SAN FRANCISCO – Immune-enriched acute myeloid leukemias might be amenable to immunotherapy that is tailored to the bone marrow tumor microenvironment, according to findings from a pan-cancer analysis of bone marrow samples.

The analysis, performed with 3D biology technology and an RNA pan-cancer immune profiling panel to characterize bone marrow specimens from 46 children and 28 adults with acute myeloid leukemia (AML), identified heterogeneous immune profiles that correlated with relapse-free survival (RFS) and overall survival (OS), Jayakumar Vadakekolathu, PhD, reported at the ASCO-SITC Clinical Immuno-Oncology Symposium.

The specimens, including 63 from nonpromyelocytic de novo AML, 7 from AML in children with complete remission, 3 from adults with secondary AML, and 1 from an adult with treatment-related AML, were analyzed with the nCounter system from NanoString Technologies, and were visualized via digital spatial profiling, said Dr. Vadakekolathu of Nottingham Trent University in England.

Sharon Worcester/Frontline Medical News

“Prognosis is determined by cytogenetic and molecular abnormalities, as well as by response to chemotherapy. De novo AML is cured in roughly 70% of children, 35%-40% of adults, and 5%-15% of elderly patients,” he said. Some patients with AML fail to respond to induction chemotherapy, and others eventually relapse despite the lack of adverse risk factors, he added.

The general therapeutic strategy in patients with AML has not changed substantially in more than 30 years, he said.

“High degrees of molecular complexity in AML present a considerable challenge in clinical implementation, and there is an urgent need to discover better biomarkers to identify high-risk patients before starting chemotherapy, which would enable testing of investigational therapeutic strategies in clinical trials,” he said.

In an effort to identify immune gene signatures across the spectrum of AML genotypes and to correlate transcriptomic and proteomic profiles with patient outcomes, he and his colleagues used a pediatric cohort from Children’s Hospital of Philadelphia (median age at diagnosis of 10 years), and an adult cohort from the Technical University of Dresden, Germany (median age at diagnosis, 55.5 years). Bone marrow samples were collected and analyzed at diagnosis.

Hierarchical clustering identified the two distinct clusters. The immune-enriched cluster A had heightened expression of T cells, natural killer cells, and cytotoxic cells, and also expressed CD8A, IFNG, FOXP3, the cell chemoattractants CXCL9 and CXCL10, and inhibitory molecules including IDO1 and the immune checkpoints LAG3, CTLA4, and PD-L1. The immune-depleted cluster B overexpressed genes associated with mast cell functions and CD8 T-cell exhaustion, and showed low expression of T-cell and B-cell genes.

Further analysis of 10 of the inflamed samples from patients with newly diagnosed AML was performed with digital spatial profiling (DSP) to visualize in situ leukemia–immune system interactions, Dr. Vadakekolathu said.

Surface antigens CD123 and CD3 were used as a visualization marker for leukemia cells and to identify bone marrow-infiltrating T cells, respectively. Protein quantification showed a higher concentration of CD3 counts in T-cell-rich versus T-cell-poor areas, and protein expression profiles showed strong correlations with various immunologically relevant molecules. The co-localization of CD8 T cells with FoxP3 Treg cells and PD-L1- and VISTA-expressing cell types evident on DSP represents an immune landscape consistent with the establishment of adaptive immune resistance mechanisms of immune escape, he noted.

The findings suggest immune enriched AMLs might be amenable to combination immunotherapies tailored to the bone marrow tumor microenvironment, such as IDO1 inhibitors and checkpoint blockade, Dr. Vadakekolathu said. “Immune gene expression profiles of AML might support rapid prediction of patient outcomes, discovery of novel immune biomarkers and therapeutic targets, and development of integrated patient stratifications,” he said.

This study was supported by grants from the Roger Counter Foundation and the Qatar National Research Fund. Dr. Vadakekolathu reported having no disclosures. Some authors reported employment or other financial relationships with NanoString Technologies.

[email protected]

SOURCE: Rutella S et al. ASCO-SITC Abstract 50

SAN FRANCISCO – Immune-enriched acute myeloid leukemias might be amenable to immunotherapy that is tailored to the bone marrow tumor microenvironment, according to findings from a pan-cancer analysis of bone marrow samples.

The analysis, performed with 3D biology technology and an RNA pan-cancer immune profiling panel to characterize bone marrow specimens from 46 children and 28 adults with acute myeloid leukemia (AML), identified heterogeneous immune profiles that correlated with relapse-free survival (RFS) and overall survival (OS), Jayakumar Vadakekolathu, PhD, reported at the ASCO-SITC Clinical Immuno-Oncology Symposium.

The specimens, including 63 from nonpromyelocytic de novo AML, 7 from AML in children with complete remission, 3 from adults with secondary AML, and 1 from an adult with treatment-related AML, were analyzed with the nCounter system from NanoString Technologies, and were visualized via digital spatial profiling, said Dr. Vadakekolathu of Nottingham Trent University in England.

Sharon Worcester/Frontline Medical News

“Prognosis is determined by cytogenetic and molecular abnormalities, as well as by response to chemotherapy. De novo AML is cured in roughly 70% of children, 35%-40% of adults, and 5%-15% of elderly patients,” he said. Some patients with AML fail to respond to induction chemotherapy, and others eventually relapse despite the lack of adverse risk factors, he added.

The general therapeutic strategy in patients with AML has not changed substantially in more than 30 years, he said.

“High degrees of molecular complexity in AML present a considerable challenge in clinical implementation, and there is an urgent need to discover better biomarkers to identify high-risk patients before starting chemotherapy, which would enable testing of investigational therapeutic strategies in clinical trials,” he said.

In an effort to identify immune gene signatures across the spectrum of AML genotypes and to correlate transcriptomic and proteomic profiles with patient outcomes, he and his colleagues used a pediatric cohort from Children’s Hospital of Philadelphia (median age at diagnosis of 10 years), and an adult cohort from the Technical University of Dresden, Germany (median age at diagnosis, 55.5 years). Bone marrow samples were collected and analyzed at diagnosis.

Hierarchical clustering identified the two distinct clusters. The immune-enriched cluster A had heightened expression of T cells, natural killer cells, and cytotoxic cells, and also expressed CD8A, IFNG, FOXP3, the cell chemoattractants CXCL9 and CXCL10, and inhibitory molecules including IDO1 and the immune checkpoints LAG3, CTLA4, and PD-L1. The immune-depleted cluster B overexpressed genes associated with mast cell functions and CD8 T-cell exhaustion, and showed low expression of T-cell and B-cell genes.

Further analysis of 10 of the inflamed samples from patients with newly diagnosed AML was performed with digital spatial profiling (DSP) to visualize in situ leukemia–immune system interactions, Dr. Vadakekolathu said.

Surface antigens CD123 and CD3 were used as a visualization marker for leukemia cells and to identify bone marrow-infiltrating T cells, respectively. Protein quantification showed a higher concentration of CD3 counts in T-cell-rich versus T-cell-poor areas, and protein expression profiles showed strong correlations with various immunologically relevant molecules. The co-localization of CD8 T cells with FoxP3 Treg cells and PD-L1- and VISTA-expressing cell types evident on DSP represents an immune landscape consistent with the establishment of adaptive immune resistance mechanisms of immune escape, he noted.

