Successful treatment of pneumonia depends on timely diagnosis and administration of antibiotics. Multidrug-resistant organisms (MDROs) complicate antibiotic therapies by rendering some antibiotic agents ineffective. Inappropriate initial therapy has been associated with a more than 2-fold increase in the risk of mortality.¹ Because culture results are not available immediately, clinicians prescribe antibiotics empirically and must rely on guidelines and knowledge of risk factors associated with MDRO infection to make these selections.

Treatment guidelines exist for hospital-acquired and ventilator-associated pneumonia (HAP/VAP) and community-acquired pneumonia (CAP) to assist with empiric antibiotic selection. For HAP/VAP, 2 to 3 antibiotics with a broad-spectrum of activity are used due to increased prevalence of MDROs in hospitals, whereastreatment of CAP involves more narrow coverage because bacteria that cause this infection typically have fewer antibiotic resistances.^2,3 The HAP/VAP guidelines stratify the risk of pneumonia due to the presence of a MDRO acquired during a hospitalization. However, neither the CAP nor HAP/VAP guidelines offer risk-stratification guidance for nonhospitalized patients who develop pneumonia but who may have become colonized with a MDRO during a previous hospitalization or from another exposure to a health care facility.

Health care-associated pneumonia (HCAP) was first described in the 2005 American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) nosocomial pneumonia guidelines and was associated with criteria intended to aid clinician identification of nonhospitalized patients at risk for MDRO pneumonia, which warranted empiric broad-spectrum antibiotic therapy.² According to these guidelines, patients were classified as having HCAP if they had been hospitalized for at least 48 hours in the past 90 days, admitted from a nursing home, received recent intravenous antibiotics, had hemodialysis in the past 30 days, had a history of home infusion therapy or wound care, received intravenous chemotherapy, or had a family member with MDRO colonization.

Since publication of the 2005 guidelines, HCAP has been criticized as being a poor predictor of MDRO infection. A 2014 meta-analysis of 24 studies investigated the discriminating ability of HCAP and reported that the specificity and sensitivity for MDRO infections was 71.2% and 53.7%, respectively.³ In 2016, the ATS/IDSA guidelines were updated to remove HCAP due to the risk of antibiotic overprescribing.⁴

Literature Review

Although criteria previously defining a patient as having HCAP have been shown to be a poor discriminator of MDRO pneumonia as a whole, MDRO infections still pose a threat to nonhospitalized patients who have exposure to the health care system. A literature review was performed to identify independent HCAP risk factors that may increase the risk of MDRO pneumonia infecting a nonhospitalized patient needing empiric broad-spectrum antibiotic therapy. All included studies were prospective or retrospective observational cohort studies that performed logistic regression analyses to assess the association between MDRO isolation and the previously defined HCAP risk factors (Table 1).

Five studies examined the risk of MDRO infection in patients with a previous hospital admission of 2 days or more in the past 90 days. Shindo and colleagues found a significant increase in MDRO infections by about 2-fold (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.2-3.4).⁵ Shorr and colleagues found a 4-fold increase in likelihood of identifying a MDRO in HCAP (AOR, 4.2; 95% CI, 2.9-6.3).⁶ Nseir and colleagues and Jung and colleagues found similar results (AOR 3.9, 95% CI 1.7-8.8; AOR 2.7, 95% CI 1.3-5.5, respectively).^7,8 Conflicting results were reported by Gross and colleagues who did not find a significant relationship between previous hospitalization and MDRO isolation (AOR 1.2, 95% CI, 0.5-3.2).⁹

In patients with pneumonia admitted from a nursing home, MDRO infection risk also was evaluated in these 5 studies. Shorr and colleagues, Nseir and colleagues, and Gross and colleagues found significant AORs of 2.7 (95% CI 1.7-4.3), 2.0 (95% CI 1.1-3.7), and 4.2 (95% CI 1.6-11.3), respectively.^6,7,9 Shindo and colleagues (AOR 1.1; 95% CI, 0.6-2.0) and Jung and colleagues (AOR 1.9, 95% CI, 0.5-6.9) found this risk factor not significant.⁵

Receipt of antibiotics within the previous 90 days was assessed in 3 studies. Shindo and colleagues, Nseir and colleagues, and Gross and colleagues all found significant AORs of 2.5 (95% CI 1.2-4.0), 2.3 (95% CI 1.2-4.3), and 2.9 (95% CI 1.1-7.5), respectively.^5,7,9 Antibiotic therapy within the previous 90 days is an established risk factor for MDRO pneumonia, and the 2016 ATS/IDSA guidelines consider this a risk factor for HAP and VAP, including pneumonia caused by methicillin resistant Staphylococcus aureus and Pseudomonas aeruginosa.⁴

The impact of hemodialysis in the previous month on acquisition of MDRO pneumonia was investigated in 4 studies. Shindo and colleagues, Jung and colleagues, and Gross and colleagues concluded that this risk factor was not significantly related to MDRO infection, reporting AORs of 2.2 (95% CI 0.5-9.7), 2.8 (95% CI 0.9-9.2) and 0.7 (95% CI 0.1-5.1), respectively.^5,8,9 Shorr and colleagues, however, found a significant AOR of 2.1 (95% CI 1.0-4.3).⁶

Shindo and colleagues investigated the impact of home infusion therapy on acquisition of pneumonia due to a MDRO and reported a nonsignificant AOR of 0.8 (95% CI 0.4-1.8).⁵ Gross and colleagues also found a nonsignificant AOR of 0 (P = .1).⁹ In the Shindo and colleagues study, resistance was found in 107 of 679 patients who did not receive infusion therapy, and 12 of 55 patients who were receiving infusion therapy.⁵ Gross and colleagues reported that home-infusion therapy was received by 0 of 20 patients with MDRO infection and 4 of the 501 patients without MDRO infection.⁹

Shindo and colleagues reported that home wound care was not found to be significantly related to MDRO pneumonia as well as did Gross and colleagues: AORs of 3.8 (0.8-18.4) and 1.4 (95% CI 0.5-4.4), respectively.^5,9 Jung and colleagues examined IV chemotherapy in the past 30 days, and found this to not significantly impact the odds of MDRO isolation (AOR = 0.62, 95% CI 0.2-1.8).⁸ No data were available reflecting the risk of a family member with a MDRO.

Limitations

The variables on which logistic regression were performed differed among the studies. Therefore, results cannot be averaged or compared quantitatively, as AORs varied, depending on the variables included. In addition, data were drawn from multiple geographic locations that may impact MDRO prevalence within each patient population. Finally, this review examines the utility of the risk factors formerly included in HCAP. However, other risk factors for MDRO pneumonia outlined by the ATS/IDSA guidelines still should be considered when evaluating patient risk. The 2016 guidelines recommend local incidence of resistant strains be considered when initiating empiric therapy. Review of medical records for previous positive cultures and duration of current hospitalization also should be considered. Although the 2016 ATS/IDSA HAP guidelines are not intended for immunosuppressed patients, this risk factor also may be taken into account.

