In order to assess the efficacy of ALL treatment without daunorubicin during induction therapy, a team of researchers from 20 centers across France and one center in Belgium initiated a multicenter Phase III clinical trial in which 1,128 pediatric patients with standard-risk B-cell ALL were randomized into two treatment arms. Arm A included 560 patients who received a standard dose of daunorubicin during induction therapy, while Arm B included 568 patients who did not receive initial therapy with daunorubicin. Both groups received doxorubicin during delayed intensification (last treatment phase before reaching maintenance) and a standard protocol of 24-month maintenance therapy from December 2000 to June 2010, during which five-year event-free survival (EFS) and overall survival (OS) were assessed.
For those patients treated with daunorubicin, the five-year EFS rate was 92.9 percent, compared to 93.3 percent in the non-daunorubicin arm. Overall survival rates were 97.2 percent and 98.2 percent in the daunorubicin and non-daunorubicin arms, respectively. Measurements of minimal residual disease, in which a small number of leukemic cells remain during treatment, were also equivalent in the two study arms. These results demonstrate similar efficacy rates of treatment strategies for standard-risk ALL that do or do not include induction treatment with daunorubicin.
"Our study data have the potential to benefit children with ALL in two important ways," said Andre Baruchel, MD, lead author and Head of the Department of Pediatric Hematology at the Robert Debre University Hospital (Assistance Publique Hopitaux de Paris) in Paris. "First, we now have strong evidence that reducing the amount of chemotherapy initially administered to these children, who constitute the majority of ALL patients, does not negatively affect their immediate outcome. Perhaps more importantly, we know and anticipate that removing harmful chemotherapy from their treatment can help minimize their risk of experiencing heart damage later in life."
Dr. Baruchel will present this study in an oral presentation on Sunday, December 9, at 5:00 p.m. EST at the Georgia World Congress Center in Room A103, Level 1, Building A.
ATRA and Arsenic Trioxide (ATO) Versus ATRA and Idarubicin (AIDA) for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia (APL): Results of the Phase III, Prospective, Randomized, Intergroup APL0406 Study by the Italian-German Cooperative Groups Gimema-SAL-AMLSG [Abstract 6]
New research demonstrates the efficacy of the first curative treatment for acute promyelocytic leukemia (APL) that does not include chemotherapy, marking an important step toward front-line use of targeted therapies for acute leukemia.
APL is an uncommon, yet aggressive, subtype of acute myeloid leukemia (AML) in which there are too many immature white blood cells in the bone marrow, leading to a shortage of normal white and red blood cells and platelets in the blood, which is associated with clotting defects that can cause serious bleeding. Without prompt diagnosis and treatment, APL can be fatal in a matter of hours or days.
Early treatment regimens for APL relied heavily on anthracycline-based chemotherapy with daunorubicin or idarubicin. In the early 1990s, research supported the addition of a non-chemotherapeutic agent, all-trans-retinoic acid (ATRA, a vitamin A derivative developed from ancient Chinese herbal medicine), to standard regimens. ATRA causes cancer cells to develop fully into mature blood cells, which progress through full differentiation and eventually die (unlike leukemia cells that are unable to fully mature). The combination regimen of chemotherapy and ATRA dramatically improved the survival outlook for those with APL and made the disease curable in up to 80 percent of patients. More recently, another natural compound, arsenic trioxide (ATO), was integrated into APL treatment, showing higher efficacy and better tolerability when compared with conventional chemotherapy. Today, as investigators continue to report the success of targeted cancer therapies (best exemplified by imatinib for chronic myeloid leukemia), researchers have questioned whether traditional toxic chemotherapy is still necessary to achieve high cure rates for patients with APL.
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