The findings suggest immune enriched AMLs might be amenable to combination immunotherapies tailored to the bone marrow tumor microenvironment, such as IDO1 inhibitors and checkpoint blockade, Dr. Vadakekolathu said. “Immune gene expression profiles of AML might support rapid prediction of patient outcomes, discovery of novel immune biomarkers and therapeutic targets, and development of integrated patient stratifications,” he said.

This study was supported by grants from the Roger Counter Foundation and the Qatar National Research Fund. Dr. Vadakekolathu reported having no disclosures. Some authors reported employment or other financial relationships with NanoString Technologies.

[email protected]

SOURCE: Rutella S et al. ASCO-SITC Abstract 50

SAN FRANCISCO – Immune-enriched acute myeloid leukemias might be amenable to immunotherapy that is tailored to the bone marrow tumor microenvironment, according to findings from a pan-cancer analysis of bone marrow samples.

The analysis, performed with 3D biology technology and an RNA pan-cancer immune profiling panel to characterize bone marrow specimens from 46 children and 28 adults with acute myeloid leukemia (AML), identified heterogeneous immune profiles that correlated with relapse-free survival (RFS) and overall survival (OS), Jayakumar Vadakekolathu, PhD, reported at the ASCO-SITC Clinical Immuno-Oncology Symposium.

The specimens, including 63 from nonpromyelocytic de novo AML, 7 from AML in children with complete remission, 3 from adults with secondary AML, and 1 from an adult with treatment-related AML, were analyzed with the nCounter system from NanoString Technologies, and were visualized via digital spatial profiling, said Dr. Vadakekolathu of Nottingham Trent University in England.

Sharon Worcester/Frontline Medical News

“Prognosis is determined by cytogenetic and molecular abnormalities, as well as by response to chemotherapy. De novo AML is cured in roughly 70% of children, 35%-40% of adults, and 5%-15% of elderly patients,” he said. Some patients with AML fail to respond to induction chemotherapy, and others eventually relapse despite the lack of adverse risk factors, he added.

The general therapeutic strategy in patients with AML has not changed substantially in more than 30 years, he said.

“High degrees of molecular complexity in AML present a considerable challenge in clinical implementation, and there is an urgent need to discover better biomarkers to identify high-risk patients before starting chemotherapy, which would enable testing of investigational therapeutic strategies in clinical trials,” he said.

In an effort to identify immune gene signatures across the spectrum of AML genotypes and to correlate transcriptomic and proteomic profiles with patient outcomes, he and his colleagues used a pediatric cohort from Children’s Hospital of Philadelphia (median age at diagnosis of 10 years), and an adult cohort from the Technical University of Dresden, Germany (median age at diagnosis, 55.5 years). Bone marrow samples were collected and analyzed at diagnosis.

Hierarchical clustering identified the two distinct clusters. The immune-enriched cluster A had heightened expression of T cells, natural killer cells, and cytotoxic cells, and also expressed CD8A, IFNG, FOXP3, the cell chemoattractants CXCL9 and CXCL10, and inhibitory molecules including IDO1 and the immune checkpoints LAG3, CTLA4, and PD-L1. The immune-depleted cluster B overexpressed genes associated with mast cell functions and CD8 T-cell exhaustion, and showed low expression of T-cell and B-cell genes.

Further analysis of 10 of the inflamed samples from patients with newly diagnosed AML was performed with digital spatial profiling (DSP) to visualize in situ leukemia–immune system interactions, Dr. Vadakekolathu said.

Surface antigens CD123 and CD3 were used as a visualization marker for leukemia cells and to identify bone marrow-infiltrating T cells, respectively. Protein quantification showed a higher concentration of CD3 counts in T-cell-rich versus T-cell-poor areas, and protein expression profiles showed strong correlations with various immunologically relevant molecules. The co-localization of CD8 T cells with FoxP3 Treg cells and PD-L1- and VISTA-expressing cell types evident on DSP represents an immune landscape consistent with the establishment of adaptive immune resistance mechanisms of immune escape, he noted.

The findings suggest immune enriched AMLs might be amenable to combination immunotherapies tailored to the bone marrow tumor microenvironment, such as IDO1 inhibitors and checkpoint blockade, Dr. Vadakekolathu said. “Immune gene expression profiles of AML might support rapid prediction of patient outcomes, discovery of novel immune biomarkers and therapeutic targets, and development of integrated patient stratifications,” he said.

This study was supported by grants from the Roger Counter Foundation and the Qatar National Research Fund. Dr. Vadakekolathu reported having no disclosures. Some authors reported employment or other financial relationships with NanoString Technologies.

[email protected]

SOURCE: Rutella S et al. ASCO-SITC Abstract 50

DALLAS – Though cervical pessaries didn’t significantly reduce the rate of births before 34 weeks’ gestation when compared to vaginal progesterone for women with short cervixes and twin pregnancies, neonatal outcomes were improved with pessary use, according to the first randomized controlled trial that directly compared the two therapies.

Of 148 women who received pessaries, 24 (16.2%) delivered before 34 weeks’ gestation, compared with 33 of 149 women (22.1%) who received vaginal progesterone (relative risk 0.73, 95% confidence interval, 0.46-1.18; P = .24). Women who received pessaries were slightly more likely to carry their twin gestations to at least 37 weeks (79/148 versus 91/149; P = .05).

Certain perinatal outcomes were also better among the pessary group. The study measured a composite poor perinatal outcome of neonatal intensive care unit (NICU) admission, intraventricular hemorrhage, respiratory distress syndrome, necrotizing enterocolitis, and neonatal sepsis. This composite poor outcome occurred in 18.6% of the pessary group, compared with 26.5% of the progesterone group (P = .02). Neonatal admissions were more common in the progesterone than in the pessary group (22.1% vs. 13.2%, P = .01)

The odds of having a baby with birth weight less than 2,500 g was also higher for those receiving progesterone, with 22.1% of the progesterone group and 13.2% of the pessary group delivering infants in this range (P less than .001).

Previous work has shown that vaginal progesterone was efficacious when compared with placebo in preventing preterm births for women who have a twin gestation and a short cervix, according to Vinh Dang, MD, the study’s first author. Similarly, he said, studies have shown that placement of a cervical pessary also reduces preterm births in the scenario of twin gestation and a short cervix.

“No randomized controlled trial has directly compared cervical pessary versus vaginal progesterone for the prevention of preterm birth” in this population, Dr. Dang said during a presentation at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Accordingly, he and his colleagues at My Duc Hospital in Ho Chi Minh City, Vietnam, conducted a comparative effectiveness trial to provide a head-to-head comparison of the use of cervical pessaries versus vaginal progesterone for women with twin gestations and short cervixes.

The investigators conducted a single-center, randomized controlled trial, enrolling women with either monochorionic or dichorionic twin pregnancies at between 16 and 22 weeks of gestation, with a cervix length of less than 38 mm, as assessed by two trained ultrasonographers.