Conclusion

Review and synthesis of published literature found previous hospital admission (of ≥ 2 days in the past 90 days), admission from a nursing home, and IV antibiotic therapy in the last 90 days to be independent risk factors for identification of MDRO pneumonia in previously nonhospitalized patients (Table 2). Additionally, although no data were found to support this risk factor, existence of an in-home (close contact) source of MDROs would provide ample opportunity for transmission, so evaluation of known exposure to MDROs from contacts should be considered. When choosing empiric antibiotic therapy for patients admitted to the hospital for treatment of pneumonia, consideration of patient history and risk factors that may contribute to infection with a MDRO are recommended.

Successful treatment of pneumonia depends on timely diagnosis and administration of antibiotics. Multidrug-resistant organisms (MDROs) complicate antibiotic therapies by rendering some antibiotic agents ineffective. Inappropriate initial therapy has been associated with a more than 2-fold increase in the risk of mortality.¹ Because culture results are not available immediately, clinicians prescribe antibiotics empirically and must rely on guidelines and knowledge of risk factors associated with MDRO infection to make these selections.

Treatment guidelines exist for hospital-acquired and ventilator-associated pneumonia (HAP/VAP) and community-acquired pneumonia (CAP) to assist with empiric antibiotic selection. For HAP/VAP, 2 to 3 antibiotics with a broad-spectrum of activity are used due to increased prevalence of MDROs in hospitals, whereastreatment of CAP involves more narrow coverage because bacteria that cause this infection typically have fewer antibiotic resistances.^2,3 The HAP/VAP guidelines stratify the risk of pneumonia due to the presence of a MDRO acquired during a hospitalization. However, neither the CAP nor HAP/VAP guidelines offer risk-stratification guidance for nonhospitalized patients who develop pneumonia but who may have become colonized with a MDRO during a previous hospitalization or from another exposure to a health care facility.

Health care-associated pneumonia (HCAP) was first described in the 2005 American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) nosocomial pneumonia guidelines and was associated with criteria intended to aid clinician identification of nonhospitalized patients at risk for MDRO pneumonia, which warranted empiric broad-spectrum antibiotic therapy.² According to these guidelines, patients were classified as having HCAP if they had been hospitalized for at least 48 hours in the past 90 days, admitted from a nursing home, received recent intravenous antibiotics, had hemodialysis in the past 30 days, had a history of home infusion therapy or wound care, received intravenous chemotherapy, or had a family member with MDRO colonization.

Since publication of the 2005 guidelines, HCAP has been criticized as being a poor predictor of MDRO infection. A 2014 meta-analysis of 24 studies investigated the discriminating ability of HCAP and reported that the specificity and sensitivity for MDRO infections was 71.2% and 53.7%, respectively.³ In 2016, the ATS/IDSA guidelines were updated to remove HCAP due to the risk of antibiotic overprescribing.⁴

Literature Review

Although criteria previously defining a patient as having HCAP have been shown to be a poor discriminator of MDRO pneumonia as a whole, MDRO infections still pose a threat to nonhospitalized patients who have exposure to the health care system. A literature review was performed to identify independent HCAP risk factors that may increase the risk of MDRO pneumonia infecting a nonhospitalized patient needing empiric broad-spectrum antibiotic therapy. All included studies were prospective or retrospective observational cohort studies that performed logistic regression analyses to assess the association between MDRO isolation and the previously defined HCAP risk factors (Table 1).

Five studies examined the risk of MDRO infection in patients with a previous hospital admission of 2 days or more in the past 90 days. Shindo and colleagues found a significant increase in MDRO infections by about 2-fold (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.2-3.4).⁵ Shorr and colleagues found a 4-fold increase in likelihood of identifying a MDRO in HCAP (AOR, 4.2; 95% CI, 2.9-6.3).⁶ Nseir and colleagues and Jung and colleagues found similar results (AOR 3.9, 95% CI 1.7-8.8; AOR 2.7, 95% CI 1.3-5.5, respectively).^7,8 Conflicting results were reported by Gross and colleagues who did not find a significant relationship between previous hospitalization and MDRO isolation (AOR 1.2, 95% CI, 0.5-3.2).⁹

In patients with pneumonia admitted from a nursing home, MDRO infection risk also was evaluated in these 5 studies. Shorr and colleagues, Nseir and colleagues, and Gross and colleagues found significant AORs of 2.7 (95% CI 1.7-4.3), 2.0 (95% CI 1.1-3.7), and 4.2 (95% CI 1.6-11.3), respectively.^6,7,9 Shindo and colleagues (AOR 1.1; 95% CI, 0.6-2.0) and Jung and colleagues (AOR 1.9, 95% CI, 0.5-6.9) found this risk factor not significant.⁵

Receipt of antibiotics within the previous 90 days was assessed in 3 studies. Shindo and colleagues, Nseir and colleagues, and Gross and colleagues all found significant AORs of 2.5 (95% CI 1.2-4.0), 2.3 (95% CI 1.2-4.3), and 2.9 (95% CI 1.1-7.5), respectively.^5,7,9 Antibiotic therapy within the previous 90 days is an established risk factor for MDRO pneumonia, and the 2016 ATS/IDSA guidelines consider this a risk factor for HAP and VAP, including pneumonia caused by methicillin resistant Staphylococcus aureus and Pseudomonas aeruginosa.⁴

The impact of hemodialysis in the previous month on acquisition of MDRO pneumonia was investigated in 4 studies. Shindo and colleagues, Jung and colleagues, and Gross and colleagues concluded that this risk factor was not significantly related to MDRO infection, reporting AORs of 2.2 (95% CI 0.5-9.7), 2.8 (95% CI 0.9-9.2) and 0.7 (95% CI 0.1-5.1), respectively.^5,8,9 Shorr and colleagues, however, found a significant AOR of 2.1 (95% CI 1.0-4.3).⁶

Shindo and colleagues investigated the impact of home infusion therapy on acquisition of pneumonia due to a MDRO and reported a nonsignificant AOR of 0.8 (95% CI 0.4-1.8).⁵ Gross and colleagues also found a nonsignificant AOR of 0 (P = .1).⁹ In the Shindo and colleagues study, resistance was found in 107 of 679 patients who did not receive infusion therapy, and 12 of 55 patients who were receiving infusion therapy.⁵ Gross and colleagues reported that home-infusion therapy was received by 0 of 20 patients with MDRO infection and 4 of the 501 patients without MDRO infection.⁹

Shindo and colleagues reported that home wound care was not found to be significantly related to MDRO pneumonia as well as did Gross and colleagues: AORs of 3.8 (0.8-18.4) and 1.4 (95% CI 0.5-4.4), respectively.^5,9 Jung and colleagues examined IV chemotherapy in the past 30 days, and found this to not significantly impact the odds of MDRO isolation (AOR = 0.62, 95% CI 0.2-1.8).⁸ No data were available reflecting the risk of a family member with a MDRO.

