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| |  Early Positive Gleevec (Imatinib Mesylate) Data in Newly Diagnosed Chronic Myeloid Leukemia Study Prompt Protocol Changes EAST HANOVER, NJ -- January 7, 2002 -- In an interim analysis of the ongoing Phase III study comparing Gleevec™ (imatinib mesylate) to standard therapy (interferon injections plus Ara-C [cytarabine] chemotherapy) for initial treatment in newly diagnosed chronic myeloid leukemia (CML) patients, the Gleevec arm was found -- early on -- to demonstrate a substantially higher response. Based on this finding, the Independent Data Monitoring Board (IDMB) has recommended a change in the protocol to enable the patients on standard therapy who have not achieved a major cytogenetic response to switch to Gleevec at this time. The changes to the study protocol as recommended by the IDMB (comprised of independent hematologists and a clinical statistician) are being communicated to investigators and patients beginning January 3. These changes allow patients on the control arm who have not achieved a major cytogenetic response after one year of treatment with interferon-alpha and cytarabine to switch to Gleevec. A cytogenetic response is the disappearance or reduction in the number of cancerous cells. Patient consent forms will be changed to inform patients of the new data, and to urge them to speak with their physicians. Called the IRIS study (International Randomized study of Interferon versus STI571 [Gleevec]), this large, international multicenter Phase III trial is evaluating Gleevec versus the combination of standard interferon and cytarabine as first line therapy in patients with CML. Between June 2000 and January 2001, the ongoing study enrolled 1106 patients in 177 centers across 16 countries. The study was designed to help determine the long-term outcome (including survival) of patients with newly diagnosed CML treated with Gleevec in comparison to the combination of interferon-alpha and cytarabine. The Independent Data Monitoring Board further recommended that a formal, peer-reviewed presentation of the 12-month data results be made to the scientific community at the earliest possible opportunity. Preliminary results from a different and smaller, single-institution study in newly diagnosed CML patients were presented in December 2001 at the annual meeting of the American Society for Hematology by Hagop Kantarjian, MD, Professor of Medicine, Chairman of the Department of Leukemia and Chief of the Section of Leukemia Developmental Therapeutics at the M.D. Anderson Cancer Center in Houston, Texas. The data from this trial on the use of Gleevec in 47 newly diagnosed patients with early chronic phase CML showed that after three months of treatment, 77 percent (36 patients) had achieved complete or major cytogenetic responses ([Ph<35 percent] Philadelphia chromosome, hallmark of the disease). The hematologic response rate was 98 percent (46 patients). In comparison, in previously reported studies of other agents (interferon-alpha alone and interferon-alpha with cytarabine and homoharringtonine [Triple Rx]) 2-24 percent of patients on other treatments achieved complete or major cytogenetic responses after three months of treatment. The majority of patients treated with Gleevec experienced adverse events at some time. Most events were of mild to moderate grade, but drug was discontinued for adverse events in 1 percent of patients in chronic phase, 2 percent in accelerated phase and 5 percent in blast crisis. Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. The most common side effects included nausea, fluid retention, vomiting, diarrhea, hemorrhage, muscle cramps, skin rash, fatigue, headache, dyspepsia and dyspnea, as well as neutropenia and thrombocytopenia. Serious and severe side effects, such as hepatoxicity (1.1 percent to 3.5 percent), fluid retention syndrome (2 percent to 10 percent), neutropenia (8 percent to 46 percent) and thrombocytopenia (less than 1 percent to 31 percent) have also been reported in some patients. There are no long-term safety data on Gleevec treatment. In most countries where Gleevec is approved, it is indicated for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The effectiveness of Gleevec is based on overall hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Gleevec is known as Glivec® (imatinib) outside the United States. SOURCE: Novartis
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