Purpose: To increase the appropriate breast cancer risk quantification, utilization of chemoprevention, and genetic counseling among Women Veterans at high risk for breast
cancer in accordance with national guidelines.

Background/Rationale: There are over 2 million women who constitute the fastest growing segment of eligible veterans within the VHA. The number of women diagnosed with breast cancer has more than tripled from 1995 to 2012. Chemoprevention reduces the risk of breast cancer by 50-62% in high risk patients. An estimated 10 million women in the U.S. may be eligible, but fewer than 5% of high risk women are offered chemoprevention.

Methods: This is an ongoing feasibility pilot study being conducted at 2 VAMCs (“VAMC 1” and “VAMC 2”) with plans for expansion to 7 more VAMCs. Participants were enrolled at the time of their regular visit to Women’s Health Clinics. Eligibility criteria includes: women age ≥ 35 with no history of breast cancer. After completing a 20 multiple choice questionnaire, 5-year and lifetime risk of invasive breast cancer is calculated using the Gail risk tool (BCRAT). A woman is considered high risk and eligible for chemoprevention if her 5-year risk is ≥ 1.67% or her lifetime risk is ≥ 20%. Eligibility for genetic counseling is based on the Breast Cancer Referral Screening Tool (B-RST), which includes a personal or family history of breast or ovarian cancer and Jewish ancestry.

Results: 72 females (42 at “VAMC 1” and 30 at “VAMC 2”) were enrolled and completed the questionnaire. Of these patients, 17/42 (40%) and 6/30 (20%) had Gail score of > 1.66 and were considered high risk for breast cancer. All 23 females at both facilities had Oncology clinic consultations for chemoprevention. Only 1 female at each center accepted chemoprevention with tamoxifen (“VAMC 1”) and anastrazole (“VAMC 2”). Six patients had telehealth genetic counseling consults.

Implications/Future Directions: Increasing awareness of breast cancer risk status and utilization of prevention options is a critical element in our program to increase screening and provide chemoprevention according to national guidelines in the VHA. Future directions include tool development and national spread of screening efforts.

Purpose: To increase the appropriate breast cancer risk quantification, utilization of chemoprevention, and genetic counseling among Women Veterans at high risk for breast
cancer in accordance with national guidelines.

Background/Rationale: There are over 2 million women who constitute the fastest growing segment of eligible veterans within the VHA. The number of women diagnosed with breast cancer has more than tripled from 1995 to 2012. Chemoprevention reduces the risk of breast cancer by 50-62% in high risk patients. An estimated 10 million women in the U.S. may be eligible, but fewer than 5% of high risk women are offered chemoprevention.

Methods: This is an ongoing feasibility pilot study being conducted at 2 VAMCs (“VAMC 1” and “VAMC 2”) with plans for expansion to 7 more VAMCs. Participants were enrolled at the time of their regular visit to Women’s Health Clinics. Eligibility criteria includes: women age ≥ 35 with no history of breast cancer. After completing a 20 multiple choice questionnaire, 5-year and lifetime risk of invasive breast cancer is calculated using the Gail risk tool (BCRAT). A woman is considered high risk and eligible for chemoprevention if her 5-year risk is ≥ 1.67% or her lifetime risk is ≥ 20%. Eligibility for genetic counseling is based on the Breast Cancer Referral Screening Tool (B-RST), which includes a personal or family history of breast or ovarian cancer and Jewish ancestry.

Results: 72 females (42 at “VAMC 1” and 30 at “VAMC 2”) were enrolled and completed the questionnaire. Of these patients, 17/42 (40%) and 6/30 (20%) had Gail score of > 1.66 and were considered high risk for breast cancer. All 23 females at both facilities had Oncology clinic consultations for chemoprevention. Only 1 female at each center accepted chemoprevention with tamoxifen (“VAMC 1”) and anastrazole (“VAMC 2”). Six patients had telehealth genetic counseling consults.

Implications/Future Directions: Increasing awareness of breast cancer risk status and utilization of prevention options is a critical element in our program to increase screening and provide chemoprevention according to national guidelines in the VHA. Future directions include tool development and national spread of screening efforts.

Purpose: To increase the appropriate breast cancer risk quantification, utilization of chemoprevention, and genetic counseling among Women Veterans at high risk for breast
cancer in accordance with national guidelines.

Background/Rationale: There are over 2 million women who constitute the fastest growing segment of eligible veterans within the VHA. The number of women diagnosed with breast cancer has more than tripled from 1995 to 2012. Chemoprevention reduces the risk of breast cancer by 50-62% in high risk patients. An estimated 10 million women in the U.S. may be eligible, but fewer than 5% of high risk women are offered chemoprevention.

Methods: This is an ongoing feasibility pilot study being conducted at 2 VAMCs (“VAMC 1” and “VAMC 2”) with plans for expansion to 7 more VAMCs. Participants were enrolled at the time of their regular visit to Women’s Health Clinics. Eligibility criteria includes: women age ≥ 35 with no history of breast cancer. After completing a 20 multiple choice questionnaire, 5-year and lifetime risk of invasive breast cancer is calculated using the Gail risk tool (BCRAT). A woman is considered high risk and eligible for chemoprevention if her 5-year risk is ≥ 1.67% or her lifetime risk is ≥ 20%. Eligibility for genetic counseling is based on the Breast Cancer Referral Screening Tool (B-RST), which includes a personal or family history of breast or ovarian cancer and Jewish ancestry.

Results: 72 females (42 at “VAMC 1” and 30 at “VAMC 2”) were enrolled and completed the questionnaire. Of these patients, 17/42 (40%) and 6/30 (20%) had Gail score of > 1.66 and were considered high risk for breast cancer. All 23 females at both facilities had Oncology clinic consultations for chemoprevention. Only 1 female at each center accepted chemoprevention with tamoxifen (“VAMC 1”) and anastrazole (“VAMC 2”). Six patients had telehealth genetic counseling consults.

Implications/Future Directions: Increasing awareness of breast cancer risk status and utilization of prevention options is a critical element in our program to increase screening and provide chemoprevention according to national guidelines in the VHA. Future directions include tool development and national spread of screening efforts.

Background: Winchester et al (1999) showed that 61% of stage 4 pancreatic cancer patients in the National Cancer Data Base (NCDB) from 1985-95 received no treatment.

Methods: NCDB was queried to evaluate treatment of stage 4 pancreatic cancer from years 2003-2013. The study included 1,525 hospitals and 61,063 patients, of which 47 hospitals and 1,528 patients were from VA hospitals. Chi-square tests were run to compare patients at all hospitals not receiving treatment to VA patients.

Results: More stage 4 pancreatic patients at the VA received no treatment compared to the average in 2003-2013 (58.5% vs 46.8%). However, the VA was still lower than the 61% Winchester found in the 1990s. The percentage of patients within each age group that did not
receive treatment was at least 10% greater at the VA compared to other hospitals. VA patients had lower incomes, greater distances traveled to hospitals, and lived in areas that had more people without a high school degree compared to patients at all hospitals. 19.5% of VA patients,
versus 6.5% of all hospital patients, traveled over 100 miles for care. 22.3% of VA patients, compared to 15.7% of all hospital patients, had an income of less than $36,000. 21.1% of VA patients, compared to 14.5% of all hospital patients had lower education as shown by living in areas where more than 23% of the population did not graduate high school. (all P < .05)

Implications: The majority of stage IV pancreatic patients at the VA are not treated. VA patients with stage 4 pancreatic cancer who did not receive treatment traveled greater distances for care, had less education, and had lower incomes compared to those at other hospitals. Further investigation must be done to determine ways to provide better care to veterans facing pancreatic cancer.

Background: Winchester et al (1999) showed that 61% of stage 4 pancreatic cancer patients in the National Cancer Data Base (NCDB) from 1985-95 received no treatment.

Methods: NCDB was queried to evaluate treatment of stage 4 pancreatic cancer from years 2003-2013. The study included 1,525 hospitals and 61,063 patients, of which 47 hospitals and 1,528 patients were from VA hospitals. Chi-square tests were run to compare patients at all hospitals not receiving treatment to VA patients.

