User login
Nonadherence to lupus drugs may play a role in frequent hospitalization
SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.
Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.
“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.
The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).
Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).
As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).
Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.
For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.
They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).
Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.
As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.
The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.
The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).
“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.
How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.
“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”
Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.
The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.
SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.
Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.
“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.
The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).
Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).
As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).
Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.
For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.
They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).
Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.
As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.
The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.
The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).
“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.
How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.
“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”
Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.
The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.
SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.
Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.
“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.
The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).
Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).
As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).
Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.
For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.
They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).
Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.
As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.
The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.
The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).
“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.
How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.
“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”
Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.
The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.
REPORTING FROM ACR 2017
Key clinical point:
Major finding: Compared with other patients hospitalized with SLE, high-risk patients had 10% lower medication adherence.
Data source: A 2-year analysis of 171 patients (28 deemed high risk) admitted for SLE at a single hospital.
Disclosures: The study authors reported no relevant disclosures. No specific study funding is reported.
Source: C. Thirukuraman et al. ACR 2017 abstract 223.
VIDEO: Dr. Sherene Loi discusses PANACEA trial and implications for pembrolizumab use
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
VIDEO: Meta-analysis lead author Dr. Richard Gray on dose intensity benefit
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
FDA approves injectable diabetes drug that improves A1c scores
The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”
The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”
The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”
Pulmonary hypertension treatment gets under the skin
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
FROM CHEST
Key clinical point: An implantable drug delivery system was successfully placed in 100% of adult PAH patients with no serious complications.
Major finding: The most common complaints among patients who received an implant system to deliver treprostinil were implant site pain (83%) and bruising (17%).
Data source: A multicenter, prospective study of 60 adults with pulmonary arterial hypertension who received implantable pumps to deliver treprostinil.
Disclosures: Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Using post-acute and long-term care quality report cards
The challenges of hospital discharge planning are well known and yet have not been adequately addressed by hospitalists and discharge teams. As the complexity of patient care needs has grown, so has the difficulty in developing appropriate discharge goals for post-acute and long term care (LTC), choosing the appropriate setting(s), and selecting appropriate providers. Post-acute and LTC needs may include rehabilitation, nursing care, home health, supportive services, and/or palliative care1 in an institutional setting or at home from a wide array of providers with varying levels of quality.
Even though 52% of U.S. hospitals received penalties for having higher-than-expected readmissions between 2013 and 2017,2 inadequate discharge planning for post-acute and LTC continues to contribute to high rates of all-cause 30-day rehospitalization. The discharge process sometimes is deficient in: discussion of goals; assessment of discharge needs; appropriate choice of discharge locations; and the provision of additional or different home services.3 Discharge decisions are complicated by the stressful circumstances of hospitalization and discharge deadlines.
Hospital discharge planning decisions fall heavily on patients, families, and caregivers, often with inadequate information about choices and options. More than 30 states have passed the Caregiver Advise, Record, and Enable (CARE) Act into law to require hospitals to provide resources for family caregiver education and instruction,7 but hospitals do not have to provide information on all LTC options and provider quality ratings.
Quality report cards about LTC providers – a major innovation for consumer education and choice – are often not used in the discharge process for a number of reasons. A significant concern is that using report cards will extend the length of stay. Rather than extending the decision-making time and the length of stay, the use of report cards can reduce length of stay.9 A focus on identifying the first available nursing home bed or LTC provider often ignores the need to identify the most appropriate high-quality providers.
Hospitals and health plans often have established networks of post-acute and LTC providers and these networks must be taken into account in the discharge process. Most hospital and health plan networks have providers with a wide range of ratings, allowing for choices within networks.
The Centers for Medicare and Medicaid Services (CMS) established a web-based nursing home report card called Nursing Home Compare in 1998 that includes information on facility characteristics, deficiencies, staffing information (since 2000), and resident quality indicators (since 2002). In 2008, the website added a “five-star” rating system for all U.S. nursing homes and all-cause 30-day readmission rates and successful discharge rates from nursing homes were incorporated into the ratings in 2016.
CMS also established a web-based home health website, which provides quality ratings. This website has general information, quality measures, and patient surveys with information on readmission rates from home health agency services.
After establishment of the CMS Nursing Home Compare rating system in 2008, nursing homes improved their scores on certain quality measures and consumer demand significantly increased for the best (5-star) facilities and decreased for 1-star facilities.10 More recently, a clinical trial of the use of a personalized version of Nursing Home Compare in the hospital discharge planning process found greater patient satisfaction, patients being more likely to go to higher ranked nursing homes, patients traveling further to nursing homes, and patients having shorter hospital stays, compared with the control group.9
Quality report cards show wide variations within and across states ranging from one star (poorest quality) to five stars (highest quality). More than one-third of nursing homes had relatively low overall star ratings (1 or 2 stars) serving 39 percent of residents in 2015.11 Federal nursing home regulatory violations range from zero to more than 40 deficiencies (average of 7) with a scope and severity ranging from minor to widespread harm or jeopardy (including deaths).12 Total nurse staffing hours (average, 4.1 hours per resident day) range from less than 3 hours to more than 5.5 hours per resident day and RN hours are 3.5 times higher in some nursing homes than in the lowest staffed homes.13 Hospital readmission rates for short-stay residents from nursing homes also vary widely (4%-52%; average, 21%).12,14
Hospitalists and discharge planners should inform patients, families, and caregivers about the federal and state LTC quality report cards, provide education and choices, and engage and assist them in the decision making process. Hospitals, health plans, and accountable care organizations also need to be more informed about the availability of and benefits of using quality report cards for developing post-acute and LTC provider networks. The use of high quality LTC network providers should be able to reduce hospital length of stay and hospital readmission rates, and improve patient and caregiver satisfaction.
Charlene Harrington, PhD, RN, is professor of sociology and nursing; Leslie Ross, PhD, is a research specialist and principal investigator of the Calqualitycare.org website project; and Jeffrey Newman, MD, MPH, is a professor at the Institute for Health and Aging, all at the University of California, San Francisco.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
2. Thompson, MP, Waters, TM, Kaplan et al. Most hospitals received annual penalties for excess readmissions, but some fared better than others. Health Aff (Millwood). 36(5):893-901.
3. Auerbach AD et al. Preventability and causes of readmissions in a national cohort of general medicine patients. JAMA Intern Med. 2016;176(4):484-93.
4. Jack B et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-87.
5. Hansen LO et al. Project BOOST: effectiveness of a multihospital effort to reduce rehospitalization. J Hosp Med. 2013;8(8)421-7.
6. Naylor MD et al. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011;30(4):746-54.
7. Coleman EA. Family caregivers as partners in care transitions: The caregiver advise record and enable act. J Hosp Med. 2016 Dec;11(12):883-5.
8. Leppin AL et al. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Internal Med. 2014;174(7):1095-107.
9. Mukamel DB et al. Personalizing nursing home compare and the discharge from hospitals to nursing homes. Health Serv Res. 2016;1(6):2076-2094.
10. Werner RM et al. Changes in consumer demand following public reporting of summary quality ratings: An evaluation in nursing homes. Health Serv Res. 2016;51 Suppl 2:1291-309.
11. Boccuti C et al. Reading the stars: nursing home quality star ratings, nationally and by state. Kaiser Family Foundation Issue Brief. May 2015.
12. Centers for Medicare and Medicaid Services. Nursing home compare data archives. May 2017 monthly files. Quality MSR Claims data. https://data.medicare.gov/data/archives/nursing-home-compare. Accessed July 15, 2017.
13. Harrington C et al. The need for higher minimum staffing standards in U.S. nursing homes. Health Serv Insights. 2016;9:13-9.
14. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
The challenges of hospital discharge planning are well known and yet have not been adequately addressed by hospitalists and discharge teams. As the complexity of patient care needs has grown, so has the difficulty in developing appropriate discharge goals for post-acute and long term care (LTC), choosing the appropriate setting(s), and selecting appropriate providers. Post-acute and LTC needs may include rehabilitation, nursing care, home health, supportive services, and/or palliative care1 in an institutional setting or at home from a wide array of providers with varying levels of quality.
