Efficacy of Hyper-CVAD drug regimen in Adult T-Cell leukemia Patients: A
Randomized Clinical Trial.
Abstract
Background: Adult T-cell leukemia (ATL) is one of the most
important hematological malignancies caused by the HTLV-I virus. The
disease has a poor prognosis due to the low median survival of the
patients. Aim: Given the need for effective therapeutic
interventions, this study aimed to investigate the efficacy of
Hyper-CVAD and As/IFN/AZT regimens and compare their performance.
Methods and Results: This study is a randomized clinical trial
conducted on individuals recently diagnosed with acute ATL. Individuals
who tested positive in a HTLV-I serological test based on ELISA and/or
PCR were randomly assigned to receive treatment with either Hyper-CVAD
or As/IFN/AZT using block randomization. The drug regimens were
administered for 60 days, and patients underwent follow-up assessments.
Overall, 29 individuals were enrolled in the trial. No significant
differences were found in gender distribution, LDH levels, and
lymphocyte counts between the two groups (P-value>0.05).
The treatment response rates for the Hyper-CVAD and As/IFN/AZT regimens
were 46.67% and 35.71%, respectively, with no significant differences
between the two groups (P-value >0.05). Survival analysis
revealed a significant difference in survival between the two groups,
favoring those under the Hyper-CVAD regimen (P-value<0.05).
The predominant toxicities were hematological toxicities; one patient in
the Hyper-CVAD group experienced Grade 3 toxicity, while three patients
in the As/IFN/AZT group experienced Grade 3 toxicity.
Conclusion: The results of this study suggest no significant
differences in efficacy between the Hyper-CVAD and As/IFN/AZT regimens.
Additionally, higher toxicity rates were observed in the As/IFN/AZT
regimen. Further investigations into frontline treatments and the timing
of the As/IFN/AZT regimen in future studies may provide valuable
insights in this regard. Clinical Trial Registration:
IRCT20210703051770N1.