Results: More stage 4 pancreatic patients at the VA received no treatment compared to the average in 2003-2013 (58.5% vs 46.8%). However, the VA was still lower than the 61% Winchester found in the 1990s. The percentage of patients within each age group that did not
receive treatment was at least 10% greater at the VA compared to other hospitals. VA patients had lower incomes, greater distances traveled to hospitals, and lived in areas that had more people without a high school degree compared to patients at all hospitals. 19.5% of VA patients,
versus 6.5% of all hospital patients, traveled over 100 miles for care. 22.3% of VA patients, compared to 15.7% of all hospital patients, had an income of less than $36,000. 21.1% of VA patients, compared to 14.5% of all hospital patients had lower education as shown by living in areas where more than 23% of the population did not graduate high school. (all P < .05)

Implications: The majority of stage IV pancreatic patients at the VA are not treated. VA patients with stage 4 pancreatic cancer who did not receive treatment traveled greater distances for care, had less education, and had lower incomes compared to those at other hospitals. Further investigation must be done to determine ways to provide better care to veterans facing pancreatic cancer.

Background: Winchester et al (1999) showed that 61% of stage 4 pancreatic cancer patients in the National Cancer Data Base (NCDB) from 1985-95 received no treatment.

Methods: NCDB was queried to evaluate treatment of stage 4 pancreatic cancer from years 2003-2013. The study included 1,525 hospitals and 61,063 patients, of which 47 hospitals and 1,528 patients were from VA hospitals. Chi-square tests were run to compare patients at all hospitals not receiving treatment to VA patients.

Results: More stage 4 pancreatic patients at the VA received no treatment compared to the average in 2003-2013 (58.5% vs 46.8%). However, the VA was still lower than the 61% Winchester found in the 1990s. The percentage of patients within each age group that did not
receive treatment was at least 10% greater at the VA compared to other hospitals. VA patients had lower incomes, greater distances traveled to hospitals, and lived in areas that had more people without a high school degree compared to patients at all hospitals. 19.5% of VA patients,
versus 6.5% of all hospital patients, traveled over 100 miles for care. 22.3% of VA patients, compared to 15.7% of all hospital patients, had an income of less than $36,000. 21.1% of VA patients, compared to 14.5% of all hospital patients had lower education as shown by living in areas where more than 23% of the population did not graduate high school. (all P < .05)

Implications: The majority of stage IV pancreatic patients at the VA are not treated. VA patients with stage 4 pancreatic cancer who did not receive treatment traveled greater distances for care, had less education, and had lower incomes compared to those at other hospitals. Further investigation must be done to determine ways to provide better care to veterans facing pancreatic cancer.

(Reuters Health) - Older people who break a bone are often receiving medications that can increase the risk of a fracture - and even after a fracture, less than 10 percent of them stop taking those drugs, according to a new study.

"One would expect that a significant health event like a fracture would result in some change in the use of prescription drugs that might have contributed to that event," said lead author Dr. Jeffrey C. Munson of the Geisel School of Medicine at Dartmouth in Lebanon, New Hampshire. "In contrast to this expectation, we observed that for the overwhelming majority of patients we studied, a fragility fracture did not lead to any change in medications that have been linked to fracture risk."

The authors used data on 168,000 Medicare beneficiaries, more than 80 percent of whom were women, on average age 80, who had experienced a hip, shoulder or wrist fracture. They compared these records with retail pharmacy claims to identify which patients had been taking medicines that increase the risk of a fall, decrease bone density or are otherwise tied to an increased risk of fracture.

About 75 percent of fracture patients had been taking one of these medications. While seven percent of people stopped taking the medication after their fracture, a similar number started to take a new medication also tied to fracture risk, the authors reported in JAMA Internal Medicine, online August 22.

"Some drugs affect balance and memory, like the sleeping pills, which can lead to a fall," said Dr. Sarah D. Berry of the Institute for Aging Research at Hebrew SeniorLife in Boston, Massachusetts, who coauthored a linked editorial.

Blood pressure medications cause changes in blood pressure that could lead to a fall. Other drugs, like prednisone or medications for heartburn, increase bone loss which can lead to a fracture, Berry told Reuters Health by email.

"Fractures are the leading cause of death from injury and one of the main reasons for nursing home placement in persons over the age of 65," she said.

"When a patient has a hip, shoulder or wrist fracture, it is important for healthcare providers to examine all the prescription medications he or she is taking, and carefully assess whether there is an opportunity to eliminate those that might cause a future fracture," Munson told Reuters Health by email.

However, he said, "In many cases, the benefits of a drug may outweigh its risks, even when those risks are significant."

Which drugs can be stopped will vary from case to case, Munson noted.

"For many of the drugs we studied, there are alternative drugs that treat the same conditions but with a lower risk of fracture," he said. "In other cases, it may be possible to eliminate a drug altogether."

SOURCE: http://bit.ly/2bc6PIN

JAMA Intern Med 2016.

(c) Copyright Thomson Reuters 2016.

(Reuters Health) - Older people who break a bone are often receiving medications that can increase the risk of a fracture - and even after a fracture, less than 10 percent of them stop taking those drugs, according to a new study.

"One would expect that a significant health event like a fracture would result in some change in the use of prescription drugs that might have contributed to that event," said lead author Dr. Jeffrey C. Munson of the Geisel School of Medicine at Dartmouth in Lebanon, New Hampshire. "In contrast to this expectation, we observed that for the overwhelming majority of patients we studied, a fragility fracture did not lead to any change in medications that have been linked to fracture risk."

The authors used data on 168,000 Medicare beneficiaries, more than 80 percent of whom were women, on average age 80, who had experienced a hip, shoulder or wrist fracture. They compared these records with retail pharmacy claims to identify which patients had been taking medicines that increase the risk of a fall, decrease bone density or are otherwise tied to an increased risk of fracture.

About 75 percent of fracture patients had been taking one of these medications. While seven percent of people stopped taking the medication after their fracture, a similar number started to take a new medication also tied to fracture risk, the authors reported in JAMA Internal Medicine, online August 22.

"Some drugs affect balance and memory, like the sleeping pills, which can lead to a fall," said Dr. Sarah D. Berry of the Institute for Aging Research at Hebrew SeniorLife in Boston, Massachusetts, who coauthored a linked editorial.

Blood pressure medications cause changes in blood pressure that could lead to a fall. Other drugs, like prednisone or medications for heartburn, increase bone loss which can lead to a fracture, Berry told Reuters Health by email.

"Fractures are the leading cause of death from injury and one of the main reasons for nursing home placement in persons over the age of 65," she said.

"When a patient has a hip, shoulder or wrist fracture, it is important for healthcare providers to examine all the prescription medications he or she is taking, and carefully assess whether there is an opportunity to eliminate those that might cause a future fracture," Munson told Reuters Health by email.

However, he said, "In many cases, the benefits of a drug may outweigh its risks, even when those risks are significant."

Which drugs can be stopped will vary from case to case, Munson noted.

"For many of the drugs we studied, there are alternative drugs that treat the same conditions but with a lower risk of fracture," he said. "In other cases, it may be possible to eliminate a drug altogether."

SOURCE: http://bit.ly/2bc6PIN

JAMA Intern Med 2016.

(c) Copyright Thomson Reuters 2016.

(Reuters Health) - Older people who break a bone are often receiving medications that can increase the risk of a fracture - and even after a fracture, less than 10 percent of them stop taking those drugs, according to a new study.

"One would expect that a significant health event like a fracture would result in some change in the use of prescription drugs that might have contributed to that event," said lead author Dr. Jeffrey C. Munson of the Geisel School of Medicine at Dartmouth in Lebanon, New Hampshire. "In contrast to this expectation, we observed that for the overwhelming majority of patients we studied, a fragility fracture did not lead to any change in medications that have been linked to fracture risk."

The authors used data on 168,000 Medicare beneficiaries, more than 80 percent of whom were women, on average age 80, who had experienced a hip, shoulder or wrist fracture. They compared these records with retail pharmacy claims to identify which patients had been taking medicines that increase the risk of a fall, decrease bone density or are otherwise tied to an increased risk of fracture.

