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WASHINGTON – Women are almost twice as likely as men to develop extra-articular manifestations of ankylosing spondylitis such as uveitis and inflammatory bowel disease, according to an analysis of patients in the Ankylosing Spondylitis Registry of Ireland.

Each of those manifestations exerts its own difficulties upon patients over and above the inflammatory back pain of the underlying disease, Gillian Fitzgerald, MD, said at the annual meeting of the American College of Rheumatology. Many patients can develop several of these separate manifestations – a circumstance that seriously affects their quality of life.

The findings of the large registry study were a bit surprising, she said during presentation of the study at a press briefing, as ankylosing spondylitis is generally thought to affect largely men. “However, this isn’t the case,” said Dr. Fitzgerald of St. James’s Hospital, Dublin. “Recent studies show that women can be affected as often as men are.”

In light of those findings, Dr. Fitzgerald and her coauthors wanted to further define the gender differences, especially with regard to extra-articular manifestations.

They accessed data on 564 patients in the registry, which was established in 2013. The majority of patients (78%) were men; the mean age was 47 years. Patients had a mean disease duration of nearly 21 years. For almost half that time (9 years) they had remained undiagnosed, Dr. Fitzgerald added. They had a mean age of about 47 years, and 78% fulfilled the modified New York criteria for ankylosing spondylitis.

Overall, extra-articular manifestations were common, with 35% having uveitis, 18% psoriasis, and 10% inflammatory bowel disease.

Uveitis was significantly more common among women (47% vs. 32%) and among those with disease duration of more than 10 years (40% vs. 22% with less than 10 years).

Inflammatory bowel disease was also significantly more common among women (16.5% vs. 8%). It wasn’t related to disease duration, but it was related to elevated baseline C-reactive protein, peptic ulcer disease, and osteoporosis.

In a multivariate regression analysis, women were 70% more likely to experience an extra-articular manifestation of the disease than were men (hazard ratio, 1.7). Having the disease for more than 10 years more than doubled the risk of an extra-articular manifestation (HR, 2.4).

Dr. Fitzgerald discussed the study’s findings in a video interview at the meeting. She had no financial disclosures.

[email protected]

On Twitter @alz_gal

WASHINGTON – Women are almost twice as likely as men to develop extra-articular manifestations of ankylosing spondylitis such as uveitis and inflammatory bowel disease, according to an analysis of patients in the Ankylosing Spondylitis Registry of Ireland.

Each of those manifestations exerts its own difficulties upon patients over and above the inflammatory back pain of the underlying disease, Gillian Fitzgerald, MD, said at the annual meeting of the American College of Rheumatology. Many patients can develop several of these separate manifestations – a circumstance that seriously affects their quality of life.

The findings of the large registry study were a bit surprising, she said during presentation of the study at a press briefing, as ankylosing spondylitis is generally thought to affect largely men. “However, this isn’t the case,” said Dr. Fitzgerald of St. James’s Hospital, Dublin. “Recent studies show that women can be affected as often as men are.”

In light of those findings, Dr. Fitzgerald and her coauthors wanted to further define the gender differences, especially with regard to extra-articular manifestations.

They accessed data on 564 patients in the registry, which was established in 2013. The majority of patients (78%) were men; the mean age was 47 years. Patients had a mean disease duration of nearly 21 years. For almost half that time (9 years) they had remained undiagnosed, Dr. Fitzgerald added. They had a mean age of about 47 years, and 78% fulfilled the modified New York criteria for ankylosing spondylitis.

Overall, extra-articular manifestations were common, with 35% having uveitis, 18% psoriasis, and 10% inflammatory bowel disease.

Uveitis was significantly more common among women (47% vs. 32%) and among those with disease duration of more than 10 years (40% vs. 22% with less than 10 years).

Inflammatory bowel disease was also significantly more common among women (16.5% vs. 8%). It wasn’t related to disease duration, but it was related to elevated baseline C-reactive protein, peptic ulcer disease, and osteoporosis.

In a multivariate regression analysis, women were 70% more likely to experience an extra-articular manifestation of the disease than were men (hazard ratio, 1.7). Having the disease for more than 10 years more than doubled the risk of an extra-articular manifestation (HR, 2.4).

Dr. Fitzgerald discussed the study’s findings in a video interview at the meeting. She had no financial disclosures.

[email protected]

On Twitter @alz_gal

WASHINGTON – Women are almost twice as likely as men to develop extra-articular manifestations of ankylosing spondylitis such as uveitis and inflammatory bowel disease, according to an analysis of patients in the Ankylosing Spondylitis Registry of Ireland.

Each of those manifestations exerts its own difficulties upon patients over and above the inflammatory back pain of the underlying disease, Gillian Fitzgerald, MD, said at the annual meeting of the American College of Rheumatology. Many patients can develop several of these separate manifestations – a circumstance that seriously affects their quality of life.

