Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Severe colitis in asymptomatic patient on screening colonoscopy (http://ow.ly/OBNp30mttPD)

Check out an update on the forum’s most popular case, involving a 51-year-old male seen for a screening colonoscopy. Biopsied samples of patchy areas throughout the colon revealed severe active chronic colitis with lymphoplasmacytic infiltrate, crypts and crypt abscesses, and no granulomas.



2. Paraplegic colonic gas (http://ow.ly/ChNM30mtEia)

Symptoms started 2 years ago for this 28-year-old paraplegic male, who was hospitalized with multiple episodes of postprandial abdominal bloating and pain. He has a permanent catheter and is on a diet mostly of meat and specific vegetables. His physician solicited the community for help with management of colonic gas and symptoms.



3. Small submucosal nodule and gastric intestinal metaplasia (http://ow.ly/Qqii30mtEpo)

The physician needs advice on next steps for a 55-year-old female who had an EGD for dyspepsia. Biopsies of a 1-cm nodule and surrounding areas revealed moderate chronic inactive gastritis with focal intestinal metaplasia and reactive hyperplastic changes with no dysplasia.

4. Perianal Crohn’s preceding luminal disease (http://ow.ly/GHV430mtEwo)

This extensive case of a 16-year-old female started with severe constipation, until she developed a painful abscess on the right perianal region. Perianal fistula with abundant granulation tissue and mucoid discharge was noted, and biopsies revealed inflammation with fibrosis, giant cell reaction, and granulomatous inflammation. This past summer, an MR enterography and pelvic MRI revealed a small right perianal intersphincteric fistula with possible drainage through the skin.

More clinical cases and discussions are at https://community.gastro.org/discussions.
 

[email protected]

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Severe colitis in asymptomatic patient on screening colonoscopy (http://ow.ly/OBNp30mttPD)

Check out an update on the forum’s most popular case, involving a 51-year-old male seen for a screening colonoscopy. Biopsied samples of patchy areas throughout the colon revealed severe active chronic colitis with lymphoplasmacytic infiltrate, crypts and crypt abscesses, and no granulomas.



2. Paraplegic colonic gas (http://ow.ly/ChNM30mtEia)

Symptoms started 2 years ago for this 28-year-old paraplegic male, who was hospitalized with multiple episodes of postprandial abdominal bloating and pain. He has a permanent catheter and is on a diet mostly of meat and specific vegetables. His physician solicited the community for help with management of colonic gas and symptoms.



3. Small submucosal nodule and gastric intestinal metaplasia (http://ow.ly/Qqii30mtEpo)

The physician needs advice on next steps for a 55-year-old female who had an EGD for dyspepsia. Biopsies of a 1-cm nodule and surrounding areas revealed moderate chronic inactive gastritis with focal intestinal metaplasia and reactive hyperplastic changes with no dysplasia.

4. Perianal Crohn’s preceding luminal disease (http://ow.ly/GHV430mtEwo)

This extensive case of a 16-year-old female started with severe constipation, until she developed a painful abscess on the right perianal region. Perianal fistula with abundant granulation tissue and mucoid discharge was noted, and biopsies revealed inflammation with fibrosis, giant cell reaction, and granulomatous inflammation. This past summer, an MR enterography and pelvic MRI revealed a small right perianal intersphincteric fistula with possible drainage through the skin.

More clinical cases and discussions are at https://community.gastro.org/discussions.
 

[email protected]

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Severe colitis in asymptomatic patient on screening colonoscopy (http://ow.ly/OBNp30mttPD)

Check out an update on the forum’s most popular case, involving a 51-year-old male seen for a screening colonoscopy. Biopsied samples of patchy areas throughout the colon revealed severe active chronic colitis with lymphoplasmacytic infiltrate, crypts and crypt abscesses, and no granulomas.



2. Paraplegic colonic gas (http://ow.ly/ChNM30mtEia)

Symptoms started 2 years ago for this 28-year-old paraplegic male, who was hospitalized with multiple episodes of postprandial abdominal bloating and pain. He has a permanent catheter and is on a diet mostly of meat and specific vegetables. His physician solicited the community for help with management of colonic gas and symptoms.



3. Small submucosal nodule and gastric intestinal metaplasia (http://ow.ly/Qqii30mtEpo)

The physician needs advice on next steps for a 55-year-old female who had an EGD for dyspepsia. Biopsies of a 1-cm nodule and surrounding areas revealed moderate chronic inactive gastritis with focal intestinal metaplasia and reactive hyperplastic changes with no dysplasia.

4. Perianal Crohn’s preceding luminal disease (http://ow.ly/GHV430mtEwo)

This extensive case of a 16-year-old female started with severe constipation, until she developed a painful abscess on the right perianal region. Perianal fistula with abundant granulation tissue and mucoid discharge was noted, and biopsies revealed inflammation with fibrosis, giant cell reaction, and granulomatous inflammation. This past summer, an MR enterography and pelvic MRI revealed a small right perianal intersphincteric fistula with possible drainage through the skin.

More clinical cases and discussions are at https://community.gastro.org/discussions.
 

[email protected]

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

Recurrence risk is significant among all patients with venous thromboembolism (VTE), though recurrence is most frequent in patients with cancer-related VTE, according to a nationwide Danish study.

Ida Ehlers Albertsen, MD, of Aalborg (Denmark) University Hospital and her coauthors followed 73,993 patients who were diagnosed with incident VTE during January 2000–December 2015. The patients’ VTEs were classified as either cancer-related, unprovoked (occurring in patients without any provoking factors), or provoked (occurring in patients with one or more provoking factors, such as recent major surgery, recent fracture/trauma, obesity, or hormone replacement therapy).

The researchers found similar risks of recurrence among patients with unprovoked and provoked VTE at 6-month follow-up, with rates per 100 person-years of 6.80 and 6.92, respectively. By comparison, the recurrence rate for cancer-related VTE at 6 months was 9.06. The findings were reported in the American Journal of Medicine.

However, at 10-year follow-up the rates were 3.70 for cancer-related VTE, 2.84 for unprovoked VTE, and 2.22 for provoked VTE, which reinforces the belief that “unprovoked venous thromboembolism is associated with long-term higher risk of recurrence than provoked venous thromboembolism.”

Additionally, at 10-year follow-up, the absolute recurrence risk of cancer-related VTE and unprovoked VTE were both at approximately 20%, with recurrence risk of provoked VTE at just above 15%. Compared with the recurrence risk of provoked VTE at 10-year follow-up, the hazard ratios of cancer-related VTE and unprovoked VTE recurrence risk were 1.23 (95% confidence interval, 1.13-1.33) and 1.18 (95% CI, 1.13-1.24), respectively.

The coauthors observed several challenges in comparing their study to previous analyses on recurrent risk, noting that the definition of provoked VTE “varies throughout the literature” and that the majority of VTE studies “provide cumulative incidence proportions and not the actual rates.” They also stated that indefinite or extended therapy for all VTE patients comes with its own potential complications, even with the improved safety of non–vitamin K antagonist oral anticoagulants, writing that “treatment should be given to patients where the benefits outweigh the risks.”

Despite the differences in recurrence rates at 6-month and 10-year follow-up, the coauthors suggested that enough risk was present in all types to warrant additional studies and reconsider how VTE patients are categorized.

“A high recurrence risk in all types of venous thromboembolism indicates that further research is needed to optimize risk stratification for venous thromboembolism patients,” they wrote.

The study was partially funded by a grant from the Obel Family Foundation. Some authors reported financial disclosures related to Janssen, Bayer, Roche, and others.

SOURCE: Albertsen IE et al. Am J Med. 2018 Sep;131(9):1067-74.e4.

The Hospitalist recently sat down with Nancy J. Rennert, MD, FACE, FACP, CPHQ, chief of endocrinology and diabetes at Norwalk (Conn.) Hospital, Western Connecticut Health Network, to discuss her institution’s glycemic control initiatives.

Tell us a bit about your program:

Norwalk Hospital is a 366-bed community teaching hospital founded 125 years ago, now part of the growing Western Connecticut Health Network. Our residency and fellowship training programs are affiliated with Yale University, New Haven, Conn., and we are a branch campus of the University of Vermont, Burlington.

With leadership support, we created our Glycemic Care Team (GCT) 4 years ago to focus on improving the quality of care for persons with diabetes who were admitted to our hospital (often for another primary medical reason). Our hospitalists – 8 on the teaching service and 11 on the nonteaching service – are key players in our efforts as they care for the majority of medical inpatients. GCT is interdisciplinary and includes stakeholders at all levels, including quality, pharmacy, nutrition, hospital medicine, diabetes education, administrative leadership, endocrinology, information technology, point-of-care testing/pathology, surgery and more. We meet monthly with an agenda that includes safety events, glucometrics, and discussion of policies and protocols. Subgroups complete tasks in between the monthly meetings, and we bring in other clinical specialties as indicated based on the issues at hand.
 

What prior challenges did you encounter that led you to enroll in the Glycemic Control (GC) eQUIPS Program?

In order to know if our GCT was making a positive difference, we needed to first measure our baseline metrics and then identify our goals and develop our processes. We wanted actionable data analysis and the ability to differentiate areas of our hospital such as individual clinical units. After researching the options, we chose SHM’s GC eQUIPS Program, which we found to be user friendly. The national benchmarking was an important aspect for us as well. As a kick-off event, I invited Greg Maynard, MD, MHM, a hospitalist and the chief quality officer, UC Davis Medical Center, to speak on inpatient diabetes and was thrilled when he accepted my invitation. This provided an exciting start to our journey with SHM’s eQUIPS data management program.