About 75 percent of fracture patients had been taking one of these medications. While seven percent of people stopped taking the medication after their fracture, a similar number started to take a new medication also tied to fracture risk, the authors reported in JAMA Internal Medicine, online August 22.

"Some drugs affect balance and memory, like the sleeping pills, which can lead to a fall," said Dr. Sarah D. Berry of the Institute for Aging Research at Hebrew SeniorLife in Boston, Massachusetts, who coauthored a linked editorial.

Blood pressure medications cause changes in blood pressure that could lead to a fall. Other drugs, like prednisone or medications for heartburn, increase bone loss which can lead to a fracture, Berry told Reuters Health by email.

"Fractures are the leading cause of death from injury and one of the main reasons for nursing home placement in persons over the age of 65," she said.

"When a patient has a hip, shoulder or wrist fracture, it is important for healthcare providers to examine all the prescription medications he or she is taking, and carefully assess whether there is an opportunity to eliminate those that might cause a future fracture," Munson told Reuters Health by email.

However, he said, "In many cases, the benefits of a drug may outweigh its risks, even when those risks are significant."

Which drugs can be stopped will vary from case to case, Munson noted.

"For many of the drugs we studied, there are alternative drugs that treat the same conditions but with a lower risk of fracture," he said. "In other cases, it may be possible to eliminate a drug altogether."

SOURCE: http://bit.ly/2bc6PIN

JAMA Intern Med 2016.

(c) Copyright Thomson Reuters 2016.

Vials of blinatumomab powder

and solution for infusion

Photo courtesy of Amgen

The US Food and Drug Administration (FDA) has granted accelerated approval for blinatumomab (Blincyto®) to treat pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL).

The approval is based on results from a phase 1/2 study.

Continued approval of blinatumomab for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Blinatumomab is a bispecific, CD19-directed, CD3 T-cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

In 2014, blinatumomab received accelerated approval from the FDA to treat adults with Ph- relapsed or refractory BCP-ALL. The FDA has also granted the drug priority review, breakthrough therapy designation, and orphan drug designation.

Blinatumomab is being developed by Amgen. Full prescribing information is available at www.blincyto.com.

‘205 trial

The latest accelerated approval of blinatumomab is based on results from the phase 1/2 ‘205 trial, in which researchers evaluated blinatumomab in 93 pediatric patients with relapsed or refractory BCP-ALL.

Amgen said treatment in this study has been completed, subjects are being monitored for long-term efficacy, and the data will be submitted for publication.

Initial results from this study were presented at ASH 2014. The abstract included data on 39 patients with relapsed/refractory BCP-ALL and a median age of 9 (range, 2-16).

The patients received blinatumomab at a dose of 5-15 µg/m²/day. Nineteen patients completed 1 cycle of blinatumomab, 4 completed 2 cycles, and 2 completed 3 cycles.

During the first 2 treatment cycles, 12 patients achieved a complete response, 5 of whom were negative for minimal residual disease.

Six of the complete responders went on to transplant. The median relapse-free survival for complete responders was 5.6 months.

At 6 months of follow-up, the median overall survival for all 39 patients was 4.3 months.

All of the patients experienced adverse events. The most common were pyrexia (74%), anemia (33%), nausea (31%), headache (28%), hypertension (26%), increased alanine aminotransferase (23%), and cough (21%).

The most common grade 3 or higher events were anemia (26%), pyrexia (21%), increased alanine aminotransferase (18%), increased aspartate aminotransferase (18%), and febrile neutropenia (15%).

Three patients developed cytokine release syndrome (2 grade 3).

Vials of blinatumomab powder

and solution for infusion

Photo courtesy of Amgen

The US Food and Drug Administration (FDA) has granted accelerated approval for blinatumomab (Blincyto®) to treat pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL).

The approval is based on results from a phase 1/2 study.

Continued approval of blinatumomab for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Blinatumomab is a bispecific, CD19-directed, CD3 T-cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

In 2014, blinatumomab received accelerated approval from the FDA to treat adults with Ph- relapsed or refractory BCP-ALL. The FDA has also granted the drug priority review, breakthrough therapy designation, and orphan drug designation.

Blinatumomab is being developed by Amgen. Full prescribing information is available at www.blincyto.com.

‘205 trial

The latest accelerated approval of blinatumomab is based on results from the phase 1/2 ‘205 trial, in which researchers evaluated blinatumomab in 93 pediatric patients with relapsed or refractory BCP-ALL.

Amgen said treatment in this study has been completed, subjects are being monitored for long-term efficacy, and the data will be submitted for publication.

Initial results from this study were presented at ASH 2014. The abstract included data on 39 patients with relapsed/refractory BCP-ALL and a median age of 9 (range, 2-16).

The patients received blinatumomab at a dose of 5-15 µg/m²/day. Nineteen patients completed 1 cycle of blinatumomab, 4 completed 2 cycles, and 2 completed 3 cycles.

During the first 2 treatment cycles, 12 patients achieved a complete response, 5 of whom were negative for minimal residual disease.

Six of the complete responders went on to transplant. The median relapse-free survival for complete responders was 5.6 months.

At 6 months of follow-up, the median overall survival for all 39 patients was 4.3 months.

All of the patients experienced adverse events. The most common were pyrexia (74%), anemia (33%), nausea (31%), headache (28%), hypertension (26%), increased alanine aminotransferase (23%), and cough (21%).

The most common grade 3 or higher events were anemia (26%), pyrexia (21%), increased alanine aminotransferase (18%), increased aspartate aminotransferase (18%), and febrile neutropenia (15%).

Three patients developed cytokine release syndrome (2 grade 3).

Vials of blinatumomab powder

and solution for infusion

Photo courtesy of Amgen

The US Food and Drug Administration (FDA) has granted accelerated approval for blinatumomab (Blincyto®) to treat pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL).

The approval is based on results from a phase 1/2 study.

Continued approval of blinatumomab for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Blinatumomab is a bispecific, CD19-directed, CD3 T-cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

In 2014, blinatumomab received accelerated approval from the FDA to treat adults with Ph- relapsed or refractory BCP-ALL. The FDA has also granted the drug priority review, breakthrough therapy designation, and orphan drug designation.

Blinatumomab is being developed by Amgen. Full prescribing information is available at www.blincyto.com.

‘205 trial

The latest accelerated approval of blinatumomab is based on results from the phase 1/2 ‘205 trial, in which researchers evaluated blinatumomab in 93 pediatric patients with relapsed or refractory BCP-ALL.

Amgen said treatment in this study has been completed, subjects are being monitored for long-term efficacy, and the data will be submitted for publication.

Initial results from this study were presented at ASH 2014. The abstract included data on 39 patients with relapsed/refractory BCP-ALL and a median age of 9 (range, 2-16).

The patients received blinatumomab at a dose of 5-15 µg/m²/day. Nineteen patients completed 1 cycle of blinatumomab, 4 completed 2 cycles, and 2 completed 3 cycles.

During the first 2 treatment cycles, 12 patients achieved a complete response, 5 of whom were negative for minimal residual disease.

Six of the complete responders went on to transplant. The median relapse-free survival for complete responders was 5.6 months.

At 6 months of follow-up, the median overall survival for all 39 patients was 4.3 months.

All of the patients experienced adverse events. The most common were pyrexia (74%), anemia (33%), nausea (31%), headache (28%), hypertension (26%), increased alanine aminotransferase (23%), and cough (21%).

The most common grade 3 or higher events were anemia (26%), pyrexia (21%), increased alanine aminotransferase (18%), increased aspartate aminotransferase (18%), and febrile neutropenia (15%).

Three patients developed cytokine release syndrome (2 grade 3).

Background: Head and neck (HAN) cancer is diagnosed in more than 50,000 Americans annually and is the third most common malignancy in the Veteran patient population. There are > 185,000 American HAN cancer survivors. The comprehensive nature of this disease causes challenges from diagnosis through survivorship. A lack of patient navigation program (PNP) for patients with HAN cancer often lead to fragmented care, delay in initiation of treatment, increased healthcare cost, poor cancer outcome, and a decrease in patient satisfaction.

