At least two incretin-based drugs – glucagon-like peptide 1 agonists and dipeptidyl peptidase 4 inhibitors – do not appear to increase the risk of acute pancreatitis in individuals with diabetes but are associated with an increased risk of bile duct and gallbladder disease.

Two studies examining the impact on the pancreas of incretin-based drugs, including dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) agonists, have been published online August 1 in JAMA Internal Medicine.

Incretin-based drugs have been associated with increased risk of elevated pancreatic enzyme levels, while GLP-1 has been shown to increase the proliferation and activity of cholangiocytes, which have raised concerns of an impact on the bile duct, gallbladder, and pancreas.

The first study was an international, population-based cohort study using the health records of more than 1.5 million individuals with type 2 diabetes, who began treatment with antidiabetic drugs between January 2007 and June 2013.

Analysis of these data showed there was no difference in the risk of hospitalization for acute pancreatitis between those taking incretin-based drugs and those on two or more other oral antidiabetic medications (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1522).

The study also found no significant increase in the risk of acute pancreatitis either with DPP-4 inhibitors or GLP-1 agonists, nor was there any increase with a longer duration of use or in patients with a history of acute or chronic pancreatitis.

Most previous observational studies of incretin-based drugs and pancreatitis had reported null findings, but four studies did find a positive association. Laurent Azoulay, PhD, from the Lady Davis Institute at Montreal’s Jewish General Hospital, and his coauthors suggested this heterogeneity was likely the result of methodologic shortcomings such as the use of inappropriate comparator groups and confoundings.

“Although it remains possible that these drugs may be associated with acute pancreatitis, the upper limit of our 95% [confidence interval] suggests that this risk is likely to be small,” the authors wrote. “Thus, the findings of this study should provide some reassurance to patients treated with incretin-based drugs.”

Meanwhile, a second population-based cohort study in 71,368 patients starting an antidiabetic drug found the use of GLP-1 analogues was associated with a significant 79% increase in the risk of bile duct and gallbladder disease, compared with the use of at least two other oral antidiabetic medications.

When stratified by duration of use, individuals taking GLP-1 analogues for less than 180 days showed a twofold increase in the risk of bile duct and gallbladder disease (adjusted hazard ratio, 2.01; 95% CI, 1.23-3.29) but those taking the drugs for longer than 180 days did not show an increased risk.

The use of GLP-1 analogues was also associated with a two-fold increase in the risk of undergoing a cholecystectomy.

However, the study found no increased risk of bile duct or gallbladder disease with DPP-4 inhibitors (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1531).

Jean-Luc Faillie, MD, PhD, of the University of Montpellier (France) and his associates suggested that rapid weight loss associated with GLP-1 analogues may explain the association with bile duct and gallbladder disease, which would also account for the observation that the association did not occur in patients taking the drugs for a longer period of time.

“Weight loss leads to supersaturation of cholesterol in the bile, a known risk factor for gallstones,” the authors wrote.

DPP-4 inhibitors have different effects on the GLP-1 pharmacologic factors and a weaker incretin action, which the authors suggested may explain the lack of association with bile duct and gallbladder disease, as well as their lower incidence of gastrointestinal adverse events.

“Although further studies are needed to confirm our findings and the mechanisms involved, physicians prescribing GLP-1 analogues should be aware of this association and carefully monitor patients for biliary tract complications.”

The first study was enabled by data-sharing agreements with the Canadian Network for Observational Drug Effect Studies, which is funded by the Canadian Institutes of Health Research. Two authors declared consulting fees, grant support, or financial compensation from the pharmaceutical industry, but there were no other conflicts of interest declared.

The second study was funded by the Canadian Institutes of Health Research. No conflicts of interest were declared.

At least two incretin-based drugs – glucagon-like peptide 1 agonists and dipeptidyl peptidase 4 inhibitors – do not appear to increase the risk of acute pancreatitis in individuals with diabetes but are associated with an increased risk of bile duct and gallbladder disease.

Two studies examining the impact on the pancreas of incretin-based drugs, including dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) agonists, have been published online August 1 in JAMA Internal Medicine.

Incretin-based drugs have been associated with increased risk of elevated pancreatic enzyme levels, while GLP-1 has been shown to increase the proliferation and activity of cholangiocytes, which have raised concerns of an impact on the bile duct, gallbladder, and pancreas.

The first study was an international, population-based cohort study using the health records of more than 1.5 million individuals with type 2 diabetes, who began treatment with antidiabetic drugs between January 2007 and June 2013.

Analysis of these data showed there was no difference in the risk of hospitalization for acute pancreatitis between those taking incretin-based drugs and those on two or more other oral antidiabetic medications (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1522).

The study also found no significant increase in the risk of acute pancreatitis either with DPP-4 inhibitors or GLP-1 agonists, nor was there any increase with a longer duration of use or in patients with a history of acute or chronic pancreatitis.

Most previous observational studies of incretin-based drugs and pancreatitis had reported null findings, but four studies did find a positive association. Laurent Azoulay, PhD, from the Lady Davis Institute at Montreal’s Jewish General Hospital, and his coauthors suggested this heterogeneity was likely the result of methodologic shortcomings such as the use of inappropriate comparator groups and confoundings.

“Although it remains possible that these drugs may be associated with acute pancreatitis, the upper limit of our 95% [confidence interval] suggests that this risk is likely to be small,” the authors wrote. “Thus, the findings of this study should provide some reassurance to patients treated with incretin-based drugs.”

Meanwhile, a second population-based cohort study in 71,368 patients starting an antidiabetic drug found the use of GLP-1 analogues was associated with a significant 79% increase in the risk of bile duct and gallbladder disease, compared with the use of at least two other oral antidiabetic medications.

When stratified by duration of use, individuals taking GLP-1 analogues for less than 180 days showed a twofold increase in the risk of bile duct and gallbladder disease (adjusted hazard ratio, 2.01; 95% CI, 1.23-3.29) but those taking the drugs for longer than 180 days did not show an increased risk.

The use of GLP-1 analogues was also associated with a two-fold increase in the risk of undergoing a cholecystectomy.

However, the study found no increased risk of bile duct or gallbladder disease with DPP-4 inhibitors (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1531).

Jean-Luc Faillie, MD, PhD, of the University of Montpellier (France) and his associates suggested that rapid weight loss associated with GLP-1 analogues may explain the association with bile duct and gallbladder disease, which would also account for the observation that the association did not occur in patients taking the drugs for a longer period of time.

“Weight loss leads to supersaturation of cholesterol in the bile, a known risk factor for gallstones,” the authors wrote.

DPP-4 inhibitors have different effects on the GLP-1 pharmacologic factors and a weaker incretin action, which the authors suggested may explain the lack of association with bile duct and gallbladder disease, as well as their lower incidence of gastrointestinal adverse events.

“Although further studies are needed to confirm our findings and the mechanisms involved, physicians prescribing GLP-1 analogues should be aware of this association and carefully monitor patients for biliary tract complications.”