At My Duc Hospital, 28.4% of women with twin pregnancies and cervical length less than 38 mm delivered earlier than 34 weeks. This meant that in order to detect a 14% reduction in preterm birth, the study would need to include 290 women for sufficient statistical power, Dr. Dang said.

Patients (n = 300) were randomized 1:1 to receive vaginal progesterone, begun on the day of enrollment, or cervical pessary placed within 1 week of study enrollment. Two patients in the pessary arm and one in the progesterone arm were lost to follow-up.

Patients were permitted to receive other therapies; 14 women in the pessary arm also received antibiotics and 1 received progesterone. In the progesterone group, 12 received antibiotics, and 4 patients were cotreated with cervical cerclage.

The study excluded women under 18 years of age, and those with a prior history of cervical surgery or cervical cerclage. Major known complications in the current pregnancy, such as twin-to-twin transfusion syndrome, major congenital anomaly, fetal demise, and any symptoms of labor or late miscarriage were also grounds for exclusion.

Patient characteristics were similar between groups. The average age was 32 years. Most of the patients (83%-90%) were nulliparous, and more than 90% of the pregnancies were the result of assisted reproduction.

In addition to the primary outcome measure of preterm birth earlier than 34 weeks, the investigators tracked a number of obstetric and neonatal outcomes as secondary endpoints.

For the obstetric measures, Dr. Dang and his colleagues recorded deliveries that occurred before 28, 32, and 27 weeks’ gestation, whether labor was induced and if tocolytics or corticosteroids were used, mode of delivery, and proportion of live births. The number of days of admission for preterm labor, presence of chorioamnionitis, and occurrence of other maternal morbidity were also measured.

Dr. Dang and his colleagues also tracked birth weight, congenital anomalies, and 1- and 5-minute Apgar scores.

A prespecified subgroup analysis of women with even shorter cervixes – less than 28 mm – showed a significant reduction in preterm birth before 34 weeks in addition to the significant improvement in neonatal outcomes.

One author reported being a consultant for ObsEva, Merck, and Guerbet. The other authors had no disclosures.

[email protected]

SOURCE: Dang V et al. The Pregnancy Meeting Abstract LB03

DALLAS – Though cervical pessaries didn’t significantly reduce the rate of births before 34 weeks’ gestation when compared to vaginal progesterone for women with short cervixes and twin pregnancies, neonatal outcomes were improved with pessary use, according to the first randomized controlled trial that directly compared the two therapies.

Of 148 women who received pessaries, 24 (16.2%) delivered before 34 weeks’ gestation, compared with 33 of 149 women (22.1%) who received vaginal progesterone (relative risk 0.73, 95% confidence interval, 0.46-1.18; P = .24). Women who received pessaries were slightly more likely to carry their twin gestations to at least 37 weeks (79/148 versus 91/149; P = .05).

Certain perinatal outcomes were also better among the pessary group. The study measured a composite poor perinatal outcome of neonatal intensive care unit (NICU) admission, intraventricular hemorrhage, respiratory distress syndrome, necrotizing enterocolitis, and neonatal sepsis. This composite poor outcome occurred in 18.6% of the pessary group, compared with 26.5% of the progesterone group (P = .02). Neonatal admissions were more common in the progesterone than in the pessary group (22.1% vs. 13.2%, P = .01)

The odds of having a baby with birth weight less than 2,500 g was also higher for those receiving progesterone, with 22.1% of the progesterone group and 13.2% of the pessary group delivering infants in this range (P less than .001).

Previous work has shown that vaginal progesterone was efficacious when compared with placebo in preventing preterm births for women who have a twin gestation and a short cervix, according to Vinh Dang, MD, the study’s first author. Similarly, he said, studies have shown that placement of a cervical pessary also reduces preterm births in the scenario of twin gestation and a short cervix.

“No randomized controlled trial has directly compared cervical pessary versus vaginal progesterone for the prevention of preterm birth” in this population, Dr. Dang said during a presentation at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Accordingly, he and his colleagues at My Duc Hospital in Ho Chi Minh City, Vietnam, conducted a comparative effectiveness trial to provide a head-to-head comparison of the use of cervical pessaries versus vaginal progesterone for women with twin gestations and short cervixes.

The investigators conducted a single-center, randomized controlled trial, enrolling women with either monochorionic or dichorionic twin pregnancies at between 16 and 22 weeks of gestation, with a cervix length of less than 38 mm, as assessed by two trained ultrasonographers.

At My Duc Hospital, 28.4% of women with twin pregnancies and cervical length less than 38 mm delivered earlier than 34 weeks. This meant that in order to detect a 14% reduction in preterm birth, the study would need to include 290 women for sufficient statistical power, Dr. Dang said.

Patients (n = 300) were randomized 1:1 to receive vaginal progesterone, begun on the day of enrollment, or cervical pessary placed within 1 week of study enrollment. Two patients in the pessary arm and one in the progesterone arm were lost to follow-up.

Patients were permitted to receive other therapies; 14 women in the pessary arm also received antibiotics and 1 received progesterone. In the progesterone group, 12 received antibiotics, and 4 patients were cotreated with cervical cerclage.

The study excluded women under 18 years of age, and those with a prior history of cervical surgery or cervical cerclage. Major known complications in the current pregnancy, such as twin-to-twin transfusion syndrome, major congenital anomaly, fetal demise, and any symptoms of labor or late miscarriage were also grounds for exclusion.

Patient characteristics were similar between groups. The average age was 32 years. Most of the patients (83%-90%) were nulliparous, and more than 90% of the pregnancies were the result of assisted reproduction.

In addition to the primary outcome measure of preterm birth earlier than 34 weeks, the investigators tracked a number of obstetric and neonatal outcomes as secondary endpoints.

For the obstetric measures, Dr. Dang and his colleagues recorded deliveries that occurred before 28, 32, and 27 weeks’ gestation, whether labor was induced and if tocolytics or corticosteroids were used, mode of delivery, and proportion of live births. The number of days of admission for preterm labor, presence of chorioamnionitis, and occurrence of other maternal morbidity were also measured.

Dr. Dang and his colleagues also tracked birth weight, congenital anomalies, and 1- and 5-minute Apgar scores.

A prespecified subgroup analysis of women with even shorter cervixes – less than 28 mm – showed a significant reduction in preterm birth before 34 weeks in addition to the significant improvement in neonatal outcomes.

One author reported being a consultant for ObsEva, Merck, and Guerbet. The other authors had no disclosures.

[email protected]

SOURCE: Dang V et al. The Pregnancy Meeting Abstract LB03

DALLAS – Though cervical pessaries didn’t significantly reduce the rate of births before 34 weeks’ gestation when compared to vaginal progesterone for women with short cervixes and twin pregnancies, neonatal outcomes were improved with pessary use, according to the first randomized controlled trial that directly compared the two therapies.

Of 148 women who received pessaries, 24 (16.2%) delivered before 34 weeks’ gestation, compared with 33 of 149 women (22.1%) who received vaginal progesterone (relative risk 0.73, 95% confidence interval, 0.46-1.18; P = .24). Women who received pessaries were slightly more likely to carry their twin gestations to at least 37 weeks (79/148 versus 91/149; P = .05).

