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hematologic malignancies

Gary H. Lyman, MD, MPH, on Myeloid Growth Factors: New Biosimilar Approvals

Gary H. Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, discusses current strategies for the use of biosimilars to treat cancer-induced anemia and neutropenia, and the need to provide evidence for the efficacy of these agents to allay any concerns about their use.

breast cancer
gynecologic cancer
hematologic malignancies
leukemia
lymphoma
symptom management

FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More

The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...

hematologic malignancies
symptom management

Letter to the Editor: Survey on DOACs in Cancer-Related Venous Thromboembolism

This letter is a follow-up to a report published previously in The ASCO Post. Recent trials report comparable or improved efficacy of direct-acting oral coagulants (DOACs) over low–molecular-weight heparins (LMWH) in the treatment of cancer-related VTE (cVTE) at the expense of increased...

solid tumors
hematologic malignancies

Standard Site-Specific Therapy Based on Gene-Expression Profiling vs Empirical Chemotherapy for Cancer of Unknown Primary

In a Japanese phase II trial reported in the Journal of Clinical Oncology, Hayashi et al found that standard site-specific treatment based on gene-expression profiling was not associated with better outcomes vs empirical paclitaxel and carboplatin in patients with cancer of unknown primary site....

colorectal cancer
solid tumors
hematologic malignancies
pancreatic cancer
symptom management

FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More

The U.S. Food and Drug Administration (FDA) recently issued the following new designations and clearances: Fast Track Designation for Itolizumab for the Treatment of Acute Graft-vs-Host Disease The FDA granted Fast Track designation to itolizumab for the treatment of acute graft-vs-host ...

hematologic malignancies

FDA Approves Ravulizumab-cwvz for Paroxysmal Nocturnal Hemoglobinuria

On December 21, 2018, the U.S. Food and Drug Administration (FDA) approved ravulizumab-cwvz (Ultomiris) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare bone marrow failure disorder that manifests with hemolytic anemia, thrombosis, and peripheral blood cytopenias....

hematologic malignancies

FDA Approves Tagraxofusp-ezrs for Blastic Plasmacytoid Dendritic Cell Neoplasm

On December 21, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. “Prior to [this] approval, there had been no...

hematologic malignancies

Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE

Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism. Readers of The ASCO Post are invited to participate in this research by completing the survey, entitled: “Perspectives and Practices in Utilization of Direct Oral Anticoagulants in Patients With Cancer-Associated Venous Thromboembolism.” The survey takes approximately 3 to 4 minutes to complete and can be taken on a mobile device or a computer. The survey link is https://yalesurvey.ca1.qualtrics.com/jfe/form/SV_3l0HxrreWZhVtBz.

hematologic malignancies

ASH 2018: Machine Learning–Based Model to Risk Stratify Patients With Myelodysplastic Syndromes

Researchers used machine learning to develop a new system to analyze genomic and clinical data to provide a personalized overall outcome that is patient-specific in myelodysplastic syndromes. In tests, the system outperformed the current standard prognostic tool, suggesting the new model may offer...

hematologic malignancies

ASH 2018: MEDALIST: Luspatercept in Patients With Myelodysplastic Syndrome Requiring Red Blood Cell Transfusion

In the phase III MEDALIST clinical trial, luspatercept significantly reduced the need for frequent blood transfusions in just over half (53%) of patients with myelodysplastic syndromes (MDS) who were anemic, required regular red blood cell transfusions, and showed abnormal iron overload in red...

hematologic malignancies

ASH 2018: Large Single-Arm Trial of Hydroxyurea for Sickle Cell Anemia in Sub-Saharan Africa

The largest prospective trial of hydroxyurea for sickle cell anemia (SCA) has shown that this treatment—long the standard of care for treating SCA in developed countries—is feasible, accepted, well tolerated, and safe for children living in sub-Saharan Africa. Tshilolo et al reported...

hematologic malignancies
leukemia

MRD-Guided Azacitidine Treatment in Myelodysplastic Syndrome and Acute Myeloid Leukemia

In a German phase II trial (RELAZA2) reported in The Lancet Oncology, Platzbecker et al found that minimal residual disease (MRD)–guided treatment with azacitidine was successful in preventing hematologic relapse in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia...

hematologic malignancies

Effect of Donor Clonal Hematopoiesis of Indeterminate Potential in Allogeneic Hematopoietic Stem Cell Transplantation

In a study reported in the Journal of Clinical Oncology, Frick et al found that allogeneic hematopoietic stem cell transplantation (HSCT) from donors with clonal hematopoiesis of indeterminate potential (CHIP) appears safe and not associated with poorer survival when donors are older, related...