As we began to obtain baseline measurements of glucose control, we needed a standardized, validated tool. The point-of-care glucose meters generated an enormous amount of data, but we were unable to sort this and analyze it in a meaningful and potentially actionable way. We were especially concerned about hypoglycemia. Our first task was to develop a prescriber ordered and nurse driven hypoglycemia protocol. How would we measure the overall effectiveness and success of the stepwise components of the protocol? The eQUIPS hypoglycemia management report was ideal in that it detailed metrics in stepwise fashion as it related to our protocol. For example, we were able to see the time from detection of hypoglycemia to the next point-of-care glucose check and to resolution of the event.

In addition, we wanted some comparative benchmarking data. The GC eQUIPS Program has a robust database of U.S. hospitals, which helped us define our ultimate goal – to be in the upper quartile of all measures. And we did it! Because of the amazing teamwork and leadership support, we were able to achieve national distinction from SHM as a “Top Performer” hospital for glycemic care.
 

How did the program help you and the team design your initiatives?

Data are powerful and convincing. We post and report our eQUIPS Glucometrics to our clinical staff monthly by unit, and through this process, we obtain the necessary “buy-ins” as well as participation to design clinical protocols and order sets. For example, we noted that many patients would be placed on “sliding scale”/coverage insulin alone at the time of hospital admission. This often would not be adjusted during the hospital stay. Our data showed that this practice was associated with more glucose fluctuations and hypoglycemia. When we reviewed this with our hospitalists, we achieved consensus and developed basal/bolus correction insulin protocols, which are embedded in the admission care sets. Following use of these order sets, we noted less hypoglycemia (decreased from 5.9% and remains less than 3.6%) and lower glucose variability. With the help of the eQUIPS metrics and benchmarking, we now have more than 20 protocols and safety rules built into our EHR system.

What were the key benefits that the GC eQUIPS Program provided that you were unable to find elsewhere?

The unique features we found most useful are the national benchmarking and “real-world” data presentation. National benchmarking allows us to compare ourselves with other hospitals (we can sort for like hospitals or all hospitals) and to periodically evaluate our processes and reexamine our goals. As part of this program, we can communicate with leaders of other high-performing hospitals and share strategies and challenges as well as discuss successes and failures. The quarterly benchmark webinar is another opportunity to be part of this professional community and we often pick up helpful information.

We particularly like the hyperglycemia/hypoglycemia scatter plots, which demonstrate the practical and important impact of glycemic control. Often there is a see-saw effect in which, if one parameter goes up, the other goes down; finding the sweet spot between hyperglycemia and hypoglycemia is key and clinically important.
 

Do you have any other comments to share related to your institution’s participation in the program?

We are fortunate to have many successes driven by our participation with the GC eQUIPS Program:

• Coordination of capillary blood glucose (CBG) testing, insulin administration and meal delivery: Use of rapid-acting insulin premeal is standard of care and requires that CBG testing, insulin, and meal delivery be precisely coordinated for optimal insulin action. We developed a process in which the catering associate calls the nurse using a voice-activated pager when the meal tray leaves the kitchen. Then, the nurse checks the CBG and gives insulin when the tray arrives. The tray contains a card to empower the patient to wait for the nurse to administer insulin prior to eating. This also provides an opportunity for nutritional education and carbohydrate awareness. Implementation of this process increased the percentage of patients who had a CBG and insulin administration within 15 minutes before a meal from less than 10% to more than 60%.
• Patient education regarding insulin use: In many cases, hospital patients may be started on insulin and their oral agents may be discontinued. This can be confusing and frightening to patients who often do not know if they will need to be on insulin long term. Our GCT created a script for the staff nurse to inform and reassure patients that this is standard practice and does not mean that they will need to remain on insulin after hospital discharge. The clinical team will communicate with the patient and together they will review treatment options. We have received many positive reviews from patients and staff for improving communication around this aspect of insulin therapy.
• Clinician and leader education: When our data revealed an uptick in hypoglycemia in our critical care units, we engaged the physicians, nurses, and staff and reviewed patient charts to identify potential process changes. To keep hypoglycemia in the spotlight, our director of critical care added hypoglycemia to the ICU checklist, which is discussed on all team clinical rounds. We are also developing an electronic metric (24-hour glucose maximum and minimum values) that can be quickly reviewed by the clinical team daily.
• Hypoglycemia and hyperkalemia: Analysis of our hypoglycemia data revealed a higher-than-expected rate in the ED in patients who did not have a diabetes diagnosis. Further review showed that this was associated with insulin treatment of hyperkalemia. Subsequently, we engaged our resident trainees and other team members in a study to characterize this hypoglycemia-hyperkalemia, and we have recently submitted a manuscript for publication detailing our findings and recommendations for glucose monitoring in these patients.
• Guideline for medical consultation on nonmedical services: Based on review of glucometrics on the nonmedical units and discussions with our hospitalist teams, we designed a guideline that includes recommendations for Medical Consultation in Nonmedical Admissions. Comanagement by a medical consultant will be requested earlier, and we will monitor if this influences glucometrics, patient and hospitalist satisfaction, etc.
• Medical student and house staff education: Two of our GCT hospitalists organize a monthly patient safety conference. After the students and trainees are asked to propose actionable solutions, the hospitalists discuss proposals generated at our GCT meetings. The students and trainees have the opportunity to participate in quality improvement, and we get great ideas from them as well.

Perhaps our biggest success is our Glycemic Care Team itself. We now receive questions and items to review from all departments and are seen as the hospital’s expert team on diabetes and hyperglycemia. It is truly a pleasure to lead this group of extremely high functioning and dedicated professionals. It is said that “team work makes the dream work.” Moving forward, I hope to expand our Glycemic Care Team to all the hospitals in our network.

The Hospitalist recently sat down with Nancy J. Rennert, MD, FACE, FACP, CPHQ, chief of endocrinology and diabetes at Norwalk (Conn.) Hospital, Western Connecticut Health Network, to discuss her institution’s glycemic control initiatives.

Tell us a bit about your program:

Norwalk Hospital is a 366-bed community teaching hospital founded 125 years ago, now part of the growing Western Connecticut Health Network. Our residency and fellowship training programs are affiliated with Yale University, New Haven, Conn., and we are a branch campus of the University of Vermont, Burlington.

With leadership support, we created our Glycemic Care Team (GCT) 4 years ago to focus on improving the quality of care for persons with diabetes who were admitted to our hospital (often for another primary medical reason). Our hospitalists – 8 on the teaching service and 11 on the nonteaching service – are key players in our efforts as they care for the majority of medical inpatients. GCT is interdisciplinary and includes stakeholders at all levels, including quality, pharmacy, nutrition, hospital medicine, diabetes education, administrative leadership, endocrinology, information technology, point-of-care testing/pathology, surgery and more. We meet monthly with an agenda that includes safety events, glucometrics, and discussion of policies and protocols. Subgroups complete tasks in between the monthly meetings, and we bring in other clinical specialties as indicated based on the issues at hand.
 

What prior challenges did you encounter that led you to enroll in the Glycemic Control (GC) eQUIPS Program?

In order to know if our GCT was making a positive difference, we needed to first measure our baseline metrics and then identify our goals and develop our processes. We wanted actionable data analysis and the ability to differentiate areas of our hospital such as individual clinical units. After researching the options, we chose SHM’s GC eQUIPS Program, which we found to be user friendly. The national benchmarking was an important aspect for us as well. As a kick-off event, I invited Greg Maynard, MD, MHM, a hospitalist and the chief quality officer, UC Davis Medical Center, to speak on inpatient diabetes and was thrilled when he accepted my invitation. This provided an exciting start to our journey with SHM’s eQUIPS data management program.

As we began to obtain baseline measurements of glucose control, we needed a standardized, validated tool. The point-of-care glucose meters generated an enormous amount of data, but we were unable to sort this and analyze it in a meaningful and potentially actionable way. We were especially concerned about hypoglycemia. Our first task was to develop a prescriber ordered and nurse driven hypoglycemia protocol. How would we measure the overall effectiveness and success of the stepwise components of the protocol? The eQUIPS hypoglycemia management report was ideal in that it detailed metrics in stepwise fashion as it related to our protocol. For example, we were able to see the time from detection of hypoglycemia to the next point-of-care glucose check and to resolution of the event.

In addition, we wanted some comparative benchmarking data. The GC eQUIPS Program has a robust database of U.S. hospitals, which helped us define our ultimate goal – to be in the upper quartile of all measures. And we did it! Because of the amazing teamwork and leadership support, we were able to achieve national distinction from SHM as a “Top Performer” hospital for glycemic care.
 

How did the program help you and the team design your initiatives?

Data are powerful and convincing. We post and report our eQUIPS Glucometrics to our clinical staff monthly by unit, and through this process, we obtain the necessary “buy-ins” as well as participation to design clinical protocols and order sets. For example, we noted that many patients would be placed on “sliding scale”/coverage insulin alone at the time of hospital admission. This often would not be adjusted during the hospital stay. Our data showed that this practice was associated with more glucose fluctuations and hypoglycemia. When we reviewed this with our hospitalists, we achieved consensus and developed basal/bolus correction insulin protocols, which are embedded in the admission care sets. Following use of these order sets, we noted less hypoglycemia (decreased from 5.9% and remains less than 3.6%) and lower glucose variability. With the help of the eQUIPS metrics and benchmarking, we now have more than 20 protocols and safety rules built into our EHR system.