Certain perinatal outcomes were also better among the pessary group. The study measured a composite poor perinatal outcome of neonatal intensive care unit (NICU) admission, intraventricular hemorrhage, respiratory distress syndrome, necrotizing enterocolitis, and neonatal sepsis. This composite poor outcome occurred in 18.6% of the pessary group, compared with 26.5% of the progesterone group (P = .02). Neonatal admissions were more common in the progesterone than in the pessary group (22.1% vs. 13.2%, P = .01)

The odds of having a baby with birth weight less than 2,500 g was also higher for those receiving progesterone, with 22.1% of the progesterone group and 13.2% of the pessary group delivering infants in this range (P less than .001).

Previous work has shown that vaginal progesterone was efficacious when compared with placebo in preventing preterm births for women who have a twin gestation and a short cervix, according to Vinh Dang, MD, the study’s first author. Similarly, he said, studies have shown that placement of a cervical pessary also reduces preterm births in the scenario of twin gestation and a short cervix.

“No randomized controlled trial has directly compared cervical pessary versus vaginal progesterone for the prevention of preterm birth” in this population, Dr. Dang said during a presentation at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Accordingly, he and his colleagues at My Duc Hospital in Ho Chi Minh City, Vietnam, conducted a comparative effectiveness trial to provide a head-to-head comparison of the use of cervical pessaries versus vaginal progesterone for women with twin gestations and short cervixes.

The investigators conducted a single-center, randomized controlled trial, enrolling women with either monochorionic or dichorionic twin pregnancies at between 16 and 22 weeks of gestation, with a cervix length of less than 38 mm, as assessed by two trained ultrasonographers.

At My Duc Hospital, 28.4% of women with twin pregnancies and cervical length less than 38 mm delivered earlier than 34 weeks. This meant that in order to detect a 14% reduction in preterm birth, the study would need to include 290 women for sufficient statistical power, Dr. Dang said.

Patients (n = 300) were randomized 1:1 to receive vaginal progesterone, begun on the day of enrollment, or cervical pessary placed within 1 week of study enrollment. Two patients in the pessary arm and one in the progesterone arm were lost to follow-up.

Patients were permitted to receive other therapies; 14 women in the pessary arm also received antibiotics and 1 received progesterone. In the progesterone group, 12 received antibiotics, and 4 patients were cotreated with cervical cerclage.

The study excluded women under 18 years of age, and those with a prior history of cervical surgery or cervical cerclage. Major known complications in the current pregnancy, such as twin-to-twin transfusion syndrome, major congenital anomaly, fetal demise, and any symptoms of labor or late miscarriage were also grounds for exclusion.

Patient characteristics were similar between groups. The average age was 32 years. Most of the patients (83%-90%) were nulliparous, and more than 90% of the pregnancies were the result of assisted reproduction.

In addition to the primary outcome measure of preterm birth earlier than 34 weeks, the investigators tracked a number of obstetric and neonatal outcomes as secondary endpoints.

For the obstetric measures, Dr. Dang and his colleagues recorded deliveries that occurred before 28, 32, and 27 weeks’ gestation, whether labor was induced and if tocolytics or corticosteroids were used, mode of delivery, and proportion of live births. The number of days of admission for preterm labor, presence of chorioamnionitis, and occurrence of other maternal morbidity were also measured.

Dr. Dang and his colleagues also tracked birth weight, congenital anomalies, and 1- and 5-minute Apgar scores.

A prespecified subgroup analysis of women with even shorter cervixes – less than 28 mm – showed a significant reduction in preterm birth before 34 weeks in addition to the significant improvement in neonatal outcomes.

One author reported being a consultant for ObsEva, Merck, and Guerbet. The other authors had no disclosures.

[email protected]

SOURCE: Dang V et al. The Pregnancy Meeting Abstract LB03

A combination of ibrutinib, lenalidomide, and rituximab produced an overall response rate of 76% at 17.8 months median follow-up among 50 adults with relapsed or refractory mantle cell lymphoma, according to an open-label, single-arm, phase 2 trial.

There were complete responses in 28 patients (56%) and partial responses in 10 (20%). Median progression-free survival was 16 months and median overall survival was 22 months. Similar proportions of patients, with and without TP53 mutations, had overall and complete responses, suggesting that triple therapy might be particularly useful in patients with high-risk genetic features.

“Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomized controlled trial,” wrote Mats Jerkeman, MD, of Lund University, Sweden, and colleagues. The report was published in The Lancet Haematology.

“Addition of lenalidomide to ibrutinib and rituximab might increase the proportion of patients who have complete remission ... Previous studies reported complete responses in 44% of patients on ibrutinib and rituximab, in 36% of patients on rituximab and lenalidomide, and in 19% of patients on ibrutinib alone,” they wrote.

Courtesy Wikimedia Commons/Nephron/Creative Commons

[email protected]

SOURCE: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.

A combination of ibrutinib, lenalidomide, and rituximab produced an overall response rate of 76% at 17.8 months median follow-up among 50 adults with relapsed or refractory mantle cell lymphoma, according to an open-label, single-arm, phase 2 trial.

There were complete responses in 28 patients (56%) and partial responses in 10 (20%). Median progression-free survival was 16 months and median overall survival was 22 months. Similar proportions of patients, with and without TP53 mutations, had overall and complete responses, suggesting that triple therapy might be particularly useful in patients with high-risk genetic features.

“Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomized controlled trial,” wrote Mats Jerkeman, MD, of Lund University, Sweden, and colleagues. The report was published in The Lancet Haematology.

“Addition of lenalidomide to ibrutinib and rituximab might increase the proportion of patients who have complete remission ... Previous studies reported complete responses in 44% of patients on ibrutinib and rituximab, in 36% of patients on rituximab and lenalidomide, and in 19% of patients on ibrutinib alone,” they wrote.

Courtesy Wikimedia Commons/Nephron/Creative Commons

[email protected]

SOURCE: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.

A combination of ibrutinib, lenalidomide, and rituximab produced an overall response rate of 76% at 17.8 months median follow-up among 50 adults with relapsed or refractory mantle cell lymphoma, according to an open-label, single-arm, phase 2 trial.

There were complete responses in 28 patients (56%) and partial responses in 10 (20%). Median progression-free survival was 16 months and median overall survival was 22 months. Similar proportions of patients, with and without TP53 mutations, had overall and complete responses, suggesting that triple therapy might be particularly useful in patients with high-risk genetic features.

“Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomized controlled trial,” wrote Mats Jerkeman, MD, of Lund University, Sweden, and colleagues. The report was published in The Lancet Haematology.

“Addition of lenalidomide to ibrutinib and rituximab might increase the proportion of patients who have complete remission ... Previous studies reported complete responses in 44% of patients on ibrutinib and rituximab, in 36% of patients on rituximab and lenalidomide, and in 19% of patients on ibrutinib alone,” they wrote.

Courtesy Wikimedia Commons/Nephron/Creative Commons

[email protected]

SOURCE: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.

WASHINGTON – Members of the Medicare Payment Advisory Commission, which advises Congress, are weighing whether to recommend a 10% increase in payments for evaluation and management services.