Limitations

The variables on which logistic regression were performed differed among the studies. Therefore, results cannot be averaged or compared quantitatively, as AORs varied, depending on the variables included. In addition, data were drawn from multiple geographic locations that may impact MDRO prevalence within each patient population. Finally, this review examines the utility of the risk factors formerly included in HCAP. However, other risk factors for MDRO pneumonia outlined by the ATS/IDSA guidelines still should be considered when evaluating patient risk. The 2016 guidelines recommend local incidence of resistant strains be considered when initiating empiric therapy. Review of medical records for previous positive cultures and duration of current hospitalization also should be considered. Although the 2016 ATS/IDSA HAP guidelines are not intended for immunosuppressed patients, this risk factor also may be taken into account.

Conclusion

Review and synthesis of published literature found previous hospital admission (of ≥ 2 days in the past 90 days), admission from a nursing home, and IV antibiotic therapy in the last 90 days to be independent risk factors for identification of MDRO pneumonia in previously nonhospitalized patients (Table 2). Additionally, although no data were found to support this risk factor, existence of an in-home (close contact) source of MDROs would provide ample opportunity for transmission, so evaluation of known exposure to MDROs from contacts should be considered. When choosing empiric antibiotic therapy for patients admitted to the hospital for treatment of pneumonia, consideration of patient history and risk factors that may contribute to infection with a MDRO are recommended.

Successful treatment of pneumonia depends on timely diagnosis and administration of antibiotics. Multidrug-resistant organisms (MDROs) complicate antibiotic therapies by rendering some antibiotic agents ineffective. Inappropriate initial therapy has been associated with a more than 2-fold increase in the risk of mortality.¹ Because culture results are not available immediately, clinicians prescribe antibiotics empirically and must rely on guidelines and knowledge of risk factors associated with MDRO infection to make these selections.

Treatment guidelines exist for hospital-acquired and ventilator-associated pneumonia (HAP/VAP) and community-acquired pneumonia (CAP) to assist with empiric antibiotic selection. For HAP/VAP, 2 to 3 antibiotics with a broad-spectrum of activity are used due to increased prevalence of MDROs in hospitals, whereastreatment of CAP involves more narrow coverage because bacteria that cause this infection typically have fewer antibiotic resistances.^2,3 The HAP/VAP guidelines stratify the risk of pneumonia due to the presence of a MDRO acquired during a hospitalization. However, neither the CAP nor HAP/VAP guidelines offer risk-stratification guidance for nonhospitalized patients who develop pneumonia but who may have become colonized with a MDRO during a previous hospitalization or from another exposure to a health care facility.

Health care-associated pneumonia (HCAP) was first described in the 2005 American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) nosocomial pneumonia guidelines and was associated with criteria intended to aid clinician identification of nonhospitalized patients at risk for MDRO pneumonia, which warranted empiric broad-spectrum antibiotic therapy.² According to these guidelines, patients were classified as having HCAP if they had been hospitalized for at least 48 hours in the past 90 days, admitted from a nursing home, received recent intravenous antibiotics, had hemodialysis in the past 30 days, had a history of home infusion therapy or wound care, received intravenous chemotherapy, or had a family member with MDRO colonization.

Since publication of the 2005 guidelines, HCAP has been criticized as being a poor predictor of MDRO infection. A 2014 meta-analysis of 24 studies investigated the discriminating ability of HCAP and reported that the specificity and sensitivity for MDRO infections was 71.2% and 53.7%, respectively.³ In 2016, the ATS/IDSA guidelines were updated to remove HCAP due to the risk of antibiotic overprescribing.⁴

Literature Review

Although criteria previously defining a patient as having HCAP have been shown to be a poor discriminator of MDRO pneumonia as a whole, MDRO infections still pose a threat to nonhospitalized patients who have exposure to the health care system. A literature review was performed to identify independent HCAP risk factors that may increase the risk of MDRO pneumonia infecting a nonhospitalized patient needing empiric broad-spectrum antibiotic therapy. All included studies were prospective or retrospective observational cohort studies that performed logistic regression analyses to assess the association between MDRO isolation and the previously defined HCAP risk factors (Table 1).

Five studies examined the risk of MDRO infection in patients with a previous hospital admission of 2 days or more in the past 90 days. Shindo and colleagues found a significant increase in MDRO infections by about 2-fold (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.2-3.4).⁵ Shorr and colleagues found a 4-fold increase in likelihood of identifying a MDRO in HCAP (AOR, 4.2; 95% CI, 2.9-6.3).⁶ Nseir and colleagues and Jung and colleagues found similar results (AOR 3.9, 95% CI 1.7-8.8; AOR 2.7, 95% CI 1.3-5.5, respectively).^7,8 Conflicting results were reported by Gross and colleagues who did not find a significant relationship between previous hospitalization and MDRO isolation (AOR 1.2, 95% CI, 0.5-3.2).⁹

In patients with pneumonia admitted from a nursing home, MDRO infection risk also was evaluated in these 5 studies. Shorr and colleagues, Nseir and colleagues, and Gross and colleagues found significant AORs of 2.7 (95% CI 1.7-4.3), 2.0 (95% CI 1.1-3.7), and 4.2 (95% CI 1.6-11.3), respectively.^6,7,9 Shindo and colleagues (AOR 1.1; 95% CI, 0.6-2.0) and Jung and colleagues (AOR 1.9, 95% CI, 0.5-6.9) found this risk factor not significant.⁵

Receipt of antibiotics within the previous 90 days was assessed in 3 studies. Shindo and colleagues, Nseir and colleagues, and Gross and colleagues all found significant AORs of 2.5 (95% CI 1.2-4.0), 2.3 (95% CI 1.2-4.3), and 2.9 (95% CI 1.1-7.5), respectively.^5,7,9 Antibiotic therapy within the previous 90 days is an established risk factor for MDRO pneumonia, and the 2016 ATS/IDSA guidelines consider this a risk factor for HAP and VAP, including pneumonia caused by methicillin resistant Staphylococcus aureus and Pseudomonas aeruginosa.⁴

The impact of hemodialysis in the previous month on acquisition of MDRO pneumonia was investigated in 4 studies. Shindo and colleagues, Jung and colleagues, and Gross and colleagues concluded that this risk factor was not significantly related to MDRO infection, reporting AORs of 2.2 (95% CI 0.5-9.7), 2.8 (95% CI 0.9-9.2) and 0.7 (95% CI 0.1-5.1), respectively.^5,8,9 Shorr and colleagues, however, found a significant AOR of 2.1 (95% CI 1.0-4.3).⁶