The findings of the large registry study were a bit surprising, she said during presentation of the study at a press briefing, as ankylosing spondylitis is generally thought to affect largely men. “However, this isn’t the case,” said Dr. Fitzgerald of St. James’s Hospital, Dublin. “Recent studies show that women can be affected as often as men are.”

In light of those findings, Dr. Fitzgerald and her coauthors wanted to further define the gender differences, especially with regard to extra-articular manifestations.

They accessed data on 564 patients in the registry, which was established in 2013. The majority of patients (78%) were men; the mean age was 47 years. Patients had a mean disease duration of nearly 21 years. For almost half that time (9 years) they had remained undiagnosed, Dr. Fitzgerald added. They had a mean age of about 47 years, and 78% fulfilled the modified New York criteria for ankylosing spondylitis.

Overall, extra-articular manifestations were common, with 35% having uveitis, 18% psoriasis, and 10% inflammatory bowel disease.

Uveitis was significantly more common among women (47% vs. 32%) and among those with disease duration of more than 10 years (40% vs. 22% with less than 10 years).

Inflammatory bowel disease was also significantly more common among women (16.5% vs. 8%). It wasn’t related to disease duration, but it was related to elevated baseline C-reactive protein, peptic ulcer disease, and osteoporosis.

In a multivariate regression analysis, women were 70% more likely to experience an extra-articular manifestation of the disease than were men (hazard ratio, 1.7). Having the disease for more than 10 years more than doubled the risk of an extra-articular manifestation (HR, 2.4).

Dr. Fitzgerald discussed the study’s findings in a video interview at the meeting. She had no financial disclosures.

[email protected]

On Twitter @alz_gal

SAN DIEGO – Using less than a drop of blood, a portable microsensor provided a comprehensive coagulation profile in minutes and perfectly distinguished various coagulopathies from normal blood samples – handily beating both activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Dubbed ClotChip, the disposable device detects coagulation factors and platelet activity by using a technique called dielectric spectroscopy, Evi X. Stavrou, MD, of Case Western Reserve University, Cleveland, said in a video interview at the annual meeting of the American Society of Hematology. It points the way for comprehensive, rapid, point-of-care assessment of critically ill or severely injured patients and those who need ongoing monitoring to evaluate response to anticoagulant therapy, she added.

By plotting rates of true positives (patients with coagulopathies) against rates of true negatives (controls), the researchers obtained areas under the receiver operating curves of 100% for ClotChip, 78% for aPTT, and 57% for PT. In other words, ClotChip correctly identified all cases and controls in this small patient cohort, which neither aPTT or PT did.

Dr. Stavrou and her coinvestigators had no relevant financial disclosures.

SAN DIEGO – Using less than a drop of blood, a portable microsensor provided a comprehensive coagulation profile in minutes and perfectly distinguished various coagulopathies from normal blood samples – handily beating both activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Dubbed ClotChip, the disposable device detects coagulation factors and platelet activity by using a technique called dielectric spectroscopy, Evi X. Stavrou, MD, of Case Western Reserve University, Cleveland, said in a video interview at the annual meeting of the American Society of Hematology. It points the way for comprehensive, rapid, point-of-care assessment of critically ill or severely injured patients and those who need ongoing monitoring to evaluate response to anticoagulant therapy, she added.

By plotting rates of true positives (patients with coagulopathies) against rates of true negatives (controls), the researchers obtained areas under the receiver operating curves of 100% for ClotChip, 78% for aPTT, and 57% for PT. In other words, ClotChip correctly identified all cases and controls in this small patient cohort, which neither aPTT or PT did.

Dr. Stavrou and her coinvestigators had no relevant financial disclosures.

SAN DIEGO – Using less than a drop of blood, a portable microsensor provided a comprehensive coagulation profile in minutes and perfectly distinguished various coagulopathies from normal blood samples – handily beating both activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Dubbed ClotChip, the disposable device detects coagulation factors and platelet activity by using a technique called dielectric spectroscopy, Evi X. Stavrou, MD, of Case Western Reserve University, Cleveland, said in a video interview at the annual meeting of the American Society of Hematology. It points the way for comprehensive, rapid, point-of-care assessment of critically ill or severely injured patients and those who need ongoing monitoring to evaluate response to anticoagulant therapy, she added.

By plotting rates of true positives (patients with coagulopathies) against rates of true negatives (controls), the researchers obtained areas under the receiver operating curves of 100% for ClotChip, 78% for aPTT, and 57% for PT. In other words, ClotChip correctly identified all cases and controls in this small patient cohort, which neither aPTT or PT did.

Dr. Stavrou and her coinvestigators had no relevant financial disclosures.

