CHICAGO – Methadone was associated with a significantly higher incidence of neonatal abstinence syndrome (NAS), compared with babies born to mothers who took buprenorphine for opioid maintenance therapy during pregnancy, a retrospective study of 204 neonates revealed.

Interestingly, among babies who developed the syndrome, the duration of treatment and length of stay did not differ significantly between groups.

“We found buprenorphine decreases [the incidence of] NAS,” said Alla Kushnir, MD, an attending neonatologist at Cooper University Hospital in Camden, N.J. The findings also demonstrate that physicians can expect to see “about the same withdrawal once they withdraw,” regardless of whether the mother took methadone or buprenorphine during pregnancy.

“We can’t make it better, but we can prevent some neonatal abstinence syndrome,” Dr. Kushnir said in an interview at the annual meeting of the American Academy of Pediatrics.

CHICAGO – Methadone was associated with a significantly higher incidence of neonatal abstinence syndrome (NAS), compared with babies born to mothers who took buprenorphine for opioid maintenance therapy during pregnancy, a retrospective study of 204 neonates revealed.

Interestingly, among babies who developed the syndrome, the duration of treatment and length of stay did not differ significantly between groups.

“We found buprenorphine decreases [the incidence of] NAS,” said Alla Kushnir, MD, an attending neonatologist at Cooper University Hospital in Camden, N.J. The findings also demonstrate that physicians can expect to see “about the same withdrawal once they withdraw,” regardless of whether the mother took methadone or buprenorphine during pregnancy.

“We can’t make it better, but we can prevent some neonatal abstinence syndrome,” Dr. Kushnir said in an interview at the annual meeting of the American Academy of Pediatrics.

CHICAGO – Methadone was associated with a significantly higher incidence of neonatal abstinence syndrome (NAS), compared with babies born to mothers who took buprenorphine for opioid maintenance therapy during pregnancy, a retrospective study of 204 neonates revealed.

Interestingly, among babies who developed the syndrome, the duration of treatment and length of stay did not differ significantly between groups.

“We found buprenorphine decreases [the incidence of] NAS,” said Alla Kushnir, MD, an attending neonatologist at Cooper University Hospital in Camden, N.J. The findings also demonstrate that physicians can expect to see “about the same withdrawal once they withdraw,” regardless of whether the mother took methadone or buprenorphine during pregnancy.

“We can’t make it better, but we can prevent some neonatal abstinence syndrome,” Dr. Kushnir said in an interview at the annual meeting of the American Academy of Pediatrics.

A global registry showed that men and women had equivalent outcomes after endovascular abdominal aortic aneurysm repair (EVAR) despite significant differences in baseline characteristics, anatomy, and off-instruction stent use.

The 5-year ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) data were presented by Marc Schermerhorn, MD, chief, division of vascular and endovascular surgery, Beth Israel Deaconess Medical Center, Boston, in a late-breaking clinical trial at the Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas.
 

The registry comprises data from 1,263 patients (133 women and 1,130 men) in 30 countries who received the Endurant II stent graft during for endovascular repair of the abdominal aortic aneurysm. ENGAGE participants are consecutively enrolled, and have 30-day and subsequent yearly evaluations, with independent data monitoring and event adjudication.

Despite many other equivalent demographic and clinical characteristics, including smoking status, hypertension, diabetes, and pulmonary disease, overall women were statistically significantly older, had less cardiac disease, had shorter and more angulated aneurysm necks, and had smaller iliac arteries. In addition they were more likely to be treated outside of the Endurant II instructions for use (IFU), according to Dr. Schemerhorn.

Women also had significantly longer hospital stays than men (7.9 days vs. 6.4 days), respectively, but had equivalent procedure duration, ICU times, and similarly successful stent delivery and deployment (99%).

But despite these differences in baseline characteristics and anatomy, the 5-year data showed equivalent outcomes between women and men at 30 days, and 1 year, and through 5 years. There were no significant differences across these periods in freedom from all-cause mortality (67.5% in men, 65.6% in women, P = 0.87), 5-year freedom from aneurysm-related mortality (97.5% men, 100% women, P = .09), 5-year freedom from rupture (98.4% men, 100% women, P = .23), and 5-year freedom from conversion (97.8% men, 99.2% women, P = .48). There were also no significant differences in type 1 endoleaks, 5-year freedom from conversion, and sac diameter changes, Dr. Schermerhorn concluded.

The ENGAGE registry is sponsored by Medtronic. Dr. Schermerhorn disclosed that he was a consultant for several medical device companies and a shareholder and owner of a health care company, but that he did not have any potential conflicts of interest for this particular study.
[email protected]

A global registry showed that men and women had equivalent outcomes after endovascular abdominal aortic aneurysm repair (EVAR) despite significant differences in baseline characteristics, anatomy, and off-instruction stent use.

The 5-year ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) data were presented by Marc Schermerhorn, MD, chief, division of vascular and endovascular surgery, Beth Israel Deaconess Medical Center, Boston, in a late-breaking clinical trial at the Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas.
 