The first study was enabled by data-sharing agreements with the Canadian Network for Observational Drug Effect Studies, which is funded by the Canadian Institutes of Health Research. Two authors declared consulting fees, grant support, or financial compensation from the pharmaceutical industry, but there were no other conflicts of interest declared.

The second study was funded by the Canadian Institutes of Health Research. No conflicts of interest were declared.

At least two incretin-based drugs – glucagon-like peptide 1 agonists and dipeptidyl peptidase 4 inhibitors – do not appear to increase the risk of acute pancreatitis in individuals with diabetes but are associated with an increased risk of bile duct and gallbladder disease.

Two studies examining the impact on the pancreas of incretin-based drugs, including dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) agonists, have been published online August 1 in JAMA Internal Medicine.

Incretin-based drugs have been associated with increased risk of elevated pancreatic enzyme levels, while GLP-1 has been shown to increase the proliferation and activity of cholangiocytes, which have raised concerns of an impact on the bile duct, gallbladder, and pancreas.

The first study was an international, population-based cohort study using the health records of more than 1.5 million individuals with type 2 diabetes, who began treatment with antidiabetic drugs between January 2007 and June 2013.

Analysis of these data showed there was no difference in the risk of hospitalization for acute pancreatitis between those taking incretin-based drugs and those on two or more other oral antidiabetic medications (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1522).

The study also found no significant increase in the risk of acute pancreatitis either with DPP-4 inhibitors or GLP-1 agonists, nor was there any increase with a longer duration of use or in patients with a history of acute or chronic pancreatitis.

Most previous observational studies of incretin-based drugs and pancreatitis had reported null findings, but four studies did find a positive association. Laurent Azoulay, PhD, from the Lady Davis Institute at Montreal’s Jewish General Hospital, and his coauthors suggested this heterogeneity was likely the result of methodologic shortcomings such as the use of inappropriate comparator groups and confoundings.

“Although it remains possible that these drugs may be associated with acute pancreatitis, the upper limit of our 95% [confidence interval] suggests that this risk is likely to be small,” the authors wrote. “Thus, the findings of this study should provide some reassurance to patients treated with incretin-based drugs.”

Meanwhile, a second population-based cohort study in 71,368 patients starting an antidiabetic drug found the use of GLP-1 analogues was associated with a significant 79% increase in the risk of bile duct and gallbladder disease, compared with the use of at least two other oral antidiabetic medications.

When stratified by duration of use, individuals taking GLP-1 analogues for less than 180 days showed a twofold increase in the risk of bile duct and gallbladder disease (adjusted hazard ratio, 2.01; 95% CI, 1.23-3.29) but those taking the drugs for longer than 180 days did not show an increased risk.

The use of GLP-1 analogues was also associated with a two-fold increase in the risk of undergoing a cholecystectomy.

However, the study found no increased risk of bile duct or gallbladder disease with DPP-4 inhibitors (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1531).

Jean-Luc Faillie, MD, PhD, of the University of Montpellier (France) and his associates suggested that rapid weight loss associated with GLP-1 analogues may explain the association with bile duct and gallbladder disease, which would also account for the observation that the association did not occur in patients taking the drugs for a longer period of time.

“Weight loss leads to supersaturation of cholesterol in the bile, a known risk factor for gallstones,” the authors wrote.

DPP-4 inhibitors have different effects on the GLP-1 pharmacologic factors and a weaker incretin action, which the authors suggested may explain the lack of association with bile duct and gallbladder disease, as well as their lower incidence of gastrointestinal adverse events.

“Although further studies are needed to confirm our findings and the mechanisms involved, physicians prescribing GLP-1 analogues should be aware of this association and carefully monitor patients for biliary tract complications.”

The first study was enabled by data-sharing agreements with the Canadian Network for Observational Drug Effect Studies, which is funded by the Canadian Institutes of Health Research. Two authors declared consulting fees, grant support, or financial compensation from the pharmaceutical industry, but there were no other conflicts of interest declared.

The second study was funded by the Canadian Institutes of Health Research. No conflicts of interest were declared.

To the Editor: In the article by Drs. Singh et al in your June issue, I was surprised that the role of hepatitis delta wasn’t mentioned as a potential cause of acute liver failure. My understanding is that this peculiar virus can only infect those with hepatitis B surface antigenemia, but when it does, it results in far more serious liver injury, including acute liver failure in some.

To the Editor: In the article by Drs. Singh et al in your June issue, I was surprised that the role of hepatitis delta wasn’t mentioned as a potential cause of acute liver failure. My understanding is that this peculiar virus can only infect those with hepatitis B surface antigenemia, but when it does, it results in far more serious liver injury, including acute liver failure in some.

To the Editor: In the article by Drs. Singh et al in your June issue, I was surprised that the role of hepatitis delta wasn’t mentioned as a potential cause of acute liver failure. My understanding is that this peculiar virus can only infect those with hepatitis B surface antigenemia, but when it does, it results in far more serious liver injury, including acute liver failure in some.

In Reply: We thank Dr. Homler for bringing hepatitis D as a potential cause of acute liver failure to our attention.

Hepatitis D virus, first described in the 1970s, requires the hepatitis B surface antigen (HBsAg) capsid to enter the hepatocyte and, thus, can only cause liver injury when the patient is also infected simultaneously with hepatitis B virus.¹ Hepatitis D virus can cause either coinfection (presence of immunoglobulin M anti-HB core antibody with or without HBsAg) or superinfection (presence of HBsAg without immunoglobulin M anti-HB core antibody) with hepatitis B virus. In India, coinfection has been reported to be the cause of acute liver failure in about 4% of all patients, and superinfection in 4.5%.²

While simultaneous treatment for hepatitis D and B viruses with pegylated interferon and any of the agents used for treatment of hepatitis B has been successful in treating chronic hepatitis, it has not been proven useful in patients with acute liver failure, and liver transplant remains the only treatment option.³

In Reply: We thank Dr. Homler for bringing hepatitis D as a potential cause of acute liver failure to our attention.

Hepatitis D virus, first described in the 1970s, requires the hepatitis B surface antigen (HBsAg) capsid to enter the hepatocyte and, thus, can only cause liver injury when the patient is also infected simultaneously with hepatitis B virus.¹ Hepatitis D virus can cause either coinfection (presence of immunoglobulin M anti-HB core antibody with or without HBsAg) or superinfection (presence of HBsAg without immunoglobulin M anti-HB core antibody) with hepatitis B virus. In India, coinfection has been reported to be the cause of acute liver failure in about 4% of all patients, and superinfection in 4.5%.²

While simultaneous treatment for hepatitis D and B viruses with pegylated interferon and any of the agents used for treatment of hepatitis B has been successful in treating chronic hepatitis, it has not been proven useful in patients with acute liver failure, and liver transplant remains the only treatment option.³

In Reply: We thank Dr. Homler for bringing hepatitis D as a potential cause of acute liver failure to our attention.