What were the key benefits that the GC eQUIPS Program provided that you were unable to find elsewhere?

The unique features we found most useful are the national benchmarking and “real-world” data presentation. National benchmarking allows us to compare ourselves with other hospitals (we can sort for like hospitals or all hospitals) and to periodically evaluate our processes and reexamine our goals. As part of this program, we can communicate with leaders of other high-performing hospitals and share strategies and challenges as well as discuss successes and failures. The quarterly benchmark webinar is another opportunity to be part of this professional community and we often pick up helpful information.

We particularly like the hyperglycemia/hypoglycemia scatter plots, which demonstrate the practical and important impact of glycemic control. Often there is a see-saw effect in which, if one parameter goes up, the other goes down; finding the sweet spot between hyperglycemia and hypoglycemia is key and clinically important.
 

Do you have any other comments to share related to your institution’s participation in the program?

We are fortunate to have many successes driven by our participation with the GC eQUIPS Program:

• Coordination of capillary blood glucose (CBG) testing, insulin administration and meal delivery: Use of rapid-acting insulin premeal is standard of care and requires that CBG testing, insulin, and meal delivery be precisely coordinated for optimal insulin action. We developed a process in which the catering associate calls the nurse using a voice-activated pager when the meal tray leaves the kitchen. Then, the nurse checks the CBG and gives insulin when the tray arrives. The tray contains a card to empower the patient to wait for the nurse to administer insulin prior to eating. This also provides an opportunity for nutritional education and carbohydrate awareness. Implementation of this process increased the percentage of patients who had a CBG and insulin administration within 15 minutes before a meal from less than 10% to more than 60%.
• Patient education regarding insulin use: In many cases, hospital patients may be started on insulin and their oral agents may be discontinued. This can be confusing and frightening to patients who often do not know if they will need to be on insulin long term. Our GCT created a script for the staff nurse to inform and reassure patients that this is standard practice and does not mean that they will need to remain on insulin after hospital discharge. The clinical team will communicate with the patient and together they will review treatment options. We have received many positive reviews from patients and staff for improving communication around this aspect of insulin therapy.
• Clinician and leader education: When our data revealed an uptick in hypoglycemia in our critical care units, we engaged the physicians, nurses, and staff and reviewed patient charts to identify potential process changes. To keep hypoglycemia in the spotlight, our director of critical care added hypoglycemia to the ICU checklist, which is discussed on all team clinical rounds. We are also developing an electronic metric (24-hour glucose maximum and minimum values) that can be quickly reviewed by the clinical team daily.
• Hypoglycemia and hyperkalemia: Analysis of our hypoglycemia data revealed a higher-than-expected rate in the ED in patients who did not have a diabetes diagnosis. Further review showed that this was associated with insulin treatment of hyperkalemia. Subsequently, we engaged our resident trainees and other team members in a study to characterize this hypoglycemia-hyperkalemia, and we have recently submitted a manuscript for publication detailing our findings and recommendations for glucose monitoring in these patients.
• Guideline for medical consultation on nonmedical services: Based on review of glucometrics on the nonmedical units and discussions with our hospitalist teams, we designed a guideline that includes recommendations for Medical Consultation in Nonmedical Admissions. Comanagement by a medical consultant will be requested earlier, and we will monitor if this influences glucometrics, patient and hospitalist satisfaction, etc.
• Medical student and house staff education: Two of our GCT hospitalists organize a monthly patient safety conference. After the students and trainees are asked to propose actionable solutions, the hospitalists discuss proposals generated at our GCT meetings. The students and trainees have the opportunity to participate in quality improvement, and we get great ideas from them as well.

Perhaps our biggest success is our Glycemic Care Team itself. We now receive questions and items to review from all departments and are seen as the hospital’s expert team on diabetes and hyperglycemia. It is truly a pleasure to lead this group of extremely high functioning and dedicated professionals. It is said that “team work makes the dream work.” Moving forward, I hope to expand our Glycemic Care Team to all the hospitals in our network.

The Hospitalist recently sat down with Nancy J. Rennert, MD, FACE, FACP, CPHQ, chief of endocrinology and diabetes at Norwalk (Conn.) Hospital, Western Connecticut Health Network, to discuss her institution’s glycemic control initiatives.

Tell us a bit about your program:

Norwalk Hospital is a 366-bed community teaching hospital founded 125 years ago, now part of the growing Western Connecticut Health Network. Our residency and fellowship training programs are affiliated with Yale University, New Haven, Conn., and we are a branch campus of the University of Vermont, Burlington.

With leadership support, we created our Glycemic Care Team (GCT) 4 years ago to focus on improving the quality of care for persons with diabetes who were admitted to our hospital (often for another primary medical reason). Our hospitalists – 8 on the teaching service and 11 on the nonteaching service – are key players in our efforts as they care for the majority of medical inpatients. GCT is interdisciplinary and includes stakeholders at all levels, including quality, pharmacy, nutrition, hospital medicine, diabetes education, administrative leadership, endocrinology, information technology, point-of-care testing/pathology, surgery and more. We meet monthly with an agenda that includes safety events, glucometrics, and discussion of policies and protocols. Subgroups complete tasks in between the monthly meetings, and we bring in other clinical specialties as indicated based on the issues at hand.
 

What prior challenges did you encounter that led you to enroll in the Glycemic Control (GC) eQUIPS Program?

In order to know if our GCT was making a positive difference, we needed to first measure our baseline metrics and then identify our goals and develop our processes. We wanted actionable data analysis and the ability to differentiate areas of our hospital such as individual clinical units. After researching the options, we chose SHM’s GC eQUIPS Program, which we found to be user friendly. The national benchmarking was an important aspect for us as well. As a kick-off event, I invited Greg Maynard, MD, MHM, a hospitalist and the chief quality officer, UC Davis Medical Center, to speak on inpatient diabetes and was thrilled when he accepted my invitation. This provided an exciting start to our journey with SHM’s eQUIPS data management program.

As we began to obtain baseline measurements of glucose control, we needed a standardized, validated tool. The point-of-care glucose meters generated an enormous amount of data, but we were unable to sort this and analyze it in a meaningful and potentially actionable way. We were especially concerned about hypoglycemia. Our first task was to develop a prescriber ordered and nurse driven hypoglycemia protocol. How would we measure the overall effectiveness and success of the stepwise components of the protocol? The eQUIPS hypoglycemia management report was ideal in that it detailed metrics in stepwise fashion as it related to our protocol. For example, we were able to see the time from detection of hypoglycemia to the next point-of-care glucose check and to resolution of the event.

In addition, we wanted some comparative benchmarking data. The GC eQUIPS Program has a robust database of U.S. hospitals, which helped us define our ultimate goal – to be in the upper quartile of all measures. And we did it! Because of the amazing teamwork and leadership support, we were able to achieve national distinction from SHM as a “Top Performer” hospital for glycemic care.
 

How did the program help you and the team design your initiatives?

Data are powerful and convincing. We post and report our eQUIPS Glucometrics to our clinical staff monthly by unit, and through this process, we obtain the necessary “buy-ins” as well as participation to design clinical protocols and order sets. For example, we noted that many patients would be placed on “sliding scale”/coverage insulin alone at the time of hospital admission. This often would not be adjusted during the hospital stay. Our data showed that this practice was associated with more glucose fluctuations and hypoglycemia. When we reviewed this with our hospitalists, we achieved consensus and developed basal/bolus correction insulin protocols, which are embedded in the admission care sets. Following use of these order sets, we noted less hypoglycemia (decreased from 5.9% and remains less than 3.6%) and lower glucose variability. With the help of the eQUIPS metrics and benchmarking, we now have more than 20 protocols and safety rules built into our EHR system.

What were the key benefits that the GC eQUIPS Program provided that you were unable to find elsewhere?

The unique features we found most useful are the national benchmarking and “real-world” data presentation. National benchmarking allows us to compare ourselves with other hospitals (we can sort for like hospitals or all hospitals) and to periodically evaluate our processes and reexamine our goals. As part of this program, we can communicate with leaders of other high-performing hospitals and share strategies and challenges as well as discuss successes and failures. The quarterly benchmark webinar is another opportunity to be part of this professional community and we often pick up helpful information.

We particularly like the hyperglycemia/hypoglycemia scatter plots, which demonstrate the practical and important impact of glycemic control. Often there is a see-saw effect in which, if one parameter goes up, the other goes down; finding the sweet spot between hyperglycemia and hypoglycemia is key and clinically important.
 

Do you have any other comments to share related to your institution’s participation in the program?

We are fortunate to have many successes driven by our participation with the GC eQUIPS Program:

• Coordination of capillary blood glucose (CBG) testing, insulin administration and meal delivery: Use of rapid-acting insulin premeal is standard of care and requires that CBG testing, insulin, and meal delivery be precisely coordinated for optimal insulin action. We developed a process in which the catering associate calls the nurse using a voice-activated pager when the meal tray leaves the kitchen. Then, the nurse checks the CBG and gives insulin when the tray arrives. The tray contains a card to empower the patient to wait for the nurse to administer insulin prior to eating. This also provides an opportunity for nutritional education and carbohydrate awareness. Implementation of this process increased the percentage of patients who had a CBG and insulin administration within 15 minutes before a meal from less than 10% to more than 60%.
• Patient education regarding insulin use: In many cases, hospital patients may be started on insulin and their oral agents may be discontinued. This can be confusing and frightening to patients who often do not know if they will need to be on insulin long term. Our GCT created a script for the staff nurse to inform and reassure patients that this is standard practice and does not mean that they will need to remain on insulin after hospital discharge. The clinical team will communicate with the patient and together they will review treatment options. We have received many positive reviews from patients and staff for improving communication around this aspect of insulin therapy.
• Clinician and leader education: When our data revealed an uptick in hypoglycemia in our critical care units, we engaged the physicians, nurses, and staff and reviewed patient charts to identify potential process changes. To keep hypoglycemia in the spotlight, our director of critical care added hypoglycemia to the ICU checklist, which is discussed on all team clinical rounds. We are also developing an electronic metric (24-hour glucose maximum and minimum values) that can be quickly reviewed by the clinical team daily.
• Hypoglycemia and hyperkalemia: Analysis of our hypoglycemia data revealed a higher-than-expected rate in the ED in patients who did not have a diabetes diagnosis. Further review showed that this was associated with insulin treatment of hyperkalemia. Subsequently, we engaged our resident trainees and other team members in a study to characterize this hypoglycemia-hyperkalemia, and we have recently submitted a manuscript for publication detailing our findings and recommendations for glucose monitoring in these patients.
• Guideline for medical consultation on nonmedical services: Based on review of glucometrics on the nonmedical units and discussions with our hospitalist teams, we designed a guideline that includes recommendations for Medical Consultation in Nonmedical Admissions. Comanagement by a medical consultant will be requested earlier, and we will monitor if this influences glucometrics, patient and hospitalist satisfaction, etc.
• Medical student and house staff education: Two of our GCT hospitalists organize a monthly patient safety conference. After the students and trainees are asked to propose actionable solutions, the hospitalists discuss proposals generated at our GCT meetings. The students and trainees have the opportunity to participate in quality improvement, and we get great ideas from them as well.

Perhaps our biggest success is our Glycemic Care Team itself. We now receive questions and items to review from all departments and are seen as the hospital’s expert team on diabetes and hyperglycemia. It is truly a pleasure to lead this group of extremely high functioning and dedicated professionals. It is said that “team work makes the dream work.” Moving forward, I hope to expand our Glycemic Care Team to all the hospitals in our network.

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SAN DIEGO – Oncologists spent on average 3 minutes less with minority patients than with nonminority patients at a critical transition visit to talk about a scan result related to advanced cancer, a study investigator reported.

The gap was most pronounced for visits where a negative scan result was communicated, said investigator Cardinale B. Smith, MD, PhD, director of Quality for Cancer Services, Mount Sinai Health System, New York.

Future work is needed to look at the content of these conversations to determine to what extent physician- or patient-specific factors may have contributed to this difference, according to Dr. Smith.

“This will be critically important to ensure that we provide high-quality care to our minority patients,” Dr. Smith said at the 2018 Palliative and Supportive Care in Oncology Symposium.

The study included 22 oncologists from four hospitals randomized to either a usual-care group or an intervention group that included several interventions designed to improve communication techniques related to goals-of-care conversations

Sixty-nine percent of the physicians were white, while 23% were Asian, 8% were Hispanic, and 5% were black, Dr. Smith said.

Postimaging encounters were audio recorded for 142 patients, more than half of whom were minorities; 32% were black and 26% were Hispanic, according to the investigator, while 38% were white and 4% were Asian.

Overall, time spent with minorities at the scan results visit was 11.5 minutes versus 16.5 minutes for nonminorities (P = .0007), Dr. Smith reported.

When the scan was positive, there was actually no significant difference in time spent on minority versus nonminority visits, (16 versus 18 minutes; P = .59), a finding that Dr. Smith said was “encouraging” in an interview. However, there was a marked difference in length of time spent on minority versus nonminority visits when the scans showed no progression (10 versus 15 minutes; P = .0003).

“There’s something about regular, routine visits, which are still just as important as [positive] scan visits, in which there is a difference in the time spent,” Dr. Smith said in an interview. “We’re really interested in doing a more in-depth analysis of those conversations to see what’s contributing to those differences.”

After adjusting for patient insurance, education, income progression, status, and hospital, investigators found that oncologists spent 13.5 minutes (interquartile range, 12-16) with minority patients versus 16.5 minutes (IQR, 16-19) for nonminority patients (P less than .0001).

In terms of the communications intervention, investigators found no difference in time spent with minorities versus nonminorities among the intervention or control physicians. However, the intervention was aimed at improving the rate of goals of care conversations rather than improving communication based on race or ethnicity, Dr. Smith said.

By contrast, the finding of decreased time spent in communication encounters with minority patients merits further study to see how much of the disparity is mediated by differences in patients versus oncologists, she added.

In literature on communication disparities in other care settings outside of oncology, care conversations with minorities tend to be more closed ended, as opposed to open ended – so instead of asking if a patient is doing well, a physician might start out with a declarative statement that the patient’s findings are positive, she said.

On the other hand, some literature suggests that minority patients may not question the physician as much as nonminorities, or may not spend as much time asking directed questions during the visit. “That may also contribute to decreased time spent during those encounters,” Dr. Smith added.

The research was supported by the Patient Centered Outcomes Research Institute. Dr. Smith reported honoraria and a consulting or advisory role with Teva.

SOURCE: Smith CB et al. PallOnc 2018, Abstract 19.

SAN DIEGO – Oncologists spent on average 3 minutes less with minority patients than with nonminority patients at a critical transition visit to talk about a scan result related to advanced cancer, a study investigator reported.

The gap was most pronounced for visits where a negative scan result was communicated, said investigator Cardinale B. Smith, MD, PhD, director of Quality for Cancer Services, Mount Sinai Health System, New York.

Future work is needed to look at the content of these conversations to determine to what extent physician- or patient-specific factors may have contributed to this difference, according to Dr. Smith.

“This will be critically important to ensure that we provide high-quality care to our minority patients,” Dr. Smith said at the 2018 Palliative and Supportive Care in Oncology Symposium.

The study included 22 oncologists from four hospitals randomized to either a usual-care group or an intervention group that included several interventions designed to improve communication techniques related to goals-of-care conversations

Sixty-nine percent of the physicians were white, while 23% were Asian, 8% were Hispanic, and 5% were black, Dr. Smith said.

Postimaging encounters were audio recorded for 142 patients, more than half of whom were minorities; 32% were black and 26% were Hispanic, according to the investigator, while 38% were white and 4% were Asian.

Overall, time spent with minorities at the scan results visit was 11.5 minutes versus 16.5 minutes for nonminorities (P = .0007), Dr. Smith reported.

When the scan was positive, there was actually no significant difference in time spent on minority versus nonminority visits, (16 versus 18 minutes; P = .59), a finding that Dr. Smith said was “encouraging” in an interview. However, there was a marked difference in length of time spent on minority versus nonminority visits when the scans showed no progression (10 versus 15 minutes; P = .0003).

“There’s something about regular, routine visits, which are still just as important as [positive] scan visits, in which there is a difference in the time spent,” Dr. Smith said in an interview. “We’re really interested in doing a more in-depth analysis of those conversations to see what’s contributing to those differences.”

After adjusting for patient insurance, education, income progression, status, and hospital, investigators found that oncologists spent 13.5 minutes (interquartile range, 12-16) with minority patients versus 16.5 minutes (IQR, 16-19) for nonminority patients (P less than .0001).

In terms of the communications intervention, investigators found no difference in time spent with minorities versus nonminorities among the intervention or control physicians. However, the intervention was aimed at improving the rate of goals of care conversations rather than improving communication based on race or ethnicity, Dr. Smith said.

By contrast, the finding of decreased time spent in communication encounters with minority patients merits further study to see how much of the disparity is mediated by differences in patients versus oncologists, she added.

In literature on communication disparities in other care settings outside of oncology, care conversations with minorities tend to be more closed ended, as opposed to open ended – so instead of asking if a patient is doing well, a physician might start out with a declarative statement that the patient’s findings are positive, she said.

On the other hand, some literature suggests that minority patients may not question the physician as much as nonminorities, or may not spend as much time asking directed questions during the visit. “That may also contribute to decreased time spent during those encounters,” Dr. Smith added.

The research was supported by the Patient Centered Outcomes Research Institute. Dr. Smith reported honoraria and a consulting or advisory role with Teva.

SOURCE: Smith CB et al. PallOnc 2018, Abstract 19.

SAN DIEGO – Oncologists spent on average 3 minutes less with minority patients than with nonminority patients at a critical transition visit to talk about a scan result related to advanced cancer, a study investigator reported.

The gap was most pronounced for visits where a negative scan result was communicated, said investigator Cardinale B. Smith, MD, PhD, director of Quality for Cancer Services, Mount Sinai Health System, New York.

Future work is needed to look at the content of these conversations to determine to what extent physician- or patient-specific factors may have contributed to this difference, according to Dr. Smith.

“This will be critically important to ensure that we provide high-quality care to our minority patients,” Dr. Smith said at the 2018 Palliative and Supportive Care in Oncology Symposium.

The study included 22 oncologists from four hospitals randomized to either a usual-care group or an intervention group that included several interventions designed to improve communication techniques related to goals-of-care conversations

Sixty-nine percent of the physicians were white, while 23% were Asian, 8% were Hispanic, and 5% were black, Dr. Smith said.

Postimaging encounters were audio recorded for 142 patients, more than half of whom were minorities; 32% were black and 26% were Hispanic, according to the investigator, while 38% were white and 4% were Asian.

Overall, time spent with minorities at the scan results visit was 11.5 minutes versus 16.5 minutes for nonminorities (P = .0007), Dr. Smith reported.

When the scan was positive, there was actually no significant difference in time spent on minority versus nonminority visits, (16 versus 18 minutes; P = .59), a finding that Dr. Smith said was “encouraging” in an interview. However, there was a marked difference in length of time spent on minority versus nonminority visits when the scans showed no progression (10 versus 15 minutes; P = .0003).

“There’s something about regular, routine visits, which are still just as important as [positive] scan visits, in which there is a difference in the time spent,” Dr. Smith said in an interview. “We’re really interested in doing a more in-depth analysis of those conversations to see what’s contributing to those differences.”

After adjusting for patient insurance, education, income progression, status, and hospital, investigators found that oncologists spent 13.5 minutes (interquartile range, 12-16) with minority patients versus 16.5 minutes (IQR, 16-19) for nonminority patients (P less than .0001).

In terms of the communications intervention, investigators found no difference in time spent with minorities versus nonminorities among the intervention or control physicians. However, the intervention was aimed at improving the rate of goals of care conversations rather than improving communication based on race or ethnicity, Dr. Smith said.

By contrast, the finding of decreased time spent in communication encounters with minority patients merits further study to see how much of the disparity is mediated by differences in patients versus oncologists, she added.

In literature on communication disparities in other care settings outside of oncology, care conversations with minorities tend to be more closed ended, as opposed to open ended – so instead of asking if a patient is doing well, a physician might start out with a declarative statement that the patient’s findings are positive, she said.

On the other hand, some literature suggests that minority patients may not question the physician as much as nonminorities, or may not spend as much time asking directed questions during the visit. “That may also contribute to decreased time spent during those encounters,” Dr. Smith added.

The research was supported by the Patient Centered Outcomes Research Institute. Dr. Smith reported honoraria and a consulting or advisory role with Teva.

SOURCE: Smith CB et al. PallOnc 2018, Abstract 19.

SAN FRANCISCO – A new analysis shows that hepatitis C–infected livers can be safely transplanted into recipients with no effect on graft survival, retransplantation, or mortality. The work confirms that readily available direct-acting antiviral therapy can protect organ recipients and open a source of organs that is typically overlooked.

Jim Kling/MDedge News

The work should encourage both physicians and patients to take a closer look at hepatitis C–infected organs, especially for sicker patients, according to Sonali Paul, MD, who presented the study at the annual meeting of the American Association for the Study of Liver Disease 2018.

“A lot of people have an ethical issue with it because we’re actively transplanting a virus into someone. We’re giving someone a disease. My take on it is that we give people Epstein Barr virus or cytomegalovirus all the time – we just [provide] prophylaxis against it, and we don’t even bat an eye. Hepatitis C can be devastating, but we have totally effective treatments for it,” said Dr. Paul, who is an assistant professor of medicine at the University of Chicago.

She cited one colleague at the University of Chicago who several years ago transplanted an organ that had been passed over 700 times, though times have changed since then. “I think people more and more are doing this practice because we know it’s so successful,” said Dr. Paul.

It’s also cost effective. Another study, presented during the same session by Jag Chhatwal, PhD, assistant professor at Harvard Medical School, Boston, showed that accepting a hepatitis C–positive liver is cost effective in patients with Model for End-Stage Liver Disease (MELD) scores ranging from 22 to 40.

“I think we’re going to find across all organ systems, if we can transplant patients rather than keep them on dialysis or keep them on wait lists, it’s got to be cost effective, especially if you think of the health care–associated costs – like a heart transplant patient waiting on the list in the ICU. That’s a huge health care cost,” said Dr. Paul.

Dr. Paul’s team performed an analysis of the Scientific Registry of Transplant Recipients, including single organ transplants from deceased donors, during 2014-2018. Over that period, the number of transplants from hepatitis C–positive donors to hepatitis C–positive recipients rose from 8 in 2014 to 269, and the number of transplants from hepatitis C–positive donors to hepatitis C–negative recipients rose from 0 to 46.

The researchers compared trends from hepatitis C–negative donors with hepatitis C–negative recipients (n = 11,270), negative donors with positive recipients (n = 4,748), positive donors with negative recipients (n = 87), and positive donors with positive recipients (n = 753). Donor status had no effect on graft survival times at 1 or 2 years, with values ranging from 92.6% (negative to negative) to 94.3% (positive to positive) at 1 year and between 85.7% (positive to negative) and 89.7% (positive to positive) at 2 years.

“For someone who has a MELD score of over 20, who has a declining quality of life and really can’t do anything, I think this is a great opportunity. And most patients are absolutely willing to take these organs. We haven’t had many people say no, especially if they feel poorly,” said Dr. Paul.

She also underscored the importance of ensuring that the patient is informed of the status of the donor liver and the need to complete treatment: “The patient has to know what’s happening, and the hospital has to have a safety net if the insurance doesn’t pay for hepatitis C treatment.”
 

SOURCE: AASLD 2018, Abstract 0249.

SAN FRANCISCO – A new analysis shows that hepatitis C–infected livers can be safely transplanted into recipients with no effect on graft survival, retransplantation, or mortality. The work confirms that readily available direct-acting antiviral therapy can protect organ recipients and open a source of organs that is typically overlooked.

Jim Kling/MDedge News

The work should encourage both physicians and patients to take a closer look at hepatitis C–infected organs, especially for sicker patients, according to Sonali Paul, MD, who presented the study at the annual meeting of the American Association for the Study of Liver Disease 2018.

“A lot of people have an ethical issue with it because we’re actively transplanting a virus into someone. We’re giving someone a disease. My take on it is that we give people Epstein Barr virus or cytomegalovirus all the time – we just [provide] prophylaxis against it, and we don’t even bat an eye. Hepatitis C can be devastating, but we have totally effective treatments for it,” said Dr. Paul, who is an assistant professor of medicine at the University of Chicago.

She cited one colleague at the University of Chicago who several years ago transplanted an organ that had been passed over 700 times, though times have changed since then. “I think people more and more are doing this practice because we know it’s so successful,” said Dr. Paul.

It’s also cost effective. Another study, presented during the same session by Jag Chhatwal, PhD, assistant professor at Harvard Medical School, Boston, showed that accepting a hepatitis C–positive liver is cost effective in patients with Model for End-Stage Liver Disease (MELD) scores ranging from 22 to 40.

“I think we’re going to find across all organ systems, if we can transplant patients rather than keep them on dialysis or keep them on wait lists, it’s got to be cost effective, especially if you think of the health care–associated costs – like a heart transplant patient waiting on the list in the ICU. That’s a huge health care cost,” said Dr. Paul.

Dr. Paul’s team performed an analysis of the Scientific Registry of Transplant Recipients, including single organ transplants from deceased donors, during 2014-2018. Over that period, the number of transplants from hepatitis C–positive donors to hepatitis C–positive recipients rose from 8 in 2014 to 269, and the number of transplants from hepatitis C–positive donors to hepatitis C–negative recipients rose from 0 to 46.

The researchers compared trends from hepatitis C–negative donors with hepatitis C–negative recipients (n = 11,270), negative donors with positive recipients (n = 4,748), positive donors with negative recipients (n = 87), and positive donors with positive recipients (n = 753). Donor status had no effect on graft survival times at 1 or 2 years, with values ranging from 92.6% (negative to negative) to 94.3% (positive to positive) at 1 year and between 85.7% (positive to negative) and 89.7% (positive to positive) at 2 years.

“For someone who has a MELD score of over 20, who has a declining quality of life and really can’t do anything, I think this is a great opportunity. And most patients are absolutely willing to take these organs. We haven’t had many people say no, especially if they feel poorly,” said Dr. Paul.

She also underscored the importance of ensuring that the patient is informed of the status of the donor liver and the need to complete treatment: “The patient has to know what’s happening, and the hospital has to have a safety net if the insurance doesn’t pay for hepatitis C treatment.”
 

SOURCE: AASLD 2018, Abstract 0249.

SAN FRANCISCO – A new analysis shows that hepatitis C–infected livers can be safely transplanted into recipients with no effect on graft survival, retransplantation, or mortality. The work confirms that readily available direct-acting antiviral therapy can protect organ recipients and open a source of organs that is typically overlooked.

Jim Kling/MDedge News

The work should encourage both physicians and patients to take a closer look at hepatitis C–infected organs, especially for sicker patients, according to Sonali Paul, MD, who presented the study at the annual meeting of the American Association for the Study of Liver Disease 2018.

“A lot of people have an ethical issue with it because we’re actively transplanting a virus into someone. We’re giving someone a disease. My take on it is that we give people Epstein Barr virus or cytomegalovirus all the time – we just [provide] prophylaxis against it, and we don’t even bat an eye. Hepatitis C can be devastating, but we have totally effective treatments for it,” said Dr. Paul, who is an assistant professor of medicine at the University of Chicago.

She cited one colleague at the University of Chicago who several years ago transplanted an organ that had been passed over 700 times, though times have changed since then. “I think people more and more are doing this practice because we know it’s so successful,” said Dr. Paul.

It’s also cost effective. Another study, presented during the same session by Jag Chhatwal, PhD, assistant professor at Harvard Medical School, Boston, showed that accepting a hepatitis C–positive liver is cost effective in patients with Model for End-Stage Liver Disease (MELD) scores ranging from 22 to 40.

“I think we’re going to find across all organ systems, if we can transplant patients rather than keep them on dialysis or keep them on wait lists, it’s got to be cost effective, especially if you think of the health care–associated costs – like a heart transplant patient waiting on the list in the ICU. That’s a huge health care cost,” said Dr. Paul.

Dr. Paul’s team performed an analysis of the Scientific Registry of Transplant Recipients, including single organ transplants from deceased donors, during 2014-2018. Over that period, the number of transplants from hepatitis C–positive donors to hepatitis C–positive recipients rose from 8 in 2014 to 269, and the number of transplants from hepatitis C–positive donors to hepatitis C–negative recipients rose from 0 to 46.

The researchers compared trends from hepatitis C–negative donors with hepatitis C–negative recipients (n = 11,270), negative donors with positive recipients (n = 4,748), positive donors with negative recipients (n = 87), and positive donors with positive recipients (n = 753). Donor status had no effect on graft survival times at 1 or 2 years, with values ranging from 92.6% (negative to negative) to 94.3% (positive to positive) at 1 year and between 85.7% (positive to negative) and 89.7% (positive to positive) at 2 years.

“For someone who has a MELD score of over 20, who has a declining quality of life and really can’t do anything, I think this is a great opportunity. And most patients are absolutely willing to take these organs. We haven’t had many people say no, especially if they feel poorly,” said Dr. Paul.

She also underscored the importance of ensuring that the patient is informed of the status of the donor liver and the need to complete treatment: “The patient has to know what’s happening, and the hospital has to have a safety net if the insurance doesn’t pay for hepatitis C treatment.”
 

SOURCE: AASLD 2018, Abstract 0249.

PARIS – A cream formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and 2, outperformed triamcinolone cream 0.1% and vehicle control in a large, phase 2, dose-ranging, randomized trial in patients with atopic dermatitis (AD), Brian S. Kim, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

This novel topical JAK inhibitor not only modulates inflammatory cytokines involved in the pathogenesis of AD, including interleukin-4, -5, -13, and -31, but Dr. Kim and his coinvestigators also demonstrated that ruxolitinib has antipruritic effects achieved by acting directly on sensory nerve fibers.

“Ultimately, these findings show that ruxolitinib cream may represent a novel and effective treatment for patients with atopic dermatitis going forward,” said Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch at Washington University, St. Louis.

The trial included 307 adults, mean age 35 years, with a median 21-year disease history and a mean of 7.3 flares within the past 12 months. Dr. Kim characterized the study population as having AD of “high-moderate” severity, with a mean involved body surface area of 9.7%, half of patients having a baseline Eczema Area and Severity Index (EASI) score greater than 7, and having a mean itch numeric rating scale of 7. Two-thirds of patients had an Investigator’s Global Assessment (IGA) score of 3 and the rest had scores of 2.

Patients were randomized to one of six study arms entailing 8 weeks of double-blind therapy: ruxolitinib cream 1.5% once daily, 1.5% twice daily; 0.5% once daily; 0.15% once daily; twice-daily vehicle; or triamcinolone cream 0.1% twice a day for 4 weeks followed by 4 weeks of vehicle.

All the ruxolitinib regimens provided dose- and time-dependent efficacy, compared with vehicle. The best results were seen with ruxolitinib 1.5% twice daily, which outperformed triamcinolone cream.

The primary study endpoint was change in EASI score from baseline to week 4, but the week 2 and week 8 data were also informative. Key secondary endpoints included the proportion of subjects achieving an EASI-75 response and/or an IGA response, which required improvement to an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

As for itch, ruxolitinib cream provided rapid and sustained improvement, said Dr. Kim. Indeed, within the first 2 days of the study, the ruxolitinib 1.5% twice-daily group had a mean 1.8-point reduction on the numeric rating scale, compared with a 0.2-point drop with vehicle and a 1-point drop with triamcinolone cream twice a day. By week 4, the twice-daily ruxolitinib 1.5% group had about a 4-point drop from baseline, the once-daily ruxolitinib 1.5% group had a 3.5-point drop, and the triamcinolone-treated patients had a 2.5-point drop.

Topical ruxolitinib was not associated with any significant safety or tolerability issues, and there were no clinically significant application site reactions, according to the dermatologist.

Session cochair Konstantine Buxtorf Friedli, MD, a Swiss dermatologist, commented that she could easily imagine this topical JAK inhibitor also being useful in other diseases with itch.

Dr. Kim reported serving as a consultant to and recipient of research funding from Incyte, which sponsored the study.

[email protected]

PARIS – A cream formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and 2, outperformed triamcinolone cream 0.1% and vehicle control in a large, phase 2, dose-ranging, randomized trial in patients with atopic dermatitis (AD), Brian S. Kim, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

This novel topical JAK inhibitor not only modulates inflammatory cytokines involved in the pathogenesis of AD, including interleukin-4, -5, -13, and -31, but Dr. Kim and his coinvestigators also demonstrated that ruxolitinib has antipruritic effects achieved by acting directly on sensory nerve fibers.

“Ultimately, these findings show that ruxolitinib cream may represent a novel and effective treatment for patients with atopic dermatitis going forward,” said Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch at Washington University, St. Louis.

The trial included 307 adults, mean age 35 years, with a median 21-year disease history and a mean of 7.3 flares within the past 12 months. Dr. Kim characterized the study population as having AD of “high-moderate” severity, with a mean involved body surface area of 9.7%, half of patients having a baseline Eczema Area and Severity Index (EASI) score greater than 7, and having a mean itch numeric rating scale of 7. Two-thirds of patients had an Investigator’s Global Assessment (IGA) score of 3 and the rest had scores of 2.

Patients were randomized to one of six study arms entailing 8 weeks of double-blind therapy: ruxolitinib cream 1.5% once daily, 1.5% twice daily; 0.5% once daily; 0.15% once daily; twice-daily vehicle; or triamcinolone cream 0.1% twice a day for 4 weeks followed by 4 weeks of vehicle.

All the ruxolitinib regimens provided dose- and time-dependent efficacy, compared with vehicle. The best results were seen with ruxolitinib 1.5% twice daily, which outperformed triamcinolone cream.

The primary study endpoint was change in EASI score from baseline to week 4, but the week 2 and week 8 data were also informative. Key secondary endpoints included the proportion of subjects achieving an EASI-75 response and/or an IGA response, which required improvement to an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

As for itch, ruxolitinib cream provided rapid and sustained improvement, said Dr. Kim. Indeed, within the first 2 days of the study, the ruxolitinib 1.5% twice-daily group had a mean 1.8-point reduction on the numeric rating scale, compared with a 0.2-point drop with vehicle and a 1-point drop with triamcinolone cream twice a day. By week 4, the twice-daily ruxolitinib 1.5% group had about a 4-point drop from baseline, the once-daily ruxolitinib 1.5% group had a 3.5-point drop, and the triamcinolone-treated patients had a 2.5-point drop.

Topical ruxolitinib was not associated with any significant safety or tolerability issues, and there were no clinically significant application site reactions, according to the dermatologist.

Session cochair Konstantine Buxtorf Friedli, MD, a Swiss dermatologist, commented that she could easily imagine this topical JAK inhibitor also being useful in other diseases with itch.

Dr. Kim reported serving as a consultant to and recipient of research funding from Incyte, which sponsored the study.

[email protected]

PARIS – A cream formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and 2, outperformed triamcinolone cream 0.1% and vehicle control in a large, phase 2, dose-ranging, randomized trial in patients with atopic dermatitis (AD), Brian S. Kim, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

This novel topical JAK inhibitor not only modulates inflammatory cytokines involved in the pathogenesis of AD, including interleukin-4, -5, -13, and -31, but Dr. Kim and his coinvestigators also demonstrated that ruxolitinib has antipruritic effects achieved by acting directly on sensory nerve fibers.

“Ultimately, these findings show that ruxolitinib cream may represent a novel and effective treatment for patients with atopic dermatitis going forward,” said Dr. Kim, a dermatologist and codirector of the Center for the Study of Itch at Washington University, St. Louis.

The trial included 307 adults, mean age 35 years, with a median 21-year disease history and a mean of 7.3 flares within the past 12 months. Dr. Kim characterized the study population as having AD of “high-moderate” severity, with a mean involved body surface area of 9.7%, half of patients having a baseline Eczema Area and Severity Index (EASI) score greater than 7, and having a mean itch numeric rating scale of 7. Two-thirds of patients had an Investigator’s Global Assessment (IGA) score of 3 and the rest had scores of 2.

Patients were randomized to one of six study arms entailing 8 weeks of double-blind therapy: ruxolitinib cream 1.5% once daily, 1.5% twice daily; 0.5% once daily; 0.15% once daily; twice-daily vehicle; or triamcinolone cream 0.1% twice a day for 4 weeks followed by 4 weeks of vehicle.

All the ruxolitinib regimens provided dose- and time-dependent efficacy, compared with vehicle. The best results were seen with ruxolitinib 1.5% twice daily, which outperformed triamcinolone cream.

The primary study endpoint was change in EASI score from baseline to week 4, but the week 2 and week 8 data were also informative. Key secondary endpoints included the proportion of subjects achieving an EASI-75 response and/or an IGA response, which required improvement to an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

As for itch, ruxolitinib cream provided rapid and sustained improvement, said Dr. Kim. Indeed, within the first 2 days of the study, the ruxolitinib 1.5% twice-daily group had a mean 1.8-point reduction on the numeric rating scale, compared with a 0.2-point drop with vehicle and a 1-point drop with triamcinolone cream twice a day. By week 4, the twice-daily ruxolitinib 1.5% group had about a 4-point drop from baseline, the once-daily ruxolitinib 1.5% group had a 3.5-point drop, and the triamcinolone-treated patients had a 2.5-point drop.

Topical ruxolitinib was not associated with any significant safety or tolerability issues, and there were no clinically significant application site reactions, according to the dermatologist.

Session cochair Konstantine Buxtorf Friedli, MD, a Swiss dermatologist, commented that she could easily imagine this topical JAK inhibitor also being useful in other diseases with itch.

Dr. Kim reported serving as a consultant to and recipient of research funding from Incyte, which sponsored the study.

[email protected]

LAS VEGAS – When treating psoriasis, a dermatologist urged colleagues to not forget tried-and-true topical treatments, which she said can be effective as monotherapy in mild cases of psoriasis.

Wavebreakmedia/Thinkstock

Topicals often are a worthwhile complement to even the most advanced systemic medications, according to Linda Stein Gold, MD, director of clinical research in the department of dermatology at the Henry Ford Health System, Detroit.

Speaking at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, she pointed out that as the variety of vehicles for topical treatments has grown, so has the need to pay attention to the potency of these treatments. “Traditionally, we had thought we had to use a thick ointment to drive the drug in and get the best efficacy,” she said. “But we’ve changed our thought process.”

For example, betamethasone dipropionate 0.05%, now comes in multiple types of ointments and creams, with different potency classes, including Diprolene ointment, 0.05%, Diprosone cream, 0.05%, Diprolene cream AF, 0.05%, and Diprolene cream, 0.05%, as well as a lotion and an emollient spray.

“It’s the same active drug, but different vehicles absolutely change the potency of the drug,” Dr. Stein Gold said.

So which is the most potent? She said you can’t tell just by the vehicle. In this case, the most potent forms – in the “superpotent” class 1 – are Diprolene cream, 0.05%, and Diprolene ointment, 0.05%. (The National Psoriasis Foundation has a potency chart for topical psoriasis medications.)

She also recommended considering combination therapy with tazarotene. Tazarotene, a vitamin A derivative, is associated with a variety of side effects in 10%-30% of patients, including pruritus, erythema, irritation, skin pain, psoriasis worsening, and burning/stinging. But combination therapy with topical corticosteroids can reduce adverse effects, and it boosts efficacy as well, Dr. Stein Gold said.

She added that tazarotene can be a tool against acne. The 0.1% cream and gel formulations are approved by the Food and Drug Administration for treating acne; the 0.05% cream and gel forms are approved only for psoriasis. “Both concentrations work well and hit the different pillars of the pathogenesis of acne,” she said.

In addition, Dr. Stein Gold noted that she led two 2018 studies that found a fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate to severe plaque psoriasis was associated with significant reductions in the severity of the clinical signs of psoriasis, and minimal safety concerns (J Am Acad Dermatol. 2018 Aug;79[2]:287-93).

As for the future in topical treatment for psoriasis, she said researchers are exploring phosphodiesterase-4 inhibitors, Janus kinase inhibitors, and aryl hydrocarbon receptor agonists.

Dr. Stein Gold disclosed speaker bureau relationships with Galderma, Leo, Valeant, Novartis, Celgene and Allergan; consulting for Sol‐Gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor and Medimetriks; receiving grant/research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan and Foamix; and serving on scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix and Promius.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – When treating psoriasis, a dermatologist urged colleagues to not forget tried-and-true topical treatments, which she said can be effective as monotherapy in mild cases of psoriasis.

Wavebreakmedia/Thinkstock

Topicals often are a worthwhile complement to even the most advanced systemic medications, according to Linda Stein Gold, MD, director of clinical research in the department of dermatology at the Henry Ford Health System, Detroit.

Speaking at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, she pointed out that as the variety of vehicles for topical treatments has grown, so has the need to pay attention to the potency of these treatments. “Traditionally, we had thought we had to use a thick ointment to drive the drug in and get the best efficacy,” she said. “But we’ve changed our thought process.”

For example, betamethasone dipropionate 0.05%, now comes in multiple types of ointments and creams, with different potency classes, including Diprolene ointment, 0.05%, Diprosone cream, 0.05%, Diprolene cream AF, 0.05%, and Diprolene cream, 0.05%, as well as a lotion and an emollient spray.

“It’s the same active drug, but different vehicles absolutely change the potency of the drug,” Dr. Stein Gold said.

So which is the most potent? She said you can’t tell just by the vehicle. In this case, the most potent forms – in the “superpotent” class 1 – are Diprolene cream, 0.05%, and Diprolene ointment, 0.05%. (The National Psoriasis Foundation has a potency chart for topical psoriasis medications.)

She also recommended considering combination therapy with tazarotene. Tazarotene, a vitamin A derivative, is associated with a variety of side effects in 10%-30% of patients, including pruritus, erythema, irritation, skin pain, psoriasis worsening, and burning/stinging. But combination therapy with topical corticosteroids can reduce adverse effects, and it boosts efficacy as well, Dr. Stein Gold said.

She added that tazarotene can be a tool against acne. The 0.1% cream and gel formulations are approved by the Food and Drug Administration for treating acne; the 0.05% cream and gel forms are approved only for psoriasis. “Both concentrations work well and hit the different pillars of the pathogenesis of acne,” she said.

In addition, Dr. Stein Gold noted that she led two 2018 studies that found a fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate to severe plaque psoriasis was associated with significant reductions in the severity of the clinical signs of psoriasis, and minimal safety concerns (J Am Acad Dermatol. 2018 Aug;79[2]:287-93).

As for the future in topical treatment for psoriasis, she said researchers are exploring phosphodiesterase-4 inhibitors, Janus kinase inhibitors, and aryl hydrocarbon receptor agonists.

Dr. Stein Gold disclosed speaker bureau relationships with Galderma, Leo, Valeant, Novartis, Celgene and Allergan; consulting for Sol‐Gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor and Medimetriks; receiving grant/research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan and Foamix; and serving on scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix and Promius.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – When treating psoriasis, a dermatologist urged colleagues to not forget tried-and-true topical treatments, which she said can be effective as monotherapy in mild cases of psoriasis.

Wavebreakmedia/Thinkstock

Topicals often are a worthwhile complement to even the most advanced systemic medications, according to Linda Stein Gold, MD, director of clinical research in the department of dermatology at the Henry Ford Health System, Detroit.

Speaking at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, she pointed out that as the variety of vehicles for topical treatments has grown, so has the need to pay attention to the potency of these treatments. “Traditionally, we had thought we had to use a thick ointment to drive the drug in and get the best efficacy,” she said. “But we’ve changed our thought process.”

For example, betamethasone dipropionate 0.05%, now comes in multiple types of ointments and creams, with different potency classes, including Diprolene ointment, 0.05%, Diprosone cream, 0.05%, Diprolene cream AF, 0.05%, and Diprolene cream, 0.05%, as well as a lotion and an emollient spray.

“It’s the same active drug, but different vehicles absolutely change the potency of the drug,” Dr. Stein Gold said.

So which is the most potent? She said you can’t tell just by the vehicle. In this case, the most potent forms – in the “superpotent” class 1 – are Diprolene cream, 0.05%, and Diprolene ointment, 0.05%. (The National Psoriasis Foundation has a potency chart for topical psoriasis medications.)

She also recommended considering combination therapy with tazarotene. Tazarotene, a vitamin A derivative, is associated with a variety of side effects in 10%-30% of patients, including pruritus, erythema, irritation, skin pain, psoriasis worsening, and burning/stinging. But combination therapy with topical corticosteroids can reduce adverse effects, and it boosts efficacy as well, Dr. Stein Gold said.

She added that tazarotene can be a tool against acne. The 0.1% cream and gel formulations are approved by the Food and Drug Administration for treating acne; the 0.05% cream and gel forms are approved only for psoriasis. “Both concentrations work well and hit the different pillars of the pathogenesis of acne,” she said.

In addition, Dr. Stein Gold noted that she led two 2018 studies that found a fixed combination of halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate to severe plaque psoriasis was associated with significant reductions in the severity of the clinical signs of psoriasis, and minimal safety concerns (J Am Acad Dermatol. 2018 Aug;79[2]:287-93).

As for the future in topical treatment for psoriasis, she said researchers are exploring phosphodiesterase-4 inhibitors, Janus kinase inhibitors, and aryl hydrocarbon receptor agonists.

Dr. Stein Gold disclosed speaker bureau relationships with Galderma, Leo, Valeant, Novartis, Celgene and Allergan; consulting for Sol‐Gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor and Medimetriks; receiving grant/research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan and Foamix; and serving on scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix and Promius.

SDEF and this news organization are owned by the same parent company.

WASHINGTON – Combination lenvatinib and pembrolizumab shows promising clinical activity and a manageable safety profile in previously treated patients with confirmed, measurable, metastatic non–small cell lung cancer (NSCLC), according to interim findings from a phase 1b/2 study.

Sharon Worcester/MDedge News

Of note, the 21 patients enrolled in the multicenter, open-label study as of March 2018 were not preselected for programmed death-ligand 1 (PD-L1) tumor expression status, Marcia S. Brose, MD, reported at the annual meeting of the Society for the Immunotherapy of Cancer.

They were treated with 20 mg of oral lenvatinib daily and 200 mg of intravenous pembrolizumab every 3 weeks, and the overall response rate at 24 weeks – the primary endpoint of the study – was 33.3%, said Dr. Brose of Abramson Cancer Center of the University of Pennsylvania, Philadelphia.

One patient had a complete response, six had a partial response, 10 had stable disease, two progressed on treatment, and the outcome in two was unknown or not evaluable, for an overall clinical benefit rate of 66%, she said, adding that the median duration of response was 10.9 months and median progression-free survival (PFS) was 5.9 months.

All patients had good performance status (ECOG score of 0-1), and nine (43%) were PD-L1–positive as defined by a tumor proportion score of at least 1%, five (24%) were PD-L1-negative, and seven (33%) were not tested for PD-L1 status. Three (14%) were treatment naive, while seven (33%), 10 (48%), and one (5%) had received one, two, or three or more prior lines of systemic therapy, respectively. No prior nivolumab or pembrolizumab treatment was allowed.

“At least one of the patients who was PD-L1–negative remained on study after 40 weeks and still continuing to respond, and ... the PD-L1–positive patients were also doing well,” Dr. Brose said.

Tumor assessments were performed by study investigators using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Grade 3 or greater treatment-related adverse events occurred in 10 patients (48%), and mainly included hypertension, fatigue, and diarrhea, but only four were considered serious treatment-related adverse events. Nineteen patients had treatment adjustments because of adverse events, four discontinued treatment due to adverse events, and one patient died from a pulmonary hemorrhage that was thought to possibly be treatment related, Dr. Brose said.

“The toxicity is really what you would have expected from either of these drugs on their own; it didn’t seem like there was anything that happened in synergy from the two that was unexpected,” she noted.

Lenvatinib is a multikinase inhibitor of vascular endothelial growth factor (VEGF) receptors 1-3, fibroblast growth factor receptors (FGFR) 1-4, platelet-derived growth factor receptor (PDGFR) alpha, and the RET and c-KIT proto-oncogenes. Pembrolizumab is an anti–PD-1 antibody approved as a monotherapy for previously treated patients with metastatic PD-L1–positive NSCLC, and it has been shown to be associated with an overall response rate of 18%, she explained.

The current results are from the NSCLC cohort of an ongoing trial of lenvatinib plus pembrolizumab in patients with solid tumors.

“Further investigation of this study drug combination in patients is warranted, but we will have to think carefully about what point in the treatment paradigm these patients should be treated in order to maximize the benefit from this combination therapy,” she concluded.

Dr. Brose has received consulting fees, research grants, and honorarium from Eisai.

SOURCE: Brose M et al. SITC 2018, Abstract P392.

WASHINGTON – Combination lenvatinib and pembrolizumab shows promising clinical activity and a manageable safety profile in previously treated patients with confirmed, measurable, metastatic non–small cell lung cancer (NSCLC), according to interim findings from a phase 1b/2 study.

Sharon Worcester/MDedge News

Of note, the 21 patients enrolled in the multicenter, open-label study as of March 2018 were not preselected for programmed death-ligand 1 (PD-L1) tumor expression status, Marcia S. Brose, MD, reported at the annual meeting of the Society for the Immunotherapy of Cancer.

They were treated with 20 mg of oral lenvatinib daily and 200 mg of intravenous pembrolizumab every 3 weeks, and the overall response rate at 24 weeks – the primary endpoint of the study – was 33.3%, said Dr. Brose of Abramson Cancer Center of the University of Pennsylvania, Philadelphia.

One patient had a complete response, six had a partial response, 10 had stable disease, two progressed on treatment, and the outcome in two was unknown or not evaluable, for an overall clinical benefit rate of 66%, she said, adding that the median duration of response was 10.9 months and median progression-free survival (PFS) was 5.9 months.

All patients had good performance status (ECOG score of 0-1), and nine (43%) were PD-L1–positive as defined by a tumor proportion score of at least 1%, five (24%) were PD-L1-negative, and seven (33%) were not tested for PD-L1 status. Three (14%) were treatment naive, while seven (33%), 10 (48%), and one (5%) had received one, two, or three or more prior lines of systemic therapy, respectively. No prior nivolumab or pembrolizumab treatment was allowed.

“At least one of the patients who was PD-L1–negative remained on study after 40 weeks and still continuing to respond, and ... the PD-L1–positive patients were also doing well,” Dr. Brose said.

Tumor assessments were performed by study investigators using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Grade 3 or greater treatment-related adverse events occurred in 10 patients (48%), and mainly included hypertension, fatigue, and diarrhea, but only four were considered serious treatment-related adverse events. Nineteen patients had treatment adjustments because of adverse events, four discontinued treatment due to adverse events, and one patient died from a pulmonary hemorrhage that was thought to possibly be treatment related, Dr. Brose said.

“The toxicity is really what you would have expected from either of these drugs on their own; it didn’t seem like there was anything that happened in synergy from the two that was unexpected,” she noted.

Lenvatinib is a multikinase inhibitor of vascular endothelial growth factor (VEGF) receptors 1-3, fibroblast growth factor receptors (FGFR) 1-4, platelet-derived growth factor receptor (PDGFR) alpha, and the RET and c-KIT proto-oncogenes. Pembrolizumab is an anti–PD-1 antibody approved as a monotherapy for previously treated patients with metastatic PD-L1–positive NSCLC, and it has been shown to be associated with an overall response rate of 18%, she explained.

The current results are from the NSCLC cohort of an ongoing trial of lenvatinib plus pembrolizumab in patients with solid tumors.

“Further investigation of this study drug combination in patients is warranted, but we will have to think carefully about what point in the treatment paradigm these patients should be treated in order to maximize the benefit from this combination therapy,” she concluded.

Dr. Brose has received consulting fees, research grants, and honorarium from Eisai.

SOURCE: Brose M et al. SITC 2018, Abstract P392.

WASHINGTON – Combination lenvatinib and pembrolizumab shows promising clinical activity and a manageable safety profile in previously treated patients with confirmed, measurable, metastatic non–small cell lung cancer (NSCLC), according to interim findings from a phase 1b/2 study.

Sharon Worcester/MDedge News

Of note, the 21 patients enrolled in the multicenter, open-label study as of March 2018 were not preselected for programmed death-ligand 1 (PD-L1) tumor expression status, Marcia S. Brose, MD, reported at the annual meeting of the Society for the Immunotherapy of Cancer.

They were treated with 20 mg of oral lenvatinib daily and 200 mg of intravenous pembrolizumab every 3 weeks, and the overall response rate at 24 weeks – the primary endpoint of the study – was 33.3%, said Dr. Brose of Abramson Cancer Center of the University of Pennsylvania, Philadelphia.

One patient had a complete response, six had a partial response, 10 had stable disease, two progressed on treatment, and the outcome in two was unknown or not evaluable, for an overall clinical benefit rate of 66%, she said, adding that the median duration of response was 10.9 months and median progression-free survival (PFS) was 5.9 months.

All patients had good performance status (ECOG score of 0-1), and nine (43%) were PD-L1–positive as defined by a tumor proportion score of at least 1%, five (24%) were PD-L1-negative, and seven (33%) were not tested for PD-L1 status. Three (14%) were treatment naive, while seven (33%), 10 (48%), and one (5%) had received one, two, or three or more prior lines of systemic therapy, respectively. No prior nivolumab or pembrolizumab treatment was allowed.

“At least one of the patients who was PD-L1–negative remained on study after 40 weeks and still continuing to respond, and ... the PD-L1–positive patients were also doing well,” Dr. Brose said.

Tumor assessments were performed by study investigators using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

Grade 3 or greater treatment-related adverse events occurred in 10 patients (48%), and mainly included hypertension, fatigue, and diarrhea, but only four were considered serious treatment-related adverse events. Nineteen patients had treatment adjustments because of adverse events, four discontinued treatment due to adverse events, and one patient died from a pulmonary hemorrhage that was thought to possibly be treatment related, Dr. Brose said.

“The toxicity is really what you would have expected from either of these drugs on their own; it didn’t seem like there was anything that happened in synergy from the two that was unexpected,” she noted.

Lenvatinib is a multikinase inhibitor of vascular endothelial growth factor (VEGF) receptors 1-3, fibroblast growth factor receptors (FGFR) 1-4, platelet-derived growth factor receptor (PDGFR) alpha, and the RET and c-KIT proto-oncogenes. Pembrolizumab is an anti–PD-1 antibody approved as a monotherapy for previously treated patients with metastatic PD-L1–positive NSCLC, and it has been shown to be associated with an overall response rate of 18%, she explained.

The current results are from the NSCLC cohort of an ongoing trial of lenvatinib plus pembrolizumab in patients with solid tumors.

“Further investigation of this study drug combination in patients is warranted, but we will have to think carefully about what point in the treatment paradigm these patients should be treated in order to maximize the benefit from this combination therapy,” she concluded.

Dr. Brose has received consulting fees, research grants, and honorarium from Eisai.

SOURCE: Brose M et al. SITC 2018, Abstract P392.