The registry comprises data from 1,263 patients (133 women and 1,130 men) in 30 countries who received the Endurant II stent graft during for endovascular repair of the abdominal aortic aneurysm. ENGAGE participants are consecutively enrolled, and have 30-day and subsequent yearly evaluations, with independent data monitoring and event adjudication.

Despite many other equivalent demographic and clinical characteristics, including smoking status, hypertension, diabetes, and pulmonary disease, overall women were statistically significantly older, had less cardiac disease, had shorter and more angulated aneurysm necks, and had smaller iliac arteries. In addition they were more likely to be treated outside of the Endurant II instructions for use (IFU), according to Dr. Schemerhorn.

Women also had significantly longer hospital stays than men (7.9 days vs. 6.4 days), respectively, but had equivalent procedure duration, ICU times, and similarly successful stent delivery and deployment (99%).

But despite these differences in baseline characteristics and anatomy, the 5-year data showed equivalent outcomes between women and men at 30 days, and 1 year, and through 5 years. There were no significant differences across these periods in freedom from all-cause mortality (67.5% in men, 65.6% in women, P = 0.87), 5-year freedom from aneurysm-related mortality (97.5% men, 100% women, P = .09), 5-year freedom from rupture (98.4% men, 100% women, P = .23), and 5-year freedom from conversion (97.8% men, 99.2% women, P = .48). There were also no significant differences in type 1 endoleaks, 5-year freedom from conversion, and sac diameter changes, Dr. Schermerhorn concluded.

The ENGAGE registry is sponsored by Medtronic. Dr. Schermerhorn disclosed that he was a consultant for several medical device companies and a shareholder and owner of a health care company, but that he did not have any potential conflicts of interest for this particular study.
[email protected]

A global registry showed that men and women had equivalent outcomes after endovascular abdominal aortic aneurysm repair (EVAR) despite significant differences in baseline characteristics, anatomy, and off-instruction stent use.

The 5-year ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) data were presented by Marc Schermerhorn, MD, chief, division of vascular and endovascular surgery, Beth Israel Deaconess Medical Center, Boston, in a late-breaking clinical trial at the Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas.
 

The registry comprises data from 1,263 patients (133 women and 1,130 men) in 30 countries who received the Endurant II stent graft during for endovascular repair of the abdominal aortic aneurysm. ENGAGE participants are consecutively enrolled, and have 30-day and subsequent yearly evaluations, with independent data monitoring and event adjudication.

Despite many other equivalent demographic and clinical characteristics, including smoking status, hypertension, diabetes, and pulmonary disease, overall women were statistically significantly older, had less cardiac disease, had shorter and more angulated aneurysm necks, and had smaller iliac arteries. In addition they were more likely to be treated outside of the Endurant II instructions for use (IFU), according to Dr. Schemerhorn.

Women also had significantly longer hospital stays than men (7.9 days vs. 6.4 days), respectively, but had equivalent procedure duration, ICU times, and similarly successful stent delivery and deployment (99%).

But despite these differences in baseline characteristics and anatomy, the 5-year data showed equivalent outcomes between women and men at 30 days, and 1 year, and through 5 years. There were no significant differences across these periods in freedom from all-cause mortality (67.5% in men, 65.6% in women, P = 0.87), 5-year freedom from aneurysm-related mortality (97.5% men, 100% women, P = .09), 5-year freedom from rupture (98.4% men, 100% women, P = .23), and 5-year freedom from conversion (97.8% men, 99.2% women, P = .48). There were also no significant differences in type 1 endoleaks, 5-year freedom from conversion, and sac diameter changes, Dr. Schermerhorn concluded.

The ENGAGE registry is sponsored by Medtronic. Dr. Schermerhorn disclosed that he was a consultant for several medical device companies and a shareholder and owner of a health care company, but that he did not have any potential conflicts of interest for this particular study.
[email protected]

In his thought provoking keynote address at the annual Association of VA Hematology and Oncology meeting in Denver on September 15, 2017, John P.A. Ioannidis, MD, DSc, of Stanford University challenged the current reliance on clinical trial research and meta-analyses. Ioannidis has published numerous examinations of medical literature and found significant biases and potential limitations, and as he noted, few health care providers are aware of the poor quality of the research and its limitations.

Ioannidis’ studies contend that in most medical research “there is no evidence to build our decision making,” although he acknowledged that hematology and oncology research is a little better than other parts of the medical research. In a study of indexed articles, for example, just 19% had at least one outcome with high quality evidence. He attributes this to a number of types of flaws, including bias, an increase in research conducted in regions without a strong tradition, and degrees of freedom to conduct research, even in clinical trials.

Complicating matters even further, Ioannidis pointed out that many of the most highly cited studies were later refuted in other studies. In a re-examination of study data made available by researchers publishing in BMJ and PLoS Medicine, Ioannidis and his colleagues found that they could reproduce a fraction of the results. Moreover, he argued, “even when we can trust the data, most clinical research is not useful for making decisions.”

To measure the usefulness of a study, Ioannidis and his colleagues noted 8 different quality measures:

1. Problem base;
2. Context placement;
3. Information gain;
4. Pragmatism;
5. Patient-centeredness;
6. Value for money;
7. Feasibility; and
8. Transparency.