Hepatitis D virus, first described in the 1970s, requires the hepatitis B surface antigen (HBsAg) capsid to enter the hepatocyte and, thus, can only cause liver injury when the patient is also infected simultaneously with hepatitis B virus.¹ Hepatitis D virus can cause either coinfection (presence of immunoglobulin M anti-HB core antibody with or without HBsAg) or superinfection (presence of HBsAg without immunoglobulin M anti-HB core antibody) with hepatitis B virus. In India, coinfection has been reported to be the cause of acute liver failure in about 4% of all patients, and superinfection in 4.5%.²

While simultaneous treatment for hepatitis D and B viruses with pegylated interferon and any of the agents used for treatment of hepatitis B has been successful in treating chronic hepatitis, it has not been proven useful in patients with acute liver failure, and liver transplant remains the only treatment option.³

In contrast to traditional chemotherapy, patients responding to biological or targeted therapies often are treated indefinitely until progression or toxicity. This therapeutic model, however, increases treatment costs, may induce greater toxicity and theoretically could select for earlier emergence of drug resistance. Moreover, little data are available regarding the outcomes of patients who discontinue targeted therapies after achieving remission. In this regard, we report 2 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who chose to stop therapy unrelated to toxicity or disease status after the induction of remission by the BTK inhibitor ibrutinib.

Patient A started ibrutinib for progressive CLL at an absolute lymphocyte count (ALC) of 137,000 mm3 and recurrent hemolytic anemia. After 5 months, the hemolysis had resolved (Hgb 15.6 g/dL), while the ALC had declined to 9,200 mm3. Treatment was then interrupted due to patient preference. One month after drug discontinuation, the ALC was in the normal range at 1,400 mm3 and remained within or near the normal range for a total of 12 months. Two months later, the ALC was again markedly elevated at 68,000 mm3 and anemia recurred. The patient then agreed to restart ibrutinib. After 4 months of re-treatment, he has had prompt resolution of the anemia and achieved a partial remission thus far.

Patient B was started on ibrutinib for a rising ALC (26,000 mm3) and severe hemolytic anemia. After 9 months of treatment, the hemoglobin was 13 g/dL and the ALC was in the normal range at 3,300 mm3. Due to unrelated medical problems, ibrutinib therapy was stopped. Currently, 6 months since drug discontinuation, the ALC remains in the normal range, and no other signs of CLL are present.

These clinical observations suggest that interruption of ibrutinib may be feasible in at least some CLL patients who achieve remission. Even if flow cytometry were performed at monthly intervals to detect early recurrence and ensure prompt re-institution of therapy, the cost savings would still be considerable. Of course, clinical trials will be necessary to confirm equivalent long-term efficacy and overall survival for intermittent versus continuous ibrutinib therapy in CLL.

In contrast to traditional chemotherapy, patients responding to biological or targeted therapies often are treated indefinitely until progression or toxicity. This therapeutic model, however, increases treatment costs, may induce greater toxicity and theoretically could select for earlier emergence of drug resistance. Moreover, little data are available regarding the outcomes of patients who discontinue targeted therapies after achieving remission. In this regard, we report 2 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who chose to stop therapy unrelated to toxicity or disease status after the induction of remission by the BTK inhibitor ibrutinib.

Patient A started ibrutinib for progressive CLL at an absolute lymphocyte count (ALC) of 137,000 mm3 and recurrent hemolytic anemia. After 5 months, the hemolysis had resolved (Hgb 15.6 g/dL), while the ALC had declined to 9,200 mm3. Treatment was then interrupted due to patient preference. One month after drug discontinuation, the ALC was in the normal range at 1,400 mm3 and remained within or near the normal range for a total of 12 months. Two months later, the ALC was again markedly elevated at 68,000 mm3 and anemia recurred. The patient then agreed to restart ibrutinib. After 4 months of re-treatment, he has had prompt resolution of the anemia and achieved a partial remission thus far.

Patient B was started on ibrutinib for a rising ALC (26,000 mm3) and severe hemolytic anemia. After 9 months of treatment, the hemoglobin was 13 g/dL and the ALC was in the normal range at 3,300 mm3. Due to unrelated medical problems, ibrutinib therapy was stopped. Currently, 6 months since drug discontinuation, the ALC remains in the normal range, and no other signs of CLL are present.

These clinical observations suggest that interruption of ibrutinib may be feasible in at least some CLL patients who achieve remission. Even if flow cytometry were performed at monthly intervals to detect early recurrence and ensure prompt re-institution of therapy, the cost savings would still be considerable. Of course, clinical trials will be necessary to confirm equivalent long-term efficacy and overall survival for intermittent versus continuous ibrutinib therapy in CLL.

In contrast to traditional chemotherapy, patients responding to biological or targeted therapies often are treated indefinitely until progression or toxicity. This therapeutic model, however, increases treatment costs, may induce greater toxicity and theoretically could select for earlier emergence of drug resistance. Moreover, little data are available regarding the outcomes of patients who discontinue targeted therapies after achieving remission. In this regard, we report 2 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who chose to stop therapy unrelated to toxicity or disease status after the induction of remission by the BTK inhibitor ibrutinib.

Patient A started ibrutinib for progressive CLL at an absolute lymphocyte count (ALC) of 137,000 mm3 and recurrent hemolytic anemia. After 5 months, the hemolysis had resolved (Hgb 15.6 g/dL), while the ALC had declined to 9,200 mm3. Treatment was then interrupted due to patient preference. One month after drug discontinuation, the ALC was in the normal range at 1,400 mm3 and remained within or near the normal range for a total of 12 months. Two months later, the ALC was again markedly elevated at 68,000 mm3 and anemia recurred. The patient then agreed to restart ibrutinib. After 4 months of re-treatment, he has had prompt resolution of the anemia and achieved a partial remission thus far.

Patient B was started on ibrutinib for a rising ALC (26,000 mm3) and severe hemolytic anemia. After 9 months of treatment, the hemoglobin was 13 g/dL and the ALC was in the normal range at 3,300 mm3. Due to unrelated medical problems, ibrutinib therapy was stopped. Currently, 6 months since drug discontinuation, the ALC remains in the normal range, and no other signs of CLL are present.

These clinical observations suggest that interruption of ibrutinib may be feasible in at least some CLL patients who achieve remission. Even if flow cytometry were performed at monthly intervals to detect early recurrence and ensure prompt re-institution of therapy, the cost savings would still be considerable. Of course, clinical trials will be necessary to confirm equivalent long-term efficacy and overall survival for intermittent versus continuous ibrutinib therapy in CLL.

In an effort to decrease the timeline from suspicion and/or cancer diagnosis to treatment, the Oncology Disease Management RNs incorporated a streamlined and integrated clinical approach. A Disease Case Management (DM) team model is a useful approach to enhance the veteran experience and expedite health care delivery. In 2007, the DM program was begun. The team consisted of 3 registered nurses (RN) who worked under the Quality Management Department rather than the oncology clinic in order to have a more wide ranged approach in both treatment and interventions.