The boost would be offset by a 4.5% decrease in all other payments on the Medicare physician fee schedule.

“The fee schedule underprices ambulatory [evaluation and management] services relative to other services,” MedPAC staff member Ariel Winter said during a Jan. 12 presentation of a draft proposal.

Payments in the physician fee schedule are based on the relative amount of time and intensity required for each service, she noted. “E&M services are labor intensive,” she said. “A clinician takes the patient’s history, examines the patient, engages in medical decision-making and so forth. These activities do not lend themselves to reductions in the time it takes to provide the visit.”

In contrast, “the time needed for other services, such as procedures, often declines over time due to productivity gains in clinical practice and technology,” Ms. Winter continued. “Ideally, the prices for these services would also be reduced to reflect these efficiency gains.”

Ms. Winter pointed out that the payment reduction that captures the efficiency gains rarely happens, and because of budget neutral requirements, it means that “payment rates for ambulatory E&M services are too low relative to other services.”

MedPAC looked at the fee schedule time estimates across four specialties (cardiology, family medicine, orthopedics, and urology) and found that across the board, the fee schedule assumed it took the specialist more time than what was actually needed.

“However, the discrepancy was much greater for the practices that focus on procedures, which suggests that the services they provide may be based on inflated time estimates,” Ms. Winter said. “For example, the hours assumed in the fee schedule were 24% higher than actual hours worked for family medicine, but 64% higher in cardiology and 92% higher in orthopedics.”

To account for this, MedPAC is considering a recommendation to Congress that would include a 10% increase in payments for ambulatory E&M codes and psychiatric services, regardless of specialty, resulting in an increase of $2.7 billion in spending on these codes. That would force a reduction of 4.5% in payments for everything else in the fee schedule under budget neutrality requirements.

utah778/Thinkstock

[email protected]

WASHINGTON – Members of the Medicare Payment Advisory Commission, which advises Congress, are weighing whether to recommend a 10% increase in payments for evaluation and management services.

The boost would be offset by a 4.5% decrease in all other payments on the Medicare physician fee schedule.

“The fee schedule underprices ambulatory [evaluation and management] services relative to other services,” MedPAC staff member Ariel Winter said during a Jan. 12 presentation of a draft proposal.

Payments in the physician fee schedule are based on the relative amount of time and intensity required for each service, she noted. “E&M services are labor intensive,” she said. “A clinician takes the patient’s history, examines the patient, engages in medical decision-making and so forth. These activities do not lend themselves to reductions in the time it takes to provide the visit.”

In contrast, “the time needed for other services, such as procedures, often declines over time due to productivity gains in clinical practice and technology,” Ms. Winter continued. “Ideally, the prices for these services would also be reduced to reflect these efficiency gains.”

Ms. Winter pointed out that the payment reduction that captures the efficiency gains rarely happens, and because of budget neutral requirements, it means that “payment rates for ambulatory E&M services are too low relative to other services.”

MedPAC looked at the fee schedule time estimates across four specialties (cardiology, family medicine, orthopedics, and urology) and found that across the board, the fee schedule assumed it took the specialist more time than what was actually needed.

“However, the discrepancy was much greater for the practices that focus on procedures, which suggests that the services they provide may be based on inflated time estimates,” Ms. Winter said. “For example, the hours assumed in the fee schedule were 24% higher than actual hours worked for family medicine, but 64% higher in cardiology and 92% higher in orthopedics.”

To account for this, MedPAC is considering a recommendation to Congress that would include a 10% increase in payments for ambulatory E&M codes and psychiatric services, regardless of specialty, resulting in an increase of $2.7 billion in spending on these codes. That would force a reduction of 4.5% in payments for everything else in the fee schedule under budget neutrality requirements.

utah778/Thinkstock

[email protected]

WASHINGTON – Members of the Medicare Payment Advisory Commission, which advises Congress, are weighing whether to recommend a 10% increase in payments for evaluation and management services.

The boost would be offset by a 4.5% decrease in all other payments on the Medicare physician fee schedule.

“The fee schedule underprices ambulatory [evaluation and management] services relative to other services,” MedPAC staff member Ariel Winter said during a Jan. 12 presentation of a draft proposal.

Payments in the physician fee schedule are based on the relative amount of time and intensity required for each service, she noted. “E&M services are labor intensive,” she said. “A clinician takes the patient’s history, examines the patient, engages in medical decision-making and so forth. These activities do not lend themselves to reductions in the time it takes to provide the visit.”

In contrast, “the time needed for other services, such as procedures, often declines over time due to productivity gains in clinical practice and technology,” Ms. Winter continued. “Ideally, the prices for these services would also be reduced to reflect these efficiency gains.”

Ms. Winter pointed out that the payment reduction that captures the efficiency gains rarely happens, and because of budget neutral requirements, it means that “payment rates for ambulatory E&M services are too low relative to other services.”

MedPAC looked at the fee schedule time estimates across four specialties (cardiology, family medicine, orthopedics, and urology) and found that across the board, the fee schedule assumed it took the specialist more time than what was actually needed.

“However, the discrepancy was much greater for the practices that focus on procedures, which suggests that the services they provide may be based on inflated time estimates,” Ms. Winter said. “For example, the hours assumed in the fee schedule were 24% higher than actual hours worked for family medicine, but 64% higher in cardiology and 92% higher in orthopedics.”

To account for this, MedPAC is considering a recommendation to Congress that would include a 10% increase in payments for ambulatory E&M codes and psychiatric services, regardless of specialty, resulting in an increase of $2.7 billion in spending on these codes. That would force a reduction of 4.5% in payments for everything else in the fee schedule under budget neutrality requirements.

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NEW YORK – New controlled trials in the treatment of pediatric acute neuropsychiatric syndrome (PANS) support the hypothesis that the cause may, in fact, be treatable, an expert said at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

PANS and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are controversial diagnoses. But ongoing research has expanded the body of literature describing symptoms and evaluating treatments, according to an overview from Barbara J. Coffey, MD, division chief in child and adolescent psychiatry at the University of Miami.

PANS and PANDAS, which are clinical diagnoses of exclusion, are characterized by an abrupt onset of one or more neuropsychiatric symptoms in children that can include signs of obsessive-compulsive disorder (OCD), tics, anxiety, irritability, and behavioral changes. Despite more than 15 years of clinical and experimental studies, almost all aspects of PANS and PANDAS remain controversial, Dr. Coffey said.

“Many pediatricians I work with do not want to see these kids, because they really do not know what to do,” she reported.

SIphotography/Thinkstock

Dr. Coffey reports financial relationships with Genco Sciences, Neurocrine Biosciences, Shire, and Teva/Nuvelution.

NEW YORK – New controlled trials in the treatment of pediatric acute neuropsychiatric syndrome (PANS) support the hypothesis that the cause may, in fact, be treatable, an expert said at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

PANS and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are controversial diagnoses. But ongoing research has expanded the body of literature describing symptoms and evaluating treatments, according to an overview from Barbara J. Coffey, MD, division chief in child and adolescent psychiatry at the University of Miami.