SAN DIEGO – For patients with indolent non-Hodgkin lymphoma, adding the anti-CD20 antibody rituximab to a standard-combination chemotherapy regimen resulted in significant improvements in survival, compared with chemotherapy alone. Obinutuzumab (Gazyva), a second-generation anti-CD20 antibody touted as the heir apparent to rituximab, is being explored in various combinations for the treatment of indolent lymphomas, including follicular lymphoma and marginal zone lymphoma.

In this video interview from the annual meeting of the American Society of Hematology, Robert Marcus, FRCP, of King’s College Hospital, London, discussed results of the phase III GALLIUM study, in which patients with untreated follicular lymphoma were randomly assigned to one of three chemotherapy regimens with either obinutuzumab or rituximab. The primary endpoint of investigator-assessed 3-year progression-free survival (PFS) at a median follow-up of 34.5 months was 80% for patients with follicular lymphoma treated with obinutuzumab and one of three standard chemotherapy regimens, compared with 73.3% for patients treated with rituximab and chemotherapy. This difference translated into a hazard ratio (HR) favoring obinutuzumab of 0.68 (P = .0012).

Respective 3-year overall survival rates at 3 years were similar, however, at 94% and 92.1% (HR, 0.75; P = .21).

The GALLIUM trial is sponsored by F. Hoffmann-La Roche. Dr. Marcus disclosed consulting with and receiving honoraria from the company, and relationships with other companies.

SAN DIEGO – For patients with indolent non-Hodgkin lymphoma, adding the anti-CD20 antibody rituximab to a standard-combination chemotherapy regimen resulted in significant improvements in survival, compared with chemotherapy alone. Obinutuzumab (Gazyva), a second-generation anti-CD20 antibody touted as the heir apparent to rituximab, is being explored in various combinations for the treatment of indolent lymphomas, including follicular lymphoma and marginal zone lymphoma.

In this video interview from the annual meeting of the American Society of Hematology, Robert Marcus, FRCP, of King’s College Hospital, London, discussed results of the phase III GALLIUM study, in which patients with untreated follicular lymphoma were randomly assigned to one of three chemotherapy regimens with either obinutuzumab or rituximab. The primary endpoint of investigator-assessed 3-year progression-free survival (PFS) at a median follow-up of 34.5 months was 80% for patients with follicular lymphoma treated with obinutuzumab and one of three standard chemotherapy regimens, compared with 73.3% for patients treated with rituximab and chemotherapy. This difference translated into a hazard ratio (HR) favoring obinutuzumab of 0.68 (P = .0012).

Respective 3-year overall survival rates at 3 years were similar, however, at 94% and 92.1% (HR, 0.75; P = .21).

The GALLIUM trial is sponsored by F. Hoffmann-La Roche. Dr. Marcus disclosed consulting with and receiving honoraria from the company, and relationships with other companies.

SAN DIEGO – For patients with indolent non-Hodgkin lymphoma, adding the anti-CD20 antibody rituximab to a standard-combination chemotherapy regimen resulted in significant improvements in survival, compared with chemotherapy alone. Obinutuzumab (Gazyva), a second-generation anti-CD20 antibody touted as the heir apparent to rituximab, is being explored in various combinations for the treatment of indolent lymphomas, including follicular lymphoma and marginal zone lymphoma.

In this video interview from the annual meeting of the American Society of Hematology, Robert Marcus, FRCP, of King’s College Hospital, London, discussed results of the phase III GALLIUM study, in which patients with untreated follicular lymphoma were randomly assigned to one of three chemotherapy regimens with either obinutuzumab or rituximab. The primary endpoint of investigator-assessed 3-year progression-free survival (PFS) at a median follow-up of 34.5 months was 80% for patients with follicular lymphoma treated with obinutuzumab and one of three standard chemotherapy regimens, compared with 73.3% for patients treated with rituximab and chemotherapy. This difference translated into a hazard ratio (HR) favoring obinutuzumab of 0.68 (P = .0012).

Respective 3-year overall survival rates at 3 years were similar, however, at 94% and 92.1% (HR, 0.75; P = .21).

The GALLIUM trial is sponsored by F. Hoffmann-La Roche. Dr. Marcus disclosed consulting with and receiving honoraria from the company, and relationships with other companies.

SAN DIEGO – Whether hydroxyurea can avert a first stroke in children with sickle cell disease is a question that may be answered by a soon-to-be-started trial in Nigeria.

An estimated 15,000 children with sickle cell anemia have strokes each year in Nigeria, which is considered to have the largest burden of sickle cell disease in the world. Without treatment, about half of those children will have a second stroke within 2 years.

With completion of its feasibility trial results, SPIN (Primary Stroke Prevention in Children With Sickle Cell Anemia in Nigeria) will begin to examine two doses of hydroxyurea therapy, 20 mg/kg per day and 10 mg/kg per day, to determine whether the drug can prevent a first stroke in high-risk children.

