Pharmacy & Therapeutics - February 2008 - (Page 111)

Meeting Highlights American Society of Hematology 49th Annual Meeting Walter Alexander More than 20,000 hematologists and oncologists from 102 countries, along with 289 exhibitors, gathered in Atlanta this past December to present and hear the latest research findings in basic science, clinical practice, and epidemiology. In all, 3,745 abstracts were accepted from 46 countries. This article covers sessions on approved agents tested in new combinations, in new patient subsets, or in specific disease stages. Lenalidomide (Revlimid) for Multiple Myeloma Presenter: Donna Weber, MD, MD Anderson Cancer Center, Houston, Tex. In a clinical trial of patients with multiple myeloma, combining lenalidomide (Revlimid, Celgene) with dexamethasone yielded better responses than using dexamethasone alone. Dr. Weber evaluated the time to progression (TTP) and long-term overall survival rates from pooled phase 3 results in trials MM-009 and MM-010. Included were 704 patients (mean age, 63 years). Patients had been treated with three or fewer therapies and were not dexamethasone-resistant. They were randomly assigned to receive oral lenalidomide 25 mg/day on days 1 to 21 plus oral dexamethasone 40 mg/day (Len/Dex) on days 1 to 4, days 9 to 12, and days 17 to 20, or to the same dose of dexamethasone (Dex) plus placebo on days 1 to 21. After four courses of therapy, the Dex dose was reduced and was to be taken only on the first to fourth days. Therapy was continued until disease progression. The primary outcome measure was time to disease progression (TTP). The response rate of the Len/Dex subjects was excellent, Dr. Weber said, at 61%; the rate of complete responses (CRs) was 15%, and the rate of CRs plus nearly complete responses (nCRs) was 24%, higher than that of Dex alone (23%). Thus, the rate of CRs was 2%, and the rate of CRs plus nCRs was 3.4% (P < 0.001). The median duration of response overall was 16 months. The TTP was significantly longer for the Len/Dex patients (median, 11.2 months) than for the Dex patients (median, 4.7 months) (P < 0.001). Median overall survival was 29.6 months for Len/Dex and 20.5 months for Dex (P < 0.001). Dr. Weber said that after the interim analysis, unblinding was recommended. At that time, the Dex patients were allowed to cross over to Len/Dex. After 47% of the patients switched to Len/Dex, overall survival times remained significantly longer with Len/Dex (at 35 months) than with Dex (31 months) (P = 0.015). At the time of the ASH meeting, Dr. Weber reported that 58% of patients in the Len/Dex group were still living. Among hematological adverse events, grade 3–4 neutropenia was the most common event with Len/Dex (in 13%), and grade 1–4 neutropenia was the most common event with Dex (in 11%). Among nonhematological adverse events, fatigue The author is a freelance medical writer living in New York City. was the most common event with both regimens (in 45%). Dr. Weber summarized her findings: “Len/Dex improved response and TTP, compared with Dex. Also, these improvements were sustained despite crossovers, regardless of age, prior therapies, prior autologous stem cell transplantation, prior thalidomide therapy, and renal function status.” Eculizumab (Soliris) for Paroxysmal Nocturnal Hemolysis Presenter: Monica Bessler, MD, PhD, Washington University, St. Louis, Mo. Comment: Charles J. Parker, MD, University of Utah School of Medicine, Salt Lake City, Utah In a clinical trial among 187 patients with paroxysmal nocturnal hemolysis (PNH), treatment with eculizumab (Soliris, Alexion), a terminal complement inhibitor, significantly reduced hemolysis and thrombosis and improved anemia and fatigue in several participating subgroups. Dr. Bessler noted that the disease burden had not previously been determined in these patients, who had lower lactate dehydrogenase (LDH) levels, higher hemoglobin values, and minimal transfusion support. Patients who had been enrolled in eculizumab trials (phase 2 pilot, phase 3 TRIUMPH, and SHEPHERD studies) and who continued to receive eculizumab in a long-term extension trial for a median of 22 months’ duration were stratified as follows: • baseline LDH: – below 1,490 U/L (n = 46) – 1,491–2,165 U/L (n = 47) – 2,166–2,785 U/L (n = 47) – above 2,785 U/L (n = 47) • baseline hemoglobin: – below 10.5 g/dL (n = 133) – 10.5 g/dL or higher (n = 54) • transfusions – no episodes or one episode in the previous year (n = 21) – more than one episode in the previous year (n = 166) Dr. Bessler noted, “All patients have a significant amount of hemolysis, as shown by LDH—even patients with mild anemia Vol. 33 No. 2 • February 2008 • P&T® 111

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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