PANS and PANDAS, which are clinical diagnoses of exclusion, are characterized by an abrupt onset of one or more neuropsychiatric symptoms in children that can include signs of obsessive-compulsive disorder (OCD), tics, anxiety, irritability, and behavioral changes. Despite more than 15 years of clinical and experimental studies, almost all aspects of PANS and PANDAS remain controversial, Dr. Coffey said.

“Many pediatricians I work with do not want to see these kids, because they really do not know what to do,” she reported.

SIphotography/Thinkstock

Dr. Coffey reports financial relationships with Genco Sciences, Neurocrine Biosciences, Shire, and Teva/Nuvelution.

NEW YORK – New controlled trials in the treatment of pediatric acute neuropsychiatric syndrome (PANS) support the hypothesis that the cause may, in fact, be treatable, an expert said at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

PANS and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are controversial diagnoses. But ongoing research has expanded the body of literature describing symptoms and evaluating treatments, according to an overview from Barbara J. Coffey, MD, division chief in child and adolescent psychiatry at the University of Miami.

PANS and PANDAS, which are clinical diagnoses of exclusion, are characterized by an abrupt onset of one or more neuropsychiatric symptoms in children that can include signs of obsessive-compulsive disorder (OCD), tics, anxiety, irritability, and behavioral changes. Despite more than 15 years of clinical and experimental studies, almost all aspects of PANS and PANDAS remain controversial, Dr. Coffey said.

“Many pediatricians I work with do not want to see these kids, because they really do not know what to do,” she reported.

SIphotography/Thinkstock

Dr. Coffey reports financial relationships with Genco Sciences, Neurocrine Biosciences, Shire, and Teva/Nuvelution.

A small study of the discussions of biologic treatment options between rheumatoid arthritis patients and their rheumatologists suggests they are limited in scope and may be influenced by clinicians’ preconceived notions about patient preferences.

In an analysis of video footage from office visits of 48 rheumatoid arthritis (RA) patients initiating biologics with 16 rheumatologists, only 5.6 minutes out of visits with an average duration of 15 minutes were spent discussing biologic therapy options. Postvisit interviews with patients highlighted problems in rheumatologists’ awareness of patients’ familiarity with biologic treatment options, particularly a lack of knowledge about intravenous (IV) options, according to findings from the ethnographic, observational study conducted by Nicholas Kottak, PhD, of Ethnographic Solutions LLC, and his colleagues and published in Arthritis Care & Research.

Of the 48 visits, the researchers found that subcutaneous (SC) therapy options were discussed in 45 visits and IV options were discussed in 35. In 27 of the 35 visits in which IV options were mentioned, the rheumatologists did not define or describe IV administration.

In postvisit interviews, all patients said they were previously aware that biologic therapy was available subcutaneously, but 22 entered their visit with no previous knowledge of IV options, 19 of whom remained unfamiliar after their visit.

According to the researchers, some patients said that they would prefer to receive IV biologic treatment and some would prefer SC delivery. However, all 16 participating rheumatologists thought that IV therapy would be less convenient for the patient than SC therapy, but only 22 of 48 patients said inconvenience was the main barrier to IV therapy. A total of 23 patients thought SC therapy would be easier, 17 thought IV therapy would be easier, 4 thought they would be the same, and 4 were unsure.

The way in which mode of biologic administration is discussed may also have financial implications, particularly for Medicare patients. “During 26 visits with Medicare patients, IV and SC therapies were mentioned during 22 and 23 visits, respectively. This is noteworthy as Medicare with supplemental insurance may preferably cover IV over SC therapy, since IV therapy qualifies as a medical benefit (Part B) and SC therapy falls under pharmacy benefits (Part D),” Dr. Kottak and his associates wrote.

Thinkstock.com

SOURCE: Kottak N et al. Arthritis Care Res. 2018 Feb 5. doi: 10/1002/acr.23527

A small study of the discussions of biologic treatment options between rheumatoid arthritis patients and their rheumatologists suggests they are limited in scope and may be influenced by clinicians’ preconceived notions about patient preferences.

In an analysis of video footage from office visits of 48 rheumatoid arthritis (RA) patients initiating biologics with 16 rheumatologists, only 5.6 minutes out of visits with an average duration of 15 minutes were spent discussing biologic therapy options. Postvisit interviews with patients highlighted problems in rheumatologists’ awareness of patients’ familiarity with biologic treatment options, particularly a lack of knowledge about intravenous (IV) options, according to findings from the ethnographic, observational study conducted by Nicholas Kottak, PhD, of Ethnographic Solutions LLC, and his colleagues and published in Arthritis Care & Research.

Of the 48 visits, the researchers found that subcutaneous (SC) therapy options were discussed in 45 visits and IV options were discussed in 35. In 27 of the 35 visits in which IV options were mentioned, the rheumatologists did not define or describe IV administration.

In postvisit interviews, all patients said they were previously aware that biologic therapy was available subcutaneously, but 22 entered their visit with no previous knowledge of IV options, 19 of whom remained unfamiliar after their visit.

According to the researchers, some patients said that they would prefer to receive IV biologic treatment and some would prefer SC delivery. However, all 16 participating rheumatologists thought that IV therapy would be less convenient for the patient than SC therapy, but only 22 of 48 patients said inconvenience was the main barrier to IV therapy. A total of 23 patients thought SC therapy would be easier, 17 thought IV therapy would be easier, 4 thought they would be the same, and 4 were unsure.

The way in which mode of biologic administration is discussed may also have financial implications, particularly for Medicare patients. “During 26 visits with Medicare patients, IV and SC therapies were mentioned during 22 and 23 visits, respectively. This is noteworthy as Medicare with supplemental insurance may preferably cover IV over SC therapy, since IV therapy qualifies as a medical benefit (Part B) and SC therapy falls under pharmacy benefits (Part D),” Dr. Kottak and his associates wrote.

Thinkstock.com

SOURCE: Kottak N et al. Arthritis Care Res. 2018 Feb 5. doi: 10/1002/acr.23527

A small study of the discussions of biologic treatment options between rheumatoid arthritis patients and their rheumatologists suggests they are limited in scope and may be influenced by clinicians’ preconceived notions about patient preferences.

In an analysis of video footage from office visits of 48 rheumatoid arthritis (RA) patients initiating biologics with 16 rheumatologists, only 5.6 minutes out of visits with an average duration of 15 minutes were spent discussing biologic therapy options. Postvisit interviews with patients highlighted problems in rheumatologists’ awareness of patients’ familiarity with biologic treatment options, particularly a lack of knowledge about intravenous (IV) options, according to findings from the ethnographic, observational study conducted by Nicholas Kottak, PhD, of Ethnographic Solutions LLC, and his colleagues and published in Arthritis Care & Research.

Of the 48 visits, the researchers found that subcutaneous (SC) therapy options were discussed in 45 visits and IV options were discussed in 35. In 27 of the 35 visits in which IV options were mentioned, the rheumatologists did not define or describe IV administration.

In postvisit interviews, all patients said they were previously aware that biologic therapy was available subcutaneously, but 22 entered their visit with no previous knowledge of IV options, 19 of whom remained unfamiliar after their visit.