In a video interview, Najibah A. Galadanci, MBBS, MPH, of Aminu Kano (Nigeria) Teaching Hospital, discusses how SPIN is addressing the unresolved clinical issue of hydroxyurea’s risks and benefits in children, and how research in Nigeria may provide adequate patient numbers to address a wide range of clinical questions about sickle cell disease.

[email protected]

On Twitter @maryjodales

SAN DIEGO – Whether hydroxyurea can avert a first stroke in children with sickle cell disease is a question that may be answered by a soon-to-be-started trial in Nigeria.

An estimated 15,000 children with sickle cell anemia have strokes each year in Nigeria, which is considered to have the largest burden of sickle cell disease in the world. Without treatment, about half of those children will have a second stroke within 2 years.

With completion of its feasibility trial results, SPIN (Primary Stroke Prevention in Children With Sickle Cell Anemia in Nigeria) will begin to examine two doses of hydroxyurea therapy, 20 mg/kg per day and 10 mg/kg per day, to determine whether the drug can prevent a first stroke in high-risk children.

In a video interview, Najibah A. Galadanci, MBBS, MPH, of Aminu Kano (Nigeria) Teaching Hospital, discusses how SPIN is addressing the unresolved clinical issue of hydroxyurea’s risks and benefits in children, and how research in Nigeria may provide adequate patient numbers to address a wide range of clinical questions about sickle cell disease.

[email protected]

On Twitter @maryjodales

SAN DIEGO – Whether hydroxyurea can avert a first stroke in children with sickle cell disease is a question that may be answered by a soon-to-be-started trial in Nigeria.

An estimated 15,000 children with sickle cell anemia have strokes each year in Nigeria, which is considered to have the largest burden of sickle cell disease in the world. Without treatment, about half of those children will have a second stroke within 2 years.

With completion of its feasibility trial results, SPIN (Primary Stroke Prevention in Children With Sickle Cell Anemia in Nigeria) will begin to examine two doses of hydroxyurea therapy, 20 mg/kg per day and 10 mg/kg per day, to determine whether the drug can prevent a first stroke in high-risk children.

In a video interview, Najibah A. Galadanci, MBBS, MPH, of Aminu Kano (Nigeria) Teaching Hospital, discusses how SPIN is addressing the unresolved clinical issue of hydroxyurea’s risks and benefits in children, and how research in Nigeria may provide adequate patient numbers to address a wide range of clinical questions about sickle cell disease.

[email protected]

On Twitter @maryjodales

SAN DIEGO – A new multi-arm clinical trial aims to transform the treatment of de novo acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially stagnant for 40 years.

Launched in October 2016, the multicenter BEAT AML Master Trial provides genomic results of bone marrow biopsies in just 7 days, according to Brian J. Druker, MD, director of the Knight Cancer Institute at Oregon Health and Science University, Portland. With results that fast, patients can quickly receive whichever therapy targets the mutation shared by most or all their leukemia cells, Dr. Druker and other researchers said at a press briefing at the annual meeting of the American Society of Hematology.

Patients who lack targetable markers will be offered investigational therapies that have shown broad activity in AML, the researchers said. The goal is for all participants to receive optimized treatment – whether or not that leads to an FDA approval, they emphasized.

Centers now participating in this trial include Memorial Sloan Kettering, Ohio State University, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Oregon Health and Science University. More centers will join soon, according to the Leukemia & Lymphoma Society, which is sponsoring the trial. Researchers designed the trial with input from the FDA and pharmaceutical companies, they said.

In a video interview, Dr. Druker discussed key aspects of the trial and how it could advance treatment options for AML. Dr. Druker, whose work on imatinib helped pioneer precision medicine in cancer, disclosed ties to a number of pharmaceutical companies.

SAN DIEGO – A new multi-arm clinical trial aims to transform the treatment of de novo acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially stagnant for 40 years.

Launched in October 2016, the multicenter BEAT AML Master Trial provides genomic results of bone marrow biopsies in just 7 days, according to Brian J. Druker, MD, director of the Knight Cancer Institute at Oregon Health and Science University, Portland. With results that fast, patients can quickly receive whichever therapy targets the mutation shared by most or all their leukemia cells, Dr. Druker and other researchers said at a press briefing at the annual meeting of the American Society of Hematology.

Patients who lack targetable markers will be offered investigational therapies that have shown broad activity in AML, the researchers said. The goal is for all participants to receive optimized treatment – whether or not that leads to an FDA approval, they emphasized.

Centers now participating in this trial include Memorial Sloan Kettering, Ohio State University, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Oregon Health and Science University. More centers will join soon, according to the Leukemia & Lymphoma Society, which is sponsoring the trial. Researchers designed the trial with input from the FDA and pharmaceutical companies, they said.