Even though 52% of U.S. hospitals received penalties for having higher-than-expected readmissions between 2013 and 2017,2 inadequate discharge planning for post-acute and LTC continues to contribute to high rates of all-cause 30-day rehospitalization. The discharge process sometimes is deficient in: discussion of goals; assessment of discharge needs; appropriate choice of discharge locations; and the provision of additional or different home services.3 Discharge decisions are complicated by the stressful circumstances of hospitalization and discharge deadlines.
Hospital discharge planning decisions fall heavily on patients, families, and caregivers, often with inadequate information about choices and options. More than 30 states have passed the Caregiver Advise, Record, and Enable (CARE) Act into law to require hospitals to provide resources for family caregiver education and instruction,7 but hospitals do not have to provide information on all LTC options and provider quality ratings.
Quality report cards about LTC providers – a major innovation for consumer education and choice – are often not used in the discharge process for a number of reasons. A significant concern is that using report cards will extend the length of stay. Rather than extending the decision-making time and the length of stay, the use of report cards can reduce length of stay.9 A focus on identifying the first available nursing home bed or LTC provider often ignores the need to identify the most appropriate high-quality providers.
Hospitals and health plans often have established networks of post-acute and LTC providers and these networks must be taken into account in the discharge process. Most hospital and health plan networks have providers with a wide range of ratings, allowing for choices within networks.
The Centers for Medicare and Medicaid Services (CMS) established a web-based nursing home report card called Nursing Home Compare in 1998 that includes information on facility characteristics, deficiencies, staffing information (since 2000), and resident quality indicators (since 2002). In 2008, the website added a “five-star” rating system for all U.S. nursing homes and all-cause 30-day readmission rates and successful discharge rates from nursing homes were incorporated into the ratings in 2016.
CMS also established a web-based home health website, which provides quality ratings. This website has general information, quality measures, and patient surveys with information on readmission rates from home health agency services.
After establishment of the CMS Nursing Home Compare rating system in 2008, nursing homes improved their scores on certain quality measures and consumer demand significantly increased for the best (5-star) facilities and decreased for 1-star facilities.10 More recently, a clinical trial of the use of a personalized version of Nursing Home Compare in the hospital discharge planning process found greater patient satisfaction, patients being more likely to go to higher ranked nursing homes, patients traveling further to nursing homes, and patients having shorter hospital stays, compared with the control group.9
Quality report cards show wide variations within and across states ranging from one star (poorest quality) to five stars (highest quality). More than one-third of nursing homes had relatively low overall star ratings (1 or 2 stars) serving 39 percent of residents in 2015.11 Federal nursing home regulatory violations range from zero to more than 40 deficiencies (average of 7) with a scope and severity ranging from minor to widespread harm or jeopardy (including deaths).12 Total nurse staffing hours (average, 4.1 hours per resident day) range from less than 3 hours to more than 5.5 hours per resident day and RN hours are 3.5 times higher in some nursing homes than in the lowest staffed homes.13 Hospital readmission rates for short-stay residents from nursing homes also vary widely (4%-52%; average, 21%).12,14
Hospitalists and discharge planners should inform patients, families, and caregivers about the federal and state LTC quality report cards, provide education and choices, and engage and assist them in the decision making process. Hospitals, health plans, and accountable care organizations also need to be more informed about the availability of and benefits of using quality report cards for developing post-acute and LTC provider networks. The use of high quality LTC network providers should be able to reduce hospital length of stay and hospital readmission rates, and improve patient and caregiver satisfaction.
Charlene Harrington, PhD, RN, is professor of sociology and nursing; Leslie Ross, PhD, is a research specialist and principal investigator of the Calqualitycare.org website project; and Jeffrey Newman, MD, MPH, is a professor at the Institute for Health and Aging, all at the University of California, San Francisco.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
2. Thompson, MP, Waters, TM, Kaplan et al. Most hospitals received annual penalties for excess readmissions, but some fared better than others. Health Aff (Millwood). 36(5):893-901.
3. Auerbach AD et al. Preventability and causes of readmissions in a national cohort of general medicine patients. JAMA Intern Med. 2016;176(4):484-93.
4. Jack B et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-87.
5. Hansen LO et al. Project BOOST: effectiveness of a multihospital effort to reduce rehospitalization. J Hosp Med. 2013;8(8)421-7.
6. Naylor MD et al. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011;30(4):746-54.
7. Coleman EA. Family caregivers as partners in care transitions: The caregiver advise record and enable act. J Hosp Med. 2016 Dec;11(12):883-5.
8. Leppin AL et al. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Internal Med. 2014;174(7):1095-107.
9. Mukamel DB et al. Personalizing nursing home compare and the discharge from hospitals to nursing homes. Health Serv Res. 2016;1(6):2076-2094.
10. Werner RM et al. Changes in consumer demand following public reporting of summary quality ratings: An evaluation in nursing homes. Health Serv Res. 2016;51 Suppl 2:1291-309.
11. Boccuti C et al. Reading the stars: nursing home quality star ratings, nationally and by state. Kaiser Family Foundation Issue Brief. May 2015.
12. Centers for Medicare and Medicaid Services. Nursing home compare data archives. May 2017 monthly files. Quality MSR Claims data. https://data.medicare.gov/data/archives/nursing-home-compare. Accessed July 15, 2017.
13. Harrington C et al. The need for higher minimum staffing standards in U.S. nursing homes. Health Serv Insights. 2016;9:13-9.
14. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
The challenges of hospital discharge planning are well known and yet have not been adequately addressed by hospitalists and discharge teams. As the complexity of patient care needs has grown, so has the difficulty in developing appropriate discharge goals for post-acute and long term care (LTC), choosing the appropriate setting(s), and selecting appropriate providers. Post-acute and LTC needs may include rehabilitation, nursing care, home health, supportive services, and/or palliative care1 in an institutional setting or at home from a wide array of providers with varying levels of quality.
Even though 52% of U.S. hospitals received penalties for having higher-than-expected readmissions between 2013 and 2017,2 inadequate discharge planning for post-acute and LTC continues to contribute to high rates of all-cause 30-day rehospitalization. The discharge process sometimes is deficient in: discussion of goals; assessment of discharge needs; appropriate choice of discharge locations; and the provision of additional or different home services.3 Discharge decisions are complicated by the stressful circumstances of hospitalization and discharge deadlines.
Hospital discharge planning decisions fall heavily on patients, families, and caregivers, often with inadequate information about choices and options. More than 30 states have passed the Caregiver Advise, Record, and Enable (CARE) Act into law to require hospitals to provide resources for family caregiver education and instruction,7 but hospitals do not have to provide information on all LTC options and provider quality ratings.
Quality report cards about LTC providers – a major innovation for consumer education and choice – are often not used in the discharge process for a number of reasons. A significant concern is that using report cards will extend the length of stay. Rather than extending the decision-making time and the length of stay, the use of report cards can reduce length of stay.9 A focus on identifying the first available nursing home bed or LTC provider often ignores the need to identify the most appropriate high-quality providers.
Hospitals and health plans often have established networks of post-acute and LTC providers and these networks must be taken into account in the discharge process. Most hospital and health plan networks have providers with a wide range of ratings, allowing for choices within networks.
The Centers for Medicare and Medicaid Services (CMS) established a web-based nursing home report card called Nursing Home Compare in 1998 that includes information on facility characteristics, deficiencies, staffing information (since 2000), and resident quality indicators (since 2002). In 2008, the website added a “five-star” rating system for all U.S. nursing homes and all-cause 30-day readmission rates and successful discharge rates from nursing homes were incorporated into the ratings in 2016.
CMS also established a web-based home health website, which provides quality ratings. This website has general information, quality measures, and patient surveys with information on readmission rates from home health agency services.