Shindo and colleagues investigated the impact of home infusion therapy on acquisition of pneumonia due to a MDRO and reported a nonsignificant AOR of 0.8 (95% CI 0.4-1.8).⁵ Gross and colleagues also found a nonsignificant AOR of 0 (P = .1).⁹ In the Shindo and colleagues study, resistance was found in 107 of 679 patients who did not receive infusion therapy, and 12 of 55 patients who were receiving infusion therapy.⁵ Gross and colleagues reported that home-infusion therapy was received by 0 of 20 patients with MDRO infection and 4 of the 501 patients without MDRO infection.⁹

Shindo and colleagues reported that home wound care was not found to be significantly related to MDRO pneumonia as well as did Gross and colleagues: AORs of 3.8 (0.8-18.4) and 1.4 (95% CI 0.5-4.4), respectively.^5,9 Jung and colleagues examined IV chemotherapy in the past 30 days, and found this to not significantly impact the odds of MDRO isolation (AOR = 0.62, 95% CI 0.2-1.8).⁸ No data were available reflecting the risk of a family member with a MDRO.

Limitations

The variables on which logistic regression were performed differed among the studies. Therefore, results cannot be averaged or compared quantitatively, as AORs varied, depending on the variables included. In addition, data were drawn from multiple geographic locations that may impact MDRO prevalence within each patient population. Finally, this review examines the utility of the risk factors formerly included in HCAP. However, other risk factors for MDRO pneumonia outlined by the ATS/IDSA guidelines still should be considered when evaluating patient risk. The 2016 guidelines recommend local incidence of resistant strains be considered when initiating empiric therapy. Review of medical records for previous positive cultures and duration of current hospitalization also should be considered. Although the 2016 ATS/IDSA HAP guidelines are not intended for immunosuppressed patients, this risk factor also may be taken into account.

Conclusion

Review and synthesis of published literature found previous hospital admission (of ≥ 2 days in the past 90 days), admission from a nursing home, and IV antibiotic therapy in the last 90 days to be independent risk factors for identification of MDRO pneumonia in previously nonhospitalized patients (Table 2). Additionally, although no data were found to support this risk factor, existence of an in-home (close contact) source of MDROs would provide ample opportunity for transmission, so evaluation of known exposure to MDROs from contacts should be considered. When choosing empiric antibiotic therapy for patients admitted to the hospital for treatment of pneumonia, consideration of patient history and risk factors that may contribute to infection with a MDRO are recommended.

Boehringer Ingelheim

LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).

The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.

Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.

These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.

“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”

In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.

The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.

The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).

The primary outcomes in this study were the risk of major bleeding and stroke.

Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).

However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).

Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].

And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).

The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.

Boehringer Ingelheim

LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).

The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.

Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.

These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.

“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”

In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.

The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.

The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).

The primary outcomes in this study were the risk of major bleeding and stroke.

Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).

However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).

Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].

And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).

The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.

Boehringer Ingelheim

LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).

The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.

Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.

These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.

“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”

In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.

The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.

The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).

The primary outcomes in this study were the risk of major bleeding and stroke.

Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).

However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).

Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].

And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).

The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.

Image from NIAID

Engineered T cells can produce durable responses in patients with Epstein Barr virus–positive (EBV+), relapsed/refractory Hodgkin lymphoma (HL), according to research published in the Journal of Clinical Oncology.

These T cells, known as DNRII-LSTs, produced responses in 4 of the 8 patients studied.

This included 3 complete responses (CRs), the longest of which has exceeded 7 years.

What’s more, these responses were achieved without the use of lymphodepleting chemotherapy.

“While the study is small, its findings are incredibly encouraging for our [patients’] families and for the cancer field,” said study author Catherine M. Bollard, MD, MBChB, of Children’s National Health System in Washington, DC.

To engineer the DNRII-LSTs, Dr Bollard and her colleagues forced expression of a dominant-negative TGF-beta receptor type 2 (DNRII) on LMP-specific T cells (LSTs), which are T cells directed to the EBV latency-associated antigens LMP-1 and LMP-2.

The goal of forcing DNRII expression was to enable the LSTs to resist the hostile tumor environment so they could seek out and kill the tumor cells.

Dr Bollard and her colleagues administered DNRII-LSTs to 8 patients with EBV+ HL. The patients ranged in age from 27 to 47.

Seven of the 8 patients had active disease at the time of DNRII-LST infusion. Two patients had stage IVB HL, 1 had stage IIIB, and 2 had stage IIB. Four patients had nodular-sclerosing HL.

Six patients had relapsed twice. The remaining 2 patients had relapsed 3 and 4 times, respectively. All patients had previously received an autologous stem cell transplant and a range of multi-agent chemotherapy regimens (eg, ABVD, R-ICE, and MOPP).

For this study, the patients received 2 to 12 infusions of DNRII-LSTs, at doses ranging from 2 × 10⁷ to 1.5 × 10⁸ cells/m².

Results

The researchers found that autologous DNRII-LSTs (given to 7 patients) did not cause autoimmunity, and donor-derived DNRII-LSTs (n=1) did not induce graft-vs-host disease.

The team also noted there were no toxicities resulting from cytokine release syndrome.

Four patients achieved a response to treatment—3 CRs and a partial response.

All complete responders are still in CR, but the partial responder progressed at 19 months and ultimately died of sepsis (2 years after the first dose of DNRII-LSTs).

The other 4 patients had stable disease (SD) for 4 months to 13 months after treatment with DNRII-LSTs.

One patient with SD died of disease progression 2 years after receiving DNRII-LSTs, and another died of transplant complications less than 2 years after the last dose of DNRII-LSTs.

One patient with SD went on to receive additional therapy and is still alive more than 6 years after receiving DNRII-LSTs (currently receiving nivolumab). Another SD patient went on to receive additional therapy, achieved a CR, and is still alive.

One of the patients who achieved a CR to DNRII-LSTs remains in CR more than 7 years after the last dose. Another patient’s CR has exceeded 2 years, and another’s has exceeded 5 years.

All 3 of these patients received doses of 2 × 10⁷ cells/m². The patients with the longest and shortest CRs each received 2 infusions of DNRII-LSTs. The patient with the CR exceeding 5 years received 12 infusions.

“These results come 18 years after this revolutionary approach was first conceptualized,” Dr Bollard said. “I started work in this area in 2000. At that time, the oncology community had little enthusiasm for the use of T-cell therapies to treat cancer.”

“Even then, when T-cell therapy was in its relative infancy, some research institutions began to see more than 90% complete responses and cure rates in some settings. This most recent study points to the potential of specialized T cells to fight even more types of immune-evading tumors.”

Image from NIAID

Engineered T cells can produce durable responses in patients with Epstein Barr virus–positive (EBV+), relapsed/refractory Hodgkin lymphoma (HL), according to research published in the Journal of Clinical Oncology.