In a video interview, Dr. Druker discussed key aspects of the trial and how it could advance treatment options for AML. Dr. Druker, whose work on imatinib helped pioneer precision medicine in cancer, disclosed ties to a number of pharmaceutical companies.

SAN DIEGO – A new multi-arm clinical trial aims to transform the treatment of de novo acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially stagnant for 40 years.

Launched in October 2016, the multicenter BEAT AML Master Trial provides genomic results of bone marrow biopsies in just 7 days, according to Brian J. Druker, MD, director of the Knight Cancer Institute at Oregon Health and Science University, Portland. With results that fast, patients can quickly receive whichever therapy targets the mutation shared by most or all their leukemia cells, Dr. Druker and other researchers said at a press briefing at the annual meeting of the American Society of Hematology.

Patients who lack targetable markers will be offered investigational therapies that have shown broad activity in AML, the researchers said. The goal is for all participants to receive optimized treatment – whether or not that leads to an FDA approval, they emphasized.

Centers now participating in this trial include Memorial Sloan Kettering, Ohio State University, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Oregon Health and Science University. More centers will join soon, according to the Leukemia & Lymphoma Society, which is sponsoring the trial. Researchers designed the trial with input from the FDA and pharmaceutical companies, they said.

In a video interview, Dr. Druker discussed key aspects of the trial and how it could advance treatment options for AML. Dr. Druker, whose work on imatinib helped pioneer precision medicine in cancer, disclosed ties to a number of pharmaceutical companies.

SAN DIEGO – After more than four decades of near stagnation in the treatment of patients with acute myeloid leukemia (AML), investigators are beginning to identify drugs that can produce rapid and deep complete remissions, which recent evidence suggests are associated with prolonged survival.

In this video interview at the annual meeting of the American Society of Hematology, Harry P. Erba, MD, PhD, professor of medicine, University of Alabama, Birmingham, describes the early results of one such agent, a novel antibody drug conjugate called vadastuximab talirine, or 33A for short. In the phase Ib clinical trial of induction therapy for newly diagnosed AML, a combination of standard 7+3 induction chemotherapy with cytarabine and daunorubicin plus 33A was associated with a 76% composite rate of complete remissions or complete remissions with incomplete recovery of platelets.

SAN DIEGO – After more than four decades of near stagnation in the treatment of patients with acute myeloid leukemia (AML), investigators are beginning to identify drugs that can produce rapid and deep complete remissions, which recent evidence suggests are associated with prolonged survival.

In this video interview at the annual meeting of the American Society of Hematology, Harry P. Erba, MD, PhD, professor of medicine, University of Alabama, Birmingham, describes the early results of one such agent, a novel antibody drug conjugate called vadastuximab talirine, or 33A for short. In the phase Ib clinical trial of induction therapy for newly diagnosed AML, a combination of standard 7+3 induction chemotherapy with cytarabine and daunorubicin plus 33A was associated with a 76% composite rate of complete remissions or complete remissions with incomplete recovery of platelets.

SAN DIEGO – After more than four decades of near stagnation in the treatment of patients with acute myeloid leukemia (AML), investigators are beginning to identify drugs that can produce rapid and deep complete remissions, which recent evidence suggests are associated with prolonged survival.

In this video interview at the annual meeting of the American Society of Hematology, Harry P. Erba, MD, PhD, professor of medicine, University of Alabama, Birmingham, describes the early results of one such agent, a novel antibody drug conjugate called vadastuximab talirine, or 33A for short. In the phase Ib clinical trial of induction therapy for newly diagnosed AML, a combination of standard 7+3 induction chemotherapy with cytarabine and daunorubicin plus 33A was associated with a 76% composite rate of complete remissions or complete remissions with incomplete recovery of platelets.

SAN DIEGO – Tyrosine kinase inhibitors have dramatically improved survival for patients with chronic myeloid leukemia, but for some patients with solid stable remissions, halving the TKI dose or even stopping therapy altogether, at least temporarily, appears to be safe and to offer both health and financial benefits,

In the British Destiny [De-escalation and Stopping Treatment of Imatinib, Nilotinib, or Sprycel (dasatinib)], there were 12 molecular relapses occurring between the second and twelfth month of dose reduction among 174 patients with either an MR3 or MR4 molecular response, and all patients had restoration of molecular remissions after resumption of full dose TKIs.

Coinvestigator Mhairi Copland, MD, PhD, of the University of Glasgow, Scotland, discussed in a video interview the potential clinical benefits of lower-dose therapy in patients in stable CML remissions, and notes that de-escalation strategy is associated with a nearly 50% saving in costs compared with full-dose TKI therapy.

