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Complete response with oblimersen combination improves survival of CLL patients
December 10, 2007Relapsed chronic lymphocytic leukemia (CLL) patients who had a complete response to combination therapy that included the drug oblimersen survived significantly longer than patients treated with chemotherapy alone, a team led by researchers at The University of Texas M. D. Anderson Cancer Center reports at the 49th Annual Meeting of the American Society of Hematology.
Patients who achieved a complete response with oblimersen have survived so well that a median survival time cannot yet be calculated, but it is estimated to exceed 49 months. Those who achieved complete response with chemotherapy alone had a median survival time of 35 months.
"In a relapsed population, that's excellent survival," says lead author Susan O'Brien, M.D., professor in M. D. Anderson's Department of Leukemia. "Survival is associated with achieving complete response."
The Phase III clinical trial compared a regimen of fludarabine and cyclophosphamide (F/C) with F/C plus oblimersen. Known commercially as Genasense(r), oblimersen blocks the Bcl-2 protein, which plays a critical role in progression of chronic lymphocytic leukemia (CLL), including development of resistance to treatment.
By stifling Bcl-2, researchers believe CLL becomes more vulnerable to chemotherapy such as the F/C combination.
In a paper published in the Journal of Clinical Oncology in March, O'Brien and colleagues showed that patients who received the oblimersen combination were more likely to have a complete response (20 out of 120 patients, or 17 percent, compared to 8 out of 121 patients, 7 percent, who received only the F/C chemotherapy).
Complete response was more durable in the oblimersen-treated patients, with a median duration of at least 36 months compared with 22 months for those on F/C alone.
The question unanswered by the JCO paper was whether this advantage in complete response translated into an advantage in survival, O'Brien says.
Patients were followed for at least three years after randomization or until death or withdrawal from the study. Of the 20 oblimersen-treated patients with a complete response at the end of the first year, 12 survived at least four years. Of the eight complete responders in the other group, four survived at least four years.
The survival data confirm that complete response is a valid endpoint for clinical trials in relapsed or resistant CLL, O'Brien says.
University of Texas M. D. Anderson Cancer Center
The Phase III clinical trial compared a regimen of fludarabine and cyclophosphamide (F/C) with F/C plus oblimersen. Known commercially as Genasense(r), oblimersen blocks the Bcl-2 protein, which plays a critical role in progression of chronic lymphocytic leukemia (CLL), including development of resistance to treatment.
By stifling Bcl-2, researchers believe CLL becomes more vulnerable to chemotherapy such as the F/C combination.
In a paper published in the Journal of Clinical Oncology in March, O'Brien and colleagues showed that patients who received the oblimersen combination were more likely to have a complete response (20 out of 120 patients, or 17 percent, compared to 8 out of 121 patients, 7 percent, who received only the F/C chemotherapy).
Complete response was more durable in the oblimersen-treated patients, with a median duration of at least 36 months compared with 22 months for those on F/C alone.
The question unanswered by the JCO paper was whether this advantage in complete response translated into an advantage in survival, O'Brien says.
Patients were followed for at least three years after randomization or until death or withdrawal from the study. Of the 20 oblimersen-treated patients with a complete response at the end of the first year, 12 survived at least four years. Of the eight complete responders in the other group, four survived at least four years.
The survival data confirm that complete response is a valid endpoint for clinical trials in relapsed or resistant CLL, O'Brien says.
University of Texas M. D. Anderson Cancer Center
Chronic Lymphocytic Leukemia Current Events and Chronic Lymphocytic Leukemia News RSSUAB Researchers Discover Antibody Receptor Identity, Propose Renaming Immune-System Gene
Researchers at the University of Alabama at Birmingham (UAB) have uncovered the genetic identity of a cellular receptor for the immune system's first-response antibody, a discovery that sheds new light on infection control and immune disorders.
Researchers examine mechanisms that help cancer cells proliferate
A process that limits the number of times a cell divides works much differently than had been thought, opening the door to potential new anticancer therapies, researchers at UT Southwestern Medical Center report in the Aug. 7 issue of the journal Cell.
Gene shut-down may offer early warning of chronic leukemia
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Silenced genes as a warning sign of blood cancer
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Limited data suggest possible association between Agent Orange exposure
A new report from the Institute of Medicine finds suggestive but limited evidence that exposure to Agent Orange and other herbicides used during the Vietnam War is associated with an increased chance of developing ischemic heart disease and Parkinson's disease for Vietnam veterans.
Green tea extract shows promise in leukemia trials
Mayo Clinic researchers are reporting positive results in early leukemia clinical trials using the chemical epigallocatechin gallate (EGCG), an active ingredient in green tea.
Study validates means to measure possible leukemia marker
A study led by cancer researchers at The Ohio State University has validated a method for reliably measuring variations in certain proteins that may make good biomarkers in chronic leukemia patients.
New biomarker may predict leukemia aggressiveness
Scientists at the University of California, San Diego and the Moores UCSD Cancer Center have evidence of a potential new biomarker to predict the aggressiveness of an often difficult-to-treat form of leukemia.
New study shows that a cough medicine ingredient could effectively treat prostate cancer
A study published today in the December issue of the European medical journal Anticancer Research demonstrates that an ingredient used in a common cough suppressant may be useful in treating advanced prostate cancer.
Interactive gene 'networks' may predict if leukemia is aggressive or slow-growing
Rather than testing for individual marker genes or proteins, researchers at the University of California, San Diego (UC San Diego) and the Moores UCSD Cancer Center have evidence that groups, or networks, of interactive genes may be more reliable in determining the likelihood that a form of leukemia is fast-moving or slow-growing.
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