After establishment of the CMS Nursing Home Compare rating system in 2008, nursing homes improved their scores on certain quality measures and consumer demand significantly increased for the best (5-star) facilities and decreased for 1-star facilities.10 More recently, a clinical trial of the use of a personalized version of Nursing Home Compare in the hospital discharge planning process found greater patient satisfaction, patients being more likely to go to higher ranked nursing homes, patients traveling further to nursing homes, and patients having shorter hospital stays, compared with the control group.9
Quality report cards show wide variations within and across states ranging from one star (poorest quality) to five stars (highest quality). More than one-third of nursing homes had relatively low overall star ratings (1 or 2 stars) serving 39 percent of residents in 2015.11 Federal nursing home regulatory violations range from zero to more than 40 deficiencies (average of 7) with a scope and severity ranging from minor to widespread harm or jeopardy (including deaths).12 Total nurse staffing hours (average, 4.1 hours per resident day) range from less than 3 hours to more than 5.5 hours per resident day and RN hours are 3.5 times higher in some nursing homes than in the lowest staffed homes.13 Hospital readmission rates for short-stay residents from nursing homes also vary widely (4%-52%; average, 21%).12,14
Hospitalists and discharge planners should inform patients, families, and caregivers about the federal and state LTC quality report cards, provide education and choices, and engage and assist them in the decision making process. Hospitals, health plans, and accountable care organizations also need to be more informed about the availability of and benefits of using quality report cards for developing post-acute and LTC provider networks. The use of high quality LTC network providers should be able to reduce hospital length of stay and hospital readmission rates, and improve patient and caregiver satisfaction.
Charlene Harrington, PhD, RN, is professor of sociology and nursing; Leslie Ross, PhD, is a research specialist and principal investigator of the Calqualitycare.org website project; and Jeffrey Newman, MD, MPH, is a professor at the Institute for Health and Aging, all at the University of California, San Francisco.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
2. Thompson, MP, Waters, TM, Kaplan et al. Most hospitals received annual penalties for excess readmissions, but some fared better than others. Health Aff (Millwood). 36(5):893-901.
3. Auerbach AD et al. Preventability and causes of readmissions in a national cohort of general medicine patients. JAMA Intern Med. 2016;176(4):484-93.
4. Jack B et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-87.
5. Hansen LO et al. Project BOOST: effectiveness of a multihospital effort to reduce rehospitalization. J Hosp Med. 2013;8(8)421-7.
6. Naylor MD et al. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011;30(4):746-54.
7. Coleman EA. Family caregivers as partners in care transitions: The caregiver advise record and enable act. J Hosp Med. 2016 Dec;11(12):883-5.
8. Leppin AL et al. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Internal Med. 2014;174(7):1095-107.
9. Mukamel DB et al. Personalizing nursing home compare and the discharge from hospitals to nursing homes. Health Serv Res. 2016;1(6):2076-2094.
10. Werner RM et al. Changes in consumer demand following public reporting of summary quality ratings: An evaluation in nursing homes. Health Serv Res. 2016;51 Suppl 2:1291-309.
11. Boccuti C et al. Reading the stars: nursing home quality star ratings, nationally and by state. Kaiser Family Foundation Issue Brief. May 2015.
12. Centers for Medicare and Medicaid Services. Nursing home compare data archives. May 2017 monthly files. Quality MSR Claims data. https://data.medicare.gov/data/archives/nursing-home-compare. Accessed July 15, 2017.
13. Harrington C et al. The need for higher minimum staffing standards in U.S. nursing homes. Health Serv Insights. 2016;9:13-9.
14. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
Half of all breast cancer survivors conceived naturally within 3 months of trying
SAN ANTONIO – Half of premenopausal breast cancer patients who had completed chemotherapy conceived by intercourse alone within 3 months of beginning to attempt conception, a study showed.
This single-center study provides some guidance for women and the physicians caring for them that an attempt at natural conception is worthwhile if ovarian function has returned after chemotherapy, said Nikita Sinha.
Speaking at the annual meeting of the American Society for Reproductive Medicine, Ms. Sinha, a medical student at the University of California, San Francisco, said that this is a worthwhile strategy, “even for patients with limited ovarian reserve, prior to using cryopreserved tissue.” Cytotoxicity of chemotherapy was not associated with decreased chances for conception, she said.
Ms. Sinha and her colleagues designed a prospective cohort study to follow women aged 18-44 years who had been diagnosed with breast cancer and had received a fertility preservation consult. A total of 297 women who had completed cancer treatment were contacted and asked to complete a survey that asked questions about their oncologic and reproductive history. Of these, 200 (67%) completed the survey, but 43 more patients were excluded because they had not received chemotherapy.
Of the remaining 157 women, 40 (25%) attempted to conceive. Return of ovarian function occurred in 36 of the 40 women (90%). Of these 36 women, 4 also began their attempts to conceive with assisted reproductive technology (ART) because of age, previous history of infertility, or a preimplantation genetic diagnosis of the BRCA mutation. Thus, a total of eight patients (20%) first attempted to conceive with ART.
Three-fourths of women in both groups had eggs or embryos cryopreserved before their chemotherapy. In the ART group, a total of five women (62.5%) became pregnant: One first attempted intrauterine insemination and became pregnant; two first attempted pregnancy by egg donation, and one became pregnant; and three of five women who attempted embryo transfer from cryopreserved eggs or embryos became pregnant.
Of the 32 women who first attempted to conceive by intercourse, 18 became pregnant after 3 months, and 16 women had a live birth, for a 50% live birth rate for this group. Of the remaining 14 women who did not become pregnant by intercourse, 8 went on to attempt conception by ART.
Of these eight women, intrauterine insemination was attempted by three, with two resulting pregnancies. The single patient who used letrozole became pregnant. Of the four patients who attempted frozen embryo transfer, two became pregnant, for a total of five pregnancies (62.5%).
Comparing the 18 women who became pregnant with the 14 women who did not, Ms. Sinha and her colleagues found no significant differences in age, parity, hormone receptor status, pre- or postchemotherapy antral follicle count, type of chemotherapy, or time since chemotherapy. Receiving leuprolide acetate during therapy was not a significant factor.
Of the patients who became pregnant, 2 of 28 (7%) have had a recurrence of their breast cancer; both of these patients are estrogen receptor positive, said Ms. Sinha. One of the 12 patients who didn’t become pregnant also has had a recurrence; she is estrogen receptor negative.
In this study, the winnowing process of patient selection resulted in a limited sample size, with the potential for selection bias, said Ms. Sinha. Data collection is ongoing for breast cancer patients who receive fertility preservation consultations at her facility, she said.
The women trying to conceive were, on average, 37 years old at their initial attempt at conception, and had completed chemotherapy about 4 years ago. Most patients received cytotoxic chemotherapy, and 25 (63%) had estrogen receptor–positive cancer.
Previous work had shown that up to 80% of women of reproductive age will have some ovarian function resume after treatment with gonadotoxic chemotherapy agents, said Ms. Sinha.
However, the fertility risk for cancer survivors is twofold, said Ms. Sinha. “While acute ovarian failure is a well-known risk, there remains an increased risk of early menopause despite resumption of menses, especially in younger aged women” who are cancer survivors, she said.
Ms. Sinha reported that her work was supported by the University of California, San Francisco Clinical and Translational Science Institute.
[email protected]
On Twitter @karioakes
SAN ANTONIO – Half of premenopausal breast cancer patients who had completed chemotherapy conceived by intercourse alone within 3 months of beginning to attempt conception, a study showed.
This single-center study provides some guidance for women and the physicians caring for them that an attempt at natural conception is worthwhile if ovarian function has returned after chemotherapy, said Nikita Sinha.
Speaking at the annual meeting of the American Society for Reproductive Medicine, Ms. Sinha, a medical student at the University of California, San Francisco, said that this is a worthwhile strategy, “even for patients with limited ovarian reserve, prior to using cryopreserved tissue.” Cytotoxicity of chemotherapy was not associated with decreased chances for conception, she said.
Ms. Sinha and her colleagues designed a prospective cohort study to follow women aged 18-44 years who had been diagnosed with breast cancer and had received a fertility preservation consult. A total of 297 women who had completed cancer treatment were contacted and asked to complete a survey that asked questions about their oncologic and reproductive history. Of these, 200 (67%) completed the survey, but 43 more patients were excluded because they had not received chemotherapy.
Of the remaining 157 women, 40 (25%) attempted to conceive. Return of ovarian function occurred in 36 of the 40 women (90%). Of these 36 women, 4 also began their attempts to conceive with assisted reproductive technology (ART) because of age, previous history of infertility, or a preimplantation genetic diagnosis of the BRCA mutation. Thus, a total of eight patients (20%) first attempted to conceive with ART.
Three-fourths of women in both groups had eggs or embryos cryopreserved before their chemotherapy. In the ART group, a total of five women (62.5%) became pregnant: One first attempted intrauterine insemination and became pregnant; two first attempted pregnancy by egg donation, and one became pregnant; and three of five women who attempted embryo transfer from cryopreserved eggs or embryos became pregnant.
Of the 32 women who first attempted to conceive by intercourse, 18 became pregnant after 3 months, and 16 women had a live birth, for a 50% live birth rate for this group. Of the remaining 14 women who did not become pregnant by intercourse, 8 went on to attempt conception by ART.
Of these eight women, intrauterine insemination was attempted by three, with two resulting pregnancies. The single patient who used letrozole became pregnant. Of the four patients who attempted frozen embryo transfer, two became pregnant, for a total of five pregnancies (62.5%).
Comparing the 18 women who became pregnant with the 14 women who did not, Ms. Sinha and her colleagues found no significant differences in age, parity, hormone receptor status, pre- or postchemotherapy antral follicle count, type of chemotherapy, or time since chemotherapy. Receiving leuprolide acetate during therapy was not a significant factor.
Of the patients who became pregnant, 2 of 28 (7%) have had a recurrence of their breast cancer; both of these patients are estrogen receptor positive, said Ms. Sinha. One of the 12 patients who didn’t become pregnant also has had a recurrence; she is estrogen receptor negative.
In this study, the winnowing process of patient selection resulted in a limited sample size, with the potential for selection bias, said Ms. Sinha. Data collection is ongoing for breast cancer patients who receive fertility preservation consultations at her facility, she said.
The women trying to conceive were, on average, 37 years old at their initial attempt at conception, and had completed chemotherapy about 4 years ago. Most patients received cytotoxic chemotherapy, and 25 (63%) had estrogen receptor–positive cancer.
Previous work had shown that up to 80% of women of reproductive age will have some ovarian function resume after treatment with gonadotoxic chemotherapy agents, said Ms. Sinha.
However, the fertility risk for cancer survivors is twofold, said Ms. Sinha. “While acute ovarian failure is a well-known risk, there remains an increased risk of early menopause despite resumption of menses, especially in younger aged women” who are cancer survivors, she said.
Ms. Sinha reported that her work was supported by the University of California, San Francisco Clinical and Translational Science Institute.
[email protected]
On Twitter @karioakes
SAN ANTONIO – Half of premenopausal breast cancer patients who had completed chemotherapy conceived by intercourse alone within 3 months of beginning to attempt conception, a study showed.
This single-center study provides some guidance for women and the physicians caring for them that an attempt at natural conception is worthwhile if ovarian function has returned after chemotherapy, said Nikita Sinha.
Speaking at the annual meeting of the American Society for Reproductive Medicine, Ms. Sinha, a medical student at the University of California, San Francisco, said that this is a worthwhile strategy, “even for patients with limited ovarian reserve, prior to using cryopreserved tissue.” Cytotoxicity of chemotherapy was not associated with decreased chances for conception, she said.
Ms. Sinha and her colleagues designed a prospective cohort study to follow women aged 18-44 years who had been diagnosed with breast cancer and had received a fertility preservation consult. A total of 297 women who had completed cancer treatment were contacted and asked to complete a survey that asked questions about their oncologic and reproductive history. Of these, 200 (67%) completed the survey, but 43 more patients were excluded because they had not received chemotherapy.
Of the remaining 157 women, 40 (25%) attempted to conceive. Return of ovarian function occurred in 36 of the 40 women (90%). Of these 36 women, 4 also began their attempts to conceive with assisted reproductive technology (ART) because of age, previous history of infertility, or a preimplantation genetic diagnosis of the BRCA mutation. Thus, a total of eight patients (20%) first attempted to conceive with ART.
Three-fourths of women in both groups had eggs or embryos cryopreserved before their chemotherapy. In the ART group, a total of five women (62.5%) became pregnant: One first attempted intrauterine insemination and became pregnant; two first attempted pregnancy by egg donation, and one became pregnant; and three of five women who attempted embryo transfer from cryopreserved eggs or embryos became pregnant.
Of the 32 women who first attempted to conceive by intercourse, 18 became pregnant after 3 months, and 16 women had a live birth, for a 50% live birth rate for this group. Of the remaining 14 women who did not become pregnant by intercourse, 8 went on to attempt conception by ART.
Of these eight women, intrauterine insemination was attempted by three, with two resulting pregnancies. The single patient who used letrozole became pregnant. Of the four patients who attempted frozen embryo transfer, two became pregnant, for a total of five pregnancies (62.5%).
Comparing the 18 women who became pregnant with the 14 women who did not, Ms. Sinha and her colleagues found no significant differences in age, parity, hormone receptor status, pre- or postchemotherapy antral follicle count, type of chemotherapy, or time since chemotherapy. Receiving leuprolide acetate during therapy was not a significant factor.
Of the patients who became pregnant, 2 of 28 (7%) have had a recurrence of their breast cancer; both of these patients are estrogen receptor positive, said Ms. Sinha. One of the 12 patients who didn’t become pregnant also has had a recurrence; she is estrogen receptor negative.
In this study, the winnowing process of patient selection resulted in a limited sample size, with the potential for selection bias, said Ms. Sinha. Data collection is ongoing for breast cancer patients who receive fertility preservation consultations at her facility, she said.
The women trying to conceive were, on average, 37 years old at their initial attempt at conception, and had completed chemotherapy about 4 years ago. Most patients received cytotoxic chemotherapy, and 25 (63%) had estrogen receptor–positive cancer.
Previous work had shown that up to 80% of women of reproductive age will have some ovarian function resume after treatment with gonadotoxic chemotherapy agents, said Ms. Sinha.
However, the fertility risk for cancer survivors is twofold, said Ms. Sinha. “While acute ovarian failure is a well-known risk, there remains an increased risk of early menopause despite resumption of menses, especially in younger aged women” who are cancer survivors, she said.
Ms. Sinha reported that her work was supported by the University of California, San Francisco Clinical and Translational Science Institute.
[email protected]
On Twitter @karioakes
AT ASRM 2017
Key clinical point:
Major finding: Of 36 women whose ovarian function resumed after chemotherapy, 18 (50%) conceived within 3 months of attempting conception.
Data source: A single-center prospective cohort study of women diagnosed with breast cancer who received fertility preservation consultation.
Disclosures: The study was funded by the University of California, San Francisco Clinical and Translational Science Institute.
ACTH and other standard treatments prove best for infantile spasms
WASHINGTON – Standard infantile spasm therapies such as adrenocorticotropic hormone appear to be significantly more effective than nonstandard therapies, according to a prospective study presented at the annual meeting of the American Epilepsy Society.
If infants currently treated with nonstandard therapies switched to adrenocorticotropic hormone (ACTH), there would be an increase of “one additional responder for every four infants with infantile spasms,” according to Renee Shellhaas, MD, a pediatric neurologist at the University of Michigan, Ann Arbor.
Dr. Shellhaas and her colleagues conducted a prospective study of 352 infants recorded to have spasms in the National Infantile Spasms Consortium from 2012 to 2016 and compared successful responses with the use of ACTH and other standard therapies against those with nonstandard therapies. They defined a successful response as a patient who did not take any other medication for infantile spasms for 60 days and had no infantile spasms for 30 days after finishing 30 days of treatment. Infants were split into four treatment arms: ACTH (n = 150), vigabatrin (68), oral steroids (90), and nonstandard therapies (44). Nonstandard therapies included topiramate, levetiracetam, clobazam, zonisamide, ketogenic diet, oxcarbazepine, and phenobarbital.