Methods: All patients who had either a suspicion for, or an actual diagnosis of cancer were followed by the DM RNs. We assessed the timeline in days for veterans to get scheduled for recommended tests and consults before and after the DM team involvement. We reviewed timeline data for patients diagnosed during fiscal years 2009 to 2015. The percentage change was calculated for Oncology Consults and Intra-facility Consults to DM team. Times from diagnosis to treatment intervention pre and post DM implementation were reviewed for Primary liver, colon and lung cancers.

Results: Rate of change: Oncology consults for Disease Management team intervention: 62% increase. Reduction in time from diagnosis to treatment intervention: Colon cancer and Lung Cancer 50% and 46% respectively. Reduction in the time required for getting primary Liver cancer patients into diagnostic tests and tumor board presentations for treatment intervention – days shortened from 92 to 31 days from baseline data 2010/11 to 2015. This reflected a 66% decrease in time to treatment /intervention.

Conclusion: The data reflect that in a VA healthcare setting, the Disease Management team model is feasible for facilitating an integrated and coordinated approach in reducing timelines for treatment. The data support that the early introduction of the disease management team model shortened the number of days from diagnosis to treatment by facilitating referrals, clinical testing, and/or treatment initiation in Veteran cancer patients resulting in timely care intervention.

In an effort to decrease the timeline from suspicion and/or cancer diagnosis to treatment, the Oncology Disease Management RNs incorporated a streamlined and integrated clinical approach. A Disease Case Management (DM) team model is a useful approach to enhance the veteran experience and expedite health care delivery. In 2007, the DM program was begun. The team consisted of 3 registered nurses (RN) who worked under the Quality Management Department rather than the oncology clinic in order to have a more wide ranged approach in both treatment and interventions.

Methods: All patients who had either a suspicion for, or an actual diagnosis of cancer were followed by the DM RNs. We assessed the timeline in days for veterans to get scheduled for recommended tests and consults before and after the DM team involvement. We reviewed timeline data for patients diagnosed during fiscal years 2009 to 2015. The percentage change was calculated for Oncology Consults and Intra-facility Consults to DM team. Times from diagnosis to treatment intervention pre and post DM implementation were reviewed for Primary liver, colon and lung cancers.

Results: Rate of change: Oncology consults for Disease Management team intervention: 62% increase. Reduction in time from diagnosis to treatment intervention: Colon cancer and Lung Cancer 50% and 46% respectively. Reduction in the time required for getting primary Liver cancer patients into diagnostic tests and tumor board presentations for treatment intervention – days shortened from 92 to 31 days from baseline data 2010/11 to 2015. This reflected a 66% decrease in time to treatment /intervention.

Conclusion: The data reflect that in a VA healthcare setting, the Disease Management team model is feasible for facilitating an integrated and coordinated approach in reducing timelines for treatment. The data support that the early introduction of the disease management team model shortened the number of days from diagnosis to treatment by facilitating referrals, clinical testing, and/or treatment initiation in Veteran cancer patients resulting in timely care intervention.

In an effort to decrease the timeline from suspicion and/or cancer diagnosis to treatment, the Oncology Disease Management RNs incorporated a streamlined and integrated clinical approach. A Disease Case Management (DM) team model is a useful approach to enhance the veteran experience and expedite health care delivery. In 2007, the DM program was begun. The team consisted of 3 registered nurses (RN) who worked under the Quality Management Department rather than the oncology clinic in order to have a more wide ranged approach in both treatment and interventions.

Methods: All patients who had either a suspicion for, or an actual diagnosis of cancer were followed by the DM RNs. We assessed the timeline in days for veterans to get scheduled for recommended tests and consults before and after the DM team involvement. We reviewed timeline data for patients diagnosed during fiscal years 2009 to 2015. The percentage change was calculated for Oncology Consults and Intra-facility Consults to DM team. Times from diagnosis to treatment intervention pre and post DM implementation were reviewed for Primary liver, colon and lung cancers.

Results: Rate of change: Oncology consults for Disease Management team intervention: 62% increase. Reduction in time from diagnosis to treatment intervention: Colon cancer and Lung Cancer 50% and 46% respectively. Reduction in the time required for getting primary Liver cancer patients into diagnostic tests and tumor board presentations for treatment intervention – days shortened from 92 to 31 days from baseline data 2010/11 to 2015. This reflected a 66% decrease in time to treatment /intervention.

Conclusion: The data reflect that in a VA healthcare setting, the Disease Management team model is feasible for facilitating an integrated and coordinated approach in reducing timelines for treatment. The data support that the early introduction of the disease management team model shortened the number of days from diagnosis to treatment by facilitating referrals, clinical testing, and/or treatment initiation in Veteran cancer patients resulting in timely care intervention.

Background: Prognostic biomarkers are increasingly important in the management of advanced colorectal cancer (ACRC). The aim of the present study was to evaluate the correlation of Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status with elevated carcinoembryonic antigen (CEA) levels in ACRC patients and their association with patients’ survival.

Methods: Patients with metastatic colorectal cancer were identified by a retrospective review of the Albany Medical Center cancer registry data from January 2006 to December 2014. Demographic, clinical, laboratory, and treatment data were retrieved after a manual review of patients’ electronic medical records. Only patients with complete data on CEA levels and KRAS mutation status were included in our analysis. Elevated CEA levels were defined as more than 3 ng/mL.

Results: Sixty-one patients with complete data were identified. Mean age was 58 years (SD 13.7, range 26-87), and 33 of them (54.1%) were male. In 23 out of 61 patients (37.7%), the rectum was involved. The pathologic diagnosis for all the patients was adenocarcinoma. Thirty-nine of 61 patients (63.9%) had wild-type KRAS (wKRAS) and 22 (36.1%) mutated KRAS (mKRAS). Out of 22 patients with mKRAS, 21 (95.5%) had elevated CEA levels prior to first treatment compared to 26 out of 39 (66.7%) with wKRAS (P = 0.011). The median CEA levels prior to treatment for patients with mKRAS was 57.5 ng/mL (IQR 12.6-79.8, range 1.8-16,512) compared to 7.8 ng/mL (2.13-17.7, 0.2-2,027; P = .037) in patients with wKRAS. Among patients with mKRAS and elevated CEA levels, the 1- and 5-year survival rates were 61.9% (13/21) and 0%, respectively, while the mean survival was 16.5 months (SD 10.6, range 1-42). The 1- and 5-year survival rates as well as mean survival for patients with wKRAS and elevated CEA levels were 84.6% (22/26), 3.8% (1/26), and 29.1 months (17.9, 8-84; P = .005) while for those with wKRAS and normal CEA levels were 91.7% (11/12), 25% (3/12), and 43.6 months (29.8, 1-108; P = .14), respectively.

Conclusion: Almost all ACRC patient with mKRAS have elevated CEA levels prior to first systemic therapy. ACRC patients with mKRAS and elevated CEA levels have lower survival rates.