Purpose: To improve care outcomes among patients with HAN cancer through the implementation of the PNP. Specifically, the program is targeted towards providing holistic patient-centered care, eliminating fragmented care and delays, and decreasing emotional distress and healthcare cost.

Method: In the First Phase, we conducted a need assessment for the PNP. In the Second Phase, we implemented the PNP in 2015 using current evidence and Deming’s (1993) Plan-Do-Study-Act (PDSA) model. During the Implementation Phase of the PNP, we developed a clinical algorithm and order set. We also strengthened our partnership with Non-VA Care Coordination
to expedite community care.

Outcomes: The PNP has served 140 Veterans with well over 500 clinical visits. Consistent with our expectation, the program has resulted in improved oncology infrastructure and timeliness of care. For instance, before the program, there was an average of 16 weeks from suspicion to initiation of treatment. After PNP implementation, the process now takes 4 to 6 weeks. The PNP has eliminated repeat computerized axial tomography, and thus, decreasing healthcare cost by $262,500 annually. Besides its economic impact, the PNP has also led to improved patient and provider satisfaction.

Clinical Implications: Overall, the PNP is a robust patientcentered care program which provides holistic care to patients from cancer suspicion to treatment initiation. Although the PNP continues to evolve, its implementation in BPVAHCS has had a significant impact in the care of HAN cancer patients. Due to the success of the current PNP, BPVAHCS is planning to include all cancer sites by 2020.

Background: Head and neck (HAN) cancer is diagnosed in more than 50,000 Americans annually and is the third most common malignancy in the Veteran patient population. There are > 185,000 American HAN cancer survivors. The comprehensive nature of this disease causes challenges from diagnosis through survivorship. A lack of patient navigation program (PNP) for patients with HAN cancer often lead to fragmented care, delay in initiation of treatment, increased healthcare cost, poor cancer outcome, and a decrease in patient satisfaction.

Purpose: To improve care outcomes among patients with HAN cancer through the implementation of the PNP. Specifically, the program is targeted towards providing holistic patient-centered care, eliminating fragmented care and delays, and decreasing emotional distress and healthcare cost.

Method: In the First Phase, we conducted a need assessment for the PNP. In the Second Phase, we implemented the PNP in 2015 using current evidence and Deming’s (1993) Plan-Do-Study-Act (PDSA) model. During the Implementation Phase of the PNP, we developed a clinical algorithm and order set. We also strengthened our partnership with Non-VA Care Coordination
to expedite community care.

Outcomes: The PNP has served 140 Veterans with well over 500 clinical visits. Consistent with our expectation, the program has resulted in improved oncology infrastructure and timeliness of care. For instance, before the program, there was an average of 16 weeks from suspicion to initiation of treatment. After PNP implementation, the process now takes 4 to 6 weeks. The PNP has eliminated repeat computerized axial tomography, and thus, decreasing healthcare cost by $262,500 annually. Besides its economic impact, the PNP has also led to improved patient and provider satisfaction.

Clinical Implications: Overall, the PNP is a robust patientcentered care program which provides holistic care to patients from cancer suspicion to treatment initiation. Although the PNP continues to evolve, its implementation in BPVAHCS has had a significant impact in the care of HAN cancer patients. Due to the success of the current PNP, BPVAHCS is planning to include all cancer sites by 2020.

Background: Head and neck (HAN) cancer is diagnosed in more than 50,000 Americans annually and is the third most common malignancy in the Veteran patient population. There are > 185,000 American HAN cancer survivors. The comprehensive nature of this disease causes challenges from diagnosis through survivorship. A lack of patient navigation program (PNP) for patients with HAN cancer often lead to fragmented care, delay in initiation of treatment, increased healthcare cost, poor cancer outcome, and a decrease in patient satisfaction.

Purpose: To improve care outcomes among patients with HAN cancer through the implementation of the PNP. Specifically, the program is targeted towards providing holistic patient-centered care, eliminating fragmented care and delays, and decreasing emotional distress and healthcare cost.

Method: In the First Phase, we conducted a need assessment for the PNP. In the Second Phase, we implemented the PNP in 2015 using current evidence and Deming’s (1993) Plan-Do-Study-Act (PDSA) model. During the Implementation Phase of the PNP, we developed a clinical algorithm and order set. We also strengthened our partnership with Non-VA Care Coordination
to expedite community care.

Outcomes: The PNP has served 140 Veterans with well over 500 clinical visits. Consistent with our expectation, the program has resulted in improved oncology infrastructure and timeliness of care. For instance, before the program, there was an average of 16 weeks from suspicion to initiation of treatment. After PNP implementation, the process now takes 4 to 6 weeks. The PNP has eliminated repeat computerized axial tomography, and thus, decreasing healthcare cost by $262,500 annually. Besides its economic impact, the PNP has also led to improved patient and provider satisfaction.

Clinical Implications: Overall, the PNP is a robust patientcentered care program which provides holistic care to patients from cancer suspicion to treatment initiation. Although the PNP continues to evolve, its implementation in BPVAHCS has had a significant impact in the care of HAN cancer patients. Due to the success of the current PNP, BPVAHCS is planning to include all cancer sites by 2020.

CTPA showing PE

Image courtesy of

Medical College of Georgia

ROME—A new study suggests the YEARS algorithm may provide a simple method for ruling out pulmonary embolism (PE) and therefore reduce the need for computed tomography pulmonary angiography (CTPA).

“[The YEARS algorithm] can replace current diagnostic algorithms, which, although safe and accurate, are often not used in busy emergency departments because they are too complex,” said study investigator Tom Van der Hulle, MD, of Leiden University Medical Center in the Netherlands.

“The advantage of the YEARS algorithm over existing algorithms is a 14% reduction in the need for CTPA imaging and, with that, reduced potential for radiation-induced harm and overdiagnosis.”

Dr Van der Hulle described his team’s results with the YEARS algorithm at ESC Congress 2016 (abstract 5727).

About the algorithm

The YEARS algorithm consists of a blood test and 3 items of the original Wells rule.

Patients presenting to the emergency department can be evaluated based on:

1. Clinical signs of deep vein thrombosis (eg, swelling, edema)
2. Hemoptysis
3. Whether the clinician considers PE to be “the most likely diagnosis.”

Using this information combined with results of a blood test measuring D-dimer, clinicians can either exclude PE or recommend CTPA for definitive diagnosis.

Based on the algorithm, PE can be excluded in patients who have either:

• None of the 3 YEARS items and a D-dimer level <1000 ng/mL
• One or more YEARS items and a D-dimer level <500 ng/mL.

Testing the algorithm

Dr Van der Hulle and his colleagues prospectively evaluated the YEARS algorithm in 3465 patients. They had a mean age of 53, and 88% were outpatients.

If patients did not have PE excluded via the algorithm, they went on to CTPA. If PE was confirmed, patients received anticoagulant therapy.

Most of the patients in whom PE was excluded (either by algorithm or CTPA) were left untreated and were followed for 3 months, although 60 patients who had PE excluded received anticoagulants anyway.

In all, 1651 patients had PE excluded with the YEARS algorithm, and 1633 of them did not receive anticoagulation.

A total of 1814 patients did not have PE excluded via the YEARS algorithm and went on to CTPA. Of these patients, 456 had PE, 42 had PE excluded via CTPA but received anticoagulation, and 1316 had PE excluded but did not receive anticoagulation.

Five patients were lost to follow-up—4 with PE excluded via the YEARS algorithm and 1 who went on to CTPA.

Patient outcomes

The primary outcome of this study was the 3-month incidence of symptomatic venous thromboembolism (VTE).

A total of 2944 patients were evaluable (because they had PE excluded, did not receive anticoagulation, and were not lost to follow-up)—1629 who had PE excluded via the YEARS algorithm and 1315 who had PE excluded via CTPA.

Symptomatic VTE occurred in 0.61% of all evaluable patients, 0.43% of patients who had PE excluded via YEARS, and 0.84% of patients who had PE excluded via CTPA.

Fatal PE occurred in 0.20% of all evaluable patients, 0.12% of patients who had PE excluded via YEARS, and 0.30% of patients who had PE excluded via CTPA.