The proportion of male infants across all arms was 50%-64%, with an average age of 6.2 months in the ACTH group, 5.5 months in the vigabatrin group, 6.7 months in the oral steroids group, and 5.5 months in the nonstandard group. A majority of infants across all arms had hypsarrhythmia on EEG, ranging from 57% to 84%.
Dr. Shellhaas and her colleagues sought to answer the question, “What would happen if this infant had been treated with ACTH instead of the given medication?” They controlled these comparisons for selection bias by weighting them for various factors that may have increased the odds of using the comparison treatment. They also controlled for potential medical center effects, but did not adjust for dosing regimen.
If the infants who had received nonstandard therapies had instead received ACTH, their response rate would have improved from 5% to 32%, according to this analysis (P less than .01).
In comparisons against other standard treatments, response rates would not have been significantly better if patients had instead received ACTH: 29% for vigabatrin vs. an estimated 37% for ACTH and 46% for oral steroids vs. an estimated 44% for ACTH.
If there was one thing to take away from this, it is that nonstandard therapies do not work nearly as well as ACTH or other standard treatments,” Dr. Shellhaas said. “It is crucial to treat these infants with treatments that are effective.”
Dr. Shellhaas and her associates uncovered certain clinical factors associated with treatment selections. Among infants with unknown infantile spasm etiology, 30% were given nonstandard treatment, whereas 47% received ACTH. Infants who were not already on antiepileptic drugs more often received nonstandard therapies than ACTH (45% vs. 17%).
However, ACTH was still more likely to be given over nonstandard therapies to infants who had hypsarrhythmia (84% vs. 57%) or a normal head circumference (77% vs. 57%).
Dr. Shellhaas reported no relevant financial disclosures. The Pediatric Epilepsy Research Foundation funded the study.
SOURCE: AES 2017 abstract 1.303
WASHINGTON – Standard infantile spasm therapies such as adrenocorticotropic hormone appear to be significantly more effective than nonstandard therapies, according to a prospective study presented at the annual meeting of the American Epilepsy Society.
If infants currently treated with nonstandard therapies switched to adrenocorticotropic hormone (ACTH), there would be an increase of “one additional responder for every four infants with infantile spasms,” according to Renee Shellhaas, MD, a pediatric neurologist at the University of Michigan, Ann Arbor.
Dr. Shellhaas and her colleagues conducted a prospective study of 352 infants recorded to have spasms in the National Infantile Spasms Consortium from 2012 to 2016 and compared successful responses with the use of ACTH and other standard therapies against those with nonstandard therapies. They defined a successful response as a patient who did not take any other medication for infantile spasms for 60 days and had no infantile spasms for 30 days after finishing 30 days of treatment. Infants were split into four treatment arms: ACTH (n = 150), vigabatrin (68), oral steroids (90), and nonstandard therapies (44). Nonstandard therapies included topiramate, levetiracetam, clobazam, zonisamide, ketogenic diet, oxcarbazepine, and phenobarbital.
The proportion of male infants across all arms was 50%-64%, with an average age of 6.2 months in the ACTH group, 5.5 months in the vigabatrin group, 6.7 months in the oral steroids group, and 5.5 months in the nonstandard group. A majority of infants across all arms had hypsarrhythmia on EEG, ranging from 57% to 84%.
Dr. Shellhaas and her colleagues sought to answer the question, “What would happen if this infant had been treated with ACTH instead of the given medication?” They controlled these comparisons for selection bias by weighting them for various factors that may have increased the odds of using the comparison treatment. They also controlled for potential medical center effects, but did not adjust for dosing regimen.
If the infants who had received nonstandard therapies had instead received ACTH, their response rate would have improved from 5% to 32%, according to this analysis (P less than .01).
In comparisons against other standard treatments, response rates would not have been significantly better if patients had instead received ACTH: 29% for vigabatrin vs. an estimated 37% for ACTH and 46% for oral steroids vs. an estimated 44% for ACTH.
If there was one thing to take away from this, it is that nonstandard therapies do not work nearly as well as ACTH or other standard treatments,” Dr. Shellhaas said. “It is crucial to treat these infants with treatments that are effective.”
Dr. Shellhaas and her associates uncovered certain clinical factors associated with treatment selections. Among infants with unknown infantile spasm etiology, 30% were given nonstandard treatment, whereas 47% received ACTH. Infants who were not already on antiepileptic drugs more often received nonstandard therapies than ACTH (45% vs. 17%).
However, ACTH was still more likely to be given over nonstandard therapies to infants who had hypsarrhythmia (84% vs. 57%) or a normal head circumference (77% vs. 57%).
Dr. Shellhaas reported no relevant financial disclosures. The Pediatric Epilepsy Research Foundation funded the study.
SOURCE: AES 2017 abstract 1.303
WASHINGTON – Standard infantile spasm therapies such as adrenocorticotropic hormone appear to be significantly more effective than nonstandard therapies, according to a prospective study presented at the annual meeting of the American Epilepsy Society.
If infants currently treated with nonstandard therapies switched to adrenocorticotropic hormone (ACTH), there would be an increase of “one additional responder for every four infants with infantile spasms,” according to Renee Shellhaas, MD, a pediatric neurologist at the University of Michigan, Ann Arbor.
Dr. Shellhaas and her colleagues conducted a prospective study of 352 infants recorded to have spasms in the National Infantile Spasms Consortium from 2012 to 2016 and compared successful responses with the use of ACTH and other standard therapies against those with nonstandard therapies. They defined a successful response as a patient who did not take any other medication for infantile spasms for 60 days and had no infantile spasms for 30 days after finishing 30 days of treatment. Infants were split into four treatment arms: ACTH (n = 150), vigabatrin (68), oral steroids (90), and nonstandard therapies (44). Nonstandard therapies included topiramate, levetiracetam, clobazam, zonisamide, ketogenic diet, oxcarbazepine, and phenobarbital.
The proportion of male infants across all arms was 50%-64%, with an average age of 6.2 months in the ACTH group, 5.5 months in the vigabatrin group, 6.7 months in the oral steroids group, and 5.5 months in the nonstandard group. A majority of infants across all arms had hypsarrhythmia on EEG, ranging from 57% to 84%.
Dr. Shellhaas and her colleagues sought to answer the question, “What would happen if this infant had been treated with ACTH instead of the given medication?” They controlled these comparisons for selection bias by weighting them for various factors that may have increased the odds of using the comparison treatment. They also controlled for potential medical center effects, but did not adjust for dosing regimen.
If the infants who had received nonstandard therapies had instead received ACTH, their response rate would have improved from 5% to 32%, according to this analysis (P less than .01).
In comparisons against other standard treatments, response rates would not have been significantly better if patients had instead received ACTH: 29% for vigabatrin vs. an estimated 37% for ACTH and 46% for oral steroids vs. an estimated 44% for ACTH.
If there was one thing to take away from this, it is that nonstandard therapies do not work nearly as well as ACTH or other standard treatments,” Dr. Shellhaas said. “It is crucial to treat these infants with treatments that are effective.”
Dr. Shellhaas and her associates uncovered certain clinical factors associated with treatment selections. Among infants with unknown infantile spasm etiology, 30% were given nonstandard treatment, whereas 47% received ACTH. Infants who were not already on antiepileptic drugs more often received nonstandard therapies than ACTH (45% vs. 17%).
However, ACTH was still more likely to be given over nonstandard therapies to infants who had hypsarrhythmia (84% vs. 57%) or a normal head circumference (77% vs. 57%).
Dr. Shellhaas reported no relevant financial disclosures. The Pediatric Epilepsy Research Foundation funded the study.