These T cells, known as DNRII-LSTs, produced responses in 4 of the 8 patients studied.

This included 3 complete responses (CRs), the longest of which has exceeded 7 years.

What’s more, these responses were achieved without the use of lymphodepleting chemotherapy.

“While the study is small, its findings are incredibly encouraging for our [patients’] families and for the cancer field,” said study author Catherine M. Bollard, MD, MBChB, of Children’s National Health System in Washington, DC.

To engineer the DNRII-LSTs, Dr Bollard and her colleagues forced expression of a dominant-negative TGF-beta receptor type 2 (DNRII) on LMP-specific T cells (LSTs), which are T cells directed to the EBV latency-associated antigens LMP-1 and LMP-2.

The goal of forcing DNRII expression was to enable the LSTs to resist the hostile tumor environment so they could seek out and kill the tumor cells.

Dr Bollard and her colleagues administered DNRII-LSTs to 8 patients with EBV+ HL. The patients ranged in age from 27 to 47.

Seven of the 8 patients had active disease at the time of DNRII-LST infusion. Two patients had stage IVB HL, 1 had stage IIIB, and 2 had stage IIB. Four patients had nodular-sclerosing HL.

Six patients had relapsed twice. The remaining 2 patients had relapsed 3 and 4 times, respectively. All patients had previously received an autologous stem cell transplant and a range of multi-agent chemotherapy regimens (eg, ABVD, R-ICE, and MOPP).

For this study, the patients received 2 to 12 infusions of DNRII-LSTs, at doses ranging from 2 × 10⁷ to 1.5 × 10⁸ cells/m².

Results

The researchers found that autologous DNRII-LSTs (given to 7 patients) did not cause autoimmunity, and donor-derived DNRII-LSTs (n=1) did not induce graft-vs-host disease.

The team also noted there were no toxicities resulting from cytokine release syndrome.

Four patients achieved a response to treatment—3 CRs and a partial response.

All complete responders are still in CR, but the partial responder progressed at 19 months and ultimately died of sepsis (2 years after the first dose of DNRII-LSTs).

The other 4 patients had stable disease (SD) for 4 months to 13 months after treatment with DNRII-LSTs.

One patient with SD died of disease progression 2 years after receiving DNRII-LSTs, and another died of transplant complications less than 2 years after the last dose of DNRII-LSTs.

One patient with SD went on to receive additional therapy and is still alive more than 6 years after receiving DNRII-LSTs (currently receiving nivolumab). Another SD patient went on to receive additional therapy, achieved a CR, and is still alive.

One of the patients who achieved a CR to DNRII-LSTs remains in CR more than 7 years after the last dose. Another patient’s CR has exceeded 2 years, and another’s has exceeded 5 years.

All 3 of these patients received doses of 2 × 10⁷ cells/m². The patients with the longest and shortest CRs each received 2 infusions of DNRII-LSTs. The patient with the CR exceeding 5 years received 12 infusions.

“These results come 18 years after this revolutionary approach was first conceptualized,” Dr Bollard said. “I started work in this area in 2000. At that time, the oncology community had little enthusiasm for the use of T-cell therapies to treat cancer.”

“Even then, when T-cell therapy was in its relative infancy, some research institutions began to see more than 90% complete responses and cure rates in some settings. This most recent study points to the potential of specialized T cells to fight even more types of immune-evading tumors.”

Image from NIAID

Engineered T cells can produce durable responses in patients with Epstein Barr virus–positive (EBV+), relapsed/refractory Hodgkin lymphoma (HL), according to research published in the Journal of Clinical Oncology.

These T cells, known as DNRII-LSTs, produced responses in 4 of the 8 patients studied.

This included 3 complete responses (CRs), the longest of which has exceeded 7 years.

What’s more, these responses were achieved without the use of lymphodepleting chemotherapy.

“While the study is small, its findings are incredibly encouraging for our [patients’] families and for the cancer field,” said study author Catherine M. Bollard, MD, MBChB, of Children’s National Health System in Washington, DC.

To engineer the DNRII-LSTs, Dr Bollard and her colleagues forced expression of a dominant-negative TGF-beta receptor type 2 (DNRII) on LMP-specific T cells (LSTs), which are T cells directed to the EBV latency-associated antigens LMP-1 and LMP-2.

The goal of forcing DNRII expression was to enable the LSTs to resist the hostile tumor environment so they could seek out and kill the tumor cells.

Dr Bollard and her colleagues administered DNRII-LSTs to 8 patients with EBV+ HL. The patients ranged in age from 27 to 47.

Seven of the 8 patients had active disease at the time of DNRII-LST infusion. Two patients had stage IVB HL, 1 had stage IIIB, and 2 had stage IIB. Four patients had nodular-sclerosing HL.

Six patients had relapsed twice. The remaining 2 patients had relapsed 3 and 4 times, respectively. All patients had previously received an autologous stem cell transplant and a range of multi-agent chemotherapy regimens (eg, ABVD, R-ICE, and MOPP).

For this study, the patients received 2 to 12 infusions of DNRII-LSTs, at doses ranging from 2 × 10⁷ to 1.5 × 10⁸ cells/m².

Results

The researchers found that autologous DNRII-LSTs (given to 7 patients) did not cause autoimmunity, and donor-derived DNRII-LSTs (n=1) did not induce graft-vs-host disease.

The team also noted there were no toxicities resulting from cytokine release syndrome.

Four patients achieved a response to treatment—3 CRs and a partial response.

All complete responders are still in CR, but the partial responder progressed at 19 months and ultimately died of sepsis (2 years after the first dose of DNRII-LSTs).

The other 4 patients had stable disease (SD) for 4 months to 13 months after treatment with DNRII-LSTs.

One patient with SD died of disease progression 2 years after receiving DNRII-LSTs, and another died of transplant complications less than 2 years after the last dose of DNRII-LSTs.

One patient with SD went on to receive additional therapy and is still alive more than 6 years after receiving DNRII-LSTs (currently receiving nivolumab). Another SD patient went on to receive additional therapy, achieved a CR, and is still alive.

One of the patients who achieved a CR to DNRII-LSTs remains in CR more than 7 years after the last dose. Another patient’s CR has exceeded 2 years, and another’s has exceeded 5 years.

All 3 of these patients received doses of 2 × 10⁷ cells/m². The patients with the longest and shortest CRs each received 2 infusions of DNRII-LSTs. The patient with the CR exceeding 5 years received 12 infusions.

“These results come 18 years after this revolutionary approach was first conceptualized,” Dr Bollard said. “I started work in this area in 2000. At that time, the oncology community had little enthusiasm for the use of T-cell therapies to treat cancer.”

“Even then, when T-cell therapy was in its relative infancy, some research institutions began to see more than 90% complete responses and cure rates in some settings. This most recent study points to the potential of specialized T cells to fight even more types of immune-evading tumors.”

Photo by Rhoda Baer

Treatment costs are the greatest threat to the growth of cancer programs, according to a survey of nearly 300 cancer program administrators and providers.

Sixty-eight percent of survey respondents said treatment costs were among the biggest threats to future cancer program growth at their organization.

Other top threats to growth included physician alignment around services and program goals—cited by 47% of respondents—and changes in healthcare coverage—cited by 46%.

This survey—the “2017 Trending Now in Cancer Care Survey”—was conducted by the Association of Community Cancer Centers (ACCC) and Advisory Board’s Oncology Roundtable. It was supported by Pfizer Oncology.

The survey was distributed via email on July 24, 2017. Respondents included 293 cancer program administrators and providers from 209 institutions. They submitted responses over 6 weeks.

Respondents identified the following “biggest threats” to cancer program growth:

• Cost of drugs and/or new treatment modalities—68%
• Physician alignment around services and program goals—47%
• Changes in healthcare coverage—46%
• Cuts to fee-for-service reimbursement—44%
• Shifting reimbursement to value-based care—43%
• Marketplace competition—35%
• Workforce planning (eg, managing staff shortages)—34%
• Network strategy and integration—33%
• Site of care policies issued by private payers—27%
• Access to capital—26%
• Quality reporting requirements—22%
• Health information technology—21%
• Other—6%.

When asked to identify their greatest opportunities for cost savings, respondents overwhelmingly pointed toward clinical standardization (63%) and drugs (62%).

Other opportunities included:

• Supplies—28%
• Capital expenses (eg, imaging technology)—24%
• Non-clinical staff (eg, billing and coding specialists)—22%
• Technology maintenance—20%
• Clinical staff—16%
• Retail pharmacy—14%
• Clinical research—10%
• Support services (eg, acupuncture)—9%
• Other—4%.

Respondents also said the investments most likely to yield a return for their cancer program were:

• Increasing the number of sub-specialists (eg, breast surgeons)—59%
• Marketing—41%
• Specialty pharmacy—36%
• Increasing the number of general oncology physicians—34%
• Screening services (eg, mobile screening unit)—29%
• Capital investments—24%
• Clinical research—16%
• Support services—15%
• Retail pharmacy—14%
• Building upgrades—14%.

More details on the “2017 Trending Now in Cancer Care Survey” can be found on the ACCC website.

Photo by Rhoda Baer

Treatment costs are the greatest threat to the growth of cancer programs, according to a survey of nearly 300 cancer program administrators and providers.

Sixty-eight percent of survey respondents said treatment costs were among the biggest threats to future cancer program growth at their organization.

Other top threats to growth included physician alignment around services and program goals—cited by 47% of respondents—and changes in healthcare coverage—cited by 46%.

This survey—the “2017 Trending Now in Cancer Care Survey”—was conducted by the Association of Community Cancer Centers (ACCC) and Advisory Board’s Oncology Roundtable. It was supported by Pfizer Oncology.

The survey was distributed via email on July 24, 2017. Respondents included 293 cancer program administrators and providers from 209 institutions. They submitted responses over 6 weeks.

Respondents identified the following “biggest threats” to cancer program growth:

• Cost of drugs and/or new treatment modalities—68%
• Physician alignment around services and program goals—47%
• Changes in healthcare coverage—46%
• Cuts to fee-for-service reimbursement—44%
• Shifting reimbursement to value-based care—43%
• Marketplace competition—35%
• Workforce planning (eg, managing staff shortages)—34%
• Network strategy and integration—33%
• Site of care policies issued by private payers—27%
• Access to capital—26%
• Quality reporting requirements—22%
• Health information technology—21%
• Other—6%.

When asked to identify their greatest opportunities for cost savings, respondents overwhelmingly pointed toward clinical standardization (63%) and drugs (62%).

Other opportunities included:

• Supplies—28%
• Capital expenses (eg, imaging technology)—24%
• Non-clinical staff (eg, billing and coding specialists)—22%
• Technology maintenance—20%
• Clinical staff—16%
• Retail pharmacy—14%
• Clinical research—10%
• Support services (eg, acupuncture)—9%
• Other—4%.

Respondents also said the investments most likely to yield a return for their cancer program were:

• Increasing the number of sub-specialists (eg, breast surgeons)—59%
• Marketing—41%
• Specialty pharmacy—36%
• Increasing the number of general oncology physicians—34%
• Screening services (eg, mobile screening unit)—29%
• Capital investments—24%
• Clinical research—16%
• Support services—15%
• Retail pharmacy—14%
• Building upgrades—14%.

More details on the “2017 Trending Now in Cancer Care Survey” can be found on the ACCC website.

Photo by Rhoda Baer

Treatment costs are the greatest threat to the growth of cancer programs, according to a survey of nearly 300 cancer program administrators and providers.

Sixty-eight percent of survey respondents said treatment costs were among the biggest threats to future cancer program growth at their organization.

Other top threats to growth included physician alignment around services and program goals—cited by 47% of respondents—and changes in healthcare coverage—cited by 46%.

This survey—the “2017 Trending Now in Cancer Care Survey”—was conducted by the Association of Community Cancer Centers (ACCC) and Advisory Board’s Oncology Roundtable. It was supported by Pfizer Oncology.

The survey was distributed via email on July 24, 2017. Respondents included 293 cancer program administrators and providers from 209 institutions. They submitted responses over 6 weeks.

Respondents identified the following “biggest threats” to cancer program growth:

• Cost of drugs and/or new treatment modalities—68%
• Physician alignment around services and program goals—47%
• Changes in healthcare coverage—46%
• Cuts to fee-for-service reimbursement—44%
• Shifting reimbursement to value-based care—43%
• Marketplace competition—35%
• Workforce planning (eg, managing staff shortages)—34%
• Network strategy and integration—33%
• Site of care policies issued by private payers—27%
• Access to capital—26%
• Quality reporting requirements—22%
• Health information technology—21%
• Other—6%.

When asked to identify their greatest opportunities for cost savings, respondents overwhelmingly pointed toward clinical standardization (63%) and drugs (62%).

Other opportunities included:

• Supplies—28%
• Capital expenses (eg, imaging technology)—24%
• Non-clinical staff (eg, billing and coding specialists)—22%
• Technology maintenance—20%
• Clinical staff—16%
• Retail pharmacy—14%
• Clinical research—10%
• Support services (eg, acupuncture)—9%
• Other—4%.

Respondents also said the investments most likely to yield a return for their cancer program were:

• Increasing the number of sub-specialists (eg, breast surgeons)—59%
• Marketing—41%
• Specialty pharmacy—36%
• Increasing the number of general oncology physicians—34%
• Screening services (eg, mobile screening unit)—29%
• Capital investments—24%
• Clinical research—16%
• Support services—15%
• Retail pharmacy—14%
• Building upgrades—14%.