“This is fully in line with that observed in studies using traditional, sequential algorithms such as the 2-level Wells score and a fixed cut-off level of D-dimer of 500 ng/mL,” Dr Van der Hulle said.

“Using the YEARS algorithm, CTPA was not indicated in 48% of our patients at baseline, but this would have been only 34% of patients using the traditional algorithm. This shows that the YEARS algorithm can safely exclude PE and resulted in an absolute reduction of required CTPA of 14%.”

“We expect that the YEARS algorithm can be easily implemented outside the participating study sites and that these safety and efficacy outcomes are representative of what could be expected in regular clinical settings.”

CTPA showing PE

Image courtesy of

Medical College of Georgia

ROME—A new study suggests the YEARS algorithm may provide a simple method for ruling out pulmonary embolism (PE) and therefore reduce the need for computed tomography pulmonary angiography (CTPA).

“[The YEARS algorithm] can replace current diagnostic algorithms, which, although safe and accurate, are often not used in busy emergency departments because they are too complex,” said study investigator Tom Van der Hulle, MD, of Leiden University Medical Center in the Netherlands.

“The advantage of the YEARS algorithm over existing algorithms is a 14% reduction in the need for CTPA imaging and, with that, reduced potential for radiation-induced harm and overdiagnosis.”

Dr Van der Hulle described his team’s results with the YEARS algorithm at ESC Congress 2016 (abstract 5727).

About the algorithm

The YEARS algorithm consists of a blood test and 3 items of the original Wells rule.

Patients presenting to the emergency department can be evaluated based on:

1. Clinical signs of deep vein thrombosis (eg, swelling, edema)
2. Hemoptysis
3. Whether the clinician considers PE to be “the most likely diagnosis.”

Using this information combined with results of a blood test measuring D-dimer, clinicians can either exclude PE or recommend CTPA for definitive diagnosis.

Based on the algorithm, PE can be excluded in patients who have either:

• None of the 3 YEARS items and a D-dimer level <1000 ng/mL
• One or more YEARS items and a D-dimer level <500 ng/mL.

Testing the algorithm

Dr Van der Hulle and his colleagues prospectively evaluated the YEARS algorithm in 3465 patients. They had a mean age of 53, and 88% were outpatients.

If patients did not have PE excluded via the algorithm, they went on to CTPA. If PE was confirmed, patients received anticoagulant therapy.

Most of the patients in whom PE was excluded (either by algorithm or CTPA) were left untreated and were followed for 3 months, although 60 patients who had PE excluded received anticoagulants anyway.

In all, 1651 patients had PE excluded with the YEARS algorithm, and 1633 of them did not receive anticoagulation.

A total of 1814 patients did not have PE excluded via the YEARS algorithm and went on to CTPA. Of these patients, 456 had PE, 42 had PE excluded via CTPA but received anticoagulation, and 1316 had PE excluded but did not receive anticoagulation.

Five patients were lost to follow-up—4 with PE excluded via the YEARS algorithm and 1 who went on to CTPA.

Patient outcomes

The primary outcome of this study was the 3-month incidence of symptomatic venous thromboembolism (VTE).

A total of 2944 patients were evaluable (because they had PE excluded, did not receive anticoagulation, and were not lost to follow-up)—1629 who had PE excluded via the YEARS algorithm and 1315 who had PE excluded via CTPA.

Symptomatic VTE occurred in 0.61% of all evaluable patients, 0.43% of patients who had PE excluded via YEARS, and 0.84% of patients who had PE excluded via CTPA.

Fatal PE occurred in 0.20% of all evaluable patients, 0.12% of patients who had PE excluded via YEARS, and 0.30% of patients who had PE excluded via CTPA.

“This is fully in line with that observed in studies using traditional, sequential algorithms such as the 2-level Wells score and a fixed cut-off level of D-dimer of 500 ng/mL,” Dr Van der Hulle said.

“Using the YEARS algorithm, CTPA was not indicated in 48% of our patients at baseline, but this would have been only 34% of patients using the traditional algorithm. This shows that the YEARS algorithm can safely exclude PE and resulted in an absolute reduction of required CTPA of 14%.”

“We expect that the YEARS algorithm can be easily implemented outside the participating study sites and that these safety and efficacy outcomes are representative of what could be expected in regular clinical settings.”

CTPA showing PE

Image courtesy of

Medical College of Georgia

ROME—A new study suggests the YEARS algorithm may provide a simple method for ruling out pulmonary embolism (PE) and therefore reduce the need for computed tomography pulmonary angiography (CTPA).

“[The YEARS algorithm] can replace current diagnostic algorithms, which, although safe and accurate, are often not used in busy emergency departments because they are too complex,” said study investigator Tom Van der Hulle, MD, of Leiden University Medical Center in the Netherlands.

“The advantage of the YEARS algorithm over existing algorithms is a 14% reduction in the need for CTPA imaging and, with that, reduced potential for radiation-induced harm and overdiagnosis.”

Dr Van der Hulle described his team’s results with the YEARS algorithm at ESC Congress 2016 (abstract 5727).

About the algorithm

The YEARS algorithm consists of a blood test and 3 items of the original Wells rule.

Patients presenting to the emergency department can be evaluated based on:

1. Clinical signs of deep vein thrombosis (eg, swelling, edema)
2. Hemoptysis
3. Whether the clinician considers PE to be “the most likely diagnosis.”

Using this information combined with results of a blood test measuring D-dimer, clinicians can either exclude PE or recommend CTPA for definitive diagnosis.

Based on the algorithm, PE can be excluded in patients who have either:

• None of the 3 YEARS items and a D-dimer level <1000 ng/mL
• One or more YEARS items and a D-dimer level <500 ng/mL.

Testing the algorithm

Dr Van der Hulle and his colleagues prospectively evaluated the YEARS algorithm in 3465 patients. They had a mean age of 53, and 88% were outpatients.

If patients did not have PE excluded via the algorithm, they went on to CTPA. If PE was confirmed, patients received anticoagulant therapy.

Most of the patients in whom PE was excluded (either by algorithm or CTPA) were left untreated and were followed for 3 months, although 60 patients who had PE excluded received anticoagulants anyway.

In all, 1651 patients had PE excluded with the YEARS algorithm, and 1633 of them did not receive anticoagulation.

A total of 1814 patients did not have PE excluded via the YEARS algorithm and went on to CTPA. Of these patients, 456 had PE, 42 had PE excluded via CTPA but received anticoagulation, and 1316 had PE excluded but did not receive anticoagulation.

Five patients were lost to follow-up—4 with PE excluded via the YEARS algorithm and 1 who went on to CTPA.

Patient outcomes

The primary outcome of this study was the 3-month incidence of symptomatic venous thromboembolism (VTE).

A total of 2944 patients were evaluable (because they had PE excluded, did not receive anticoagulation, and were not lost to follow-up)—1629 who had PE excluded via the YEARS algorithm and 1315 who had PE excluded via CTPA.

Symptomatic VTE occurred in 0.61% of all evaluable patients, 0.43% of patients who had PE excluded via YEARS, and 0.84% of patients who had PE excluded via CTPA.

Fatal PE occurred in 0.20% of all evaluable patients, 0.12% of patients who had PE excluded via YEARS, and 0.30% of patients who had PE excluded via CTPA.

“This is fully in line with that observed in studies using traditional, sequential algorithms such as the 2-level Wells score and a fixed cut-off level of D-dimer of 500 ng/mL,” Dr Van der Hulle said.

“Using the YEARS algorithm, CTPA was not indicated in 48% of our patients at baseline, but this would have been only 34% of patients using the traditional algorithm. This shows that the YEARS algorithm can safely exclude PE and resulted in an absolute reduction of required CTPA of 14%.”

“We expect that the YEARS algorithm can be easily implemented outside the participating study sites and that these safety and efficacy outcomes are representative of what could be expected in regular clinical settings.”

Warfarin tablets

ROME—The novel oral anticoagulant edoxaban is a feasible treatment option for patients with atrial fibrillation (AF) who need anticoagulation before cardioversion, according to researchers.