SOURCE: AES 2017 abstract 1.303
REPORTING FROM AES 2017
Key clinical point:
Major finding: If the infants who had received nonstandard therapies had instead received ACTH, their response rate would have improved from 5% to 32% (P less than .01).
Data source: Prospective study of 352 infants gathered from the National Infantile Spasms Consortium database from 2012-2016.
Disclosures: The presenter reported no relevant financial disclosures. The Pediatric Epilepsy Research Foundation funded the study.
Source: R. Shellhaas, et al. AES 2017 abstract 1.303
No benefit to trastuzumab in low HER2 breast cancer
SAN ANTONIO – Adding trastuzumab to the standard regimen for patients with early-stage breast cancer and low levels of HER2 does not improve outcomes, according to new findings presented at the San Antonio Breast Cancer Symposium.
In a randomized trial of more than 3,000 patients, the
Patients in both arms did well, explained lead study author Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo (Calif.) Medical Center. “But the primary endpoint of IDFS was not met and none of the secondary endpoints were met. No trends of efficacy were seen.”
Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows high levels of HER2 protein, defined as IHC 3+, or increased copies of the HER2 gene in situ hybridization. Adding 1 year of treatment with trastuzumab to standard adjuvant chemotherapy has been found to significantly reduce cancer recurrence and to improve survival for patients with early-stage HER2-positive breast cancer.
However, data from some of the early trastuzumab clinical trials suggested that patients with HER2-low breast cancer may benefit from the HER2-targeted treatment as well.
In 2005, the “stunning” results from the NSABP B-31 trial, of trastuzumab used in HER2+ breast cancer, were presented at the annual meeting of the American Society of Clinical Oncology. The study criteria included having a FISH+ test greater than 2.0 or IHC 3+, and testing was initially performed at a local laboratory site. When testing was conducted by the NSABP, submitted tissue samples showed that 9.7% of patients were not HER2 IHC 3+ or FISH+ greater than 2.0.
There were 174 patients defined as HER2 low, and not HER2 +.
“When the analysis was performed looking at the benefit of using trastuzumab in these patients considered low, it was found that the result was essentially identical, the benefit was equal, and statistically there was no interaction between FISH testing of IHC testing,” said Dr. Fehrenbacher. “These results were bewildering as the hypothesis was that only the HER2 amplified patients would benefit.
Because of these results, the NCI [National Cancer Institute] and the NSABP [National Surgical Adjuvant Breast and Bowel Project] initiated another trial, the N9831, which also found the same benefit in patients who were HER2 low.
About 15% of breast cancers are HER2 positive and another 45% have low levels of HER2, but these patients are not currently treated with adjuvant trastuzumab. Therefore, the current study, the NSABP-B-47, was designed and conducted to see if these early results could be validated in a large, prospective, randomized trial.
The study included 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.
The standard regimen consisted of either one of the two chemotherapy regimens, per physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for six cycles; the anthracycline regimen is AC followed by weekly paclitaxel (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously either every 3 weeks or every 2 weeks. The same regimen applied to the group that received additional trastuzumab.
The primary endpoint was to determine whether the addition of trastuzumab to chemotherapy improved invasive disease-free survival.
At a median follow-up of 46.1 months, 264 patients had IDFS events. The 5-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.
There was no difference in outcomes for IHC 1+ (HR for IDFS 0.88, 95% CI, 0.63-1.22) or IHC 2+ (HR for IDFS 1.14 95% CI, 0.79-1.65).
“The retrospective outcome difference between local tested HER2 + and center tested HER2-low patients identified in two major adjuvant trials are not readily explained,” said Dr. Fehrenbacher. “There is no benefit with trastuzumab therapy in patients with a FISH ratio of less than 2 and IHC staining intensity of 1+ or 2+.
SOURCE: Fehrenbacher et al. GS1-02
SAN ANTONIO – Adding trastuzumab to the standard regimen for patients with early-stage breast cancer and low levels of HER2 does not improve outcomes, according to new findings presented at the San Antonio Breast Cancer Symposium.
In a randomized trial of more than 3,000 patients, the
Patients in both arms did well, explained lead study author Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo (Calif.) Medical Center. “But the primary endpoint of IDFS was not met and none of the secondary endpoints were met. No trends of efficacy were seen.”
Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows high levels of HER2 protein, defined as IHC 3+, or increased copies of the HER2 gene in situ hybridization. Adding 1 year of treatment with trastuzumab to standard adjuvant chemotherapy has been found to significantly reduce cancer recurrence and to improve survival for patients with early-stage HER2-positive breast cancer.
However, data from some of the early trastuzumab clinical trials suggested that patients with HER2-low breast cancer may benefit from the HER2-targeted treatment as well.
In 2005, the “stunning” results from the NSABP B-31 trial, of trastuzumab used in HER2+ breast cancer, were presented at the annual meeting of the American Society of Clinical Oncology. The study criteria included having a FISH+ test greater than 2.0 or IHC 3+, and testing was initially performed at a local laboratory site. When testing was conducted by the NSABP, submitted tissue samples showed that 9.7% of patients were not HER2 IHC 3+ or FISH+ greater than 2.0.
There were 174 patients defined as HER2 low, and not HER2 +.
“When the analysis was performed looking at the benefit of using trastuzumab in these patients considered low, it was found that the result was essentially identical, the benefit was equal, and statistically there was no interaction between FISH testing of IHC testing,” said Dr. Fehrenbacher. “These results were bewildering as the hypothesis was that only the HER2 amplified patients would benefit.
Because of these results, the NCI [National Cancer Institute] and the NSABP [National Surgical Adjuvant Breast and Bowel Project] initiated another trial, the N9831, which also found the same benefit in patients who were HER2 low.
About 15% of breast cancers are HER2 positive and another 45% have low levels of HER2, but these patients are not currently treated with adjuvant trastuzumab. Therefore, the current study, the NSABP-B-47, was designed and conducted to see if these early results could be validated in a large, prospective, randomized trial.
The study included 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.
The standard regimen consisted of either one of the two chemotherapy regimens, per physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for six cycles; the anthracycline regimen is AC followed by weekly paclitaxel (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously either every 3 weeks or every 2 weeks. The same regimen applied to the group that received additional trastuzumab.
The primary endpoint was to determine whether the addition of trastuzumab to chemotherapy improved invasive disease-free survival.
At a median follow-up of 46.1 months, 264 patients had IDFS events. The 5-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.
There was no difference in outcomes for IHC 1+ (HR for IDFS 0.88, 95% CI, 0.63-1.22) or IHC 2+ (HR for IDFS 1.14 95% CI, 0.79-1.65).
“The retrospective outcome difference between local tested HER2 + and center tested HER2-low patients identified in two major adjuvant trials are not readily explained,” said Dr. Fehrenbacher. “There is no benefit with trastuzumab therapy in patients with a FISH ratio of less than 2 and IHC staining intensity of 1+ or 2+.
SOURCE: Fehrenbacher et al. GS1-02
SAN ANTONIO – Adding trastuzumab to the standard regimen for patients with early-stage breast cancer and low levels of HER2 does not improve outcomes, according to new findings presented at the San Antonio Breast Cancer Symposium.
In a randomized trial of more than 3,000 patients, the
Patients in both arms did well, explained lead study author Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo (Calif.) Medical Center. “But the primary endpoint of IDFS was not met and none of the secondary endpoints were met. No trends of efficacy were seen.”
Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows high levels of HER2 protein, defined as IHC 3+, or increased copies of the HER2 gene in situ hybridization. Adding 1 year of treatment with trastuzumab to standard adjuvant chemotherapy has been found to significantly reduce cancer recurrence and to improve survival for patients with early-stage HER2-positive breast cancer.
However, data from some of the early trastuzumab clinical trials suggested that patients with HER2-low breast cancer may benefit from the HER2-targeted treatment as well.
