Cytarabine administered as bolus resulted in non-significant response rates but no differences in survival compared to when it was administered by continuous infusion in patients with acute myeloid leukemia (AML), according to a German study published online ahead of print in Annals of Oncology.
Andreas Thiel, MD, of the Klinikum Chemnitz and fellow researchers examined 252 adult patients with relapsed or refractory AML were randomly allocated to either Mito-FLAG with cytarabine as bolus or continuous infusion in combination with mitoxantrone, fludarabine, and G-CSF.
“Cytarabine is a key drug in the treatment of AML patients,” the authors noted. “There is still uncertainly (sic) regarding its optimal dose and infusion schedule.”
Primary endpoint was complete remission rate after the first cycle of Mito-FLAG, and autologous or allogeneic hematopoietic stem-cell transplantation was offered as consolidation therapy.
They found that complete remission rates were 54 percent with bolus and 43 percent with continuous infusion.
No differences in rates of grade 3/4 neutropenia, thrombocytopenia, mucositis, renal and liver toxicity were found.
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However, there were more infections with bolus (80 percent) compared to continuous infusion (69 percent).
In both groups, early death rate by day 42 was 13 percent, and median disease-free survival as well as overall survival were comparable.
- Thiel, A., et al. “Mito-FLAG with Ara-C as Bolus versus Continuous Infusion in Recurrent or Refractory AML – Long-term Results of a Prospective Randomized Intergroup Study of the East German Study Group Hematology/Oncology (OSHO) and the Study Alliance Leukemia (SAL).” Annals of Oncology. doi: 10.1093/annonc/mdv205. [epub ahead of print]. April 28, 2015.