According to Ioannidis, few trials or studies hit 5 of 8 measures, and he has yet to find a study that incorporates all 8. Even articles in the most prestigious journals tend to score fairly low, he noted.

Meta-analyses are not immune to these structural problems, according to Ioannidis. Close to 100,000 meta-analysis have been published, with nearly 1,000 new studies published each month. Some, he noted, have been “hijacked to serve other agendas,” while many others simply summarized biased information.

Despite these concerns, Ioannidis remains optimistic. “We need to maximize diversity, minimize co-occurrence and incoherence” in the medical literature he argued.

In his thought provoking keynote address at the annual Association of VA Hematology and Oncology meeting in Denver on September 15, 2017, John P.A. Ioannidis, MD, DSc, of Stanford University challenged the current reliance on clinical trial research and meta-analyses. Ioannidis has published numerous examinations of medical literature and found significant biases and potential limitations, and as he noted, few health care providers are aware of the poor quality of the research and its limitations.

Ioannidis’ studies contend that in most medical research “there is no evidence to build our decision making,” although he acknowledged that hematology and oncology research is a little better than other parts of the medical research. In a study of indexed articles, for example, just 19% had at least one outcome with high quality evidence. He attributes this to a number of types of flaws, including bias, an increase in research conducted in regions without a strong tradition, and degrees of freedom to conduct research, even in clinical trials.

Complicating matters even further, Ioannidis pointed out that many of the most highly cited studies were later refuted in other studies. In a re-examination of study data made available by researchers publishing in BMJ and PLoS Medicine, Ioannidis and his colleagues found that they could reproduce a fraction of the results. Moreover, he argued, “even when we can trust the data, most clinical research is not useful for making decisions.”

To measure the usefulness of a study, Ioannidis and his colleagues noted 8 different quality measures:

1. Problem base;
2. Context placement;
3. Information gain;
4. Pragmatism;
5. Patient-centeredness;
6. Value for money;
7. Feasibility; and
8. Transparency.

According to Ioannidis, few trials or studies hit 5 of 8 measures, and he has yet to find a study that incorporates all 8. Even articles in the most prestigious journals tend to score fairly low, he noted.

Meta-analyses are not immune to these structural problems, according to Ioannidis. Close to 100,000 meta-analysis have been published, with nearly 1,000 new studies published each month. Some, he noted, have been “hijacked to serve other agendas,” while many others simply summarized biased information.

Despite these concerns, Ioannidis remains optimistic. “We need to maximize diversity, minimize co-occurrence and incoherence” in the medical literature he argued.

In his thought provoking keynote address at the annual Association of VA Hematology and Oncology meeting in Denver on September 15, 2017, John P.A. Ioannidis, MD, DSc, of Stanford University challenged the current reliance on clinical trial research and meta-analyses. Ioannidis has published numerous examinations of medical literature and found significant biases and potential limitations, and as he noted, few health care providers are aware of the poor quality of the research and its limitations.

Ioannidis’ studies contend that in most medical research “there is no evidence to build our decision making,” although he acknowledged that hematology and oncology research is a little better than other parts of the medical research. In a study of indexed articles, for example, just 19% had at least one outcome with high quality evidence. He attributes this to a number of types of flaws, including bias, an increase in research conducted in regions without a strong tradition, and degrees of freedom to conduct research, even in clinical trials.

Complicating matters even further, Ioannidis pointed out that many of the most highly cited studies were later refuted in other studies. In a re-examination of study data made available by researchers publishing in BMJ and PLoS Medicine, Ioannidis and his colleagues found that they could reproduce a fraction of the results. Moreover, he argued, “even when we can trust the data, most clinical research is not useful for making decisions.”

To measure the usefulness of a study, Ioannidis and his colleagues noted 8 different quality measures:

1. Problem base;
2. Context placement;
3. Information gain;
4. Pragmatism;
5. Patient-centeredness;
6. Value for money;
7. Feasibility; and
8. Transparency.

According to Ioannidis, few trials or studies hit 5 of 8 measures, and he has yet to find a study that incorporates all 8. Even articles in the most prestigious journals tend to score fairly low, he noted.

Meta-analyses are not immune to these structural problems, according to Ioannidis. Close to 100,000 meta-analysis have been published, with nearly 1,000 new studies published each month. Some, he noted, have been “hijacked to serve other agendas,” while many others simply summarized biased information.

Despite these concerns, Ioannidis remains optimistic. “We need to maximize diversity, minimize co-occurrence and incoherence” in the medical literature he argued.

Of the 55 accepted posters and abstracts presented at the 2017 Association of VA Hematology/Oncology Annual Meeting, 3 were recognized for their innovation and importance. A panel of judges examined each abstract and poster and talked to the presenter before recognizing the 3 winners.

In addition, AVAHO also recognized Katherine Faricy-Anderson, MD, MPH, of the Providence VAMC as the recipient of the inaugural AVAHO Research Schoalrship Award for her submission titled, “Optimization of Palliative Oncology Care within the VA Healthcare System – Assessing the Availability of Outpatient Palliative Care within VA Oncology Clinics.” This $10,000 scholarship challenges applicants to develop research initiatives that foster collaboration across multiple medical facilities. Five reviewers evaluated submissions for “the merits of (1) innovation, (2) likelihood that findings will improve patient outcomes, (3) relevance to veterans and the VHA, (4) subject matter expertise (or available mentorship), (5) likelihood of collaboration with other VA investigators, and (6) opportunity to support the pursuit of future funding.” AVAHO announced plans to continue this scholarship program next year and increase the award to $25,000.