In 2005, the “stunning” results from the NSABP B-31 trial, of trastuzumab used in HER2+ breast cancer, were presented at the annual meeting of the American Society of Clinical Oncology. The study criteria included having a FISH+ test greater than 2.0 or IHC 3+, and testing was initially performed at a local laboratory site. When testing was conducted by the NSABP, submitted tissue samples showed that 9.7% of patients were not HER2 IHC 3+ or FISH+ greater than 2.0.
There were 174 patients defined as HER2 low, and not HER2 +.
“When the analysis was performed looking at the benefit of using trastuzumab in these patients considered low, it was found that the result was essentially identical, the benefit was equal, and statistically there was no interaction between FISH testing of IHC testing,” said Dr. Fehrenbacher. “These results were bewildering as the hypothesis was that only the HER2 amplified patients would benefit.
Because of these results, the NCI [National Cancer Institute] and the NSABP [National Surgical Adjuvant Breast and Bowel Project] initiated another trial, the N9831, which also found the same benefit in patients who were HER2 low.
About 15% of breast cancers are HER2 positive and another 45% have low levels of HER2, but these patients are not currently treated with adjuvant trastuzumab. Therefore, the current study, the NSABP-B-47, was designed and conducted to see if these early results could be validated in a large, prospective, randomized trial.
The study included 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.
The standard regimen consisted of either one of the two chemotherapy regimens, per physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered intravenously every 3 weeks for six cycles; the anthracycline regimen is AC followed by weekly paclitaxel (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously either every 3 weeks or every 2 weeks. The same regimen applied to the group that received additional trastuzumab.
The primary endpoint was to determine whether the addition of trastuzumab to chemotherapy improved invasive disease-free survival.
At a median follow-up of 46.1 months, 264 patients had IDFS events. The 5-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.
There was no difference in outcomes for IHC 1+ (HR for IDFS 0.88, 95% CI, 0.63-1.22) or IHC 2+ (HR for IDFS 1.14 95% CI, 0.79-1.65).
“The retrospective outcome difference between local tested HER2 + and center tested HER2-low patients identified in two major adjuvant trials are not readily explained,” said Dr. Fehrenbacher. “There is no benefit with trastuzumab therapy in patients with a FISH ratio of less than 2 and IHC staining intensity of 1+ or 2+.
SOURCE: Fehrenbacher et al. GS1-02
REPORTING FROM SABCS 2017
Key clinical point: In contrast to earlier reports, trastuzumab does not improve outcomes in breast cancer patients with low HER2 levels.
Major finding: The 5-year invasive disease–free survival was 89.6% for those who received trastuzumab, compared with 89.2% for those who did not (HR 0.98 95% CI 0.77-1.26, P = .90).
Data source: Phase 3 randomized, prospective clinical trial of 3,720 heavily pretreated breast cancer patients with low HER2 levels.
Disclosures: The National Cancer Institute and Genentech supported the study. Dr. Fehrenbacher declared no conflicts of interest.
Source: Fehrenbacher et al. GS1-02.
Rheumatology 911: Inside the rheumatologic emergency
SAN DIEGO – At first glance, rheumatology may seem like the perfect specialty for physicians who don’t want to be bothered by medical emergencies. But the reality can be more complicated.
As Bharat Kumar, MD, explained to an audience at the annual meeting of the American College of Rheumatology, rheumatologists will at times encounter patients in urgent need of their care due to dire medical conditions. In these situations, he said, there may be no time for careful and cautious diagnostics.
“You have to have an awareness of how you think about things,” advised Dr. Kumar, a rheumatologist/immunologist and clinical assistant professor of internal medicine at the University of Iowa, Iowa City. “During emergencies, you have to rely more on intuition to quickly get at answers.”
Q: When do rheumatologists have to deal with medical emergencies?
A: Rheumatology is considered mostly an outpatient specialty. Most of the time, rheumatologists don’t receive off-hour emergency calls.
But there are conditions in which rheumatologists have to be at the front lines in diagnosing and managing medical emergencies. These range from issues like septic arthritis to scleroderma renal crisis and vasculitis affecting vital organs such as the heart, lungs, and kidneys. These are more common at academic settings, but even rheumatologists in private practice should be aware of these conditions.
Q: How often do rheumatologists come across true emergencies in normal practice?
A: It depends on where the rheumatologist is practicing. In our academic setting, we have to see patients in the hospital several times per week.
Rarer are the emergencies that show up to clinic and require evaluation in the emergency department or hospitalization. Over the past year, that has happened perhaps three times to me.
This is likely much less in the private setting, where patients tend to be less sick and less complicated. But that is no guarantee that an emergency won’t crop up.
Q: What is the scariest emergency situation that you’ve come across?
A: It occurred when I entered a room to see a patient of mine with adult-onset Still’s disease.
She was huddled, shivering, barely answering questions. Her eyes were glazed. Her blood pressure was below 90/60 mm Hg, and her pulse was 130 beats per minute. I was petrified that she was in the midst of a cytokine storm secondary to either hemophagocytic lymphohistiocytosis (HLH) or sepsis. Given the high mortality of both, we immediately called our colleagues in the emergency department and sent her for hospitalization. It turned out that she did have HLH, and we had to pursue intensive immunosuppression to abate that cytokine storm.
It was particularly scary because there is no good way to differentiate between the two conditions, apart from going with clinical intuition.
Treating a patient who is potentially septic with immunosuppression is extremely dangerous, and ultimately, we would not have known if our intuition was correct until the infection presented itself.
Fortunately, we were correct. She recovered after 1 week of hospitalization, and we have been following her since then. But it still gives me goosebumps to think, “What if we were wrong?”
Q: Do emergencies in rheumatology tend to appear suddenly or are they more likely to occur because of a long-standing and perhaps untreated condition?
A: While it is true that uncontrolled disease activity can predispose patients to emergencies, other emergencies can occur sporadically and out of the blue.
Many times, an emergency is the first manifestation of disease. The literature is littered with cases of renal crisis being the first manifestation of systemic sclerosis. And internists are often baffled by sudden kidney failure due to previously undiagnosed lupus.
In addition, all rheumatologists have great reverence for septic arthritis and know that it can mimic gout very closely. If a swollen joint is mistaken for gout instead of septic arthritis, this can lead to worsening infection and ultimately, loss of joint function.
Q: What are some potentially dire conditions that may test the diagnostic powers of rheumatologists?
A: Rheumatologists are becoming more aware of HLH. Because it may look clinically indistinguishable from severe infection but needs to be treated with immunosuppression instead of antimicrobial therapy, rheumatologists have to keep it in mind and revisit the diagnosis often in case patients are not improving on the prescribed therapy.
Pulmonary vasculitis is another concerning condition because an otherwise negligible cough can turn into massive pulmonary hemorrhage very quickly.
Q: Do you have tips about dealing with ER doctors, primary doctors and others who may be involved with an emergency?
A: Rheumatologists think differently from other specialists. We are cognitive specialists and think more in the long term. Emergency medicine doctors are more concerned about the short term and how to deal with more immediate issues.
Signposting concerns is essential to optimizing communication. Education of other physicians is also important because more frequently than not, patients with rheumatologic diseases present very differently.
Lastly, there’s a very fine line between advocating for patients and overstepping your bounds as a consultant rheumatologist. Maintaining close collaboration and establishing clear and open lines of communication can prevent this.
Dr. Kumar has no relevant disclosures.
SAN DIEGO – At first glance, rheumatology may seem like the perfect specialty for physicians who don’t want to be bothered by medical emergencies. But the reality can be more complicated.
As Bharat Kumar, MD, explained to an audience at the annual meeting of the American College of Rheumatology, rheumatologists will at times encounter patients in urgent need of their care due to dire medical conditions. In these situations, he said, there may be no time for careful and cautious diagnostics.
“You have to have an awareness of how you think about things,” advised Dr. Kumar, a rheumatologist/immunologist and clinical assistant professor of internal medicine at the University of Iowa, Iowa City. “During emergencies, you have to rely more on intuition to quickly get at answers.”
Q: When do rheumatologists have to deal with medical emergencies?
A: Rheumatology is considered mostly an outpatient specialty. Most of the time, rheumatologists don’t receive off-hour emergency calls.
