Treating Acute Leukemia without Chemotherapy
Posted on: January 10, 2013
Hematology Update From ASH
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Hematology Update From ASH
By Gigi Chen, MD
The American Society of Hematology meeting was held in December in Atlanta. Here are some exciting new reports from the meeting….
Treating acute leukemia without chemo- therapy, is that possible? The Italian investigator reported a very exciting phase III trial comparing ATRA and Arsenic Trioxide versus ATRA and ida- rubicin in newly diagnosed non-high risk, acute promyelocytic leukemia (APL) and demonstrated 2 year event free survival was 97% for ATRA and Arsenic arm and 86.7% for ATRA and chemotherapy arm. Overall survival rate were 98.7% vs. 91.1% respectively. The ATRA and Arsenic arm had signifi- cantly less toxicities as expected. Al- though APL only constitutes a small fraction of acute leukemia, these results certainly represent exciting break- through in the treatment of acute leuke- mia.
The CYTO-PV trial compared cardio- vascular events in patients with poly- cythemia vera when Hct is kept less than 45 vs. between 45 to 50. Previous two large randomized clinical trials failed to show a different incidence of major thrombosis when HCT levels were kept in the range between 40 to 50. In the current trial, the incidence of major car- diovascular events was 4 fold higher in patients who maintained HCT levels greater than 45. Therefore, the goal of HCT for patients with PV should be kept below 45.
There were many abstract discussing new oral anticoagulants. Recent reports of EINSTEIN DVT and EINSTEIN PE studies showed that rivaroxaban was non -inferior to standard therapy of subcuta- neous enoxaparin followed by vitamin K antagonist for the treatment of sympto- matic DVT and PE, with similar occur- rence of clinically relevant bleeding. Apixaban, an another oral factor Xa inhibitor, was studied in a large interna- tional randomized, double-blind study) compared two apixaban doses (2.5 or 5 mg twice daily) with placebo for 12 months in patients with venous throm- boembolism who had completed 6–12 months of anticoagulation. The primary efficacy outcome was symptomatic re- current venous thromboembolism or all- cause mortality. Rates of the primary efficacy outcome were 11.6% in the placebo group, compared with 3.8% and 4.2% in the apixaban 2.5 mg and 5 mg groups (p<0.001) . Bleeding risk was 2.7% in placebo vs. 3.2% and 4.3% in apixaban 2,5 and 5mg arm, but not statistically significant.
Another abstract addressed the question of whether it is beneficial to give pro- phylactic platelets. In 2008 in US, 2 million platelet transfusions were given. Two thirds were given prophylactically. Only one thirds were given to treat ac- tual bleeding. Average cost is about $1000 per platelet transfusion. Re- searchers from UK and Australia pre- sented “The effect of a non-prophylactic vs. prophylactic platelet transfusion strategy on bleeding in patients with hematologic malignancy and severe thrombocytopenia (TOPPS trial). It is a randomized controlled, noninferiority trial that enrolled 600 patients undergo- ing treatments for hematological malig- nancies, chemotherapy or stem cell transplants at 14 UK and Australian hospitals. Prophylactic transfusion was defined as transfusion for platelet <10K. Not surprisingly, no prophylactic group had fewer platelet transfusions than the prophylactic group. Grade 3 and 4 bleeding occurred in 1 of 298 patients in prophylactic arm and 6 of 300 in non-prophylactic arm, thus did not meet the primary endpoint. However, these data do suggest that we transfuse many patients unnecessarily. Further trial needs to address risk stratification to identify the patients who will benefit prophylactic transfusion when platelet is less than 10K.
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