According to the researchers, some patients said that they would prefer to receive IV biologic treatment and some would prefer SC delivery. However, all 16 participating rheumatologists thought that IV therapy would be less convenient for the patient than SC therapy, but only 22 of 48 patients said inconvenience was the main barrier to IV therapy. A total of 23 patients thought SC therapy would be easier, 17 thought IV therapy would be easier, 4 thought they would be the same, and 4 were unsure.

The way in which mode of biologic administration is discussed may also have financial implications, particularly for Medicare patients. “During 26 visits with Medicare patients, IV and SC therapies were mentioned during 22 and 23 visits, respectively. This is noteworthy as Medicare with supplemental insurance may preferably cover IV over SC therapy, since IV therapy qualifies as a medical benefit (Part B) and SC therapy falls under pharmacy benefits (Part D),” Dr. Kottak and his associates wrote.

Thinkstock.com

SOURCE: Kottak N et al. Arthritis Care Res. 2018 Feb 5. doi: 10/1002/acr.23527

The Food and Drug Administration has approved expanding the indication for the drug combination of ceftazidime and avibactam (Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan, the drug’s manufacturer.

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The Food and Drug Administration has approved expanding the indication for the drug combination of ceftazidime and avibactam (Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan, the drug’s manufacturer.

[email protected]

The Food and Drug Administration has approved expanding the indication for the drug combination of ceftazidime and avibactam (Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan, the drug’s manufacturer.

[email protected]

Photo by Rhoda Baer

Socioeconomic deprivation may decrease survival in adults with acute lymphoblastic leukemia (ALL), according to research published in BMC Cancer.

Researchers found that ALL patients living in more deprived areas of England had a 16% to 21% greater risk of dying than patients living in the least deprived areas.

The researchers also observed a 33% higher risk of mortality in patients who were treated at hospitals that manage few ALL patients.

“The findings are likely to have significant implications for the organization of NHS [National Health Service] services for the treatment of adults with this rare but serious condition,” said study author Ravi Maheswaran, MD, of the University of Sheffield in Sheffield, UK.

To conduct this study, Dr Maheswaran and Nick Morley, MBBS, of Royal Hallamshire Hospital in Sheffield, analyzed anonymized NHS data on hospital admissions.

The researchers identified 2921 adults (age 18 and older) who were diagnosed with ALL from 2001 to 2012 and assessed follow-up data on survival rates up to 2013.

There were 1870 deaths during follow-up, and the 5-year survival rate was 32%.

As expected, survival decreased with age but increased over time. The mortality hazard ratio (HR) was 1.38 for patients ages 30 to 39, 3.72 for patients ages 60 to 69, and 9.02 for patients age 80 and older.

The HR was 0.98 for patients diagnosed from 2005 to 2008 and 0.70 for patients diagnosed from 2009 to 2012, compared to 1.00 for patients diagnosed from 2001 to 2004.

Patients living in areas of socioeconomic deprivation had a greater risk of death, but it did not seem to matter whether the patients lived in rural or urban areas.

The mortality HR was 1.16 for patients living in the most deprived areas and 1.21 for patients in intermediate areas (with the least deprived areas as the reference, 1.00). The HR was 1.00 for both rural and urban areas.

The risk of death was higher for patients treated at hospitals with low volumes of adults with ALL. The mortality HR was 1.33 for low-volume hospitals, which were defined as hospitals with 15 or fewer ALL patients admitted over a 3-year time period for which data were available.

“These results, although concerning, are from a single study, and further work is needed to confirm our findings,” Dr Maheswaran said.

“If the association between high deprivation and poorer survival is confirmed, more investigation will be needed to understand why adults with this type of leukemia living in deprived areas have poorer survival and what can be done to address this inequality.”

“Confirmation that hospitals treating few patients with this rare condition have worse outcomes would mean that the NHS should seriously consider if treatment services for adults with acute lymphoblastic leukemia should mainly be provided by specialist centers in order to improve survival.”

Photo by Rhoda Baer

Socioeconomic deprivation may decrease survival in adults with acute lymphoblastic leukemia (ALL), according to research published in BMC Cancer.

Researchers found that ALL patients living in more deprived areas of England had a 16% to 21% greater risk of dying than patients living in the least deprived areas.

The researchers also observed a 33% higher risk of mortality in patients who were treated at hospitals that manage few ALL patients.

“The findings are likely to have significant implications for the organization of NHS [National Health Service] services for the treatment of adults with this rare but serious condition,” said study author Ravi Maheswaran, MD, of the University of Sheffield in Sheffield, UK.

To conduct this study, Dr Maheswaran and Nick Morley, MBBS, of Royal Hallamshire Hospital in Sheffield, analyzed anonymized NHS data on hospital admissions.

The researchers identified 2921 adults (age 18 and older) who were diagnosed with ALL from 2001 to 2012 and assessed follow-up data on survival rates up to 2013.

There were 1870 deaths during follow-up, and the 5-year survival rate was 32%.

As expected, survival decreased with age but increased over time. The mortality hazard ratio (HR) was 1.38 for patients ages 30 to 39, 3.72 for patients ages 60 to 69, and 9.02 for patients age 80 and older.

The HR was 0.98 for patients diagnosed from 2005 to 2008 and 0.70 for patients diagnosed from 2009 to 2012, compared to 1.00 for patients diagnosed from 2001 to 2004.

Patients living in areas of socioeconomic deprivation had a greater risk of death, but it did not seem to matter whether the patients lived in rural or urban areas.

The mortality HR was 1.16 for patients living in the most deprived areas and 1.21 for patients in intermediate areas (with the least deprived areas as the reference, 1.00). The HR was 1.00 for both rural and urban areas.

The risk of death was higher for patients treated at hospitals with low volumes of adults with ALL. The mortality HR was 1.33 for low-volume hospitals, which were defined as hospitals with 15 or fewer ALL patients admitted over a 3-year time period for which data were available.

“These results, although concerning, are from a single study, and further work is needed to confirm our findings,” Dr Maheswaran said.

“If the association between high deprivation and poorer survival is confirmed, more investigation will be needed to understand why adults with this type of leukemia living in deprived areas have poorer survival and what can be done to address this inequality.”

“Confirmation that hospitals treating few patients with this rare condition have worse outcomes would mean that the NHS should seriously consider if treatment services for adults with acute lymphoblastic leukemia should mainly be provided by specialist centers in order to improve survival.”

Photo by Rhoda Baer

Socioeconomic deprivation may decrease survival in adults with acute lymphoblastic leukemia (ALL), according to research published in BMC Cancer.

Researchers found that ALL patients living in more deprived areas of England had a 16% to 21% greater risk of dying than patients living in the least deprived areas.

The researchers also observed a 33% higher risk of mortality in patients who were treated at hospitals that manage few ALL patients.

“The findings are likely to have significant implications for the organization of NHS [National Health Service] services for the treatment of adults with this rare but serious condition,” said study author Ravi Maheswaran, MD, of the University of Sheffield in Sheffield, UK.

To conduct this study, Dr Maheswaran and Nick Morley, MBBS, of Royal Hallamshire Hospital in Sheffield, analyzed anonymized NHS data on hospital admissions.

