(HealthDay News) — Iron chelation therapy (ICT) seems beneficial for iron-overloaded patients with low- or intermediate-1-risk myelodysplastic syndromes (MDS), according to a study published online March 24 in the Annals of Internal Medicine.
Emanuele Angelucci, M.D., from the IRCCS Ospedale Policlinico San Martino in Genova, Italy, and colleagues randomly assigned 225 patients with serum ferritin levels >2,247 pmol/L to either deferasirox dispersible tablets or matching placebo (149 and 76 individuals, respectively) to assess event-free survival (EFS) and safety of ICT.
The researchers found that the median time on treatment was 1.6 years and 1.0 year in the deferasirox and placebo groups, respectively. With deferasirox versus placebo, median EFS was prolonged by about one year (3.9 versus 3.0 years; hazard ratio, 0.64). Adverse events occurred in 97.3 and 90.8 percent of deferasirox and placebo recipients, respectively. In deferasirox versus placebo recipients, exposure-adjusted incidence rates of adverse events (≥15 events per 100 patient treatment-years) were 24.7 versus 23.9 for diarrhea, 21.8 versus 18.7 for pyrexia, 16.7 versus 22.7 for upper respiratory tract infection, and 15.9 versus 0.9 for increased serum creatinine concentration.
“The results of TELESTO represent an important contribution to the field because it is unlikely that, in the current treatment landscape, a similar placebo-controlled study could be conducted,” the authors write. “Since the TELESTO trial was initiated, more evidence has become available on the deleterious effects of iron overload in patients with MDS, and therefore similar placebo-controlled trials would be unethical.”
Several authors disclosed financial ties to pharmaceutical companies, including Novartis, which manufactures deferasirox and funded the study.