healing as early as within 2 days.

The epidermal harvesting was initially developed for pigment problems, such as piebaldism. (Dermatol Surg. 2017 Jan;43[1]:159-60). “We quickly realized it might have applicability for nonhealing wounds,” Dr. Kirsner said.

Deeper wound healing

A novel strategy for triggering deeper wound healing evolved from fractional laser technology, which remove columns of skin to generate healing. Instead, Rox Anderson, MD, of Massachusetts General Hospital, Boston, “envisioned pulling up microcolumns of full thickness epidermis, all the way to the fat, placing them into a wound, and the wound would heal with very little donor site morbidity,” Dr. Kirsner said.

This tool is coming out in spring of this year, he noted. It will resemble a fractional laser, “but now you have the skin available to place in another wound.” Prior animal studies revealed a healing benefit with very little scarring, he added.
 

Is hairier better?

Does the donor site matter? Dr. Kirsner asked. Although dermatologists typically graft skin from an abdomen or thigh, a hair-bearing site may be a better option because of the presence of pluripotent stem cells, according to a case report (Wounds. 2016 Apr;28[4]:109-11). J.D. Fox of the University of Miami, Dr. Kirsner, and their colleagues treated a large, chronic venous leg ulcer, almost 60 cm², with punch grafts from a variety of donor sites.

“The side that got scalp punch grafts healed better, suggesting with skin taken from richly hairy area, you’ll get better results,” Dr. Kirsner said.

Another study supports this strategy (J Am Acad Dermatol. 2016 Nov;75[5]:1007-14). These researchers reported greater wound size reduction using grafts containing hair follicles versus nonhairy areas, again suggesting follicular stem cells play a role in better wound healing, Dr. Kirsner said. “This may be a better source of donor skin in the future.”

Dr. Kirsner is a consultant for Cardinal Health, Mölnlycke, Amniox, Organogenesis, Kerecis, Keretec, and KCI, an Acelity company.

MIAMI – Pinch grafting can accelerate the healing of chronic, treatment-resistant wounds such as leg ulcers, while at the same time reducing morbidity to the donor skin site. A new epidermal harvesting device also is showing promise, as is a new tool that minces autologous skin grafts prior to application to promote wound healing.

These and other advances in wound healing were presented at the Orlando Dermatology Aesthetic and Clinical Conference. The pinch grafts and minced grafts each rely on the newly added skin to stimulate cytokines. Interestingly, there is evidence that grafts taken from hair-bearing donor sites could be superior for stimulating cytokines and accelerating wound healing, said Robert Kirsner, MD, PhD, of the University of Miami Health System.
 

Islands of regrowth

Physicians perform pinch grafting by taking small punches of skin from a donor site on the thigh, abdomen, or elsewhere, and then transferring the grafts to serve as islands of regrowth in a wound. Pinch grafting can be faster and less expensive than techniques typically performed in an operating room, such as meshed auto-grafting. In contrast, pinch grafting can be accomplished in an office setting “and patients can do quite well.” Dr. Kirsner said. In terms of outcomes, “our data is typical,” he added. “About 50% of refractory ulcers heal, 25% improve, and a percentage recur.”

Spreadable skin grafts

Another autologous grafting technique that can be performed at the bedside uses the Xpansion Micro-Autografting Kit, which minces autologous, split thickness skin grafts. “Then you apply them like peanut butter to bread,” Dr. Kirsner said.

The micro-autografts can help heal both acute and chronic wounds, including full thickness wounds from trauma, some burn wounds, diabetic foot ulcers, and venous ulcers, according to the manufacturer’s website.
 

Epidermal harvesting (without anesthesia)

Epidermal grafting can make sense because the epidermis regenerates. “You can lift off just the epidermis with heat or suction, “ Dr. Kirsner said. For the first time, he added, a new tool allows epidermal grafting without the need for anesthesia (Cellutome Epidermal Harvesting System). The device raises little microdomes of epidermis down to the basal layer, including basal keratinocytes and melanocytes, and a dermatologist can use a sterile dressing to transfer them to the wound. Confocal microscopy shows the dermoepidermal junction healing as early as within 2 days.

The epidermal harvesting was initially developed for pigment problems, such as piebaldism. (Dermatol Surg. 2017 Jan;43[1]:159-60). “We quickly realized it might have applicability for nonhealing wounds,” Dr. Kirsner said.

Deeper wound healing

A novel strategy for triggering deeper wound healing evolved from fractional laser technology, which remove columns of skin to generate healing. Instead, Rox Anderson, MD, of Massachusetts General Hospital, Boston, “envisioned pulling up microcolumns of full thickness epidermis, all the way to the fat, placing them into a wound, and the wound would heal with very little donor site morbidity,” Dr. Kirsner said.

This tool is coming out in spring of this year, he noted. It will resemble a fractional laser, “but now you have the skin available to place in another wound.” Prior animal studies revealed a healing benefit with very little scarring, he added.
 

Is hairier better?