SAN DIEGO – Tyrosine kinase inhibitors have dramatically improved survival for patients with chronic myeloid leukemia, but for some patients with solid stable remissions, halving the TKI dose or even stopping therapy altogether, at least temporarily, appears to be safe and to offer both health and financial benefits,

In the British Destiny [De-escalation and Stopping Treatment of Imatinib, Nilotinib, or Sprycel (dasatinib)], there were 12 molecular relapses occurring between the second and twelfth month of dose reduction among 174 patients with either an MR3 or MR4 molecular response, and all patients had restoration of molecular remissions after resumption of full dose TKIs.

Coinvestigator Mhairi Copland, MD, PhD, of the University of Glasgow, Scotland, discussed in a video interview the potential clinical benefits of lower-dose therapy in patients in stable CML remissions, and notes that de-escalation strategy is associated with a nearly 50% saving in costs compared with full-dose TKI therapy.

SAN DIEGO – Tyrosine kinase inhibitors have dramatically improved survival for patients with chronic myeloid leukemia, but for some patients with solid stable remissions, halving the TKI dose or even stopping therapy altogether, at least temporarily, appears to be safe and to offer both health and financial benefits,

In the British Destiny [De-escalation and Stopping Treatment of Imatinib, Nilotinib, or Sprycel (dasatinib)], there were 12 molecular relapses occurring between the second and twelfth month of dose reduction among 174 patients with either an MR3 or MR4 molecular response, and all patients had restoration of molecular remissions after resumption of full dose TKIs.

Coinvestigator Mhairi Copland, MD, PhD, of the University of Glasgow, Scotland, discussed in a video interview the potential clinical benefits of lower-dose therapy in patients in stable CML remissions, and notes that de-escalation strategy is associated with a nearly 50% saving in costs compared with full-dose TKI therapy.

SAN DIEGO – Call it “7+3+1”: an experimental induction regimen combining standard chemotherapy with an antibody drug conjugate induced rapid and deep remissions in a majority of patients with newly diagnosed acute myeloid leukemia in a small study.

Among 42 evaluable patients with previously untreated AML, the combination of cytarabine and an anthracycline (7+3, also known as 3+7), and the investigational antibody drug conjugate vadastuximab talirine was associated with a 60% complete remission (CR) rate, and 17% complete remission with incomplete recovery of platelets (CRi), reported Harry P. Erba, MD, PhD, of the University of Alabama at Birmingham, who discussed the findings in a video interview.

Rapid complete remissions

In the phase Ib trial reported at ASH 2016 by Dr. Erba, adults aged 18-65 years with untreated primary or secondary AML (except acute promyelocytic leukemia) were enrolled.

The patients received 33A in combination with 7+3 induction therapy (cytarabine 100 mg/m² and daunorubicin 60 mg/m²) on days 1 and 4 of a 28-day treatment cycle. Patients were assessed for response on days 1 and 28 according to International Working Group Criteria.

Second induction regimens and postremission therapies were permitted at the investigators discretion, and did not include 33A.

The median patient age was 45.5 years. The patients had generally good performance status (Eastern Cooperative Oncology Group 0 or 1). In all, 17% of patients had secondary AML. In all, 12% had favorable cytogenetic risk disease, 50% had intermediate risk, and 36% had adverse risk. Ten percent of patients had NPM1 mutated disease, and 14% had FLT-3 mutations.

As noted, the composite CR/CRi rate was 76%, consisting of 60% CR and 17% CRI.

All five patients with favorable risk disease had a CR. The rate of CR/CRi was 86% among patients with intermediate-risk disease, and 60 for those with adverse-risk disease.

Of the 32 patients who achieved a CR or CRi, 94% did so after 1 cycle of therapy, and 25 were MRD negative, as evaluated by an independent laboratory using 10-color multi-parameter flow cytometry.

Treatment-related adverse hematologic events included febrile neutropenia (primarily grade 3) in 43% of patients, thrombocytopenia (mostly grade 4) in 38%, anemia (all grade 3) in 24%, and neutropenia (mostly grade 4) in 17%. Other treatment related events were similar to those seen with 7 + 3 alone, and included nausea, diarrhea, decreased appetite and fatigue, mostly grade 1 or 2. One patient had a grade 3 irreversible hepatic toxicity.

The death rate was 2%.

“What we felt we showed is that we were able to combine active doses of 33A with 7 + 3. The doses here were less than the doses used as a single agent, but all doses used in our phase 1b study, including lower doses that what we actually used here, showed complete remissions as a single agent.”

33A “added acceptable on-target myelosuppression. We saw platelet counts recovering to over 100,000, and neutrophils over 1,000 by about four-and-a-half to five weeks, which we felt was reasonable, and patients were able to go on to get post-remission therapy.

A randomized phase II trial comparing 33A and 7+3 to 7+3 alone is slated to launch in the first quarter of 2017.

Dr. Erba disclosed serving as a consultant to and receiving research funding from Seattle Genetics, which supported the study.