More details on the “2017 Trending Now in Cancer Care Survey” can be found on the ACCC website.

ATLANTA – There were a lot of new data presented during the annual meeting of the American Society of Hematology. But what findings could actually change the way you practice?

Robert A. Brodsky, MD, director of the division of hematology at Johns Hopkins University in Baltimore and the moderator for the late-breaking abstract session at ASH, highlighted results from two studies.

Data from the MURANO trial showed robust results for a combination of venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). At a median follow-up of 23.8 months, median progression-free survival -had not been reached in patients randomized to venetoclax/rituximab, while patients who received bendamustine plus rituximab had a median PFS of 17 months.

The venetoclax/rituximab combination will “probably emerge as a new standard therapy” for refractory CLL based on the data presented, Dr. Brodsky said.

Another “enormously exciting and practice-changing” finding is that direct oral anticoagulants can be used safely in patients with cancer, Dr. Brodsky said in an interview.

In a randomized, open-label study, 12 months of daily treatment with edoxaban was noninferior to standard subcutaneous therapy with dalteparin for treatment of venous thromboembolism in cancer patients.

[email protected]

ATLANTA – There were a lot of new data presented during the annual meeting of the American Society of Hematology. But what findings could actually change the way you practice?

Robert A. Brodsky, MD, director of the division of hematology at Johns Hopkins University in Baltimore and the moderator for the late-breaking abstract session at ASH, highlighted results from two studies.

Data from the MURANO trial showed robust results for a combination of venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). At a median follow-up of 23.8 months, median progression-free survival -had not been reached in patients randomized to venetoclax/rituximab, while patients who received bendamustine plus rituximab had a median PFS of 17 months.

The venetoclax/rituximab combination will “probably emerge as a new standard therapy” for refractory CLL based on the data presented, Dr. Brodsky said.

Another “enormously exciting and practice-changing” finding is that direct oral anticoagulants can be used safely in patients with cancer, Dr. Brodsky said in an interview.

In a randomized, open-label study, 12 months of daily treatment with edoxaban was noninferior to standard subcutaneous therapy with dalteparin for treatment of venous thromboembolism in cancer patients.

[email protected]

ATLANTA – There were a lot of new data presented during the annual meeting of the American Society of Hematology. But what findings could actually change the way you practice?

Robert A. Brodsky, MD, director of the division of hematology at Johns Hopkins University in Baltimore and the moderator for the late-breaking abstract session at ASH, highlighted results from two studies.

Data from the MURANO trial showed robust results for a combination of venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). At a median follow-up of 23.8 months, median progression-free survival -had not been reached in patients randomized to venetoclax/rituximab, while patients who received bendamustine plus rituximab had a median PFS of 17 months.

The venetoclax/rituximab combination will “probably emerge as a new standard therapy” for refractory CLL based on the data presented, Dr. Brodsky said.

Another “enormously exciting and practice-changing” finding is that direct oral anticoagulants can be used safely in patients with cancer, Dr. Brodsky said in an interview.

In a randomized, open-label study, 12 months of daily treatment with edoxaban was noninferior to standard subcutaneous therapy with dalteparin for treatment of venous thromboembolism in cancer patients.

[email protected]

Ofatumumab (Arzerra), a monoclonal antibody treatment for chronic lymphocytic leukemia, will soon be available outside the United States through compassionate use programs only. The drug will continue to be widely available in the United States.

Novartis announced in January that it would begin limiting the availability of the drug outside of the United States and would work with regulatory authorities to set up compassionate use programs for patients who are currently being treated with the drug. Patients who use these programs will receive the drug for free.

The decision was driven by the surge in CLL drugs that have become available over the last 5 years, according to Novartis.

The decision to pull the drug from international markets will not affect its use in ongoing clinical trials, particularly two phase 3 studies in relapsing multiple sclerosis and indolent non-Hodgkin lymphoma.

[email protected]

Ofatumumab (Arzerra), a monoclonal antibody treatment for chronic lymphocytic leukemia, will soon be available outside the United States through compassionate use programs only. The drug will continue to be widely available in the United States.

Novartis announced in January that it would begin limiting the availability of the drug outside of the United States and would work with regulatory authorities to set up compassionate use programs for patients who are currently being treated with the drug. Patients who use these programs will receive the drug for free.

The decision was driven by the surge in CLL drugs that have become available over the last 5 years, according to Novartis.

The decision to pull the drug from international markets will not affect its use in ongoing clinical trials, particularly two phase 3 studies in relapsing multiple sclerosis and indolent non-Hodgkin lymphoma.

[email protected]

Ofatumumab (Arzerra), a monoclonal antibody treatment for chronic lymphocytic leukemia, will soon be available outside the United States through compassionate use programs only. The drug will continue to be widely available in the United States.

Novartis announced in January that it would begin limiting the availability of the drug outside of the United States and would work with regulatory authorities to set up compassionate use programs for patients who are currently being treated with the drug. Patients who use these programs will receive the drug for free.

The decision was driven by the surge in CLL drugs that have become available over the last 5 years, according to Novartis.

The decision to pull the drug from international markets will not affect its use in ongoing clinical trials, particularly two phase 3 studies in relapsing multiple sclerosis and indolent non-Hodgkin lymphoma.

[email protected]

LAS VEGAS – Emergent colectomies for ulcerative colitis in the United States decreased more than 7% annually between 2000 and 2014, a large database analysis has shown.

“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.

In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.

*This story was updated on 3/26.

[email protected]

SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.

LAS VEGAS – Emergent colectomies for ulcerative colitis in the United States decreased more than 7% annually between 2000 and 2014, a large database analysis has shown.

“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.

In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.

*This story was updated on 3/26.

[email protected]

SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.

LAS VEGAS – Emergent colectomies for ulcerative colitis in the United States decreased more than 7% annually between 2000 and 2014, a large database analysis has shown.

“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.

In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.

*This story was updated on 3/26.

[email protected]

SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.

The 1-minute walk test is as effective as the 6-minute walk test at predicting transplant-free survival in patients with idiopathic pulmonary fibrosis (IPF), based on data from 179 adults. The findings were presented at the CHEST annual meeting.

The 6-minute test is often used to evaluate functional capacity in IPF patients, but is not always practical in a busy clinic setting, according to Flavia S. Nunes, MD, of Inova Fairfax Hospital in Falls Church, VA, and colleagues.

czardases/Thinkstock

The 1-minute walk test is as effective as the 6-minute walk test at predicting transplant-free survival in patients with idiopathic pulmonary fibrosis (IPF), based on data from 179 adults. The findings were presented at the CHEST annual meeting.