hematologic malignancies
cost of care

New Report Demonstrates Cost of Blood Cancer Care

The costs to treat blood cancer are higher than costs for other cancers, and the costs incurred by a patient diagnosed with a blood cancer do not return to precancer levels, according to a Milliman study commissioned by The Leukemia & Lymphoma Society (LLS). The study—The...

hematologic malignancies
immunotherapy

Adoptive T-Cell Therapy for Progressive Multifocal Leukoencephalopathy

An emerging treatment known as adoptive T-cell therapy has proven effective in a phase II clinical trial for treating progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection sometimes observed in patients with cancer and other diseases in which the immune...

hematologic malignancies

Genomic Classification of Myeloproliferative Neoplasms and Integration in Predictive Models

In a study reported in The New England Journal of Medicine, Grinfeld et al identified distinct genomic subgroups among patients with myeloproliferative neoplasms that, when combined with clinical variables, offered the potential for individualized predictions of clinical outcomes. Study Details...

hematologic malignancies
immunotherapy

Frederick L. Locke, MD, on CAR T-Cell Therapy: Major Milestones

Frederick L. Locke, MD, of Moffitt Cancer Center, discusses the key studies behind the development of CAR T cells, major adverse events and management strategies, and the potential of this revolutionary treatment.

hematologic malignancies

Outcomes Associated With Mutation Persistence After HSCT for Myelodysplastic Syndrome

In a single-institution study reported in The New England Journal of Medicine, Duncavage et al found that mutation clearance after allogeneic hematopoietic stem cell transplantation (HSCT) was associated with better outcomes in patients with myelodysplastic syndrome. Study Details The study...

hematologic malignancies

FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy

The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...

solid tumors
hematologic malignancies

FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant

The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...

hematologic malignancies

Response to Ibrutinib in Symptomatic Untreated Waldenström’s Macroglobulinemia

In a study reported in the Journal of Clinical Oncology, Treon et al found that ibrutinib monotherapy was highly active in patients with previously untreated Waldenström’s macroglobulinemia, with better response in patients without CXCR4 mutation. Ibrutinib has been shown to be active in ...

solid tumors
hematologic malignancies

Monthly High-Dose Vitamin D and Cancer Risk

In a study reported in JAMA Oncology, Scragg et al found that monthly high-dose vitamin D supplementation, without calcium, was not associated with a reduced risk of developing cancer. Study Details The current analysis is a post hoc analysis of the Vitamin D Assessment (ViDA) study, which...

hematologic malignancies

FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...

hematologic malignancies

EHA 2018: Ruxolitinib Reduces Risk of Thrombosis, Death in Patients With Polycythemia Vera

A new comparison study showed that among polycythemia vera patients who were resistant or intolerant to hydroxyurea, those treated with ruxolitinib (Jakavi) had a significantly reduced risk of thrombosis and death compared to those who received best available therapy. The study findings are based...

hematologic malignancies
immunotherapy

2018 ASCO: iNNOVATE Trial Evaluates Ibrutinib in Combination With Rituximab in Patients With Waldenström's Macroglobulinemia

Results from a preplanned interim analysis of the phase III iNNOVATE (PCYC-1127) study evaluating the investigational use of ibrutinib (Imbruvica) in combination with rituximab (Rituxan) in relapsed/refractory and treatment-naive patients with Waldenström’s macroglobulinemia were...

hematologic malignancies
immunotherapy

Meletios A. Dimopoulos, MD, on Waldenström’s Macroglobulinemia

Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, discusses phase III findings on ibrutinib/rituximab vs placebo/rituximab in Waldenström’s macroglobulinemia (Abstract 8003).

solid tumors
hematologic malignancies

Update Regarding Tazemetostat Clinical Program

On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...

hematologic malignancies

FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients

On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen ...

hematologic malignancies

Clinical Hold Lifted on U.S. Studies of BPX-501

On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...

solid tumors
hematologic malignancies

AACR 2018: Prior Chemotherapies May Impair Pediatric Patients’ Ability to Develop Effective CAR T Cells

Pediatric patients with solid tumors may have poor quality T cells compared to patients with leukemia, and certain chemotherapies were detrimental to the T cells and their potential to become chimeric antigen receptor (CAR) T cells, according to data presented during a media preview for the...

hematologic malignancies

Novel PI3Kδ Inhibitor in Relapsed or Refractory Hematologic Malignancies

In a phase I trial reported in The Lancet Oncology, Burris et al determined the phase II dose of the next-generation PI3Kδ inhibitor umbralisib and found evidence of the agent’s activity in relapsed or refractory hematologic malignancies. Umbralisib exhibits improved PI3K isoform...

