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The Food and Drug Administration has approvedZolinza (vorinostat, Merck) as a once-a-day oral treatment of the skinmanifestations of cutaneous T-cell lymphoma(CTCL) in patients whose diseasehas persisted, progressed, or recurredduring or following two systemic therapies.

Merck & Co, Inc, recently announced that the Food and Drug Administration (FDA) has approved oral vorinostat (Zolinza), 400 mg once daily, for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, who have progressive, persistent, or recurrent disease on or following two systemic therapies. CTCL is a cancer of the T cells that affects the skin.

Patients with advanced follicular non-Hodgkin's lymphoma who received a new combination of chemotherapy and targeted radiation (radioimmunotherapy) lived significantly longer than patients treated with standard chemotherapy alone on previous trials. Five-year follow-up data from the phase II trial was published in the September 1 issue of the Journal of Clinical Oncology.

Improved compliance with imatinib (Gleevec) therapy for patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) is associated with decreased total and disease-related health care costs

A 5-year follow-up of the largest study to evaluate imatinib (Gleevec) in the treatment of patients with chronic myeloid leukemia (CML) continues to show prolonged response to treatment and a steady decline in rate of disease progression with each additional year of treatment.

The FDA has granted accelerated approval to Bristol-Myers Squibb's Sprycel (dasatinib) Tablets for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy, including imatinib (Gleevec). Sprycel also received regular FDA approval for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

At a median of 4.9 months of therapy with the investigational agent nilotinib (Tasigna, formerly AMN107), 92% of patients with treatment-resistant chronic phase Ph+ chronic myeloid leukemia (CML) achieved a complete hematologic response with normalization of white blood cell counts, and 35% had a complete cytogenetic response. All patient had shown resistance or intolerance to optimized imatinib (Gleevec) therapy

In a randomized open-label phase II clinical trial (START-R) presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (abstract 6507), the oral multitargeted kinase inhibitor dasatinib achieved major cytogenetic responses in 35% of patients with chronic myeloid leukemia (CML) in chronic phase who had resistance or intolerance to imatinib (Gleevec) (aee also report on page 1 on FDA approval of dasatinib).

Molecular discoveries and clinical advances over the past few decades have made the treatment of chronic myeloid leukemia (CML) one of the great success stories of modern medicine. Before the 1980s, the focus was on maintaining normal white blood cell counts with agents such as hydroxyurea and busulfan. With the use of interferon, treatment strategies turned more toward cytogenetic remission. In 1998, targeted therapy was introduced to this setting with the first studies of imatinib mesylate. Since then, treatment objectives have shifted toward the attainment of molecular remission. In this review, we consider the variety of approaches to treating CML, efforts to minimize treatment failures, and possible future directions in therapy.

The FDA has granted priority review to dasatinib (BMS-354825), developed by Bristol-Myers Squibb, for treatment of imatinib (Gleevec)-resistant or refractory chronic myelogenous leukemia (CML) in adults.

Analysis of an early trial of a peptide vaccine, CMLVAX100, provides evidence of disease responses, including some complete molecular responses in patients with previously treated chronic myelogenous leukemia (CML), according to Monica Bocchia, MD, Department of Hematology, University of Siena, Italy. "Despite high rates of clinical and cytogenetic remission achieved by imatinib [Gleevec], most patients still have some degree of molecular residual disease," Dr. Bocchia said at the 47th Annual Meeting of the American College of Hematology (abstract 167). Furthermore, she noted that discontinuation of imatinib (Gleevec) usually results in recurrence of leukemia.

According to a study of late transplant outcomes for more than 6,500 chronic myeloid leukemia (CML) patients, those patients alive in remission 5 years after allogeneic hematopoietic cell transplantation (HCT) enjoy relatively low rates of subsequent disease relapse and death.

The past 20 years have brought significant advances in our ability to manage patients with non-Hodgkin's lymphoma. More precise classification systems, improvements in diagnosis and staging, and effective new treatments have improved outcomes and made cure a reasonable goal for many patients with these disorders.

First results of four phase II studies of the investigational oral, multitargeted kinase inhibitor dasatinib (BMS-354825) showed significant efficacy in imatinib (Gleevec) resistant and intolerant patients with chronic, accelerated, and blast phase (myeloid and lymphoid) chronic myeloid leukemia (CML).

Acute myelogenous leukemia (AML) is a disorder marked by infiltration of the bone marrow by abnormal hematopoietic progenitors. These cells are unable to differentiate in a normal fashion into myeloid, erythroid, and/or megakaryocytic cell lines and, unlike normal progenitors, are capable of infiltrating vital organs.

Chronic lymphocytic leukemia (CLL) is the most common adult leukemia in the Western hemisphere, accounting for 30% of the leukemias in this population. The disease results from a clonal expansion of small B-lymphocytes. CLL always involves the bone marrow and peripheral blood. The disease also can be demonstrated in lymph nodes, liver, and spleen.

The curability of the aggressive, large-cell lymphomas was first convincinglyreported by Levitt et al in 1972.[1] Patients with “reticulum cellsarcoma” were treated with a regimen that came to be known as COMLA(cyclophosphamide, vincristine [Oncovin], methotrexate, leucovorin, cytarabine[Ara-C]). A more commonly quoted paper was published in 1975 by DeVita et aldescribing the cure of advanced “diffuse histiocytic lymphoma” with COPP (cyclophosphamide,vincristine [Oncovin], procarbazine, prednisone).[2] During the 1970sthe CHOP regimen (cyclophosphamide, doxorubicin HCl, vincristine [Oncovin],prednisone) was described by McKelvey et al[3]; it quickly became the mostwidely used treatment for the aggressive large-cell lymphomas. Patients treatedwith two cycles of CHOP beyond documentation of a complete remission wereoften cured.[4]

SAN DIEGO, California-An investigational drug, BMS-354825, overcame resistance to imatinib (Gleevec) in Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in two small but dramatic phase I trials presented at the 46th Annual Meeting of the American Society of Hematology (ASH). After up to 9 months of treatment with BMS-354825, 31 of 36 chronic-phase patients (86%) had a complete hematological response, Charles L. Sawyers, MD, a Howard Hughes Medical Institute researcher at UCLA, reported (abstract 1). Among 29 patients who reached 3 months on treatment and could be evaluated for cytogenetic response, 13 responses were observed overall, including 8 major cytogenetic responses (28%), of which 5 were complete.