Leukemia

On August 22, 2008, the US Food and Drug Administration (FDA) granted marketing approval (licensure) to romiplostim (Nplate, Amgen Inc) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Drs. Hernandez-Ilizaliturri and Czuczman should be complimented on their comprehensive review of management options for patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL).

A triple therapy with fludarabine, cyclophosphamide, and rituximab (Rituxan) was hailed as the new standard of care for chronic lymphocytic leukemia at ASH 2008 in San Francisco. Now a new study has deemed low-dose fludarabine and cyclophosphamide combined with high-dose rituximab (FCR-Lite) as highly effective in untreated CLL patients.

SAN FRANCISCO-While genetics has opened up new possibilities for predicting treatment response in patients with acute myeloid leukemia, there are still unanswered questions about the relationship between genetic mutations and treatment outcome, according to Bob Lowenberg, MD, PhD, who delivered the Ham-Wasserman lecture at ASH 200

SAN FRANCISCO-As a single agent, pralatrexate (PDX) shows promising clinical activity in relapsed or refractory peripheral T-cell lymphoma, producing responses in 27% of the patients enrolled in a major prospective clinical trial.

Two of the largest trials to date on the treatment of chronic lymphocytic leukemia indicate that the combination treatment of fludarabine, cyclophosphamide, and rituximab (Rituxan) should become the new standard of care for both untreated and previously treated patients.

Cephalon, Inc, announced that the US Food and Drug Administration (FDA) has approved injectable bendamustine hydrochloride (Treanda) for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab (Rituxan) or a rituximab-containing regimen. The data supporting the FDA approval show that bendamustine is effective, has a tolerable side effect profile in patients with indolent NHL, and that treatment results in a high durable response rate. In March of this year, bendamustine received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the United States.

Results from the multinational randomized phase III REACH trial demonstrate that the combination known as FCR (fludarabine, cyclophosphamide, rituximab [Rituxan]) provides a 10-month improvement in progression-free survival, compared with fludarabine/cyclophosphamide (FC) alone, and a near doubling of complete response rates in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The study results were presented by lead investigator Tadeusz Robak, md, of the Medical University of Lodz in Poland, at the 50th Annual Meeting of the American Society of Hematology (ASH), held Dec 6–9 in San Francisco (abstract LBA-1).

Results of the first clinical study examining the use of fostamatinib disodium, an investigational treatment that targets a protein called SYK (spleen tyrosine kinase), showed that the new agent represents a safe and novel therapeutic approach that should be further developed for the treatment of B-cell non-Hodgkin lymphoma.

The results of an international randomized trial found that the use of dexamethasone in the induction phase of combination chemotherapy led to a one-third reduction in the risk of relapse as compared with the standard corticosteroid, prednisone, translating into a significant benefit in terms of event-free survival in children with acute lymphoblastic leukemia.

PROPEL, a multicenter phase II open-label study-the largest prospective clinical trial in patients with relapsed or refractory peripheral T-cell lymphoma-found that the investigational chemotherapy agent pralatrexate produces complete responses (disappearance of all signs of cancer) in patients who had previously failed an average of three treatment regimens, including an autologous stem cell transplant for some patients. Designed to be selectively transported into tumor cells, the novel antifolate pralatrexate accumulates to high concentrations in the tumor cell, inhibiting DNA synthesis, said Owen A. O’Connor, md, phd, Columbia University Medical Center, New York, at the ASH meeting (abstract 261).

Results from a multinational phase III clinical trial suggest that fludarabine, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy may become the new standard first-line therapy for the treatment of advanced chronic lymphocytic leukemia.

Results from three studies presented at the ASH meeting showed that treatment with alemtuzumab (Campath) had activity in high-risk chronic lymphocytic leukemia (CLL) patients who have poor prognostic indicators.

Burkitt lymphoma (BL) is a unique B-cell lymphoma characterized by a high proliferation rate and cytogenetic changes related to c-myc proto-oncogene overexpression. Burkitt lymphoma is a highly aggressive B-cell lymphoma that is most frequently seen in children and young adults in endemic areas.

Hodgkin lymphoma (HL) is one of the most curable malignancies in adults. However, survival rates for elderly patients with HL (often defined as ≥ 60 years of age) are inferior to those achieved by younger populations.

In this issue of ONCOLOGY, Evens et al present a thoughtful and compelling argument that Hodgkin lymphoma in elderly patients deserves to be a focus for clinical research.

As the authors have correctly pointed out, Hodgkin lymphoma (HL) in elderly patients is an orphan disease that has been the subject of very few specific studies, particularly regarding treatment.

Eisai Corporation of North America announced that the US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for denileukin diftitox (Ontak) solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+).

Socioeconomic factors and the type of treatment received have an impact on a non-Hodgkin lymphoma (NHL) patient’s risk of dying.

This supplement to ONCOLOGY provides a comprehensive look at state-of-the-art management of three of the most prevalent hematological malignancies in the US today.

The investigational tyrosine kinase inhibitor bosutinib has an acceptable safety profile and appears to be efficacious among patients with chronic-phase chronic myelogenous leukemia who have intolerance or resistance to other TKIs, according to new data presented at ASCO 2008 (abstract 7001).

WOODCLIFF LAKE, New Jersey-Eisai Corporation of North America has announced that FDA has accepted for priority review a supplemental biologics license application for the company’s fusion toxin protein Ontak (denileukin diftitox).

Eisai Corporation of North America announced today that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for denileukin diftitox (Ontak). The sBLA seeks to convert an accelerated approval indication into full approval. It is based on a placebo-controlled phase III clinical trial to confirm the clinical effectiveness of the drug in certain patients with cutaneous T-cell lymphoma (CTCL).

The NCCN has added nilotinib to its practice guideline for CML for use after any imatinib failure point in the chronic phase of disease.

Cephalon recently announced that the US Food and Drug Administration (FDA) has approved bendamustine hydrochloride (Treanda) for the treatment of patients with chronic lymphocytic leukemia (CLL).

The introduction of imatinib mesylate (Gleevec) has dramatically changed the management and prognostic outlook of patients with chronic myeloid leukemia (CML).

Chronic myelogeneous leukemia (CML) is a biologically unique neoplasm resulting from a mutation producing a single abnormal protein that induces unregulated proliferation of myelopoiesis. Imatinib mesylate (Gleevec) profoundly inhibits the chimeric bcr/abl tyrosine kinase, and has dramatically improved the outlook for patients with CML in chronic phase.

The introduction of the tyrosine kinase inhibitor imatinib mesylate (Gleevec) has profoundly changed the treatment paradigm for patients with chronic myelogenous leukemia (CML).

The management of patients with chronic myelogenous leukemia (CML) has been altered dramatically since the introduction of tyrosine kinase inhibitors by Druker et al in the late 1990s.

Long-term results of a German randomized trial suggest that a novel escalated-dose regimen may replace the current chemotherapy standard of care for treatment of advanced-stage Hodgkin lymphoma. Volker Diehl, MD, of the University of Cologne, Germany, presented 10-year follow-up data on behalf of the German Hodgkin Study Group at ASH 2007 (abstract 211).