The abstract award winners were:

1. Staging and Survival of Colorectal Cancer in Octogenarians: Nationwide Study of U.S. Veterans

Virk G, Jafri M, Ashley C, Mehdi S

Awarded $1,000

2. National Comprehensive Cancer Network Distress Thermometer Versus Veteran Symptom Assessment Screen: Year in Review at the Cleveland VAMC

Smith J, Arfons L, Cmolik B, Fox D, Dimick J, Berman S, Woods K, Simon J

Awarded $500

3. Hypertension Among Veterans Affairs Colorectal Cancer Survivors: A Matched Case-Control Analysis

Zullig LL, Lindquist J, Smith VA, Williams CD, Weinberger M, Povenzale D, Jackson GL, Kelley MJ, Danus S, Bosworth HB

Awarded $250

Click here to view all the 2017 abstracts.

Of the 55 accepted posters and abstracts presented at the 2017 Association of VA Hematology/Oncology Annual Meeting, 3 were recognized for their innovation and importance. A panel of judges examined each abstract and poster and talked to the presenter before recognizing the 3 winners.

In addition, AVAHO also recognized Katherine Faricy-Anderson, MD, MPH, of the Providence VAMC as the recipient of the inaugural AVAHO Research Schoalrship Award for her submission titled, “Optimization of Palliative Oncology Care within the VA Healthcare System – Assessing the Availability of Outpatient Palliative Care within VA Oncology Clinics.” This $10,000 scholarship challenges applicants to develop research initiatives that foster collaboration across multiple medical facilities. Five reviewers evaluated submissions for “the merits of (1) innovation, (2) likelihood that findings will improve patient outcomes, (3) relevance to veterans and the VHA, (4) subject matter expertise (or available mentorship), (5) likelihood of collaboration with other VA investigators, and (6) opportunity to support the pursuit of future funding.” AVAHO announced plans to continue this scholarship program next year and increase the award to $25,000.

The abstract award winners were:

1. Staging and Survival of Colorectal Cancer in Octogenarians: Nationwide Study of U.S. Veterans

Virk G, Jafri M, Ashley C, Mehdi S

Awarded $1,000

2. National Comprehensive Cancer Network Distress Thermometer Versus Veteran Symptom Assessment Screen: Year in Review at the Cleveland VAMC

Smith J, Arfons L, Cmolik B, Fox D, Dimick J, Berman S, Woods K, Simon J

Awarded $500

3. Hypertension Among Veterans Affairs Colorectal Cancer Survivors: A Matched Case-Control Analysis

Zullig LL, Lindquist J, Smith VA, Williams CD, Weinberger M, Povenzale D, Jackson GL, Kelley MJ, Danus S, Bosworth HB

Awarded $250

Click here to view all the 2017 abstracts.

Of the 55 accepted posters and abstracts presented at the 2017 Association of VA Hematology/Oncology Annual Meeting, 3 were recognized for their innovation and importance. A panel of judges examined each abstract and poster and talked to the presenter before recognizing the 3 winners.

In addition, AVAHO also recognized Katherine Faricy-Anderson, MD, MPH, of the Providence VAMC as the recipient of the inaugural AVAHO Research Schoalrship Award for her submission titled, “Optimization of Palliative Oncology Care within the VA Healthcare System – Assessing the Availability of Outpatient Palliative Care within VA Oncology Clinics.” This $10,000 scholarship challenges applicants to develop research initiatives that foster collaboration across multiple medical facilities. Five reviewers evaluated submissions for “the merits of (1) innovation, (2) likelihood that findings will improve patient outcomes, (3) relevance to veterans and the VHA, (4) subject matter expertise (or available mentorship), (5) likelihood of collaboration with other VA investigators, and (6) opportunity to support the pursuit of future funding.” AVAHO announced plans to continue this scholarship program next year and increase the award to $25,000.

The abstract award winners were:

1. Staging and Survival of Colorectal Cancer in Octogenarians: Nationwide Study of U.S. Veterans

Virk G, Jafri M, Ashley C, Mehdi S

Awarded $1,000

2. National Comprehensive Cancer Network Distress Thermometer Versus Veteran Symptom Assessment Screen: Year in Review at the Cleveland VAMC

Smith J, Arfons L, Cmolik B, Fox D, Dimick J, Berman S, Woods K, Simon J

Awarded $500

3. Hypertension Among Veterans Affairs Colorectal Cancer Survivors: A Matched Case-Control Analysis

Zullig LL, Lindquist J, Smith VA, Williams CD, Weinberger M, Povenzale D, Jackson GL, Kelley MJ, Danus S, Bosworth HB

Awarded $250

Click here to view all the 2017 abstracts.

In their addresses to the assembly, both the outgoing and incoming Association of VA Hematology and Oncology (AVAHO) presidents laid out the challenges and opportunities for the growing organization. Nearly 500 people attended the meeting, which was held in Denver, Colorado September 15 to September 17. Next year the meeting will be held in the Chicago area September 28 to 30, 2018.

As Mary Thomas, MS, CNS, AOCN noted, it is a challenging time to provide care at the VA. Public scrutiny and criticism, coupled with both understaffing and difficulties in employee retention at most facilities has left many health care providers feeling overwhelmed. Amid the challenges of working within the VA and for vulnerable veteran patients AVAHO provides its members an "essential opportunity to support each other" Thomas insisted in her farewell address. "One of our strategic goals is to enhance the value of the group for our members and to broaden our base by offering other functions and activities," Thomas added. "There is something for everyone.

Over the past year AVAHO has hired a part-time executive director to focus on the business and operations of the organization, proactively hired an accounting firm to ensure that the financial processes are done properly, and developed a formal relationship with the National Association of Veterans Research to increase access to clinical trials to improve clinical research. Thomas also highlighted a new relationship between AVAHO and an organization that develops continuing education programs. These programs will be available at VA hospitals throughout the country. "As a result of these relationships," Thomas told Federal Practitioner, "we have the ability to step up to the plate to assist the VA to be a more active partner in clinical research--that's really, really exciting."

Russell "Rusty" Crawford, B Pharm, BCOP, struck an upbeat note as he closed the meeting. Noting the significant progress made during Thomas' tenure, Crawford also laid out a more ambitious goal to "make AVAHO the authoritative expert on cancer care for veterans," he said "Our patients are unique and don't fit into a National Comprehensive Cancer Network box."

Mark Klein, MD, an oncologist at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota, in Minneapolis was named president elect.

In their addresses to the assembly, both the outgoing and incoming Association of VA Hematology and Oncology (AVAHO) presidents laid out the challenges and opportunities for the growing organization. Nearly 500 people attended the meeting, which was held in Denver, Colorado September 15 to September 17. Next year the meeting will be held in the Chicago area September 28 to 30, 2018.

As Mary Thomas, MS, CNS, AOCN noted, it is a challenging time to provide care at the VA. Public scrutiny and criticism, coupled with both understaffing and difficulties in employee retention at most facilities has left many health care providers feeling overwhelmed. Amid the challenges of working within the VA and for vulnerable veteran patients AVAHO provides its members an "essential opportunity to support each other" Thomas insisted in her farewell address. "One of our strategic goals is to enhance the value of the group for our members and to broaden our base by offering other functions and activities," Thomas added. "There is something for everyone.

Over the past year AVAHO has hired a part-time executive director to focus on the business and operations of the organization, proactively hired an accounting firm to ensure that the financial processes are done properly, and developed a formal relationship with the National Association of Veterans Research to increase access to clinical trials to improve clinical research. Thomas also highlighted a new relationship between AVAHO and an organization that develops continuing education programs. These programs will be available at VA hospitals throughout the country. "As a result of these relationships," Thomas told Federal Practitioner, "we have the ability to step up to the plate to assist the VA to be a more active partner in clinical research--that's really, really exciting."

Russell "Rusty" Crawford, B Pharm, BCOP, struck an upbeat note as he closed the meeting. Noting the significant progress made during Thomas' tenure, Crawford also laid out a more ambitious goal to "make AVAHO the authoritative expert on cancer care for veterans," he said "Our patients are unique and don't fit into a National Comprehensive Cancer Network box."

Mark Klein, MD, an oncologist at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota, in Minneapolis was named president elect.

In their addresses to the assembly, both the outgoing and incoming Association of VA Hematology and Oncology (AVAHO) presidents laid out the challenges and opportunities for the growing organization. Nearly 500 people attended the meeting, which was held in Denver, Colorado September 15 to September 17. Next year the meeting will be held in the Chicago area September 28 to 30, 2018.

As Mary Thomas, MS, CNS, AOCN noted, it is a challenging time to provide care at the VA. Public scrutiny and criticism, coupled with both understaffing and difficulties in employee retention at most facilities has left many health care providers feeling overwhelmed. Amid the challenges of working within the VA and for vulnerable veteran patients AVAHO provides its members an "essential opportunity to support each other" Thomas insisted in her farewell address. "One of our strategic goals is to enhance the value of the group for our members and to broaden our base by offering other functions and activities," Thomas added. "There is something for everyone.

Over the past year AVAHO has hired a part-time executive director to focus on the business and operations of the organization, proactively hired an accounting firm to ensure that the financial processes are done properly, and developed a formal relationship with the National Association of Veterans Research to increase access to clinical trials to improve clinical research. Thomas also highlighted a new relationship between AVAHO and an organization that develops continuing education programs. These programs will be available at VA hospitals throughout the country. "As a result of these relationships," Thomas told Federal Practitioner, "we have the ability to step up to the plate to assist the VA to be a more active partner in clinical research--that's really, really exciting."

Russell "Rusty" Crawford, B Pharm, BCOP, struck an upbeat note as he closed the meeting. Noting the significant progress made during Thomas' tenure, Crawford also laid out a more ambitious goal to "make AVAHO the authoritative expert on cancer care for veterans," he said "Our patients are unique and don't fit into a National Comprehensive Cancer Network box."

Mark Klein, MD, an oncologist at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota, in Minneapolis was named president elect.

Photo from Novartis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the authorized use for nilotinib (Tasigna) to include pediatric patients.

At present, nilotinib is approved for use in the European Economic Area to treat adults with chronic myeloid leukemia (CML).

The drug is used to treat adults with newly diagnosed, Philadelphia-chromosome-positive (Ph+), chronic phase CML and adults with chronic or accelerated phase, Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

The CHMP has recommended expanding the marketing authorization of nilotinib to include pediatric patients with newly diagnosed, Ph+, chronic phase CML and pediatric patients with chronic phase, Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

Detailed recommendations for the use of nilotinib will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report. It will be available in all official European Union languages after a decision on this change to the marketing authorization has been granted by the European Commission (EC).

The EC typically adheres to the CHMP’s recommendations and delivers its final decision within 67 days of the CHMP’s recommendation.

The EC’s decision will be applicable to the entire European Economic Area—all member states of the European Union plus Iceland, Liechtenstein, and Norway.

Photo from Novartis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the authorized use for nilotinib (Tasigna) to include pediatric patients.

At present, nilotinib is approved for use in the European Economic Area to treat adults with chronic myeloid leukemia (CML).

The drug is used to treat adults with newly diagnosed, Philadelphia-chromosome-positive (Ph+), chronic phase CML and adults with chronic or accelerated phase, Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

The CHMP has recommended expanding the marketing authorization of nilotinib to include pediatric patients with newly diagnosed, Ph+, chronic phase CML and pediatric patients with chronic phase, Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

Detailed recommendations for the use of nilotinib will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report. It will be available in all official European Union languages after a decision on this change to the marketing authorization has been granted by the European Commission (EC).

The EC typically adheres to the CHMP’s recommendations and delivers its final decision within 67 days of the CHMP’s recommendation.

The EC’s decision will be applicable to the entire European Economic Area—all member states of the European Union plus Iceland, Liechtenstein, and Norway.

Photo from Novartis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the authorized use for nilotinib (Tasigna) to include pediatric patients.

At present, nilotinib is approved for use in the European Economic Area to treat adults with chronic myeloid leukemia (CML).

The drug is used to treat adults with newly diagnosed, Philadelphia-chromosome-positive (Ph+), chronic phase CML and adults with chronic or accelerated phase, Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

The CHMP has recommended expanding the marketing authorization of nilotinib to include pediatric patients with newly diagnosed, Ph+, chronic phase CML and pediatric patients with chronic phase, Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

Detailed recommendations for the use of nilotinib will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report. It will be available in all official European Union languages after a decision on this change to the marketing authorization has been granted by the European Commission (EC).

The EC typically adheres to the CHMP’s recommendations and delivers its final decision within 67 days of the CHMP’s recommendation.

The EC’s decision will be applicable to the entire European Economic Area—all member states of the European Union plus Iceland, Liechtenstein, and Norway.

It’s National Suicide Prevention Week (Sept. 10-16, 2017) and few psychiatrists would disagree that suicide is a bad outcome, that it is often preventable, and that the loss and pain that follow an untimely act are nothing short of tragic.

It’s also an epidemic on the rise, with more than 40,000 deaths a year, half of those by self-inflicted gunshot. Because 90% of those who suicide suffer from mental illness, one target becomes clear: We need to identify those at risk and make it easy for them to get help. Still, treatment is not a clear panacea; in the decades since selective serotonin reuptake inhibitors have become so readily available, suicide rates have risen, and many who die have gotten help of some type. The issue is a complicated one that reaches well beyond the arena of mental health.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

It’s National Suicide Prevention Week (Sept. 10-16, 2017) and few psychiatrists would disagree that suicide is a bad outcome, that it is often preventable, and that the loss and pain that follow an untimely act are nothing short of tragic.

It’s also an epidemic on the rise, with more than 40,000 deaths a year, half of those by self-inflicted gunshot. Because 90% of those who suicide suffer from mental illness, one target becomes clear: We need to identify those at risk and make it easy for them to get help. Still, treatment is not a clear panacea; in the decades since selective serotonin reuptake inhibitors have become so readily available, suicide rates have risen, and many who die have gotten help of some type. The issue is a complicated one that reaches well beyond the arena of mental health.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

It’s National Suicide Prevention Week (Sept. 10-16, 2017) and few psychiatrists would disagree that suicide is a bad outcome, that it is often preventable, and that the loss and pain that follow an untimely act are nothing short of tragic.

It’s also an epidemic on the rise, with more than 40,000 deaths a year, half of those by self-inflicted gunshot. Because 90% of those who suicide suffer from mental illness, one target becomes clear: We need to identify those at risk and make it easy for them to get help. Still, treatment is not a clear panacea; in the decades since selective serotonin reuptake inhibitors have become so readily available, suicide rates have risen, and many who die have gotten help of some type. The issue is a complicated one that reaches well beyond the arena of mental health.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

The Food and Drug Administration has permitted marketing of the first mobile medical application aimed at helping to treat substance use disorders (SUDs) in adults, the agency announced Sept. 14.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in a statement.

“More therapy tools means a greater potential to help improve outcomes ... for patients with substance use disorder,” Dr. Peña added.

[email protected]

On Twitter @abbbbeeeyyy

The Food and Drug Administration has permitted marketing of the first mobile medical application aimed at helping to treat substance use disorders (SUDs) in adults, the agency announced Sept. 14.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in a statement.

“More therapy tools means a greater potential to help improve outcomes ... for patients with substance use disorder,” Dr. Peña added.

[email protected]

On Twitter @abbbbeeeyyy

The Food and Drug Administration has permitted marketing of the first mobile medical application aimed at helping to treat substance use disorders (SUDs) in adults, the agency announced Sept. 14.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in a statement.

“More therapy tools means a greater potential to help improve outcomes ... for patients with substance use disorder,” Dr. Peña added.

[email protected]

On Twitter @abbbbeeeyyy

MADRID – Adding the investigational PI3K inhibitor taselisib to letrozole (Femara) significantly improved overall response rates, compared with neoadjuvant letrozole alone, in postmenopausal women with early estrogen receptor–positive, human epidermal growth factor receptor 2–negative (ER+/HER2–) breast cancer, results of the LORELEI trial show.

In this phase 2 trial, the overall response rate (ORR), the primary endpoint, was 50% for 166 patients assigned to letrozole plus taselisib, compared with 39.3% for 168 patients assigned to letrozole plus placebo, reported Cristina Saura, MD, of Vall d’Hebron University Hospital in Barcelona.

MADRID – Adding the investigational PI3K inhibitor taselisib to letrozole (Femara) significantly improved overall response rates, compared with neoadjuvant letrozole alone, in postmenopausal women with early estrogen receptor–positive, human epidermal growth factor receptor 2–negative (ER+/HER2–) breast cancer, results of the LORELEI trial show.

In this phase 2 trial, the overall response rate (ORR), the primary endpoint, was 50% for 166 patients assigned to letrozole plus taselisib, compared with 39.3% for 168 patients assigned to letrozole plus placebo, reported Cristina Saura, MD, of Vall d’Hebron University Hospital in Barcelona.

MADRID – Adding the investigational PI3K inhibitor taselisib to letrozole (Femara) significantly improved overall response rates, compared with neoadjuvant letrozole alone, in postmenopausal women with early estrogen receptor–positive, human epidermal growth factor receptor 2–negative (ER+/HER2–) breast cancer, results of the LORELEI trial show.

In this phase 2 trial, the overall response rate (ORR), the primary endpoint, was 50% for 166 patients assigned to letrozole plus taselisib, compared with 39.3% for 168 patients assigned to letrozole plus placebo, reported Cristina Saura, MD, of Vall d’Hebron University Hospital in Barcelona.

In patients with advanced liposarcoma, eribulin was superior to dacarbazine in improving both overall and progression-free survival, investigators report.

In a phase 3 trial that included 452 patients with advanced liposarcoma (LPS), those treated with eribulin had an overall survival of 15.6 months, compared with 8.4 months with dacarbazine (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P less than .001).

Longer overall survival was also seen in all histologic subtypes of LPS and in all geographic regions included in the study.

Median progression-free survival was significantly longer among patients in the eribulin arm, compared with those who received dacarbazine, at 2.9 versus 1.7 months (HR, 0.521; 95% CI, 0.35 to 0.78; nominal P = .0015).

“Our findings demonstrate that eribulin is an important treatment option for patients with previously treated LPS, a sarcoma subtype for which limited treatment options are available,” wrote lead author George D. Demetri, MD, of the Dana-Farber Cancer Institute and Brigham and Women’s Cancer Center, both in Boston, and his colleagues (J Clin Oncol. 2017 Aug 30. doi: 10.1200/JCO.2016.71.6605).

A larger randomized, phase 3 prospective study had found that eribulin significantly improved overall survival versus dacarbazine (13.5 versus 11.5 months, respectively; HR, 0.77; 95% CI, 0.62-0.95; P = .0169) in patients with LPS and leiomyosarcoma. Toxicity was also manageable and similar to that observed when used to treat breast cancer.

However, the survival benefit with eribulin was greater in patients with LPS than those with leiomyosarcoma; on the basis of this trial, eribulin was approved in both the United States and European Union for use in advanced LPS in patients who have received a prior anthracycline-containing regimen.

The current study is a subgroup analysis of 452 patients with advanced or metastatic LPS that is dedifferentiated, myxoid/round cell, or pleomorphic and has been deemed incurable by surgery or radiotherapy; patients were randomized to receive either eribulin mesylate (1.4 mg/m² intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m² intravenously on day 1) every 21 days.

The largest difference in overall survival for eribulin versus dacarbazine was observed in patients with pleomorphic LPS (22.2 versus 6.7 months), but there were only 23 patients (16.2%) with this disease subtype included in the study. Thus, the authors caution that this particular finding should be interpreted carefully.

All patients who received eribulin and 95.8% treated with dacarbazine experienced adverse events, with the majority being treatment related (95.7% versus 84.7% in the eribulin and dacarbazine arms, respectively).