Results of the ENSURE-AF trial suggest edoxaban is “an effective and safe alternative” to standard therapy with warfarin and enoxaparin and may allow for prompt cardioversion with transesophageal echocardiography (TEE), said Andreas Goette, MD, of St. Vincenz-Hospital in Paderborn, Germany.

“These results may have important clinical implications for newly diagnosed, non-anticoagulated AF patients undergoing cardioversion,” Dr Goette noted.

“According to the study protocol, a newly diagnosed, non-anticoagulated AF patient was started on edoxaban, and the cardioversion procedure was scheduled as early as 2 hours following the start of treatment, when applying a TEE-guided approach.”

Dr Goette presented results from ENSURE-AF at ESC Congress 2016 (abstract 5715). The data were simultaneously published in The Lancet. The study was supported by Daiichi Sankyo.

This phase 3b study included 2199 patients with documented non-valvular AF who were scheduled for electrical cardioversion after anticoagulation therapy.

Patients were randomized to receive edoxaban (n=1095) or warfarin with enoxaparin bridging (n=1104). Edoxaban was dosed at 60 mg once daily, but the dose was reduced to 30 mg if one or more of the following factors were present: renal impairment, low body weight, or concomitant use of certain P-glycoprotein inhibitors.

Patients were stratified according to the cardioversion approach (TEE or non-TEE), a patient’s prior experience taking anticoagulants at the time of randomization (ie, anticoagulant-experienced or naïve), and edoxaban dose (60 mg or 30 mg). Patients were randomized in a 1:1 ratio to 2 treatment groups within each stratum.

The primary efficacy endpoint was the composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death at day 28.

This endpoint occurred at a comparable rate in both treatment arms—0.5% in the edoxaban arm and 1.0% in the enoxaparin/warfarin arm (odds ratio [OR]=0.46; 95% CI, 0.12–1.43).

The primary safety endpoint was the composite of major and clinically relevant non-major bleeding events at 30 days.

This endpoint also occurred at a comparable rate in both arms—1.5% in the edoxaban arm and 1.0% in the enoxaparin/warfarin arm (OR=1.48; 95% CI, 0.64–3.55).

The result for the net clinical outcome—a composite of stroke, systemic embolic event, myocardial infarction, cardiovascular mortality, and major bleeding—was 0.7% in the edoxaban arm and 1.4% in the enoxaparin/warfarin arm (OR=0.50; 95% CI, 0.19–1.25) during the overall study period.

The researchers said the ORs recorded in this trial should be viewed with caution because the trial was not adequately powered to show statistically significant differences for efficacy or safety endpoints.

Still, the team said the results suggest edoxaban can provide an alternative to standard therapy.

“At a practical level, our study results show that newly diagnosed, non-anticoagulated AF patients can start edoxaban as early as 2 hours prior to their cardioversion procedure if they have access to [TEE] or 3 weeks prior without,” Dr Goette said.

Warfarin tablets

ROME—The novel oral anticoagulant edoxaban is a feasible treatment option for patients with atrial fibrillation (AF) who need anticoagulation before cardioversion, according to researchers.

Results of the ENSURE-AF trial suggest edoxaban is “an effective and safe alternative” to standard therapy with warfarin and enoxaparin and may allow for prompt cardioversion with transesophageal echocardiography (TEE), said Andreas Goette, MD, of St. Vincenz-Hospital in Paderborn, Germany.

“These results may have important clinical implications for newly diagnosed, non-anticoagulated AF patients undergoing cardioversion,” Dr Goette noted.

“According to the study protocol, a newly diagnosed, non-anticoagulated AF patient was started on edoxaban, and the cardioversion procedure was scheduled as early as 2 hours following the start of treatment, when applying a TEE-guided approach.”

Dr Goette presented results from ENSURE-AF at ESC Congress 2016 (abstract 5715). The data were simultaneously published in The Lancet. The study was supported by Daiichi Sankyo.

This phase 3b study included 2199 patients with documented non-valvular AF who were scheduled for electrical cardioversion after anticoagulation therapy.

Patients were randomized to receive edoxaban (n=1095) or warfarin with enoxaparin bridging (n=1104). Edoxaban was dosed at 60 mg once daily, but the dose was reduced to 30 mg if one or more of the following factors were present: renal impairment, low body weight, or concomitant use of certain P-glycoprotein inhibitors.

Patients were stratified according to the cardioversion approach (TEE or non-TEE), a patient’s prior experience taking anticoagulants at the time of randomization (ie, anticoagulant-experienced or naïve), and edoxaban dose (60 mg or 30 mg). Patients were randomized in a 1:1 ratio to 2 treatment groups within each stratum.

The primary efficacy endpoint was the composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death at day 28.

This endpoint occurred at a comparable rate in both treatment arms—0.5% in the edoxaban arm and 1.0% in the enoxaparin/warfarin arm (odds ratio [OR]=0.46; 95% CI, 0.12–1.43).

The primary safety endpoint was the composite of major and clinically relevant non-major bleeding events at 30 days.

This endpoint also occurred at a comparable rate in both arms—1.5% in the edoxaban arm and 1.0% in the enoxaparin/warfarin arm (OR=1.48; 95% CI, 0.64–3.55).

The result for the net clinical outcome—a composite of stroke, systemic embolic event, myocardial infarction, cardiovascular mortality, and major bleeding—was 0.7% in the edoxaban arm and 1.4% in the enoxaparin/warfarin arm (OR=0.50; 95% CI, 0.19–1.25) during the overall study period.

The researchers said the ORs recorded in this trial should be viewed with caution because the trial was not adequately powered to show statistically significant differences for efficacy or safety endpoints.

Still, the team said the results suggest edoxaban can provide an alternative to standard therapy.

“At a practical level, our study results show that newly diagnosed, non-anticoagulated AF patients can start edoxaban as early as 2 hours prior to their cardioversion procedure if they have access to [TEE] or 3 weeks prior without,” Dr Goette said.

Warfarin tablets

ROME—The novel oral anticoagulant edoxaban is a feasible treatment option for patients with atrial fibrillation (AF) who need anticoagulation before cardioversion, according to researchers.

Results of the ENSURE-AF trial suggest edoxaban is “an effective and safe alternative” to standard therapy with warfarin and enoxaparin and may allow for prompt cardioversion with transesophageal echocardiography (TEE), said Andreas Goette, MD, of St. Vincenz-Hospital in Paderborn, Germany.

“These results may have important clinical implications for newly diagnosed, non-anticoagulated AF patients undergoing cardioversion,” Dr Goette noted.

“According to the study protocol, a newly diagnosed, non-anticoagulated AF patient was started on edoxaban, and the cardioversion procedure was scheduled as early as 2 hours following the start of treatment, when applying a TEE-guided approach.”

Dr Goette presented results from ENSURE-AF at ESC Congress 2016 (abstract 5715). The data were simultaneously published in The Lancet. The study was supported by Daiichi Sankyo.

This phase 3b study included 2199 patients with documented non-valvular AF who were scheduled for electrical cardioversion after anticoagulation therapy.

Patients were randomized to receive edoxaban (n=1095) or warfarin with enoxaparin bridging (n=1104). Edoxaban was dosed at 60 mg once daily, but the dose was reduced to 30 mg if one or more of the following factors were present: renal impairment, low body weight, or concomitant use of certain P-glycoprotein inhibitors.

Patients were stratified according to the cardioversion approach (TEE or non-TEE), a patient’s prior experience taking anticoagulants at the time of randomization (ie, anticoagulant-experienced or naïve), and edoxaban dose (60 mg or 30 mg). Patients were randomized in a 1:1 ratio to 2 treatment groups within each stratum.

The primary efficacy endpoint was the composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death at day 28.

This endpoint occurred at a comparable rate in both treatment arms—0.5% in the edoxaban arm and 1.0% in the enoxaparin/warfarin arm (odds ratio [OR]=0.46; 95% CI, 0.12–1.43).

The primary safety endpoint was the composite of major and clinically relevant non-major bleeding events at 30 days.

This endpoint also occurred at a comparable rate in both arms—1.5% in the edoxaban arm and 1.0% in the enoxaparin/warfarin arm (OR=1.48; 95% CI, 0.64–3.55).