But there are conditions in which rheumatologists have to be at the front lines in diagnosing and managing medical emergencies. These range from issues like septic arthritis to scleroderma renal crisis and vasculitis affecting vital organs such as the heart, lungs, and kidneys. These are more common at academic settings, but even rheumatologists in private practice should be aware of these conditions.
Q: How often do rheumatologists come across true emergencies in normal practice?
A: It depends on where the rheumatologist is practicing. In our academic setting, we have to see patients in the hospital several times per week.
Rarer are the emergencies that show up to clinic and require evaluation in the emergency department or hospitalization. Over the past year, that has happened perhaps three times to me.
This is likely much less in the private setting, where patients tend to be less sick and less complicated. But that is no guarantee that an emergency won’t crop up.
Q: What is the scariest emergency situation that you’ve come across?
A: It occurred when I entered a room to see a patient of mine with adult-onset Still’s disease.
She was huddled, shivering, barely answering questions. Her eyes were glazed. Her blood pressure was below 90/60 mm Hg, and her pulse was 130 beats per minute. I was petrified that she was in the midst of a cytokine storm secondary to either hemophagocytic lymphohistiocytosis (HLH) or sepsis. Given the high mortality of both, we immediately called our colleagues in the emergency department and sent her for hospitalization. It turned out that she did have HLH, and we had to pursue intensive immunosuppression to abate that cytokine storm.
It was particularly scary because there is no good way to differentiate between the two conditions, apart from going with clinical intuition.
Treating a patient who is potentially septic with immunosuppression is extremely dangerous, and ultimately, we would not have known if our intuition was correct until the infection presented itself.
Fortunately, we were correct. She recovered after 1 week of hospitalization, and we have been following her since then. But it still gives me goosebumps to think, “What if we were wrong?”
Q: Do emergencies in rheumatology tend to appear suddenly or are they more likely to occur because of a long-standing and perhaps untreated condition?
A: While it is true that uncontrolled disease activity can predispose patients to emergencies, other emergencies can occur sporadically and out of the blue.
Many times, an emergency is the first manifestation of disease. The literature is littered with cases of renal crisis being the first manifestation of systemic sclerosis. And internists are often baffled by sudden kidney failure due to previously undiagnosed lupus.
In addition, all rheumatologists have great reverence for septic arthritis and know that it can mimic gout very closely. If a swollen joint is mistaken for gout instead of septic arthritis, this can lead to worsening infection and ultimately, loss of joint function.
Q: What are some potentially dire conditions that may test the diagnostic powers of rheumatologists?
A: Rheumatologists are becoming more aware of HLH. Because it may look clinically indistinguishable from severe infection but needs to be treated with immunosuppression instead of antimicrobial therapy, rheumatologists have to keep it in mind and revisit the diagnosis often in case patients are not improving on the prescribed therapy.
Pulmonary vasculitis is another concerning condition because an otherwise negligible cough can turn into massive pulmonary hemorrhage very quickly.
Q: Do you have tips about dealing with ER doctors, primary doctors and others who may be involved with an emergency?
A: Rheumatologists think differently from other specialists. We are cognitive specialists and think more in the long term. Emergency medicine doctors are more concerned about the short term and how to deal with more immediate issues.
Signposting concerns is essential to optimizing communication. Education of other physicians is also important because more frequently than not, patients with rheumatologic diseases present very differently.
Lastly, there’s a very fine line between advocating for patients and overstepping your bounds as a consultant rheumatologist. Maintaining close collaboration and establishing clear and open lines of communication can prevent this.
Dr. Kumar has no relevant disclosures.
SAN DIEGO – At first glance, rheumatology may seem like the perfect specialty for physicians who don’t want to be bothered by medical emergencies. But the reality can be more complicated.
As Bharat Kumar, MD, explained to an audience at the annual meeting of the American College of Rheumatology, rheumatologists will at times encounter patients in urgent need of their care due to dire medical conditions. In these situations, he said, there may be no time for careful and cautious diagnostics.
“You have to have an awareness of how you think about things,” advised Dr. Kumar, a rheumatologist/immunologist and clinical assistant professor of internal medicine at the University of Iowa, Iowa City. “During emergencies, you have to rely more on intuition to quickly get at answers.”
Q: When do rheumatologists have to deal with medical emergencies?
A: Rheumatology is considered mostly an outpatient specialty. Most of the time, rheumatologists don’t receive off-hour emergency calls.
But there are conditions in which rheumatologists have to be at the front lines in diagnosing and managing medical emergencies. These range from issues like septic arthritis to scleroderma renal crisis and vasculitis affecting vital organs such as the heart, lungs, and kidneys. These are more common at academic settings, but even rheumatologists in private practice should be aware of these conditions.
Q: How often do rheumatologists come across true emergencies in normal practice?
A: It depends on where the rheumatologist is practicing. In our academic setting, we have to see patients in the hospital several times per week.
Rarer are the emergencies that show up to clinic and require evaluation in the emergency department or hospitalization. Over the past year, that has happened perhaps three times to me.
This is likely much less in the private setting, where patients tend to be less sick and less complicated. But that is no guarantee that an emergency won’t crop up.
Q: What is the scariest emergency situation that you’ve come across?
A: It occurred when I entered a room to see a patient of mine with adult-onset Still’s disease.
She was huddled, shivering, barely answering questions. Her eyes were glazed. Her blood pressure was below 90/60 mm Hg, and her pulse was 130 beats per minute. I was petrified that she was in the midst of a cytokine storm secondary to either hemophagocytic lymphohistiocytosis (HLH) or sepsis. Given the high mortality of both, we immediately called our colleagues in the emergency department and sent her for hospitalization. It turned out that she did have HLH, and we had to pursue intensive immunosuppression to abate that cytokine storm.
It was particularly scary because there is no good way to differentiate between the two conditions, apart from going with clinical intuition.
Treating a patient who is potentially septic with immunosuppression is extremely dangerous, and ultimately, we would not have known if our intuition was correct until the infection presented itself.
Fortunately, we were correct. She recovered after 1 week of hospitalization, and we have been following her since then. But it still gives me goosebumps to think, “What if we were wrong?”
Q: Do emergencies in rheumatology tend to appear suddenly or are they more likely to occur because of a long-standing and perhaps untreated condition?
A: While it is true that uncontrolled disease activity can predispose patients to emergencies, other emergencies can occur sporadically and out of the blue.
Many times, an emergency is the first manifestation of disease. The literature is littered with cases of renal crisis being the first manifestation of systemic sclerosis. And internists are often baffled by sudden kidney failure due to previously undiagnosed lupus.
In addition, all rheumatologists have great reverence for septic arthritis and know that it can mimic gout very closely. If a swollen joint is mistaken for gout instead of septic arthritis, this can lead to worsening infection and ultimately, loss of joint function.
Q: What are some potentially dire conditions that may test the diagnostic powers of rheumatologists?
A: Rheumatologists are becoming more aware of HLH. Because it may look clinically indistinguishable from severe infection but needs to be treated with immunosuppression instead of antimicrobial therapy, rheumatologists have to keep it in mind and revisit the diagnosis often in case patients are not improving on the prescribed therapy.
Pulmonary vasculitis is another concerning condition because an otherwise negligible cough can turn into massive pulmonary hemorrhage very quickly.
Q: Do you have tips about dealing with ER doctors, primary doctors and others who may be involved with an emergency?
A: Rheumatologists think differently from other specialists. We are cognitive specialists and think more in the long term. Emergency medicine doctors are more concerned about the short term and how to deal with more immediate issues.
Signposting concerns is essential to optimizing communication. Education of other physicians is also important because more frequently than not, patients with rheumatologic diseases present very differently.
Lastly, there’s a very fine line between advocating for patients and overstepping your bounds as a consultant rheumatologist. Maintaining close collaboration and establishing clear and open lines of communication can prevent this.
Dr. Kumar has no relevant disclosures.
EXPERT ANALYSIS FROM ACR 2017