Does the donor site matter? Dr. Kirsner asked. Although dermatologists typically graft skin from an abdomen or thigh, a hair-bearing site may be a better option because of the presence of pluripotent stem cells, according to a case report (Wounds. 2016 Apr;28[4]:109-11). J.D. Fox of the University of Miami, Dr. Kirsner, and their colleagues treated a large, chronic venous leg ulcer, almost 60 cm², with punch grafts from a variety of donor sites.

“The side that got scalp punch grafts healed better, suggesting with skin taken from richly hairy area, you’ll get better results,” Dr. Kirsner said.

Another study supports this strategy (J Am Acad Dermatol. 2016 Nov;75[5]:1007-14). These researchers reported greater wound size reduction using grafts containing hair follicles versus nonhairy areas, again suggesting follicular stem cells play a role in better wound healing, Dr. Kirsner said. “This may be a better source of donor skin in the future.”

Dr. Kirsner is a consultant for Cardinal Health, Mölnlycke, Amniox, Organogenesis, Kerecis, Keretec, and KCI, an Acelity company.

MIAMI – Pinch grafting can accelerate the healing of chronic, treatment-resistant wounds such as leg ulcers, while at the same time reducing morbidity to the donor skin site. A new epidermal harvesting device also is showing promise, as is a new tool that minces autologous skin grafts prior to application to promote wound healing.

These and other advances in wound healing were presented at the Orlando Dermatology Aesthetic and Clinical Conference. The pinch grafts and minced grafts each rely on the newly added skin to stimulate cytokines. Interestingly, there is evidence that grafts taken from hair-bearing donor sites could be superior for stimulating cytokines and accelerating wound healing, said Robert Kirsner, MD, PhD, of the University of Miami Health System.
 

Islands of regrowth

Physicians perform pinch grafting by taking small punches of skin from a donor site on the thigh, abdomen, or elsewhere, and then transferring the grafts to serve as islands of regrowth in a wound. Pinch grafting can be faster and less expensive than techniques typically performed in an operating room, such as meshed auto-grafting. In contrast, pinch grafting can be accomplished in an office setting “and patients can do quite well.” Dr. Kirsner said. In terms of outcomes, “our data is typical,” he added. “About 50% of refractory ulcers heal, 25% improve, and a percentage recur.”

Spreadable skin grafts

Another autologous grafting technique that can be performed at the bedside uses the Xpansion Micro-Autografting Kit, which minces autologous, split thickness skin grafts. “Then you apply them like peanut butter to bread,” Dr. Kirsner said.

The micro-autografts can help heal both acute and chronic wounds, including full thickness wounds from trauma, some burn wounds, diabetic foot ulcers, and venous ulcers, according to the manufacturer’s website.
 

Epidermal harvesting (without anesthesia)

Epidermal grafting can make sense because the epidermis regenerates. “You can lift off just the epidermis with heat or suction, “ Dr. Kirsner said. For the first time, he added, a new tool allows epidermal grafting without the need for anesthesia (Cellutome Epidermal Harvesting System). The device raises little microdomes of epidermis down to the basal layer, including basal keratinocytes and melanocytes, and a dermatologist can use a sterile dressing to transfer them to the wound. Confocal microscopy shows the dermoepidermal junction healing as early as within 2 days.

The epidermal harvesting was initially developed for pigment problems, such as piebaldism. (Dermatol Surg. 2017 Jan;43[1]:159-60). “We quickly realized it might have applicability for nonhealing wounds,” Dr. Kirsner said.

Deeper wound healing

A novel strategy for triggering deeper wound healing evolved from fractional laser technology, which remove columns of skin to generate healing. Instead, Rox Anderson, MD, of Massachusetts General Hospital, Boston, “envisioned pulling up microcolumns of full thickness epidermis, all the way to the fat, placing them into a wound, and the wound would heal with very little donor site morbidity,” Dr. Kirsner said.

This tool is coming out in spring of this year, he noted. It will resemble a fractional laser, “but now you have the skin available to place in another wound.” Prior animal studies revealed a healing benefit with very little scarring, he added.
 

Is hairier better?

Does the donor site matter? Dr. Kirsner asked. Although dermatologists typically graft skin from an abdomen or thigh, a hair-bearing site may be a better option because of the presence of pluripotent stem cells, according to a case report (Wounds. 2016 Apr;28[4]:109-11). J.D. Fox of the University of Miami, Dr. Kirsner, and their colleagues treated a large, chronic venous leg ulcer, almost 60 cm², with punch grafts from a variety of donor sites.

“The side that got scalp punch grafts healed better, suggesting with skin taken from richly hairy area, you’ll get better results,” Dr. Kirsner said.

Another study supports this strategy (J Am Acad Dermatol. 2016 Nov;75[5]:1007-14). These researchers reported greater wound size reduction using grafts containing hair follicles versus nonhairy areas, again suggesting follicular stem cells play a role in better wound healing, Dr. Kirsner said. “This may be a better source of donor skin in the future.”

Dr. Kirsner is a consultant for Cardinal Health, Mölnlycke, Amniox, Organogenesis, Kerecis, Keretec, and KCI, an Acelity company.

The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.

“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”

Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.

Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.

“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.

“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.

[email protected]

The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.

“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”

Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.

Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.

“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.

“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.

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The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.

“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”

Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.

Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.

“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.

“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.

[email protected]