The result for the net clinical outcome—a composite of stroke, systemic embolic event, myocardial infarction, cardiovascular mortality, and major bleeding—was 0.7% in the edoxaban arm and 1.4% in the enoxaparin/warfarin arm (OR=0.50; 95% CI, 0.19–1.25) during the overall study period.

The researchers said the ORs recorded in this trial should be viewed with caution because the trial was not adequately powered to show statistically significant differences for efficacy or safety endpoints.

Still, the team said the results suggest edoxaban can provide an alternative to standard therapy.

“At a practical level, our study results show that newly diagnosed, non-anticoagulated AF patients can start edoxaban as early as 2 hours prior to their cardioversion procedure if they have access to [TEE] or 3 weeks prior without,” Dr Goette said.

Monoclonal antibodies

Photo by Linda Bartlett

The European Commission has granted orphan drug designation to ALXN1007 for the treatment of graft-versus-host disease (GVHD).

ALXN1007 is an anti-inflammatory monoclonal antibody targeting complement protein C5a.

The drug is currently under investigation in a phase 2 trial of patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD).

ALXN1007 is being developed by Alexion Pharmaceuticals, Inc.

About orphan designation

Orphan designation from the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity in the European Union if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.

Phase 2 trial of ALXN1007

Results from the phase 2 trial of ALXN1007 in patients with newly diagnosed, acute GI-GVHD were presented at the 21st Congress of the European Hematology Association (abstract LB2269).

The presentation included 15 patients with biopsy-confirmed acute GI-GVHD. The patients had a median age of 60 (range, 25-69), and 60% were male.

Patients had acute myeloid leukemia/myelodysplastic syndrome (n=8), acute lymphoblastic leukemia (n=2), acute lymphocytic leukemia (n=1), acute myeloblastic leukemia (n=1), aplastic anemia (n=1), cutaneous T-cell lymphoma (n=1), or mantle cell lymphoma (n=1).

Most patients received transplants from matched, unrelated donors (n=11), 3 had matched, related donors, and 1 had a mismatched donor. Ten patients received peripheral blood grafts, 4 received cord blood, and 1 received a bone marrow transplant.

Patients had grade 1 (n=7), grade 2 (n=2), and grade 3 acute GI-GVHD (n=6).

The patients received weekly doses of ALXN1007 at 10 mg/kg, in combination with methylprednisolone at an initial dose of 2 mg/kg, through day 56.

Thirteen patients were evaluable for efficacy. One patient experienced leukemia relapse at day 18, and 1 withdrew from the study early.

The overall acute GVHD response rate was 77% (10/13), both at day 28 and day 56. The complete GI-GVHD response rate was 69% at day 28 and 77% at day 56.

At day 180, the nonrelapse mortality rate was 12.5%, and the overall survival rate was 69.2%.

All of the patients had treatment-emergent adverse events (AEs), and 11 patients (69%) had serious treatment-emergent AEs.

Five patients experienced a total of 12 treatment-related AEs (1 case each)—adenovirus infection, bronchopulmonary aspergillosis, chills, corona virus infection, viral cystitis, Epstein-Barr virus infection, hypersensitivity, influenza, influenza-like illness, infusion-related reaction, respiratory syncytial virus infection, and tremor.

There were 6 deaths, but none were considered treatment-related.

Monoclonal antibodies

Photo by Linda Bartlett

The European Commission has granted orphan drug designation to ALXN1007 for the treatment of graft-versus-host disease (GVHD).

ALXN1007 is an anti-inflammatory monoclonal antibody targeting complement protein C5a.

The drug is currently under investigation in a phase 2 trial of patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD).

ALXN1007 is being developed by Alexion Pharmaceuticals, Inc.

About orphan designation

Orphan designation from the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity in the European Union if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.

Phase 2 trial of ALXN1007

Results from the phase 2 trial of ALXN1007 in patients with newly diagnosed, acute GI-GVHD were presented at the 21st Congress of the European Hematology Association (abstract LB2269).

The presentation included 15 patients with biopsy-confirmed acute GI-GVHD. The patients had a median age of 60 (range, 25-69), and 60% were male.

Patients had acute myeloid leukemia/myelodysplastic syndrome (n=8), acute lymphoblastic leukemia (n=2), acute lymphocytic leukemia (n=1), acute myeloblastic leukemia (n=1), aplastic anemia (n=1), cutaneous T-cell lymphoma (n=1), or mantle cell lymphoma (n=1).

Most patients received transplants from matched, unrelated donors (n=11), 3 had matched, related donors, and 1 had a mismatched donor. Ten patients received peripheral blood grafts, 4 received cord blood, and 1 received a bone marrow transplant.

Patients had grade 1 (n=7), grade 2 (n=2), and grade 3 acute GI-GVHD (n=6).

The patients received weekly doses of ALXN1007 at 10 mg/kg, in combination with methylprednisolone at an initial dose of 2 mg/kg, through day 56.

Thirteen patients were evaluable for efficacy. One patient experienced leukemia relapse at day 18, and 1 withdrew from the study early.

The overall acute GVHD response rate was 77% (10/13), both at day 28 and day 56. The complete GI-GVHD response rate was 69% at day 28 and 77% at day 56.

At day 180, the nonrelapse mortality rate was 12.5%, and the overall survival rate was 69.2%.

All of the patients had treatment-emergent adverse events (AEs), and 11 patients (69%) had serious treatment-emergent AEs.

Five patients experienced a total of 12 treatment-related AEs (1 case each)—adenovirus infection, bronchopulmonary aspergillosis, chills, corona virus infection, viral cystitis, Epstein-Barr virus infection, hypersensitivity, influenza, influenza-like illness, infusion-related reaction, respiratory syncytial virus infection, and tremor.

There were 6 deaths, but none were considered treatment-related.

Monoclonal antibodies

Photo by Linda Bartlett

The European Commission has granted orphan drug designation to ALXN1007 for the treatment of graft-versus-host disease (GVHD).

ALXN1007 is an anti-inflammatory monoclonal antibody targeting complement protein C5a.

The drug is currently under investigation in a phase 2 trial of patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD).

ALXN1007 is being developed by Alexion Pharmaceuticals, Inc.

About orphan designation

Orphan designation from the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity in the European Union if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.

Phase 2 trial of ALXN1007

Results from the phase 2 trial of ALXN1007 in patients with newly diagnosed, acute GI-GVHD were presented at the 21st Congress of the European Hematology Association (abstract LB2269).

The presentation included 15 patients with biopsy-confirmed acute GI-GVHD. The patients had a median age of 60 (range, 25-69), and 60% were male.

Patients had acute myeloid leukemia/myelodysplastic syndrome (n=8), acute lymphoblastic leukemia (n=2), acute lymphocytic leukemia (n=1), acute myeloblastic leukemia (n=1), aplastic anemia (n=1), cutaneous T-cell lymphoma (n=1), or mantle cell lymphoma (n=1).

Most patients received transplants from matched, unrelated donors (n=11), 3 had matched, related donors, and 1 had a mismatched donor. Ten patients received peripheral blood grafts, 4 received cord blood, and 1 received a bone marrow transplant.

Patients had grade 1 (n=7), grade 2 (n=2), and grade 3 acute GI-GVHD (n=6).

The patients received weekly doses of ALXN1007 at 10 mg/kg, in combination with methylprednisolone at an initial dose of 2 mg/kg, through day 56.

Thirteen patients were evaluable for efficacy. One patient experienced leukemia relapse at day 18, and 1 withdrew from the study early.

The overall acute GVHD response rate was 77% (10/13), both at day 28 and day 56. The complete GI-GVHD response rate was 69% at day 28 and 77% at day 56.

At day 180, the nonrelapse mortality rate was 12.5%, and the overall survival rate was 69.2%.

All of the patients had treatment-emergent adverse events (AEs), and 11 patients (69%) had serious treatment-emergent AEs.

Five patients experienced a total of 12 treatment-related AEs (1 case each)—adenovirus infection, bronchopulmonary aspergillosis, chills, corona virus infection, viral cystitis, Epstein-Barr virus infection, hypersensitivity, influenza, influenza-like illness, infusion-related reaction, respiratory syncytial virus infection, and tremor.