“On the basis of its activity in patients with advanced LPS, eribulin merits further exploration in earlier lines of treatment, either alone or in combination with other therapies,” the authors concluded.

In patients with advanced liposarcoma, eribulin was superior to dacarbazine in improving both overall and progression-free survival, investigators report.

In a phase 3 trial that included 452 patients with advanced liposarcoma (LPS), those treated with eribulin had an overall survival of 15.6 months, compared with 8.4 months with dacarbazine (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P less than .001).

Longer overall survival was also seen in all histologic subtypes of LPS and in all geographic regions included in the study.

Median progression-free survival was significantly longer among patients in the eribulin arm, compared with those who received dacarbazine, at 2.9 versus 1.7 months (HR, 0.521; 95% CI, 0.35 to 0.78; nominal P = .0015).

“Our findings demonstrate that eribulin is an important treatment option for patients with previously treated LPS, a sarcoma subtype for which limited treatment options are available,” wrote lead author George D. Demetri, MD, of the Dana-Farber Cancer Institute and Brigham and Women’s Cancer Center, both in Boston, and his colleagues (J Clin Oncol. 2017 Aug 30. doi: 10.1200/JCO.2016.71.6605).

A larger randomized, phase 3 prospective study had found that eribulin significantly improved overall survival versus dacarbazine (13.5 versus 11.5 months, respectively; HR, 0.77; 95% CI, 0.62-0.95; P = .0169) in patients with LPS and leiomyosarcoma. Toxicity was also manageable and similar to that observed when used to treat breast cancer.

However, the survival benefit with eribulin was greater in patients with LPS than those with leiomyosarcoma; on the basis of this trial, eribulin was approved in both the United States and European Union for use in advanced LPS in patients who have received a prior anthracycline-containing regimen.

The current study is a subgroup analysis of 452 patients with advanced or metastatic LPS that is dedifferentiated, myxoid/round cell, or pleomorphic and has been deemed incurable by surgery or radiotherapy; patients were randomized to receive either eribulin mesylate (1.4 mg/m² intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m² intravenously on day 1) every 21 days.

The largest difference in overall survival for eribulin versus dacarbazine was observed in patients with pleomorphic LPS (22.2 versus 6.7 months), but there were only 23 patients (16.2%) with this disease subtype included in the study. Thus, the authors caution that this particular finding should be interpreted carefully.

All patients who received eribulin and 95.8% treated with dacarbazine experienced adverse events, with the majority being treatment related (95.7% versus 84.7% in the eribulin and dacarbazine arms, respectively).

“On the basis of its activity in patients with advanced LPS, eribulin merits further exploration in earlier lines of treatment, either alone or in combination with other therapies,” the authors concluded.

In patients with advanced liposarcoma, eribulin was superior to dacarbazine in improving both overall and progression-free survival, investigators report.

In a phase 3 trial that included 452 patients with advanced liposarcoma (LPS), those treated with eribulin had an overall survival of 15.6 months, compared with 8.4 months with dacarbazine (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P less than .001).

Longer overall survival was also seen in all histologic subtypes of LPS and in all geographic regions included in the study.

Median progression-free survival was significantly longer among patients in the eribulin arm, compared with those who received dacarbazine, at 2.9 versus 1.7 months (HR, 0.521; 95% CI, 0.35 to 0.78; nominal P = .0015).

“Our findings demonstrate that eribulin is an important treatment option for patients with previously treated LPS, a sarcoma subtype for which limited treatment options are available,” wrote lead author George D. Demetri, MD, of the Dana-Farber Cancer Institute and Brigham and Women’s Cancer Center, both in Boston, and his colleagues (J Clin Oncol. 2017 Aug 30. doi: 10.1200/JCO.2016.71.6605).

A larger randomized, phase 3 prospective study had found that eribulin significantly improved overall survival versus dacarbazine (13.5 versus 11.5 months, respectively; HR, 0.77; 95% CI, 0.62-0.95; P = .0169) in patients with LPS and leiomyosarcoma. Toxicity was also manageable and similar to that observed when used to treat breast cancer.

However, the survival benefit with eribulin was greater in patients with LPS than those with leiomyosarcoma; on the basis of this trial, eribulin was approved in both the United States and European Union for use in advanced LPS in patients who have received a prior anthracycline-containing regimen.

The current study is a subgroup analysis of 452 patients with advanced or metastatic LPS that is dedifferentiated, myxoid/round cell, or pleomorphic and has been deemed incurable by surgery or radiotherapy; patients were randomized to receive either eribulin mesylate (1.4 mg/m² intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m² intravenously on day 1) every 21 days.

The largest difference in overall survival for eribulin versus dacarbazine was observed in patients with pleomorphic LPS (22.2 versus 6.7 months), but there were only 23 patients (16.2%) with this disease subtype included in the study. Thus, the authors caution that this particular finding should be interpreted carefully.

All patients who received eribulin and 95.8% treated with dacarbazine experienced adverse events, with the majority being treatment related (95.7% versus 84.7% in the eribulin and dacarbazine arms, respectively).

“On the basis of its activity in patients with advanced LPS, eribulin merits further exploration in earlier lines of treatment, either alone or in combination with other therapies,” the authors concluded.