hematologic malignancies
symptom management

Cognitive Decline Prevalent Among Elderly Patients With Hematologic Cancers

A sizable percentage of elderly patients with blood-related cancers such as leukemia and multiple myeloma are apt to show signs of diminished cognitive functioning—a decline that may impact their survival—a new study by investigators at Dana-Farber Cancer Institute and Brigham and...

hematologic malignancies

Clinical Hold on BPX-501 Trials in the United States Announced

On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed...

hematologic malignancies
immunotherapy

Stephen M. Ansell, MD, PhD, on Hematologic Malignancies: Immunotherapy Update

Stephen M. Ansell, MD, PhD, of the Mayo Clinic, discusses integrating immune checkpoint inhibitors, improving efficacy, and reducing toxicity when treating blood cancers.

hematologic malignancies

Cognitive Function After Hematopoietic Cell Transplantation for Hematologic Malignancy

In a prospective longitudinal study reported in the Journal of Clinical Oncology, Sharafeldin et al found that cognitive function after hematopoietic cell transplantation (HCT) for hematologic malignancy was impaired among those receiving myeloablative allogeneic HCT, with a delayed effect being...

hematologic malignancies
symptom management

ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer

People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...

hematologic malignancies

ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura

In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...

hematologic malignancies
symptom management

ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant

Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials

In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...

hematologic malignancies
issues in oncology
cost of care

Alok A. Khorana, MD, on The Costs of VTE in Cancer Patients: Expert Perspective

Alok A. Khorana, MD, of the Cleveland Clinic, discusses the prevalence of venous thromboembolism in cancer patients treated at U. S. emergency departments and associated costs, mortality, and hospital admissions in the United States (Abstract 219).

hematologic malignancies

ASH 2017: Rapid Responses, Few Adverse Effects Seen With Targeted Agent in Phase I Trial in Systemic Mastocytosis

In a phase I trial, patients with an advanced or aggressive form of systemic mastocytosis, a rare blood disorder, had rapid and durable responses with few adverse effects following treatment with an investigational drug that targets the genetic mutation found in more than 90% of cases. Results were ...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

Watch for More From ASH 2017

Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...

hematologic malignancies
issues in oncology

ASH 2017: Direct Oral Anticoagulant May Reduce Recurrence of VTE in Patients With Cancer

People with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE). International guidelines recommend treatment using low–molecular-weight heparin, an anticoagulant that is injected subcutaneously; however, new results from ...

hematologic malignancies

ASCO Clinical Practice Guideline Update: Platelet Transfusion for Patients With Cancer

As reported in the Journal of Clinical Oncology by Charles A. Schiffer, MD, of Karmanos Cancer Institute, Wayne State University School of Medicine, and colleagues, ASCO has issued a clinical practice guideline update on platelet transfusions in patients with cancer. The updated guideline replaces ...

hematologic malignancies

FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients

Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...

hematologic malignancies

FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease

On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...

hematologic malignancies

Anti–T-Lymphocyte Globulin and Chronic GVHD-Free Survival in Unrelated Myeloablative HCT

A double-blind phase III trial has shown no benefit of anti–T-lymphocyte globulin (ATLG) vs placebo on chronic graft-vs-host disease (GVHD)-free survival in patients undergoing human leukocyte antigen (HLA)-matched unrelated myeloablative hematopoietic cell transplantation (HCT). The study...

hematologic malignancies

Ruben A. Mesa, MD, on Myeloproliferative Neoplasms: Managing PV and ET

Ruben A. Mesa, MD, of The University of Texas Health San Antonio Cancer Center, discusses the role of JAK2 inhibitors in treating polycythemia vera and essential thrombocythemia and how to develop individualized therapy based on risk stratification.

hematologic malignancies

Potential Biomarkers to Identify Patients at Risk for Neurotoxicity From CAR T-Cell Therapy

Although lymphodepletion chemotherapy followed by an infusion of CD19-targeted chimeric antigen receptor (CAR)-modified T cells has produced high response rates in phase I studies of patients with refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia...

hematologic malignancies

Momelotinib vs Ruxolitinib in Janus Kinase Inhibitor–Naive Myelofibrosis

In the phase III SIMPLIFY-1 noninferiority trial reported in the Journal of Clinical Oncology, Mesa et al found that the selective Janus kinase (JAK) 1 and 2 inhibitor momelotinib was noninferior to ruxolitinib (Jakafi) in spleen response, but not symptom response, in JAK inhibitor–naive...

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