There were 6 deaths, but none were considered treatment-related.

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Click here to read supplement

Click here to read supplement

Duration of illness, age, and the presence of specific symptoms are key predictors of hospitalization risk due to respiratory infection, according to a study published in The Lancet. These demographic and clinical factors should guide a primary care physician’s decision to prescribe antibiotics.

“More than 80% of all health-service antibiotics [are] prescribed by primary care clinicians,” reported Alastair Hay, MD, of the University of Bristol, England, and his associates.

“Antibiotic prescribing in primary care is increasing and directly affects antimicrobial resistance,” the researchers noted, adding that many primary care clinicians prescribe antibiotics to pediatric patients with respiratory tract infections and/or cough to “mitigate perceived risk of future hospital admission and complications.”

A total of 8,394 pediatric patients who presented with acute cough and one or more other symptoms of respiratory tract infection (such as fever and coryza) were enrolled in the study by primary care physicians at 247 clinical sites in England. All eligible patients were between the ages of 3 months and 16 years; children were excluded if they presented with noninfective exacerbation of asthma, were at high risk of serious infection, or required a throat swab. The study’s primary outcome was hospital admission for any respiratory tract infection within 30 days of enrollment; the data were collected from a review of electronic medical records (Lancet. 2016. Sept 1. doi: 10.1016/S2213-2600[16]30223-5).

©Ryan McVay/ thinkstockphotos.com

The median age of the pediatric cohort was 3 years, 52% were male, and 78% were white. A total of 3,121 patients (37%) were prescribed an antibiotic by their primary care physicians, but only 78 patients (0.9%) were admitted to the hospital, and 27% of discharge diagnoses suggested a possible bacterial cause (lower respiratory tract infection, tonsillitis, and pneumonia).

Multivariate modeling with bootstrap validation demonstrated that duration of illness, age, and the presence or absence of specific respiratory symptoms were the key factors that should be used to identify children at low, normal, and high risk for hospitalization due to respiratory infection. Younger patients with shorter illness durations who presented with wheeze, fever, vomiting, intercostal or subcostal recession, and/or asthma were at higher risk for hospitalization.

“Our data show that 1,846 (33%) of the very-low-risk stratum children received antibiotics. Because these children represent the majority (67%) of all the participants, a 10% overall reduction in antibiotic prescription would be achieved if prescription in this group halved, remained static in the normal risk stratum, and increased to 90% in the high risk stratum, resulting in a similar effect size to other contemporary antimicrobial stewardship interventions,” Dr. Hay and his associates concluded.

This study received funding and sponsorship from the National Institute for Health Research and the University of Bristol. Two investigators reported receiving financial compensation or honoraria from multiple companies including companies with an interest in diagnostic microbiology in respiratory tract infections.

[email protected]

On Twitter @jessnicolecraig

Duration of illness, age, and the presence of specific symptoms are key predictors of hospitalization risk due to respiratory infection, according to a study published in The Lancet. These demographic and clinical factors should guide a primary care physician’s decision to prescribe antibiotics.

“More than 80% of all health-service antibiotics [are] prescribed by primary care clinicians,” reported Alastair Hay, MD, of the University of Bristol, England, and his associates.

“Antibiotic prescribing in primary care is increasing and directly affects antimicrobial resistance,” the researchers noted, adding that many primary care clinicians prescribe antibiotics to pediatric patients with respiratory tract infections and/or cough to “mitigate perceived risk of future hospital admission and complications.”

A total of 8,394 pediatric patients who presented with acute cough and one or more other symptoms of respiratory tract infection (such as fever and coryza) were enrolled in the study by primary care physicians at 247 clinical sites in England. All eligible patients were between the ages of 3 months and 16 years; children were excluded if they presented with noninfective exacerbation of asthma, were at high risk of serious infection, or required a throat swab. The study’s primary outcome was hospital admission for any respiratory tract infection within 30 days of enrollment; the data were collected from a review of electronic medical records (Lancet. 2016. Sept 1. doi: 10.1016/S2213-2600[16]30223-5).

©Ryan McVay/ thinkstockphotos.com

The median age of the pediatric cohort was 3 years, 52% were male, and 78% were white. A total of 3,121 patients (37%) were prescribed an antibiotic by their primary care physicians, but only 78 patients (0.9%) were admitted to the hospital, and 27% of discharge diagnoses suggested a possible bacterial cause (lower respiratory tract infection, tonsillitis, and pneumonia).

Multivariate modeling with bootstrap validation demonstrated that duration of illness, age, and the presence or absence of specific respiratory symptoms were the key factors that should be used to identify children at low, normal, and high risk for hospitalization due to respiratory infection. Younger patients with shorter illness durations who presented with wheeze, fever, vomiting, intercostal or subcostal recession, and/or asthma were at higher risk for hospitalization.

“Our data show that 1,846 (33%) of the very-low-risk stratum children received antibiotics. Because these children represent the majority (67%) of all the participants, a 10% overall reduction in antibiotic prescription would be achieved if prescription in this group halved, remained static in the normal risk stratum, and increased to 90% in the high risk stratum, resulting in a similar effect size to other contemporary antimicrobial stewardship interventions,” Dr. Hay and his associates concluded.

This study received funding and sponsorship from the National Institute for Health Research and the University of Bristol. Two investigators reported receiving financial compensation or honoraria from multiple companies including companies with an interest in diagnostic microbiology in respiratory tract infections.

[email protected]

On Twitter @jessnicolecraig

Duration of illness, age, and the presence of specific symptoms are key predictors of hospitalization risk due to respiratory infection, according to a study published in The Lancet. These demographic and clinical factors should guide a primary care physician’s decision to prescribe antibiotics.

“More than 80% of all health-service antibiotics [are] prescribed by primary care clinicians,” reported Alastair Hay, MD, of the University of Bristol, England, and his associates.

“Antibiotic prescribing in primary care is increasing and directly affects antimicrobial resistance,” the researchers noted, adding that many primary care clinicians prescribe antibiotics to pediatric patients with respiratory tract infections and/or cough to “mitigate perceived risk of future hospital admission and complications.”

A total of 8,394 pediatric patients who presented with acute cough and one or more other symptoms of respiratory tract infection (such as fever and coryza) were enrolled in the study by primary care physicians at 247 clinical sites in England. All eligible patients were between the ages of 3 months and 16 years; children were excluded if they presented with noninfective exacerbation of asthma, were at high risk of serious infection, or required a throat swab. The study’s primary outcome was hospital admission for any respiratory tract infection within 30 days of enrollment; the data were collected from a review of electronic medical records (Lancet. 2016. Sept 1. doi: 10.1016/S2213-2600[16]30223-5).

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The median age of the pediatric cohort was 3 years, 52% were male, and 78% were white. A total of 3,121 patients (37%) were prescribed an antibiotic by their primary care physicians, but only 78 patients (0.9%) were admitted to the hospital, and 27% of discharge diagnoses suggested a possible bacterial cause (lower respiratory tract infection, tonsillitis, and pneumonia).

Multivariate modeling with bootstrap validation demonstrated that duration of illness, age, and the presence or absence of specific respiratory symptoms were the key factors that should be used to identify children at low, normal, and high risk for hospitalization due to respiratory infection. Younger patients with shorter illness durations who presented with wheeze, fever, vomiting, intercostal or subcostal recession, and/or asthma were at higher risk for hospitalization.

“Our data show that 1,846 (33%) of the very-low-risk stratum children received antibiotics. Because these children represent the majority (67%) of all the participants, a 10% overall reduction in antibiotic prescription would be achieved if prescription in this group halved, remained static in the normal risk stratum, and increased to 90% in the high risk stratum, resulting in a similar effect size to other contemporary antimicrobial stewardship interventions,” Dr. Hay and his associates concluded.

This study received funding and sponsorship from the National Institute for Health Research and the University of Bristol. Two investigators reported receiving financial compensation or honoraria from multiple companies including companies with an interest in diagnostic microbiology in respiratory tract infections.

[email protected]

On Twitter @jessnicolecraig