SAN DIEGO – Call it “7+3+1”: an experimental induction regimen combining standard chemotherapy with an antibody drug conjugate induced rapid and deep remissions in a majority of patients with newly diagnosed acute myeloid leukemia in a small study.

Among 42 evaluable patients with previously untreated AML, the combination of cytarabine and an anthracycline (7+3, also known as 3+7), and the investigational antibody drug conjugate vadastuximab talirine was associated with a 60% complete remission (CR) rate, and 17% complete remission with incomplete recovery of platelets (CRi), reported Harry P. Erba, MD, PhD, of the University of Alabama at Birmingham, who discussed the findings in a video interview.

Rapid complete remissions

In the phase Ib trial reported at ASH 2016 by Dr. Erba, adults aged 18-65 years with untreated primary or secondary AML (except acute promyelocytic leukemia) were enrolled.

The patients received 33A in combination with 7+3 induction therapy (cytarabine 100 mg/m² and daunorubicin 60 mg/m²) on days 1 and 4 of a 28-day treatment cycle. Patients were assessed for response on days 1 and 28 according to International Working Group Criteria.

Second induction regimens and postremission therapies were permitted at the investigators discretion, and did not include 33A.

The median patient age was 45.5 years. The patients had generally good performance status (Eastern Cooperative Oncology Group 0 or 1). In all, 17% of patients had secondary AML. In all, 12% had favorable cytogenetic risk disease, 50% had intermediate risk, and 36% had adverse risk. Ten percent of patients had NPM1 mutated disease, and 14% had FLT-3 mutations.

As noted, the composite CR/CRi rate was 76%, consisting of 60% CR and 17% CRI.

All five patients with favorable risk disease had a CR. The rate of CR/CRi was 86% among patients with intermediate-risk disease, and 60 for those with adverse-risk disease.

Of the 32 patients who achieved a CR or CRi, 94% did so after 1 cycle of therapy, and 25 were MRD negative, as evaluated by an independent laboratory using 10-color multi-parameter flow cytometry.

Treatment-related adverse hematologic events included febrile neutropenia (primarily grade 3) in 43% of patients, thrombocytopenia (mostly grade 4) in 38%, anemia (all grade 3) in 24%, and neutropenia (mostly grade 4) in 17%. Other treatment related events were similar to those seen with 7 + 3 alone, and included nausea, diarrhea, decreased appetite and fatigue, mostly grade 1 or 2. One patient had a grade 3 irreversible hepatic toxicity.

The death rate was 2%.

“What we felt we showed is that we were able to combine active doses of 33A with 7 + 3. The doses here were less than the doses used as a single agent, but all doses used in our phase 1b study, including lower doses that what we actually used here, showed complete remissions as a single agent.”

33A “added acceptable on-target myelosuppression. We saw platelet counts recovering to over 100,000, and neutrophils over 1,000 by about four-and-a-half to five weeks, which we felt was reasonable, and patients were able to go on to get post-remission therapy.

A randomized phase II trial comparing 33A and 7+3 to 7+3 alone is slated to launch in the first quarter of 2017.

Dr. Erba disclosed serving as a consultant to and receiving research funding from Seattle Genetics, which supported the study.

SAN DIEGO – Call it “7+3+1”: an experimental induction regimen combining standard chemotherapy with an antibody drug conjugate induced rapid and deep remissions in a majority of patients with newly diagnosed acute myeloid leukemia in a small study.

Among 42 evaluable patients with previously untreated AML, the combination of cytarabine and an anthracycline (7+3, also known as 3+7), and the investigational antibody drug conjugate vadastuximab talirine was associated with a 60% complete remission (CR) rate, and 17% complete remission with incomplete recovery of platelets (CRi), reported Harry P. Erba, MD, PhD, of the University of Alabama at Birmingham, who discussed the findings in a video interview.

Rapid complete remissions

In the phase Ib trial reported at ASH 2016 by Dr. Erba, adults aged 18-65 years with untreated primary or secondary AML (except acute promyelocytic leukemia) were enrolled.

The patients received 33A in combination with 7+3 induction therapy (cytarabine 100 mg/m² and daunorubicin 60 mg/m²) on days 1 and 4 of a 28-day treatment cycle. Patients were assessed for response on days 1 and 28 according to International Working Group Criteria.

Second induction regimens and postremission therapies were permitted at the investigators discretion, and did not include 33A.

The median patient age was 45.5 years. The patients had generally good performance status (Eastern Cooperative Oncology Group 0 or 1). In all, 17% of patients had secondary AML. In all, 12% had favorable cytogenetic risk disease, 50% had intermediate risk, and 36% had adverse risk. Ten percent of patients had NPM1 mutated disease, and 14% had FLT-3 mutations.

As noted, the composite CR/CRi rate was 76%, consisting of 60% CR and 17% CRI.

