efficacy of hyper-cvad drug regimen in adult t-cell leukemia (atl) patients: a randomized clinical trial

Introduction:adult t-cell leukemia (atl), a hematologic malignancy caused by human t-lymphotropic virus type 1 (htlv-i) infection, is known for its aggressive course, limited treatment responsiveness, and short survival. this clinical trial compared the therapeutic effects of two treatment approaches-hyper-cvad and the combination of arsenic trioxide, interferon-alpha, and zidovudine (as/ifn/azt)-in newly diagnosed acute atl patients. materials and methods: in this randomized study, patients with confirmed htlv-i infection by elisa and/or pcr were assigned using block randomization to receive either hyper-cvad or as /ifn/azt over a 60-day treatment period. a total of 29 patients completed the protocol, and therapeutic responses were assessed following completion of therapy. results: baseline characteristics, including gender distribution, serum lactate dehydrogenase (ldh) levels, and lymphocyte counts, showed no significant differences between the groups (p > 0.05). response rates were 46.67% in the hyper-cvad group and 35.71% in the as/ifn/azt group, without statistical significance (p > 0.05). however, survival analysis indicated better outcomes with hyper-cvad (p < 0.05). hematologic toxicity was the most common adverse event, with grade 3 events observed in one patient receiving hyper-cvad and three patients receiving as/ifn/azt. conclusion:while both regimens demonstrated comparable efficacy in overall response, the as/ifn/azt protocol was associated with higher toxicity. larger-scale investigations are needed to determine its optimal role and timing as a first-line option for atl.