The 6-minute test is often used to evaluate functional capacity in IPF patients, but is not always practical in a busy clinic setting, according to Flavia S. Nunes, MD, of Inova Fairfax Hospital in Falls Church, VA, and colleagues.

czardases/Thinkstock

The 1-minute walk test is as effective as the 6-minute walk test at predicting transplant-free survival in patients with idiopathic pulmonary fibrosis (IPF), based on data from 179 adults. The findings were presented at the CHEST annual meeting.

The 6-minute test is often used to evaluate functional capacity in IPF patients, but is not always practical in a busy clinic setting, according to Flavia S. Nunes, MD, of Inova Fairfax Hospital in Falls Church, VA, and colleagues.

czardases/Thinkstock

Trainee and early-career members made an impact in the GI field this past year, especially through contributing to and engaging in various collaborations via the American Gastroenterological Association’s member-only online discussion forum – the AGA Community.

We’re proud to announce that the title of 2017 top contributor is held by an early-career member: Meet Dmitriy Kedrin, MD, PhD, of Elliot Hospital in Manchester, N.H., and find out a little more about how the AGA Community is an important part of his routine in this brief Q&A session.

Thanks for being such an active member of the AGA Community! Why do you contribute?

“I think it is important for GI docs to be a part of a larger community, stay informed on the latest guidelines, research publications, and approaches to difficult cases, where more than one road can be taken. I feel that it is a great forum for someone like me, a relatively junior gastroenterologist.”

Why do you enjoy being part of the AGA Community?

“I find the case discussions informative. I learn a great deal about current trends and opinions on important topics in the GI world.”

What do you like to do in your free time?

“I bake bread and run a gastroenterology literature review podcast called ‘GI Pearls.’ ”

What’s your approach to handling a difficult patient case you come across in your practice?

“I often seek advice of other clinicians, some with more expertise in a particular area. I also go to the literature and try to learn more that way, to help expand my differential as well as figure out the best therapeutic approach.”

Was there a conversation in the AGA Community in 2017 that was your favorite?

“Oh, there were several. I recall a patient case where there were several thought leaders in the field who had a disagreement about the best approach to treatment. The work-life balance conversation was also very good. I also enjoyed reading about different opinions regarding the values of clinical versus observational trials that happened a while back.”



Here are other trainee and early-career members who made the list of top contributors in the AGA Community last year:

• Avinash Ketwaroo, MD
• Hüseyin Bozkurt, MD
• Peter Liang, MD, MPH
• Fola May, MD, PhD
• Richa Shukla, MD
• Arthur Beyder, MD, PhD
• Shazia Siddique, MD
• Brigid Boland, MD

Check the achievements section of your AGA Community profile to see whether you made the list. We look forward to seeing you all in the forum in 2018!

Trainee and early-career members made an impact in the GI field this past year, especially through contributing to and engaging in various collaborations via the American Gastroenterological Association’s member-only online discussion forum – the AGA Community.

We’re proud to announce that the title of 2017 top contributor is held by an early-career member: Meet Dmitriy Kedrin, MD, PhD, of Elliot Hospital in Manchester, N.H., and find out a little more about how the AGA Community is an important part of his routine in this brief Q&A session.

Thanks for being such an active member of the AGA Community! Why do you contribute?

“I think it is important for GI docs to be a part of a larger community, stay informed on the latest guidelines, research publications, and approaches to difficult cases, where more than one road can be taken. I feel that it is a great forum for someone like me, a relatively junior gastroenterologist.”

Why do you enjoy being part of the AGA Community?

“I find the case discussions informative. I learn a great deal about current trends and opinions on important topics in the GI world.”

What do you like to do in your free time?

“I bake bread and run a gastroenterology literature review podcast called ‘GI Pearls.’ ”

What’s your approach to handling a difficult patient case you come across in your practice?

“I often seek advice of other clinicians, some with more expertise in a particular area. I also go to the literature and try to learn more that way, to help expand my differential as well as figure out the best therapeutic approach.”

Was there a conversation in the AGA Community in 2017 that was your favorite?

“Oh, there were several. I recall a patient case where there were several thought leaders in the field who had a disagreement about the best approach to treatment. The work-life balance conversation was also very good. I also enjoyed reading about different opinions regarding the values of clinical versus observational trials that happened a while back.”



Here are other trainee and early-career members who made the list of top contributors in the AGA Community last year:

• Avinash Ketwaroo, MD
• Hüseyin Bozkurt, MD
• Peter Liang, MD, MPH
• Fola May, MD, PhD
• Richa Shukla, MD
• Arthur Beyder, MD, PhD
• Shazia Siddique, MD
• Brigid Boland, MD

Check the achievements section of your AGA Community profile to see whether you made the list. We look forward to seeing you all in the forum in 2018!

Trainee and early-career members made an impact in the GI field this past year, especially through contributing to and engaging in various collaborations via the American Gastroenterological Association’s member-only online discussion forum – the AGA Community.

We’re proud to announce that the title of 2017 top contributor is held by an early-career member: Meet Dmitriy Kedrin, MD, PhD, of Elliot Hospital in Manchester, N.H., and find out a little more about how the AGA Community is an important part of his routine in this brief Q&A session.

Thanks for being such an active member of the AGA Community! Why do you contribute?

“I think it is important for GI docs to be a part of a larger community, stay informed on the latest guidelines, research publications, and approaches to difficult cases, where more than one road can be taken. I feel that it is a great forum for someone like me, a relatively junior gastroenterologist.”

Why do you enjoy being part of the AGA Community?

“I find the case discussions informative. I learn a great deal about current trends and opinions on important topics in the GI world.”

What do you like to do in your free time?

“I bake bread and run a gastroenterology literature review podcast called ‘GI Pearls.’ ”

What’s your approach to handling a difficult patient case you come across in your practice?

“I often seek advice of other clinicians, some with more expertise in a particular area. I also go to the literature and try to learn more that way, to help expand my differential as well as figure out the best therapeutic approach.”

Was there a conversation in the AGA Community in 2017 that was your favorite?

“Oh, there were several. I recall a patient case where there were several thought leaders in the field who had a disagreement about the best approach to treatment. The work-life balance conversation was also very good. I also enjoyed reading about different opinions regarding the values of clinical versus observational trials that happened a while back.”



Here are other trainee and early-career members who made the list of top contributors in the AGA Community last year:

• Avinash Ketwaroo, MD
• Hüseyin Bozkurt, MD
• Peter Liang, MD, MPH
• Fola May, MD, PhD
• Richa Shukla, MD
• Arthur Beyder, MD, PhD
• Shazia Siddique, MD
• Brigid Boland, MD

Check the achievements section of your AGA Community profile to see whether you made the list. We look forward to seeing you all in the forum in 2018!

Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.

“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).

©thinkstockphotos.com

[email protected]

Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.

“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).

©thinkstockphotos.com

[email protected]

Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.

“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).

©thinkstockphotos.com

[email protected]