All five patients with favorable risk disease had a CR. The rate of CR/CRi was 86% among patients with intermediate-risk disease, and 60 for those with adverse-risk disease.

Of the 32 patients who achieved a CR or CRi, 94% did so after 1 cycle of therapy, and 25 were MRD negative, as evaluated by an independent laboratory using 10-color multi-parameter flow cytometry.

Treatment-related adverse hematologic events included febrile neutropenia (primarily grade 3) in 43% of patients, thrombocytopenia (mostly grade 4) in 38%, anemia (all grade 3) in 24%, and neutropenia (mostly grade 4) in 17%. Other treatment related events were similar to those seen with 7 + 3 alone, and included nausea, diarrhea, decreased appetite and fatigue, mostly grade 1 or 2. One patient had a grade 3 irreversible hepatic toxicity.

The death rate was 2%.

“What we felt we showed is that we were able to combine active doses of 33A with 7 + 3. The doses here were less than the doses used as a single agent, but all doses used in our phase 1b study, including lower doses that what we actually used here, showed complete remissions as a single agent.”

33A “added acceptable on-target myelosuppression. We saw platelet counts recovering to over 100,000, and neutrophils over 1,000 by about four-and-a-half to five weeks, which we felt was reasonable, and patients were able to go on to get post-remission therapy.

A randomized phase II trial comparing 33A and 7+3 to 7+3 alone is slated to launch in the first quarter of 2017.

Dr. Erba disclosed serving as a consultant to and receiving research funding from Seattle Genetics, which supported the study.

SAN DIEGO – An artificial red blood cell has come close to emulating the key functions of natural cells and does not appear to be associated with the side effects such as vasospasm and poor response to changes in blood pH that hampered the development of previous artificial blood products, Allan Doctor, MD, reported at the annual meeting of the American Society of Hematology.

The bio-synthetic cells, called ErythroMer, are about 1/50th the size of natural red blood cells. They can be stored at room temperature and reconstituted with water when needed for use.

In a mouse model, the ErythroMer cells were shown to capture oxygen in the lungs and release it to tissue in a pattern that was nearly identical to blood transfusion. In a rat model of shock, ErythroMer was effective for resuscitation.

In a video interview, Dr. Doctor of Washington University in St. Louis discussed the pharmacokinetics of ErythroMer, the need for a readily available blood substitute for treating trauma patients, other potential uses for artificial blood cells, and next steps for testing the product.

Dr. Doctor has equity ownership in KaloCyte, the company developing ErythroMer. He receives research funding from Children’s Discovery Institute and the National Institutes of Health.

[email protected]

SAN DIEGO – An artificial red blood cell has come close to emulating the key functions of natural cells and does not appear to be associated with the side effects such as vasospasm and poor response to changes in blood pH that hampered the development of previous artificial blood products, Allan Doctor, MD, reported at the annual meeting of the American Society of Hematology.

The bio-synthetic cells, called ErythroMer, are about 1/50th the size of natural red blood cells. They can be stored at room temperature and reconstituted with water when needed for use.

In a mouse model, the ErythroMer cells were shown to capture oxygen in the lungs and release it to tissue in a pattern that was nearly identical to blood transfusion. In a rat model of shock, ErythroMer was effective for resuscitation.

In a video interview, Dr. Doctor of Washington University in St. Louis discussed the pharmacokinetics of ErythroMer, the need for a readily available blood substitute for treating trauma patients, other potential uses for artificial blood cells, and next steps for testing the product.

Dr. Doctor has equity ownership in KaloCyte, the company developing ErythroMer. He receives research funding from Children’s Discovery Institute and the National Institutes of Health.

[email protected]

SAN DIEGO – An artificial red blood cell has come close to emulating the key functions of natural cells and does not appear to be associated with the side effects such as vasospasm and poor response to changes in blood pH that hampered the development of previous artificial blood products, Allan Doctor, MD, reported at the annual meeting of the American Society of Hematology.

The bio-synthetic cells, called ErythroMer, are about 1/50th the size of natural red blood cells. They can be stored at room temperature and reconstituted with water when needed for use.

In a mouse model, the ErythroMer cells were shown to capture oxygen in the lungs and release it to tissue in a pattern that was nearly identical to blood transfusion. In a rat model of shock, ErythroMer was effective for resuscitation.

In a video interview, Dr. Doctor of Washington University in St. Louis discussed the pharmacokinetics of ErythroMer, the need for a readily available blood substitute for treating trauma patients, other potential uses for artificial blood cells, and next steps for testing the product.

Dr. Doctor has equity ownership in KaloCyte, the company developing ErythroMer. He receives research funding from Children’s Discovery Institute and the National Institutes of Health.

[email protected]

WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.

“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray,  chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.

“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray,  chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.

“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray,  chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler