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“ Improving the outcome for pediatric and adolescent patients with lymphoma remains a challenge .”
— EVA LANDMANN , MD may cause dizziness or confusional state without adequate medical advice [ see Warnings and Precautions ( 5.7 )].
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POM _ HCP _ BSv . 005 06 _ 2016 with T-cell lymphoma seen in previous studies were reproducible and identifying predictors of response to either prednisone , dexamethasone , or treatment reintensification .
Though the NHL-BFM90 is “ the backbone of [ acute lymphocytic leukemia ] treatment in many countries ,” the authors wrote , based on the results from this trial , “ improving the outcome for pediatric and adolescent patients with lymphoma remains a challenge .”
EURO-LB02 included patients younger than age 22 who were newly diagnosed with lymphoma ; patients were excluded if they had a previous malignancy , preexisting disease prohibiting chemotherapy outlined in the NHL-BFM90 protocol , or previously received systemic corticosteroid treatment within two months before the start of therapy .
A total of 319 patients were enrolled in the trial ( median age = 8.76 years ; range = 0.3-18.8 years ): 233 with T-cell lymphoma , 66 with precursor B-cell lymphoma , 12 with mixed phenotype , and eight with unclassifiable disease .
Patients were treated according to the NHL-BFM90 protocol :
• cytoreductive phase : prednisone , methotrexate
• induction phase Ia : vincristine , daunorubicin , asparaginase , methotrexate , either prednisone or dexamethasone
• induction phase Ib : cyclophosphamide , cytarabine , 6-mercaptopurine , methotrexate
• consolidation phase M : 6-mercaptopurine , methotrexate
Patients with stage III / IV disease underwent re-intensification with dexamethasone , vincristine , doxorubicin , asparaginase ( phase IIa ) and cyclophosphamide , cytarabine , methotrexate , 6-thioguanine ( phase IIb ).
Thirty-five of 40 patients with stage I / II disease completed all of the treatment protocol ; 270 patients with stage III , IV , or unknown-stage disease received additional re-intensification therapy . During the induction phase , 215 patients received prednisone ( standard group ) and 104 patients received dexamethasone ( experimental group ).
With a median follow-up period of 6.8 years ( range = 3.0-10.3 years ), the five-year EFS was 82 percent ; all patients with mixed phenotype lymphoma were alive at five years , and rates for precursor B-cell and T-cell lymphoma were 80 percent and 82 percent , respectively .
“ The outstanding result of a fiveyear EFS of 90 percent for patients with T-cell lymphoma reported in [ an earlier trial evaluating NHL-BFM90 ] could not be replicated in [ the present study ],” the authors noted , primarily due to higher rates of toxic deaths and central nervous system ( CNS ) relapses .
Twelve patients ( 3.8 %) died because of toxicity during study follow-up . By day 33 of induction therapy , 39 patients relapsed and five developed secondary malignancies .
In the subgroup of patients with T-cell lymphoma , the median time from
December 2017