Background: Prognostic biomarkers are increasingly important in the management of advanced colorectal cancer (ACRC). The aim of the present study was to evaluate the correlation of Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status with elevated carcinoembryonic antigen (CEA) levels in ACRC patients and their association with patients’ survival.

Methods: Patients with metastatic colorectal cancer were identified by a retrospective review of the Albany Medical Center cancer registry data from January 2006 to December 2014. Demographic, clinical, laboratory, and treatment data were retrieved after a manual review of patients’ electronic medical records. Only patients with complete data on CEA levels and KRAS mutation status were included in our analysis. Elevated CEA levels were defined as more than 3 ng/mL.

Results: Sixty-one patients with complete data were identified. Mean age was 58 years (SD 13.7, range 26-87), and 33 of them (54.1%) were male. In 23 out of 61 patients (37.7%), the rectum was involved. The pathologic diagnosis for all the patients was adenocarcinoma. Thirty-nine of 61 patients (63.9%) had wild-type KRAS (wKRAS) and 22 (36.1%) mutated KRAS (mKRAS). Out of 22 patients with mKRAS, 21 (95.5%) had elevated CEA levels prior to first treatment compared to 26 out of 39 (66.7%) with wKRAS (P = 0.011). The median CEA levels prior to treatment for patients with mKRAS was 57.5 ng/mL (IQR 12.6-79.8, range 1.8-16,512) compared to 7.8 ng/mL (2.13-17.7, 0.2-2,027; P = .037) in patients with wKRAS. Among patients with mKRAS and elevated CEA levels, the 1- and 5-year survival rates were 61.9% (13/21) and 0%, respectively, while the mean survival was 16.5 months (SD 10.6, range 1-42). The 1- and 5-year survival rates as well as mean survival for patients with wKRAS and elevated CEA levels were 84.6% (22/26), 3.8% (1/26), and 29.1 months (17.9, 8-84; P = .005) while for those with wKRAS and normal CEA levels were 91.7% (11/12), 25% (3/12), and 43.6 months (29.8, 1-108; P = .14), respectively.

Conclusion: Almost all ACRC patient with mKRAS have elevated CEA levels prior to first systemic therapy. ACRC patients with mKRAS and elevated CEA levels have lower survival rates.

Background: Prognostic biomarkers are increasingly important in the management of advanced colorectal cancer (ACRC). The aim of the present study was to evaluate the correlation of Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status with elevated carcinoembryonic antigen (CEA) levels in ACRC patients and their association with patients’ survival.

Methods: Patients with metastatic colorectal cancer were identified by a retrospective review of the Albany Medical Center cancer registry data from January 2006 to December 2014. Demographic, clinical, laboratory, and treatment data were retrieved after a manual review of patients’ electronic medical records. Only patients with complete data on CEA levels and KRAS mutation status were included in our analysis. Elevated CEA levels were defined as more than 3 ng/mL.

Results: Sixty-one patients with complete data were identified. Mean age was 58 years (SD 13.7, range 26-87), and 33 of them (54.1%) were male. In 23 out of 61 patients (37.7%), the rectum was involved. The pathologic diagnosis for all the patients was adenocarcinoma. Thirty-nine of 61 patients (63.9%) had wild-type KRAS (wKRAS) and 22 (36.1%) mutated KRAS (mKRAS). Out of 22 patients with mKRAS, 21 (95.5%) had elevated CEA levels prior to first treatment compared to 26 out of 39 (66.7%) with wKRAS (P = 0.011). The median CEA levels prior to treatment for patients with mKRAS was 57.5 ng/mL (IQR 12.6-79.8, range 1.8-16,512) compared to 7.8 ng/mL (2.13-17.7, 0.2-2,027; P = .037) in patients with wKRAS. Among patients with mKRAS and elevated CEA levels, the 1- and 5-year survival rates were 61.9% (13/21) and 0%, respectively, while the mean survival was 16.5 months (SD 10.6, range 1-42). The 1- and 5-year survival rates as well as mean survival for patients with wKRAS and elevated CEA levels were 84.6% (22/26), 3.8% (1/26), and 29.1 months (17.9, 8-84; P = .005) while for those with wKRAS and normal CEA levels were 91.7% (11/12), 25% (3/12), and 43.6 months (29.8, 1-108; P = .14), respectively.

Conclusion: Almost all ACRC patient with mKRAS have elevated CEA levels prior to first systemic therapy. ACRC patients with mKRAS and elevated CEA levels have lower survival rates.

Purpose: To utilize a distress screening tool that can be used across VAMCs that fulfills cancer center requirements and accreditation standards.

Background: The American College of Surgeon’s (ACOS) Commission on Cancer (COC), Standard 3.2 Distress Screening requires all new cancer diagnoses be screened at diagnosis and at pivotal points across the cancer care continuum. The Louis Stokes Cleveland VAMC (LSCVAMC) used the NCCN DT from May 2012 through March 2016. Collaborating with the Durham VAMC, the LSCVAMC began to pilot the VSAS screening tool in place of the NCCN DT. This initiative was an attempt to use 1 tool that could satisfy both ACOS COC accreditation standards as well as the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) Certification.

Methods: An interdisciplinary team composed of an oncology social worker, oncology psychologist, medical oncologist, survivorship advanced practice nurse and the Cancer Center Program Administrator gathered to compare elements of both the NCCN DT and the VSAS tool. Social elements of distress related to transportation, housing and insurance deemed important to our veteran population were incorporated into the existing VSAS tool.

Data Analysis: During March through June 2016 there have been 47 VSAS tools completed on 47 unique patients. Nursing staff administer, document, and order applicable consults for the screening process. The time required to complete the screen is approximately 2-4 minutes depending on the complexity of the patient. Preliminary data regarding specific elements of the VSAS will be forthcoming at the time of poster presentation.

Results: Patients with a new diagnosis of cancer were asked to complete the form at their initial visit. Initial results from the team piloting the VSAS found that the tool actually allowed providers to hone in on more of the areas that were causing the Veteran the most distress. Whereas, with DT only having 1 thermometer made narrowing down what was causing the most distress more difficult.

Implications: Finding tools that can be implemented across VA facilities for both COC and QOPI initiatives will streamline processes and allow for multicenter data collection benefiting the VA as a whole and decreasing variability in cancer care between facilities.

Purpose: To utilize a distress screening tool that can be used across VAMCs that fulfills cancer center requirements and accreditation standards.

Background: The American College of Surgeon’s (ACOS) Commission on Cancer (COC), Standard 3.2 Distress Screening requires all new cancer diagnoses be screened at diagnosis and at pivotal points across the cancer care continuum. The Louis Stokes Cleveland VAMC (LSCVAMC) used the NCCN DT from May 2012 through March 2016. Collaborating with the Durham VAMC, the LSCVAMC began to pilot the VSAS screening tool in place of the NCCN DT. This initiative was an attempt to use 1 tool that could satisfy both ACOS COC accreditation standards as well as the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) Certification.

Methods: An interdisciplinary team composed of an oncology social worker, oncology psychologist, medical oncologist, survivorship advanced practice nurse and the Cancer Center Program Administrator gathered to compare elements of both the NCCN DT and the VSAS tool. Social elements of distress related to transportation, housing and insurance deemed important to our veteran population were incorporated into the existing VSAS tool.

Data Analysis: During March through June 2016 there have been 47 VSAS tools completed on 47 unique patients. Nursing staff administer, document, and order applicable consults for the screening process. The time required to complete the screen is approximately 2-4 minutes depending on the complexity of the patient. Preliminary data regarding specific elements of the VSAS will be forthcoming at the time of poster presentation.

Results: Patients with a new diagnosis of cancer were asked to complete the form at their initial visit. Initial results from the team piloting the VSAS found that the tool actually allowed providers to hone in on more of the areas that were causing the Veteran the most distress. Whereas, with DT only having 1 thermometer made narrowing down what was causing the most distress more difficult.

Implications: Finding tools that can be implemented across VA facilities for both COC and QOPI initiatives will streamline processes and allow for multicenter data collection benefiting the VA as a whole and decreasing variability in cancer care between facilities.

Purpose: To utilize a distress screening tool that can be used across VAMCs that fulfills cancer center requirements and accreditation standards.

Background: The American College of Surgeon’s (ACOS) Commission on Cancer (COC), Standard 3.2 Distress Screening requires all new cancer diagnoses be screened at diagnosis and at pivotal points across the cancer care continuum. The Louis Stokes Cleveland VAMC (LSCVAMC) used the NCCN DT from May 2012 through March 2016. Collaborating with the Durham VAMC, the LSCVAMC began to pilot the VSAS screening tool in place of the NCCN DT. This initiative was an attempt to use 1 tool that could satisfy both ACOS COC accreditation standards as well as the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) Certification.

Methods: An interdisciplinary team composed of an oncology social worker, oncology psychologist, medical oncologist, survivorship advanced practice nurse and the Cancer Center Program Administrator gathered to compare elements of both the NCCN DT and the VSAS tool. Social elements of distress related to transportation, housing and insurance deemed important to our veteran population were incorporated into the existing VSAS tool.

Data Analysis: During March through June 2016 there have been 47 VSAS tools completed on 47 unique patients. Nursing staff administer, document, and order applicable consults for the screening process. The time required to complete the screen is approximately 2-4 minutes depending on the complexity of the patient. Preliminary data regarding specific elements of the VSAS will be forthcoming at the time of poster presentation.

Results: Patients with a new diagnosis of cancer were asked to complete the form at their initial visit. Initial results from the team piloting the VSAS found that the tool actually allowed providers to hone in on more of the areas that were causing the Veteran the most distress. Whereas, with DT only having 1 thermometer made narrowing down what was causing the most distress more difficult.

Implications: Finding tools that can be implemented across VA facilities for both COC and QOPI initiatives will streamline processes and allow for multicenter data collection benefiting the VA as a whole and decreasing variability in cancer care between facilities.

Purpose: This study sought to characterize the incidence of cisplatin-induced hearing change by cancer location and aspects of the treatment regimen in a sample of Veterans undergoing chemotherapy at the VA Portland HCS. An additional goal was to characterize the severity of hearing loss prior to treatment and the contributions of cisplatin-induced hearing loss in relation to the need for auditory rehabilitation.

Background: Between 2008 and 2014, 17,173 Veterans were treated with cisplatin chemotherapy. Many began treatment with pre-existing hearing loss and up to half likely sustained ototoxicity. Even minor shifts in hearing, left untreated, can constrain effective provider-Veteran treatment partnerships, family and workplace communication, and can significantly limit optimal quality of life following cancer.

Methods: Serial hearing testing and medical records data were obtained prospectively from 2011-2016 in N = 87 cancer patients. Baseline hearing tests were completed within 24 hours of the first cisplatin treatment, during and after treatment. The primary outcome was a shift in the audiogram based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-4 and American Speech-Language-Hearing Association (ASHA) guidelines for a significant ototoxic shift. Hearing shifts that met criteria for CTCAE Grade 1 were further evaluated in relation to cisplatin cumulative dose, initial dose, concurrent radiation and cancer location.

Data Analysis: Descriptive statistics characterize the severity of pre-existing hearing loss and ototoxic changes. Effects of cisplatin dose, cancer location, and radiation on the risks for CTCAE Grade 1 ototoxic event were estimated using hierarchical logistic regression.

Results: Ototoxicity meeting CTCAE grade 3 were found at a rate of 19% for head and neck cancers. This group warrants priority surveillance. Less severe (Grade 1) shifts were found at high rates across other cancer locations assessed in this study. CTCAE Grade 1 ototoxicity is associated with cancer location, starting dose, and concurrent radiation. Importantly, Grade 1 exceeds the magnitude of an ASHA-significant hearing shift by definition. These Veterans are a high priority group for hearing monitoring and rehabilitation service provision by Audiology.

Implications: CTCAE Grade 1 ototoxicity is a commonly occurring toxicity that may limit Veteran-provider communication and quality of life.

Purpose: This study sought to characterize the incidence of cisplatin-induced hearing change by cancer location and aspects of the treatment regimen in a sample of Veterans undergoing chemotherapy at the VA Portland HCS. An additional goal was to characterize the severity of hearing loss prior to treatment and the contributions of cisplatin-induced hearing loss in relation to the need for auditory rehabilitation.

Background: Between 2008 and 2014, 17,173 Veterans were treated with cisplatin chemotherapy. Many began treatment with pre-existing hearing loss and up to half likely sustained ototoxicity. Even minor shifts in hearing, left untreated, can constrain effective provider-Veteran treatment partnerships, family and workplace communication, and can significantly limit optimal quality of life following cancer.

Methods: Serial hearing testing and medical records data were obtained prospectively from 2011-2016 in N = 87 cancer patients. Baseline hearing tests were completed within 24 hours of the first cisplatin treatment, during and after treatment. The primary outcome was a shift in the audiogram based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-4 and American Speech-Language-Hearing Association (ASHA) guidelines for a significant ototoxic shift. Hearing shifts that met criteria for CTCAE Grade 1 were further evaluated in relation to cisplatin cumulative dose, initial dose, concurrent radiation and cancer location.

Data Analysis: Descriptive statistics characterize the severity of pre-existing hearing loss and ototoxic changes. Effects of cisplatin dose, cancer location, and radiation on the risks for CTCAE Grade 1 ototoxic event were estimated using hierarchical logistic regression.

Results: Ototoxicity meeting CTCAE grade 3 were found at a rate of 19% for head and neck cancers. This group warrants priority surveillance. Less severe (Grade 1) shifts were found at high rates across other cancer locations assessed in this study. CTCAE Grade 1 ototoxicity is associated with cancer location, starting dose, and concurrent radiation. Importantly, Grade 1 exceeds the magnitude of an ASHA-significant hearing shift by definition. These Veterans are a high priority group for hearing monitoring and rehabilitation service provision by Audiology.

Implications: CTCAE Grade 1 ototoxicity is a commonly occurring toxicity that may limit Veteran-provider communication and quality of life.

Purpose: This study sought to characterize the incidence of cisplatin-induced hearing change by cancer location and aspects of the treatment regimen in a sample of Veterans undergoing chemotherapy at the VA Portland HCS. An additional goal was to characterize the severity of hearing loss prior to treatment and the contributions of cisplatin-induced hearing loss in relation to the need for auditory rehabilitation.

Background: Between 2008 and 2014, 17,173 Veterans were treated with cisplatin chemotherapy. Many began treatment with pre-existing hearing loss and up to half likely sustained ototoxicity. Even minor shifts in hearing, left untreated, can constrain effective provider-Veteran treatment partnerships, family and workplace communication, and can significantly limit optimal quality of life following cancer.

Methods: Serial hearing testing and medical records data were obtained prospectively from 2011-2016 in N = 87 cancer patients. Baseline hearing tests were completed within 24 hours of the first cisplatin treatment, during and after treatment. The primary outcome was a shift in the audiogram based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-4 and American Speech-Language-Hearing Association (ASHA) guidelines for a significant ototoxic shift. Hearing shifts that met criteria for CTCAE Grade 1 were further evaluated in relation to cisplatin cumulative dose, initial dose, concurrent radiation and cancer location.

Data Analysis: Descriptive statistics characterize the severity of pre-existing hearing loss and ototoxic changes. Effects of cisplatin dose, cancer location, and radiation on the risks for CTCAE Grade 1 ototoxic event were estimated using hierarchical logistic regression.

Results: Ototoxicity meeting CTCAE grade 3 were found at a rate of 19% for head and neck cancers. This group warrants priority surveillance. Less severe (Grade 1) shifts were found at high rates across other cancer locations assessed in this study. CTCAE Grade 1 ototoxicity is associated with cancer location, starting dose, and concurrent radiation. Importantly, Grade 1 exceeds the magnitude of an ASHA-significant hearing shift by definition. These Veterans are a high priority group for hearing monitoring and rehabilitation service provision by Audiology.

Implications: CTCAE Grade 1 ototoxicity is a commonly occurring toxicity that may limit Veteran-provider communication and quality of life.

Purpose: Describe symptom burden and distress among Veteran cancer survivors.

Background: Survivorship is an important component of cancer care as patients transition from treatment to surveillance and cope with long-term effects of therapy. Veterans receiving care at the VA are quite different from those described in existing survivorship literature, with lower income and health literacy, poorer physical andmental health, and more comorbidities compared to the general population. Survivorship needs have not been well defined in this population.

Methods: Veterans are referred or recruited to survivorship clinic after completing definitive therapy. An NCCN distress thermometer (DT) is completed in survivorship clinic as part of routine clinical care.

Data Analysis: This analysis was restricted to cancer survivors meeting Commission on Cancer guidance for survivorship care eligibility. Descriptive statistics summarized findings from the DT. To place symptom burden in context, a comparison group was selected consisting of Veterans with comparable cancer site and stage who completed a DT at their first treatment appointment. Reported symptoms were compared to those from survivors with chi-square analysis.

Results: The DT was completed by 47 lung, colorectal, anal, and head and neck cancer survivors between February 2015 and April 2016. Most were white males, with an average age of 66. Of 39 practical, family, emotional, and physical problems included on the DT, survivors reported an average of 9.2 issues (range 0-22). The most common problems were dyspnea (64%), fatigue (60%), pain (57%), sleep (45%), worry (43%), and depression (40%). The average distress score was 3.6 (range 0-9).

The comparison group contained 147 Veterans; they reported an average of 7.4 issues as sources of distress.

Survivors were significantly more likely to report difficulty with breathing, constipation, depression, anhedonia, sadness, sleep concerns, and tingling in the hands and feet. The only issues more common in patients at the start of treatment compared to survivors were nervousness and transportation concerns. There was no difference in concerns regarding treatment decisions, pain, or finances.

Implications: Veteran cancer survivors reported significant symptom burden, particularly concerning mental health and side effects of treatment. Cancer survivorship clinic can play an important role in identifying and addressing the significant symptom burden. A multidisciplinary approach, particularly one including mental health services, is very important.

Purpose: Describe symptom burden and distress among Veteran cancer survivors.

Background: Survivorship is an important component of cancer care as patients transition from treatment to surveillance and cope with long-term effects of therapy. Veterans receiving care at the VA are quite different from those described in existing survivorship literature, with lower income and health literacy, poorer physical andmental health, and more comorbidities compared to the general population. Survivorship needs have not been well defined in this population.

Methods: Veterans are referred or recruited to survivorship clinic after completing definitive therapy. An NCCN distress thermometer (DT) is completed in survivorship clinic as part of routine clinical care.

Data Analysis: This analysis was restricted to cancer survivors meeting Commission on Cancer guidance for survivorship care eligibility. Descriptive statistics summarized findings from the DT. To place symptom burden in context, a comparison group was selected consisting of Veterans with comparable cancer site and stage who completed a DT at their first treatment appointment. Reported symptoms were compared to those from survivors with chi-square analysis.

Results: The DT was completed by 47 lung, colorectal, anal, and head and neck cancer survivors between February 2015 and April 2016. Most were white males, with an average age of 66. Of 39 practical, family, emotional, and physical problems included on the DT, survivors reported an average of 9.2 issues (range 0-22). The most common problems were dyspnea (64%), fatigue (60%), pain (57%), sleep (45%), worry (43%), and depression (40%). The average distress score was 3.6 (range 0-9).

The comparison group contained 147 Veterans; they reported an average of 7.4 issues as sources of distress.

Survivors were significantly more likely to report difficulty with breathing, constipation, depression, anhedonia, sadness, sleep concerns, and tingling in the hands and feet. The only issues more common in patients at the start of treatment compared to survivors were nervousness and transportation concerns. There was no difference in concerns regarding treatment decisions, pain, or finances.

Implications: Veteran cancer survivors reported significant symptom burden, particularly concerning mental health and side effects of treatment. Cancer survivorship clinic can play an important role in identifying and addressing the significant symptom burden. A multidisciplinary approach, particularly one including mental health services, is very important.

Purpose: Describe symptom burden and distress among Veteran cancer survivors.

Background: Survivorship is an important component of cancer care as patients transition from treatment to surveillance and cope with long-term effects of therapy. Veterans receiving care at the VA are quite different from those described in existing survivorship literature, with lower income and health literacy, poorer physical andmental health, and more comorbidities compared to the general population. Survivorship needs have not been well defined in this population.

Methods: Veterans are referred or recruited to survivorship clinic after completing definitive therapy. An NCCN distress thermometer (DT) is completed in survivorship clinic as part of routine clinical care.

Data Analysis: This analysis was restricted to cancer survivors meeting Commission on Cancer guidance for survivorship care eligibility. Descriptive statistics summarized findings from the DT. To place symptom burden in context, a comparison group was selected consisting of Veterans with comparable cancer site and stage who completed a DT at their first treatment appointment. Reported symptoms were compared to those from survivors with chi-square analysis.

Results: The DT was completed by 47 lung, colorectal, anal, and head and neck cancer survivors between February 2015 and April 2016. Most were white males, with an average age of 66. Of 39 practical, family, emotional, and physical problems included on the DT, survivors reported an average of 9.2 issues (range 0-22). The most common problems were dyspnea (64%), fatigue (60%), pain (57%), sleep (45%), worry (43%), and depression (40%). The average distress score was 3.6 (range 0-9).

The comparison group contained 147 Veterans; they reported an average of 7.4 issues as sources of distress.

Survivors were significantly more likely to report difficulty with breathing, constipation, depression, anhedonia, sadness, sleep concerns, and tingling in the hands and feet. The only issues more common in patients at the start of treatment compared to survivors were nervousness and transportation concerns. There was no difference in concerns regarding treatment decisions, pain, or finances.

Implications: Veteran cancer survivors reported significant symptom burden, particularly concerning mental health and side effects of treatment. Cancer survivorship clinic can play an important role in identifying and addressing the significant symptom burden. A multidisciplinary approach, particularly one including mental health services, is very important.

Purpose: To evaluate the utilization of national drug Criteria for Use documents for oncologic drugs in VHA.

Background: VHA National Pharmacy Benefits Management (PBM) has been developing Criteria for Use (CFU) documents for oncologic therapies since 2001. There is no formalized mechanism to track the utilization of these documents.

Methods: A sample of clinical oncology pharmacy specialists participated in an online survey of five questions regarding recollection of CFU use. A total of 23 active CFU documents were included: 11 for oral and 12 for injectable drugs. 5 questions focused on pharmacist’s recollection of the following: 1) general use of CFU documents as a reference in the past month; 2) use of particular CFU document(s) in the past month; 3) useful document(s); 4) useless document(s); and 5) specific subsections of outdated CFU that need to be updated.

Results: Nineteen pharmacists were surveyed. Responses were provided by 11 for a response rate of 58%. The majority (70%) recall using the ibrutinib CFU in the past month, followed by use of the abiraterone CFU (60%). On average, 36% recall referring to national CFU documents 3-5 times when evaluating drug orders, and 18% recall referring to them more than 5 times. The abiraterone CFU were considered to be useful by 50% of those surveyed. Both abiraterone and enzalutamide were ranked as useful documents (Q#3, n = 10) by 50%, followed by regorafenib and ibrutinib (each 40%). Aprepitant and capecitabine documents were considered to be no longer useful (Q#4, n = 6). When asked about specific areas of the CFU that are in need of update, the overwhelming majority of question responders (Q#5, n = 5) agreed that both Inclusion Criteria (100%) and Exclusion Criteria (80%) were the areas on which to focus. CFU documents for oral therapies were used more often, compared to the injectable therapies (34 vs 15%).

Implications: This pilot highlights variance in utilization and perceived usefulness of CFU documents. Expansion of this pilot with a larger sample size can help direct improvements to increase utilization.

Purpose: To evaluate the utilization of national drug Criteria for Use documents for oncologic drugs in VHA.

Background: VHA National Pharmacy Benefits Management (PBM) has been developing Criteria for Use (CFU) documents for oncologic therapies since 2001. There is no formalized mechanism to track the utilization of these documents.

Methods: A sample of clinical oncology pharmacy specialists participated in an online survey of five questions regarding recollection of CFU use. A total of 23 active CFU documents were included: 11 for oral and 12 for injectable drugs. 5 questions focused on pharmacist’s recollection of the following: 1) general use of CFU documents as a reference in the past month; 2) use of particular CFU document(s) in the past month; 3) useful document(s); 4) useless document(s); and 5) specific subsections of outdated CFU that need to be updated.

Results: Nineteen pharmacists were surveyed. Responses were provided by 11 for a response rate of 58%. The majority (70%) recall using the ibrutinib CFU in the past month, followed by use of the abiraterone CFU (60%). On average, 36% recall referring to national CFU documents 3-5 times when evaluating drug orders, and 18% recall referring to them more than 5 times. The abiraterone CFU were considered to be useful by 50% of those surveyed. Both abiraterone and enzalutamide were ranked as useful documents (Q#3, n = 10) by 50%, followed by regorafenib and ibrutinib (each 40%). Aprepitant and capecitabine documents were considered to be no longer useful (Q#4, n = 6). When asked about specific areas of the CFU that are in need of update, the overwhelming majority of question responders (Q#5, n = 5) agreed that both Inclusion Criteria (100%) and Exclusion Criteria (80%) were the areas on which to focus. CFU documents for oral therapies were used more often, compared to the injectable therapies (34 vs 15%).

Implications: This pilot highlights variance in utilization and perceived usefulness of CFU documents. Expansion of this pilot with a larger sample size can help direct improvements to increase utilization.

Purpose: To evaluate the utilization of national drug Criteria for Use documents for oncologic drugs in VHA.

Background: VHA National Pharmacy Benefits Management (PBM) has been developing Criteria for Use (CFU) documents for oncologic therapies since 2001. There is no formalized mechanism to track the utilization of these documents.

Methods: A sample of clinical oncology pharmacy specialists participated in an online survey of five questions regarding recollection of CFU use. A total of 23 active CFU documents were included: 11 for oral and 12 for injectable drugs. 5 questions focused on pharmacist’s recollection of the following: 1) general use of CFU documents as a reference in the past month; 2) use of particular CFU document(s) in the past month; 3) useful document(s); 4) useless document(s); and 5) specific subsections of outdated CFU that need to be updated.

Results: Nineteen pharmacists were surveyed. Responses were provided by 11 for a response rate of 58%. The majority (70%) recall using the ibrutinib CFU in the past month, followed by use of the abiraterone CFU (60%). On average, 36% recall referring to national CFU documents 3-5 times when evaluating drug orders, and 18% recall referring to them more than 5 times. The abiraterone CFU were considered to be useful by 50% of those surveyed. Both abiraterone and enzalutamide were ranked as useful documents (Q#3, n = 10) by 50%, followed by regorafenib and ibrutinib (each 40%). Aprepitant and capecitabine documents were considered to be no longer useful (Q#4, n = 6). When asked about specific areas of the CFU that are in need of update, the overwhelming majority of question responders (Q#5, n = 5) agreed that both Inclusion Criteria (100%) and Exclusion Criteria (80%) were the areas on which to focus. CFU documents for oral therapies were used more often, compared to the injectable therapies (34 vs 15%).

Implications: This pilot highlights variance in utilization and perceived usefulness of CFU documents. Expansion of this pilot with a larger sample size can help direct improvements to increase utilization.