The researchers identified 2921 adults (age 18 and older) who were diagnosed with ALL from 2001 to 2012 and assessed follow-up data on survival rates up to 2013.

There were 1870 deaths during follow-up, and the 5-year survival rate was 32%.

As expected, survival decreased with age but increased over time. The mortality hazard ratio (HR) was 1.38 for patients ages 30 to 39, 3.72 for patients ages 60 to 69, and 9.02 for patients age 80 and older.

The HR was 0.98 for patients diagnosed from 2005 to 2008 and 0.70 for patients diagnosed from 2009 to 2012, compared to 1.00 for patients diagnosed from 2001 to 2004.

Patients living in areas of socioeconomic deprivation had a greater risk of death, but it did not seem to matter whether the patients lived in rural or urban areas.

The mortality HR was 1.16 for patients living in the most deprived areas and 1.21 for patients in intermediate areas (with the least deprived areas as the reference, 1.00). The HR was 1.00 for both rural and urban areas.

The risk of death was higher for patients treated at hospitals with low volumes of adults with ALL. The mortality HR was 1.33 for low-volume hospitals, which were defined as hospitals with 15 or fewer ALL patients admitted over a 3-year time period for which data were available.

“These results, although concerning, are from a single study, and further work is needed to confirm our findings,” Dr Maheswaran said.

“If the association between high deprivation and poorer survival is confirmed, more investigation will be needed to understand why adults with this type of leukemia living in deprived areas have poorer survival and what can be done to address this inequality.”

“Confirmation that hospitals treating few patients with this rare condition have worse outcomes would mean that the NHS should seriously consider if treatment services for adults with acute lymphoblastic leukemia should mainly be provided by specialist centers in order to improve survival.”

SAN DIEGO – A paradox of treating people with the monoclonal antibody alemtuzumab is that the agent can be an effective therapy for many people living with multiple sclerosis, but in some patients is associated with the development of other autoimmune diseases.

“I counsel patients with multiple sclerosis that this is a high risk, high gain drug,” Alasdair Coles, MD, of the University of Cambridge (England), said at the meeting, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Patients can make it safer through strict compliance with the drug’s risk monitoring program. But without patient compliance, alemtuzumab becomes a dangerous drug, he said in a video interview.

Knowing in advance which patients are at an elevated risk for subsequent autoimmune diseases has been difficult to predict. But researchers are getting closer, Dr. Coles said. In the future, measuring a serum factor, potentially interleukin 21, could produce a pretreatment risk assessment for each individual.

SAN DIEGO – A paradox of treating people with the monoclonal antibody alemtuzumab is that the agent can be an effective therapy for many people living with multiple sclerosis, but in some patients is associated with the development of other autoimmune diseases.

“I counsel patients with multiple sclerosis that this is a high risk, high gain drug,” Alasdair Coles, MD, of the University of Cambridge (England), said at the meeting, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Patients can make it safer through strict compliance with the drug’s risk monitoring program. But without patient compliance, alemtuzumab becomes a dangerous drug, he said in a video interview.

Knowing in advance which patients are at an elevated risk for subsequent autoimmune diseases has been difficult to predict. But researchers are getting closer, Dr. Coles said. In the future, measuring a serum factor, potentially interleukin 21, could produce a pretreatment risk assessment for each individual.

SAN DIEGO – A paradox of treating people with the monoclonal antibody alemtuzumab is that the agent can be an effective therapy for many people living with multiple sclerosis, but in some patients is associated with the development of other autoimmune diseases.

“I counsel patients with multiple sclerosis that this is a high risk, high gain drug,” Alasdair Coles, MD, of the University of Cambridge (England), said at the meeting, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Patients can make it safer through strict compliance with the drug’s risk monitoring program. But without patient compliance, alemtuzumab becomes a dangerous drug, he said in a video interview.

Knowing in advance which patients are at an elevated risk for subsequent autoimmune diseases has been difficult to predict. But researchers are getting closer, Dr. Coles said. In the future, measuring a serum factor, potentially interleukin 21, could produce a pretreatment risk assessment for each individual.

DALLAS – Compared to acetaminophen, ibuprofen does not prolong the time needed to control postpartum hypertension in women who experience preeclampsia with severe features, Nathan Blue MD, reported at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Ibuprofen did not exacerbate postpartum hypertension, as some studies have suggested, and women randomized to it for postpartum pain control reached their target blood pressure at a mean of 35 hours after delivery, similar to the 38 hours needed among women receiving acetaminophen.

Dr. Blue’s findings contradict the recommendation by the American College of Obstetricians and Gynecologists to avoid the use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control in women who experience preeclampsia or other hypertensive disorders of pregnancy.

“While our study was not meant to answer all questions about the potential problems of nonsteroidal anti-inflammatories [in this population], I would conclude from these results that providers and patients can make a decision together and feel good about the use of NSAIDs,” in the presence of postpartum hypertension, said Dr. Blue, a fellow at the University of New Mexico, Albuquerque.

Michele G. Sullivan/Frontline Medical News

[email protected]

SOURCE: Blue et al. The Pregnancy Meeting 2018 Abstract LB04.

DALLAS – Compared to acetaminophen, ibuprofen does not prolong the time needed to control postpartum hypertension in women who experience preeclampsia with severe features, Nathan Blue MD, reported at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Ibuprofen did not exacerbate postpartum hypertension, as some studies have suggested, and women randomized to it for postpartum pain control reached their target blood pressure at a mean of 35 hours after delivery, similar to the 38 hours needed among women receiving acetaminophen.

Dr. Blue’s findings contradict the recommendation by the American College of Obstetricians and Gynecologists to avoid the use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control in women who experience preeclampsia or other hypertensive disorders of pregnancy.

“While our study was not meant to answer all questions about the potential problems of nonsteroidal anti-inflammatories [in this population], I would conclude from these results that providers and patients can make a decision together and feel good about the use of NSAIDs,” in the presence of postpartum hypertension, said Dr. Blue, a fellow at the University of New Mexico, Albuquerque.

Michele G. Sullivan/Frontline Medical News

[email protected]

SOURCE: Blue et al. The Pregnancy Meeting 2018 Abstract LB04.

DALLAS – Compared to acetaminophen, ibuprofen does not prolong the time needed to control postpartum hypertension in women who experience preeclampsia with severe features, Nathan Blue MD, reported at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Ibuprofen did not exacerbate postpartum hypertension, as some studies have suggested, and women randomized to it for postpartum pain control reached their target blood pressure at a mean of 35 hours after delivery, similar to the 38 hours needed among women receiving acetaminophen.

Dr. Blue’s findings contradict the recommendation by the American College of Obstetricians and Gynecologists to avoid the use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control in women who experience preeclampsia or other hypertensive disorders of pregnancy.

“While our study was not meant to answer all questions about the potential problems of nonsteroidal anti-inflammatories [in this population], I would conclude from these results that providers and patients can make a decision together and feel good about the use of NSAIDs,” in the presence of postpartum hypertension, said Dr. Blue, a fellow at the University of New Mexico, Albuquerque.

Michele G. Sullivan/Frontline Medical News

[email protected]

SOURCE: Blue et al. The Pregnancy Meeting 2018 Abstract LB04.